CHAPTER 219
[SUBSIDIARY LEGISLATION]
INDEX TO SUBSIDIARY LEGISLATION
NOTICES
(Section 49)
[1st October, 1999]
G.N. No. 440 of 1999
WHEREAS Section 49 of the Pharmaceutical and Poisons Act * prohibits the advertisement of certain diseases.
AND WHEREAS the Act requires the Minister upon recommendation of the Board by Notice published in the Gazette to prohibit the advertisement certain diseases.
AND WHEREAS the Board has recommended to the Minister to publish in the Government Gazette the Code of Conduct For Drug Promoters public awareness.
Now THEREFORE, the members of public are hereby notified as follows:
1. This Notice may be cited as the Pharmaceuticals and Poisons (Code of Conduct for Drug Promoters) Notice.
2. [Omitted.]
3. The members of public are hereby notified that any person intending to conduct drug promotion activities in Tanzania shall be required to abide by the Code of Conduct for Drug Promoters set out in the Schedule to this Notice.
4. Any person who fails to comply with the terms and conditions set out in the Code of Conduct For Drug Promoters shall be guilty of an offence punishable under the Pharmaceutical and Poisons Act *.
SCHEDULE
FOREWORD
The code highlights the requirements to be borne in mind by all people intending to conduct drug promotion activities in Tanzania. Special emphasis of this code is to maintain and develop excellence in collection, processing and dissemination of drug safety information.
This code is targeted to manufacturers and distributors, advertising agencies, market research organisations and health personnel involved in the distribution of medicines. The general media including publishers and editors of medical journals and related publications are also an important group of professionals to whom this code is focused.
The code of conduct for Drug promoters has been prepared in reference to the requirements stipulated under section 49 of the Pharmaceutical and Poisons Act * and the Tanzania National Drug Policy, 1991.
All health care professionals and the general public are advised to assist the Drug Regulatory Authority in ensuring that promotional activities are done in an ethnical manner in order to protect the public health.
Aaron D Chiduo
Minister for Health
1. INTRODUCTION
Drug promotion is defined as all informational and persuasive activities conducted by manufacturers and distributors, the effect of which being to induce the prescription, supply, purchase and/ or use of medicinal drugs.
Promotional activities can be in form of seminars, news broadcasts, rallies, advertisement in any media, use of medical representatives who may distribute printed audiovisual materials, displays, and exhibition materials at conferences, free samples and gifts.
Examples of forms of promotion activities targeted at health workers include industry sponsorship of professional activities such as scientific meetings, supplements of medical journals, research, television and radio programs.
Promotion targeted to the public includes advertisement in the public media, point of sale displays in pharmacies, sponsorship of radio, television programs and sports promotion. This also includes production of articles in newspapers, television and radio programs addressing individual or classes of drugs, using news releases or other materials to encourage news or stories about new drug discoveries.
Advertisements are part of a drug promotion targeted to the consumers and health care professionals at large. Medicines advertised as such eg. "Over The Counter drugs (OTC)" are intended for self-medication and therefore accurate information is necessary to help the consumer make rational choice on use of the drug. For health workers, advertisements are also educative as they give the prescriber or dispenser more information on that particular drug.
Irrational drug use could lead to treatment failures being a result of wrong drug therapies caused by economic hardship as drugs are expensive, wastage of scarce national health resources, economic hardship to the needy patients and emergence of drug resistant strains of microorganisms.
This code constitutes standard principles, which should be adhered to by all persons involved in the pharmaceutical industry in the United Republic of Tanzania. All these are required to use the code as appropriate to their spheres of competence, activity and responsibility.
The code applies to prescription medicines, non-prescription medicinal drugs ("over the counter drugs"), and to any other product promoted as a medicine.
Any promotional activities (advertisement) not conforming to this code should be reported to the Registrar, Pharmacy Board.
The complaints can be verbal or written giving the following details:
(i) Name of the product advertised;
(ii) The name of the advertising company;
(iii) The media used;
(iv) The day it appeared on the media; and
(v) Any other information on the advertisement or activity involved.
The Pharmacy Board would like to assure all reporters of any complaints that such information shall be kept confidential.
2. WHY HAVE LIMITATIONS TO DRUG PROMOTION
Control of drug promotion must be looked as a way–
2.1 To support and encourage the improvement of health care provided on through the rational use of medicinal drugs.
2.2 To ensure that only reliable drug information is available and disseminated in order to support and encourage rational use of drugs.
2.3 To encourage Good Manufacturing Practice (GMP). This is because GMP does not end only with the manufacturing process but includes all other processes like marketing and post-marketing surveillance.
2.4 To protect consumers whose lack of medicinal knowledge could lead to their exploitation by unscrupulous people.
3. PRINCIPLES OF DRUG PROMOTION
3.1 All drug promotion activities shall be done in accordance with the National Drug Policy, in compliance with Part IV of the Pharmaceutical and Poisons Act * and this Code.
3.2 All drug Promotion activities in the country shall take place only with respect to drugs that have been registered by the Pharmacy Board.
3.3 All promotion-making claims concerning medicinal drugs should be reliable, accurate, truthful, informative, balanced, up to date, and capable of substantiation and in good taste.
3.4 Promotion material should not contain misleading or unverifiable statements or omissions likely to induce medically unjustifiable drug use or to give rise to undue risks.
3.5 Promotional material making safety claims should only be used where properly qualified.
3.6 Comparison of products for competition purposes is prohibited.
3.7 Promotional material should not be designed so as to disguise a drug's real nature.
3.8 Scientific data in the public domain should be made available to health care workers, on request, as appropriate to their requirements.
3.9 Financial or material benefits should not be offered to or sought by health care workers to influence them in the prescription or dispensation of drugs.
4. PRINCIPLES OF DRUG ADVERTISEMENT
4.1 ADVERTISEMENTS IN ALL FORMS TO HEALTH WORKERS
4.1.1 Advertisement should contain full product information, as defined by the approved scientific data sheet or similar document approved by the Pharmacy Board during registration of the drug concerned.
4.2 ADVERTISEMENTS IN AIL FORMS TO THE GENERAL PUBLIC
4.2.1 Only Over the Counter (OTC) drugs shall be targeted to the general public.
4.2.2 Advertisements to the general public should help people to make rational decisions on the choice and use of drugs determined to be legally available without a prescription.
4.2.3 Advertisements should take account of people's legitimate desire for information regarding their health.
4.2.4 Contents of advertisements should not take undue advantage of people's concern for their health.
4.2.5 Drug advertisements should not be directed at children.
4.2.6 Advertisements should indicate appropriate limitations to the use of the drug.
4.2.7 When lay language is used, the information should be consistent with the approved scientific data sheet or other legally determined scientific basis for approval.
4.2.8 Language that brings about fear or distress should not be used.
4.2.9 The following are the minimum information requirements for a drug advertisement targeted to the general public:
(a) The name(s) of the active ingredient(s) using either international non-proprietary names (INN) or the approved generic name of the drug.
(b) The brand name.
(c) Approved major indication(s) for use.
(d) Major precautions, contra-indications and warnings.
(e) Name and address of manufacturer or distributor.
4.2.10 The advertisement should explicitly indicate the dosage regimen of the drug.
4.3 MEDICAL REPRESENTATIVES
4.3.1 Medical representatives should make available to prescribers and dispensers complete and unbiased information for each product. The information provided should be within the limitations of the law, regulations and policies of the country.
4.3.2 Pharmaceutical companies shall be responsible for the statements and activities of their medical representatives.
4.3.3 Medical representatives should not offer inducements to prescribers and dispensers to prescribe/dispense or sell their products.
4.4 FREE SAMPLES
4.4.1 Free samples of legally available prescription drugs may be provided in small quantities to prescribers and dispensers on request.
4.4.2 1 Free samples of non-prescription drugs to the general public for a promotional purpose is prohibited.
4.5 SYMPOSIA, PRODUCT LAUNCHING AND OTHER SCIENTIFIC MEETINGS
4.5.1 Scientific contents and objectives of any symposium related to drug should be sent to the Pharmacy Board at least 2 weeks prior to the event for approval.
4.5.2 Sponsorship by a pharmaceutical manufacturer or distributor should be clearly stated in advance, at the meeting and in any proceedings.
4.5.3 Presentations by independent scientists and health professionals are only allowed if the information being presented is not biased towards the companies' products.
4.5.4 Presentations should be factual and accurate without omissions.
4.5.5 Presentations which call for comparison of a new drug presumed to be better than existing ones, should be done in a scientific and factual way.
4.5.6 Any support to individual health practitioners to participate in any domestic or international symposia should not be conditional or an obligation to promote any medicinal product.
4.6 POST-MARKETING SCIENTIFIC STUDIES, SURVEILLANCE AND DISSEMINATION OF INFORMATION
4.6.1 All clinical trials must be approved by the Board.
4.6.2 The Pharmacy Board should be made aware of any clinical trials being conducted in this country or even when a small part of the trial is conducted locally.
4.6.3 The results of such trials should also be reported to the Board before their dissemination.
4.6.4 All such trials should have been approved by the appropriate ethical committee approved by the Ministry of Health.
4.6.5 Wing scientific studies and surveillance should not be used as a form of promotion.
4.6.6 All drug promoters should report any information on suspected adverse drug reactions to the Pharmacy Board immediately.
4.7 PACKAGING, LABELLING AND INFORMATION TO PATIENTS
4.7.1 All packaging and labelling materials should provide information consistent with that approved by the Pharmacy Board as specified in the Pharmaceutical and Poisons Act * and consistent with product Registration.
4.7.2 Adequate information on the use of medicinal drugs should be made available to patients.
4.7.3 When package inserts or leaflets are provided, manufacturers or distributors should ensure that they reflect only the information that has been agreed upon in this document.
4.7.4 For imported products, importers should make sure that the information provided is in English or Swahili in compliance with market authorisation of the product.
4.8 PROCEDURE FOR APPROVAL OF ADVERTISEMENTS BY THE PHARMACY BOARD
4.8.1 Two copies of the advertisement should be sent to the Registrar, Pharmacy Board P. 0. Box 77150 Dar es Salaam. Telephone No. +255 (51) 450512, +255 (51) 45075 1, Fax No. +255 (51) 450793 and E-mail: pharmacy board@twiga.com.
ORDERS
(Section 33)
[1st January, 1980]
G.Ns. Nos.
22 of 1980
61 of 1988
1. This Order may be cited as the Poisons List (Declaration) Order.
2. The list of substances set out in the Schedule to this Order is hereby declared to be the Poisons List the substances specified in which shall be treated as poisons for the purposes of the Pharmaceutical and Poisons Act *.
3. In construing the contents of the list, unless the contrary intention appears–
(a) a reference to a substance shall include a reference to that substance prepared either from natural sources or artificially;
(b) a reference to a substance shall include a reference to that substance when contained as such in any preparation, solution, admixture or natural substance.
4. [Revokes the Poisons List (Confirmation) Order *.]
SCHEDULE
THE POISONS LIST
PART I
Acebutalol.
Acetazolamide.
Acetohexamide.
Acetylcarbromal.
Acocanthera, glycosides of Acyclovir.
Adrenaline.
Alkali fluorides, except as provided in Part II of this list.
Alkaloids, the following: their salts, simple or complex; their quaternary compounds.
Atropine.
Belladonna, alkaloids of, except as provided in Part II of this list.
Calabar Bean, alkaloids of Colchicum, alkaloids of Curare, alkaloids of curare bases.
Ergot, alkaloids of and its esters and semisynthetic alkaloids.
Emetine.
Ephedra, alkaloids of Homatropine.
Hyoscine.
Hyoscyamine - except as provided in Part II of this list.
Jaborandi, alkaloids of Lobelia, alkaloids of Raowolfia, alkaloids of their derivatives.
Solanaceous alkaloids not otherwise included in this list except as provided in Part II of this list.
Strychnine - except as provided in Part II of this list.
Amino-alcohols esterified with benzoic acid, phenylpropionic acid, cinnamic acid or the derivatives of these acids; their salts.
P-Aminobenzenesulphonamide; its salts; derivatives of P-aminobenzenesulphonamide having any of the hydrogen atoms of the P-amine group of the sulphonamide group substituted by another radical; their salts.
P-Aminopropylbenzene and P-aminoisopropylbenzene and any compound structurally derived from either of those substances by substitution in the side chain or by ring closure therein (or by both such substitution and such closure) except ephedrine.
N-ethylephedrine N-diethy-laminoephedrine and phenylamine; and salt of any substance falling within this item.
P-Aminosalicylic acid; its salts
Any preparation of P-aminosalicylic acid; its salts.
Amitriptyline; its salts.
Amylnitrite.
Angiotensinamide.
Antibiotics: That is to say, any substances produced by a living organism and which have suppressive or destructive action on other organisms; their synthetic equivalents; their salts, preparations of such substances and their salts; their esters and salts or such esters.
Antihistamine Substances; all their salts and esters except as provided in Part II of this list.
Substances being tetra-substituted N-derivatives of ethylenediamine or propylenediamine.
Antimony, chlorides of; oxides and sulphides of; antimonates; organic compounds of antimony.
Arsenical substances, the following, except as provided in Part II of this list; halides of arsenic; oxides of arsenic, sulphides of arsenic; arsenates; organic compounds of arsenic.
Atenolol.
Azacyclonol; its salts.
Barium, salts of; other than barium sulphate and except as provided in Part II of this list.
Benactyzine; its salts.
Bendrofluazide.
Benzactamide.
Benzhexol; its salts.
Benztropine and its homologies; their salts.
Bethanidine; its salts.
Bismuth; salts of; compounds of in a form suitable for injection.
Bromhexine.
Bromvaletone.
Buphenine hydrochloride.
Bulsuphan; its salts.
Butylchloral hydrate.
Captotril.
Caramiphen; its salts.
Carbachol.
Carbamazepine.
Carbenoxolone.
Carbromal.
Carisprodol.
Chloral; its addition and its condensation products; their molecular compounds-except as provided in Part II of this list.
Chlorambucil.
Chlormethiazole; its salts.
Chloroform, except as provided in Part II of this list.
Chlorothiazide and other derivatives of benzol-1.2.4-thiadazine-7-sulphonamide-1-dioxide whether hydrogenated or not.
Chlorphenoxamine.
Chlorphentermine; its salts.
Chlorpropamide; its salts.
Chlorprothixine and other derivatives of 9-methylenethixanthen; their salts.
Chlorthalidone.
Choline theophylinate.
Cimetidine.
Clofazimine.
Clofibrate.
Clomiphene.
Clonidine hydrochloride.
Clonitazene; its salts.
Cloquinate (natural salts of chloroquinol and chiniaform).
Chlorexolone.
Corticosteroids, natural and synthetic.
Coumarin; its salts and derivatives.
Creosote obtained from wood.
Cyclarbamate.
Cyclopentamine hydrochloride.
Cyclophosphamide.
Cycloserine.
Cycrimine; its salts.
Dapsone.
Debrisoquine; its salts.
Dehydroemetine; its salts.
Desipramine; its salts.
Di-(4-amidinophenyl)-triazine (N-1:3).
Diaceturate; its salts; derivatives of and their salts.
4-4-Diamidino-diazoaminobenzene; their salts (diminazene aceturate).
Diclofenac acid; its salts.
Diels-alder compounds, except as provided in Part II of this list.
Diethylcarbamazine; its salts.
Diethylether.
Diethylpropion.
Diflunisal.
Digitalis, glycosides of; other active principles of digitalis.
Dihydroergocristine.
1:3-Dimethyl-4-phenyl-4-propenyl-oxyhexametheneamine; its salts.
Dinitrocresols (DNOC); their compounds with a metal or a base except as provided in Part II of this list.
Dinitronaphthyls.
Dinitrophenols.
Dinitrothymois dinosam; its compounds with a metal or base, except as provided in Part II of this list.
Diperodon; its salts.
Dipyridamole; its salts.
Dipyrone.
Disopyramide.
Disulfiram.
Diethylallylamines; their salts.
Dopamine.
Dothiepin; its salts.
Doxepine.
Dyflos.
Econazole.
Ecothlopate iodide.
Ectylurea.
Elantrine; its salts.
Emylcamate.
Endosulphan; except as provided in Part II of this list.
Endothal; its salts, except as provided in Part II of this list.
Enflurane.
Erythrityl tetranitrate.
Ethacrynic acid.
Ethambutol.
Ethchlorvynol.
Ethidium bromide.
Ethinamate.
Ethionamide.
Ethosuximide.
Fenfluramine; its salts.
Fenoterol hydrobromide.
Ferrous salts.
Flavoxate; its salts, its esters; their salts.
Fluothane.
Flupenthixol.
Fluphenazine.
Folic acid.
Flusemide.
Gallamine; its salts, its quarternary compounds.
Glibenclamine.
Glipizide.
Glyceryl trinitrate.
Griesofulvin.
Guanethidine; its salts.
Guanidines, the following polymethylene diguanidines; di-P-anisylphenetyl guanidine.
Haloperidol and other 4-substituted derivatives of N-(3-fluorobenzopropylpiperidine).
Haloprogin.
Hexapropymate.
Hormones, natural and synthetic; any preparation, admixture, extract or other substances containing any proportion of any substance having the action of any hormone.
Hydrazines, benzyl, phenethyl or phenoxyethl; their alphamethyl derivatives; acyl derivatives of any of the foregoing substances comprised in this item; salts of any compounds in this item.
1-(3-hydroxyphenyl)-hydroxy-2-ethylaminethane hydrochloride.
Hydroxyzine; its salts.
Ibuprofen.
Impramine; its salts.
Indometheqin; its salts.
Iprindole; its salts.
Isoaminile; its salts.
Isoetharine; its salts.
Isometheptene hydrochloride, mucate.
Isoniazid; its salts, derivatives of isoniazid, their salts.
Isoprenaline and salts.
Isopropamide.
Isosorbide nitrate.
Ketoconazole.
Ketoprofen.
Ketotifen.
Lanatoside C.
Levamisole.
Levodopa.
Lithium carbonate.
Mannityl hexanitrate.
Mannomustine; its salts.
Maprotiline.
Mebutamate.
Meclofenoxate; its salts.
Mefenamic acid; its salts; its esters; their salts.
Mephenesin; its salts.
Mephentermine; its salts.
Mercaptopurine; its salts; derivatives of mercaptopurine; their salts.
Mesterrolone.
Metaraminol; its salts.
Metaxalone.
Methixene; its salts.
Methocarbomol.
Methotrexate.
Methoxamine hydrochloride.
Methoxyphenamine hydrochloride.
Methylaminoheptane; its salts when present in nasal preparation.
Methyldopa.
Methylpentynol; its esters and other derivatives.
Methyprylone.
Metopon; its salts.
Metoprolol.
Metrifonate.
Metronidazole.
Miconazole.
Minoxidil.
Monofluoroacetic acid; its salts.
Mustine and any other N-substituted derivatives of di-(2-Chloroethyl) amine; their salts.
Nalidixic acid.
Narcotics, all narcotics controlled under the International Narcotics Conventions.
Niflumic acid.
Niridazole.
Nitrobenzene except as provided in Part II of this list.
n-Nitrophenol; o-Nitrophenol; p-Nitrophenol.
Nortriptyline; its salts.
Opipramol hydrochloride.
Orciprenaline sulphate.
Organotin compounds, the following fentin compounds.
Orthenadrine; its salts.
Oxalic acid; metallic oxalates - except as provided in Part II of this list.
Oxaminiquine.
Oxethazaine.
Oxprenolol.
Oxyphencyclimine hydrochloride.
Oxytocins, natural and synthetic.
Pamaquin.
Paraldehyde.
Paramethadione.
Pargyline; its salts.
Pemoline; its salts.
Penfluridol.
Pentacrylthritol tetranitrate.
Phenaglycodol.
Phenamidine; its salts - except as provided in Part II of this list.
Phenanthridium: its salts; its derivatives, their salts; its compounds with other substances.
Phenindione.
Phenols (any member of the series of phenols of which the first member is phenol and of which the molecular composition varies from member to member by one atom of carbon and two atoms of hydrogen) except in substances containing less than sixty per cent weight of phenols; compounds of phenol with a metal, except in substances containing less than the equivalent of sixty per cent, weight in weight, or phenols.
Phenothazine; derivatives of; their salts - except dimethoxanate; its salts; promethazine; its salts and its molecular compounds.
Phenoxybenzamine.
Phenylbutazone; its salts.
5-Phenylhydantoin; its alkyl and acyl derivatives; their salts.
Phenylpropanolamine hydrochloride.
Phosphorus, yellow - except as in Part II of this list.
Phosphorus compounds, the following except as provided in Part II of this list–
amiton, azinophos-ethyl, azinophos-methyl demeton-o, demeton-s, demeton-o-methyl, demeton-s-methyl, dichlorvos, diethyl 4-methyl-7-coumarinyl phosphorathionate, diethyl p-nitrophenyl phosphate, dimefox, ethyl-p-nitrophenyl, phenylphosphonathionate, mazidox, mecarbam, mevinphos, mipafox, oxydemeton-methyl
parathion, phentapton, phorate, phosphamidon, sulffotep, TEPP (HEPT) thionazin, triphosphoricpentadimen-thylamide, vamidonthion.
Picric Acid.
Picrotoxin.
Pindolol.
Pirenzepine.
Pirprofen.
Poldine methylsuphate.
Praziquantel.
Prazosin.
Prenylamine.
Primawuine.
Primidone.
Probenecid.
Procainamide; its salts.
Procarbazine; its salts.
Procylidine; its salts.
Proguanil.
Propantheline bromide.
Propranolol; its salts.
Propylhexedrine; its salts.
Propinylcyclohexanol.
Prothidium bromide.
Prothionamide.
Prothipendyl; its salts.
Protriptyline hydrochloride.
Psychotropic substances, all psychotropic substances controlled by the Psychotropic Substances Convention of 1971.
Pyrithioxine base.
Quinapyramine; its salts; its derivatives, their salts compounds of quinapyramine with other substances.
Quinethazone.
Quinidine; its salts.
Quinine hydrochloride; its salts.
Quinuronium; its salts - except as provided in Part II of this list.
Salbutamol; its salts.
Selenium; its compounds.
Spirolactone.
Strophanthus; glycosides of strophanthus.
Styramate.
Sulphin pyrazone.
Sulphones; their salts; their derivatives.
Suramin.
Syrosingopine.
Telbutaline sulphate.
Terbutatine.
Tetrabanazine; its salts.
Thalidomide; its salts.
Thiacetazone; its salts; its derivatives.
Thiocarlide; its salts.
Thioridazine hydrochloride.
Tiaprofenic acid.
Timolol.
Tinidazole.
Tolbutamide.
Tozaphene - except as provided in Part II of this list.
Tretamine; its salts.
Triamterene.
Triaziquone.
2:2:2-trichloroethyl alcohol; esters of; their salts.
Trifluoperazine.
Trimipramine; its salts.
Tropicamide.
Troxidone.
Vesopressin, natural and synthetic.
Verapamil; its salts.
Zidovudine.
Zinc phosphide, except as provided in Part II of this list.
Drugs in a form prepared for injection.
PART II
GROUP C |
|
Poison | Percentage pharmaceutical form |
Alkaloids, the following and their salts, simple or complex; their quarternary compounds | Less than 0.15 percentage calculated as hyoscyamine. |
Belladonna, alkaloids of .......................... | |
Ephedrine salts, when contained in a preparation containing less than 0-2 percent of the alkaloids of ephedra. | |
Ethylmorphine ......................................... | Less than 0-2 percent |
Hyoscyamine .......................................... | Less than 0-15 percent |
Morphine in approved preparation containing less than 0-2 percent of anhydrous morphine. | |
Nux Vomica ............................................. | Less than 0-2 percent of alkaloids calculated as strychnine. |
Opium ..................................................... | Preparations for external use containing less than 0-2 percent alkaloids as calculated as anhydrous morphine. |
Pholcodine; its salts ................................. | Less than 1 percent calculated as pholcodine in approved preparations. |
Stramonium, alkaloids of ........................... | Less than 0-15 percent calculated as hyoscyamine. |
Strychnine................................................ | Less than 0.2 percent. |
Antihelminthitics, the following: | |
Albendazone ........................................... | Oral form |
Bephenium hydroxynaphtoate.................... | Oral form |
Mebendazole............................................ | Oral form |
Niclosamide ............................................ | Oral form |
Piperazine ............................................... | Oral form |
Pyrantel .................................................. | Oral form |
Thiabendazole ......................................... | Oral form |
Antihistamines, only when contained in preparations for external application only other than for the eye or nose, and in preparations containing not more than 1 percent of an antihistamine substance intended for application only to the eye or nose. |
|
Arsenical substances .............................. | Less than equivalent of 0.01 percent less than 0.5 percent acetarsol in dentifrices. |
Bis(p-acetoxyphenyl)-2-pyridylmethane ..... | Oral and rectal form. |
Chloral..................................................... | Less than 10 percent of chloral hydrate. |
Magnesium trislicate compounds of ........... | In oral form. |
Mercury oxide........................................... | Yellow oxide of mercury ointment. |
Vitamins, the following: | |
Vitamin B. Complex ................................. | Oral form. |
Vitamin C. .............................................. | Oral form. |
Multivitamins .......................................... | Oral form. |
(Section 58)
[1st May, 1999]
G.N. No. 352 of 1999
WHEREAS section 58 of the Pharmaceutical and Poisons Act * requires the Minister upon recommendation of the Board, by Order published in the Gazette to prohibit, control, the preparation, importation or sale of any pharmaceutical.
AND WHEREAS the Board has recommended to the Minister to declare and publish in the Gazette the Guidelines for Good Manufacturing of pharmaceuticals for public awareness.
NOW THEREFORE, it is hereby declared as follows–
1. This Order may be cited as the Pharmaceuticals and Poisons (Guidelines for Good Manufacturing Practice) Order.
2. [Omitted.]
3. It is hereby provided that after the date of the commencement of this Order no person shall be allowed to manufacture any pharmaceutical without following the Guidelines provided in the Schedule to this Order.
4. Any person who contravenes or fails to comply with this order shall be guilty of an offence punishable under the Pharmaceutical and Poisons Act *.
SCHEDULE
GUIDELINES FOR GOOD MANUFACTURING PRACTICE
FOREWORD
The manufacture of pharmaceutical preparations is a basic philosophy which embraces many clearly defined principles, each of which combines certain specialised features and functions requiring constant attention and vigilance by highly trained personnel.
Quality cannot be tested into a product, but must be built into it by conscientious workers in every phase of processing and production. The excellence of a company's products reflects the integrity, competence, and pride of all the men and women involved in the design, production, and marketing of the products.
Quality is a summation of the intangible factors necessary and sufficient to assure performance of desired functions.
One of the most well known sets of regulations that have had a major impact on the drug industries are called Good Manufacturing Practices (GMP). These guidelines describe the minimum requirements that the Government consider necessary for the production of human drugs, veterinary drugs, or medical devices. They address the manufacturing methods, facilities, controls, packaging, storage, and installations for medical devices and drug manufacturing operations.
The guidelines should be considered as general guides and should be adapted to meet individual needs, making sure that the established standards of drug quality are still achieved. They are intended to apply to the manufacturing processes including packaging and labelling used in the production of drugs in their finished dosage forms.
This guide to GMP shall be used to justify GMP status through the assessment of applications for manufacturing authorisations and as a basis for the inspection of manufacturing facilities. It will also be used as training material for Pharmacy Board Inspectors, as well as for production and quality control personnel in the industry.
It is my sincere hope that all concerned will adhere to the guide for the benefit of Tanzania community.
DR. AARON D. CHIDUO,
Minister for Health
TABLE OF CONTENTS
FOREWORD
CHAPTER 1: DEFINITIONS
CHAPTER 2: INTRODUCTION
CHAPTER 3: QUALITY MANAGEMENT
Principle
Quality Assurance
Good Manufacturing Practices for Pharmaceutical Products (GMP)
Quality Control
CHAPTER 4: PERSONNEL
Principle
General
Key Personnel
Training
Personnel hygiene
CHAPTER 5: PREMISES AND EQUIPMENT
Principle
General
Production area
Storage areas
Weighing areas
Quality control area
Ancillary areas
Equipment
Equipment cleaning and use log
CHAPTER 6: DOCUMENTATION
Principle
General
Documents required
Labels
Specifications and testing procedures
Specifications for starting and packaging materials
Specifications for intermediate and bulk products
Specifications for finished products
Master formulae
Packaging instructions
Batch processing records
Batch packaging records
Standard operating procedures and records
Records and reports
Distribution records
Complaint files
Returned drug products
Drug product salvaging
Batch envelope
General
Contents of the batch envelope
Control of the batch envelope
File sample retention
CHAPTER 7: PRODUCTION
Principle
General
Prevention of cross-contamination and bacterial contamination in production
Processing operations
Packaging operations
Materials
Principle
General
Starting materials
Packaging materials
Intermediate and bulk products
Finished products
Rejected and recovered materials
Recalled products
Returned goods
Waste materials
Miscellaneous
Component, drug product container, closure, and labelling records
Master production and control records
Batch production and control records
CHAPTER 8: QUALITY CONTROL
Principle
General
Control of starting materials and intermediate, bulk, and finished products
Test requirements
Production record review
Stability studies
Reagents and culture media
Reference standards
CHAPTER 9: CONTRACT MANUFACTURE AND ANALYSIS
Principle
General
The contract giver
The contract acceptor
The contract
CHAPTER 10: COMPLAINTS AND PRODUCT RECALL
Principle
Complaints
Product recalls
CHAPTER 11: SELF-INSPECTION AND QUALITY AUDITS
Principle
Items for self-inspection
Self-inspection team
Frequency of self-inspection
Self-inspection report
Follow-up action
Quality audit
Supplier's audits
CHAPTER 12: MANUFACTURE OF STERILE MEDICINAL PRODUCTS
Principle
Explanation
General
Manufacture of sterile preparations
Terminally sterilised products
Sterile filtered products
Personnel
Premises
Equipment
Sanitation
Processing
Sterilisation
Sterilisation by heat
Sterilisation by moist heat
Sterilisation by dry heat
Sterilisation by radiation
Sterilisation by ethylene oxide
Filtration of pharmaceutical products that cannot be sterilised in their final container
Finishing of sterile products
Quality control
CHAPTER 1
INTRODUCTION
In the manufacture of drugs, overall control is essential to ensure that the consumer receives drugs of high quality. Haphazard operations cannot be permitted in the manufacture of substances that may be necessary to save or to restore or preserve health.
Difficulties will undoubtedly arise in establishing the necessary criteria for the manufacture of drugs that will meet the established specifications and that can therefore be used with confidence. Recommended practices for the manufacture of drugs of desired quality are set forth below. Adherence to these practices, complementing the various control tests followed from the beginning to the end of the manufacturing cycle, will contribute substantially to the manufacture of consistently uniform hatches of high quality drugs.
The manufacturer must assume responsibility for the quality of the drugs he produces. He alone can avoid mistakes and prevent mishaps by exercising adequate care in both his manufacturing and control procedures.
The good practices outlined in this guide are designed to ensure that drugs received by the consumer have been subjected to stringent controls from the beginning to the end of the manufacturing cycle to ensure that they are of high quality. The expression "manufacturing" for this purpose refers to all operations involved in the production of a drug, including processing, compounding, formulating, filling, packaging, and labelling.
The requirements set forth in this guide are intended to apply primarily to preparations for human administration. However, this should not detract from the need for similar quality considerations in the manufacture of veterinary preparations. The requirements represent general guides stipulating minimum standards. They are not designed to replace other legal controls, but rather to complement or supplement them.
The principle of Good Manufacturing Practice and its related guidelines are applicable to all operations of manufacturing of pharmaceutical products. They are also relevant for all other large scale pharmaceutical manufacturing processes, such as that undertaken in hospitals and for the preparation of products for use in clinical trials.
The Pharmacy Board having recognised the need to upgrade the status of manufacturing pharmaceuticals in Tanzania, has developed the first guide of its own kind to form the minimum requirements in pharmaceutical manufacturing.
This guide forms the basis for licensing pharmaceutical manufacturers in the country. It should therefore be used as a training material for the holder of a manufacturing licence and a guide to drug inspectors performing inspectorate activities to the manufacturing plants.
CHAPTER 2
DEFINITIONS
These Guidelines may be cited as the Pharmaceuticals and Poisons (Guidelines for Good Manufacturing Practice), Notice 1999.*
In these Guidelines, unless the context otherwise requires–*
"Active pharmaceutical ingredient" means a substance or compound that is intended to be used in the manufacture of a pharmaceutical product as a pharmacologically active compound (ingredient).
"Airlock" means an enclosed space with two or more doors, which is interposed between two or more rooms, e.g., of different classes of cleanliness, for the purpose of controlling the airflow between those rooms when they need to be entered. An airlock is designed for and used by either people or goods.
"Authorised person" means a person(s) responsible for the release of batches of finished product for sale. The batch documentation of a batch of finished product must be signed by an authorised person from the production department and the batch test results by an authorised person from the quality control department for batch release.
"Batch (or lot)" means defined quantity of starting material, packaging material, or product processed in a single process or series of processes so that it could be expected to be homogeneous. In the case of continuous manufacture, the batch must correspond to a defined fraction of the production, characterised by its intended homogeneity. It may sometimes be necessary to divide a batch into a number of sub-batches, which are later brought together to form a final homogeneous batch.
"Batch number (or lot number)" means a distinctive combination of numbers and / or letters which specifically identifies a batch on labels, the batch records, the certificates of analysis, etc.
"Batch numbering system" means standard operating procedure describing the details of the batch numbering.
"Batch records" means all documents associated with the manufacture of a batch of bulk product or finished product. They provide a history of each batch of product and of all circumstances pertinent to the quality of the final product.
"Bulk product" means any product that has completed all processing stages up to, but not including, final packaging.
"Calibration" means the set of operations that establish, under specified conditions, the relationship between values indicated by an instrument or system for measuring (especially weighing), recording, and controlling, or the values represented by a material measure, and the corresponding known values of a reference standard. Limits for acceptance of the results of measuring should be established.
"Clean area" means an area with defined environmental control of particulate and microbial contamination, constructed and used in such a way as to reduce the introduction, generation, and retention of contaminants within the area.
"Consignment (or delivery)" means the quantity of starting material, or of a drug product, made by one manufacturer and supplied at one time in response to a particular request or order. A consignment may comprise on or more packages or containers and may include material belonging to more than one batch.
"Critical process" means a process that may cause variation in the quality of the pharmaceutical product.
"Cross-contamination" means contamination of a starting material, intermediate product, or finished product with another starting material or product during production.
"Finished product" means a product that has undergone all stages of production, including packaging in its final container and labelling.
"In-process control" means checks performed during production in order to monitor and if necessary to adjust the process to ensure that the product confirms to its specifications. The control of the environment or equipment may also be regarded as part of in-process control.
"Intermediate product" partly processed material that must undergo further manufacturing steps before it becomes a bulk product.
"Large-volume parenterals" means sterile solutions intended for parenterals application with a volume of 100 ml or more in one container of the finished dosage form.
"Manufacture" means all operations of purchase of materials and products, production, quality control, release, storage, shipment of finished products, and the related controls.
"Manufacturer" a company that carries out at least one step of manufacture.
"Marketing authorisation (product licence, registration certificate)" means a legal document issued by the Pharmacy Board or any other drug regulatory authority that establishes the detailed composition and formulation of the product and the pharmacopoeial or other recognised specifications of its ingredients and of the final product itself, and includes details of packaging, labelling, and shelf life.
"Master formula" is a document or set of documents specifying the starting materials with their quantities and the packaging materials, together with a description of the procedures and precautions required to produce a specified quantity of a finished product as well as the processing instructions, including the in-process controls.
"Master record" a document or set of documents that serve as a basis for the batch documentation (blank batch record).
"Packaging" all operations, including filling and labelling, that a bulk product has to undergo in order to become a finished product. Sterile filling is not normally regarded as part of packaging, the bulk product being the filled, but not the finally packaged, primary container.
"Packaging material" any material, including printed material, employed in the packaging of a pharmaceutical product, excluding any outer packaging used for transportation or shipment packaging materials are referred to as primary or secondary according to whether or not they are intended to be in direct contact with the product.
"Pharmaceutical product" means any medicine intended for human use or veterinary product administered to food-producing animals, presented in its finished dosage form or as a starting material for use in such a dosage form, that is subject to control by pharmaceutical legislation (The Pharmaceutical and Poisons Act * and its respective regulations).
"Processing instructions" - see the meaning of the phrase "Master formula".
"Production" means and includes all operations involved in the preparation of a pharmaceutical product, from receipt of materials, through processing and packaging, to completion of the finished product.
"Quality assurance" as provided for under Chapter Three;
"Quality control" as provided for under Chapter Three;
"Quarantine" means the status of starting or packaging materials, intermediates, or bulk or finished products isolated physically or by other effective means while a decision is awaited on their release, rejection, or reprocessing.
"Reconciliation" means a comparison, making due allowance for normal variation, between the amount of product or materials theoretically produced or used and the amount actually produced or used.
"Recovery (or blending)" means the introducting of all or part of previous batches (or of re-distilled solvents and similar products) of the required quality into another batch at a defined stage of manufacture.
"Reprocessing" means the reworking of all or part of a batch of product of an acceptable quality from a defined stage of production so that its quality may be rendered acceptable by one or more additional operations.
"Returned product" means the finished product sent back to the manufacturer.
"Specification" means a document describing in detail the requirements with which the products or materials used or obtained during manufacture have to conform. Specifications serve as a basis for quality evaluation.
"Standard operation procedure (SOP)" means an authorised written procedure giving instructions for performing operations not necessarily specific to a given product or material but of a more general nature (e.g., equipment operation, maintenance and cleaning; validation; cleaning of premises and environmental control, sampling and inspection). Certain SOPs may be used to supplement product-specific master and batch production documentation.
"Starting material" means any substance of a defined quality used in the production of a pharmaceutical product, but excluding packaging materials.
"System" means a regulated pattern of interacting activities and techniques that are united to form an organised whole.
"Validation" means the documented act of proving that any procedure, process, equipment, material, activity, or system actually leads to the expected results.
CHAPTER 3
QUALITY MANAGEMENT
Principle:
3.0 In the drug industry at large, quality management is the aspect of management function that determines and implements the "quality policy", i.e., the overally intentions and direction of an organisation regarding quality, as formally expressed and authorised by top management.
The basic elements if quality management are:
• An appropriate infrastructure or "quality system", encompassing the organisational structure, processes, and resources; and
• Systematic actions necessary to ensure adequate confidence that a product (or service) will satisfy given requirements for quality. The totality of these actions is termed "quality assurance".
Within an organisation, quality assurance serves as a management tool. In contractual situations, quality assurance also serves to generate confidence in the supplier.
In drug manufacture and supply, the terminology differs. In particular, the term "Quality Control" is inter-related of quality management. They are described here in order to emphasize their relationship and their fundamental importance to the production and control of pharmaceutical products.
Quality Assurance:
3.1 Quality assurance is a wide-ranging concept covering all matters that individually or collectively influence the quality of a product. It is the totality of the arrangement made with the object of ensuring that pharmaceutical products are of the quality required for their intended use. Quality assurance therefore incorporates Good Manufacturing Practice and other factors, including those outside the scope of this guide such as product design and development.
The system of quality assurance appropriate to the manufacture of pharmaceutical products should ensure that–
(a) pharmaceutical products are designed and developed in a way that takes account of the requirements of GMP and other associated codes such as those of Good Laboratory Practice;
(b) production and control operations are clearly specified in a written form and GMP requirements are adopted;
(c) managerial responsibilities are clearly specified in job descriptions;
(d) arrangements are made or the manufacture, supply, and use of the correct starting materials;
(e) all necessary controls on starting materials, intermediate products, and bulk products and other in-process controls, calibrations, and validations are carried out;
(f) the finished product is correctly processed and checked, according to the defined procedures;
(g) pharmaceutical products are not sold or supplied before the authorised persons have certified that each production batch has been produced and controlled in accordance with the requirements of the marketing authorisation and any other regulations relevant to the production, control and release of pharmaceutical products;
(h) satisfactory arrangements exist to ensure as far as possible, that the pharmaceutical products are stored by the manufacturer, distributed, and subsequently handled so that quality is maintained throughout their shelf life;
(i) there is a procedure for self-inspection and/or quality audit that regularly appraises the effectiveness and applicability of the quality assurance system.
3.2 The manufacturer must assume responsibility for the quality of the pharmaceutical products to ensure that they are fit for their intended use, comply with the requirements of the marketing authorisation and do not place patients as risk due to inadequate safety, quality, or efficacy. The attainment of this quality objective is the responsibility of senior management and requires the participation and commitment of the staff in many different departments and at all levels within the company, the company's supplier, and distributors. To achieve the quality objective reliably there must be a comprehensively designed and correctly implemented system of quality assurance incorporating GMP and quality control. It should be fully documented and its effectiveness monitored. All parts of the quality assurance system should be adequately staffed with competent personnel, and should have suitable and sufficient premises, equipment, and facilities.
3.3 Sanitation and hygiene
3.3.1 A high level of sanitation and hygiene should be practised in every aspect of the manufacture of drug products. The scope of sanitation and hygiene should cover personnel, premises, equipment and apparatus, production materials and containers, products for cleaning and disinfection, and anything that could become a source of contamination to the product. Potential sources of contamination should be eliminated through an integrated comprehensive programme of sanitation and hygiene. (For Hygiene refer to Chapter 4, "Personnel", and for Sanitation refer to Chapter 5, "Equipment".)
3.4 Validation
3.4.1 Validation studies are an essential part of GMP and should be conducted in accordance with predefined protocols. A written report summarising recorded results and conclusions should be prepared and stored. Processes and procedures should be established on the basis of a validation study and undergo periodic revalidation to ensure that they remain capable of achieving the intended results. Particular attention should be accorded to the validation of processing, testing, and cleaning procedures.
3.5 Process validation
3.5.1 Critical process should be validated, prospectively or retrospectively.
3.5.2 When any new master formula or method of preparation is adopted, steps should be taken to demonstrate its suitability for routine processing. The defined process, using the materials and equipment specified, should be shown to yield a product consistently of the required quality.
3.5.3 Signification amendments to the manufacturing process, including any change in equipment or materials that may affect product quality and/or the reproducibility of the process, should be validated.
Good Manufacturing Practices for Pharmaceutical Products (GMP):
3.6 Good manufacturing practices is that part of quality assurance which ensures that products are consistently produced and controlled to the quality standards appropriate for the intended use and as required by the Pharmaceutical and Poisons Act *. GMP rules are directed primarily to diminishing the risks, inherent in any pharmaceutical production, that cannot be prevented completely through the testing of final products. Such risks are essentially of two types: Cross-contamination (in particular by unexpected contaminants) and mix-ups (confusion) caused by false labels being put on container. Under GMP:
(a) all manufacturing processes are clearly defined, systematically reviewed in the light of experience, and shown to be capable of consistently manufacturing pharmaceutical products of the required quality that comply with their specifications;
(b) critical steps of manufacturing processes and any significant changes made to the processes are validated;
(c) all necessary facilities are provided, including–
(i) appropriately qualified and trained personnel;
(ii) adequate premises and space;
(iii) suitable equipment and services;
(iv) correct materials, containers, and labels;
(v) approved procedures and instructions;
(vi) suitable storage and transport; and
(vii) adequate personnel, laboratories, and equipment for in-process controls under the responsibility of the production management;
(d) instructions and procedures are written in clear and unambiguous language, specifically applicable to the facilities provided;
(e) operators are trained to carry out procedures correctly;
(f) records are made (manually and/or by recording instruments) during manufacture to show that all the steps required by the defined procedures and instructions have in fact been taken and that the quantity and quality of the product are as expected, any significant deviations are fully recorded and investigated;
(g) records covering manufacture and distribution, which enable the complete history of a batch to be traced, are retained in a comprehensible and accessible form;
(h) the proper storage and distribution of the products minimises any risk to their quality;
(i) a system is available to recall any batch of product from sale or supply;
(j) complaints about marketed products are examined, the causes of quality defects investigated, and appropriate measures taken in respect of the defective products and to prevent recurrence.
Quality Control:
3.7 Quality control is that part of GMP concerned with sampling, specifications, and testing and with the organisation, documentation, and release procedures which ensure that the necessary and relevant tests are actually carried out and that materials are not released for use, nor products released for sale or supply, until their quality has been judged to be satisfactory. Quality control is not confined to laboratory operations but must be involved in all decisions concerning the quality of the product.
3.8 Each holder of a manufacturing authorisation should have a quality control department. The independence of quality control from production is considered fundamental. The quality control department should be independent of other departments and under the authority of a person with appropriate qualifications and experience who has one or several control laboratories at his or her disposal. Adequate resources must be available to ensure that all the quality control arrangements are effectively and reliably carried out.
3.9 The basic requirements for quality control are–
(a) adequate facilities, trained personnel and approved procedures must be available for sampling, inspecting, and testing materials, packaging materials, and intermediate, bulk, and finished products, and where appropriate for monitoring environmental conditions for GMP purposes;
(b) samples of starting materials, packaging materials, intermediate products, bulk products and finished products must be taken by methods and personnel approved by the quality control department;
(c) test methods must be validated;
(d) records must be maintained (manually and/or by recording instruments) demonstrating that all the required sampling, inspecting, and testing procedures have actually been carried out and that any deviations have been fully recorded and investigated;
(e) the finished products must contain ingredients complying with the qualitative and quantitative composition of the product described in the marketing authorisation; the ingredients must be of the required purity, in their proper container, and correctly labelled;
(f) records must be made of the results of inspecting and testing materials and intermediate, bulk, and finished products against specifications; product assessment must include a review and evaluation of the relevant production documentation and an assessment of deviations from specified procedures;
(g) no batch of product is to be released for sale or supply without prior certification by the authorised person(s) that it is in accordance with the requirements of the marketing authorisation;
(h) sufficient samples of starting materials and products must be retained to permit future examination of the product if necessary; the retained product must be kept in its final pack unless the pack is exceptionally large.
3.10 The quality control department as a whole will also have other duties, such as to establish, validate, and implement all quality control procedures, to evaluate, maintain, and store the reference standards for substances, to ensure that the stability of the active pharmaceutical ingredients and products is monitored, to participate in environment monitoring. All these operations should be carried out in accordance with written procedures and recorded.
3.11 Assessment of finished products should embrace all relevant factors, including the production conditions, the results of in-process testing, the manufacturing (including packaging) documentation, compliance with the specification for finished product, and an examination of the finished pack.
3.12 Quality control personnel must have access to production areas for sampling and investigation as appropriate.
CHAPTER 4
PERSONNEL
Principle:
4.0 The establishment and maintenance of a satisfactory system of quality assurance and the correct manufacture and control of pharmaceutical products and active ingredients rely upon people, for this reason there must be sufficient qualified personnel to carry out all the tasks for which the manufacturer is responsible. Individual responsibilities should be clearly understood by the individuals concerned and recorded as written descriptions. All personnel should be aware of the principles of GMP that affect them.
General:
4.1 The manufacturer should have an adequate number of personnel with the necessary qualifications and practical experience. The responsibilities placed on any one individual should not be so extensive as to present any risk to quality.
4.2 The manufacturer should have an organisation chart. All responsible staff should have their specific duties recorded in written descriptions and adequate authority to carry out their responsibilities. Their duties may be delegated to designated deputies of a satisfactory qualification level. There should be no gaps or unexplained overlaps in the responsibilities of personnel concerned with the application of GMP.
4.3 All personnel should be aware of the principles of GMP that affect them and receive initial and continuing training, including hygiene instructions, relevant to their needs, all personnel should be motivated to support the establishment and maintenance of high-quality standards.
4.4 Steps should be taken to prevent unauthorised people from entering production, storage, and quality control areas. Personnel who do not work in these areas should not use them as a passageway.
Key Personnel:
4.5 Key personnel include the head of production, the head of quality control, the head of sales/distribution, and authorised person(s). Key posts should be occupied by full-time personnel. The heads of production and quality control should be independent of each other. In large organisations, it may be necessary to delegate some of the functions; however, the responsibility cannot be delegated.
4.6 Key personnel responsible for supervising the manufacture and quality control of pharmaceutical products should possess the qualifications of a scientific education and practical experience as stipulated in the Pharmaceutical and Poisons Act *. Their education should include the study of an appropriate combination of:
(a) Pharmaceutical sciences and technology;
(b) chemical engineering;
(c) microbiology;
(d) chemistry (analytical or organic) or biochemistry;
(e) pharmacology and toxicology;
(f) physiology; or
(g) other related sciences.
They should also have adequate practical experience in the manufacture and quality assurance of pharmaceutical products, in order to gain such experience, a preparatory period shall be required, during which they shall exercise their duties under professional guidance. The scientific education and practical experience of experts should be such as to enable them to exercise independent professional judgement, based on the application of scientific principles and understanding to the practical problems encountered in the manufacture and quality control of pharmaceutical products.
4.7 The heads of the production and quality control departments generally have some shared, or jointly exercised, responsibilities relating to quality. These include–
(a) the authorisation of written procedures and other documents, including amendments;
(b) the monitoring and control of the manufacturing environment;
(c) plant hygiene;
(d) process validation and calibration of analytical apparatus;
(e) training, including the application and principles of quality assurance;
(f) the approval and monitoring of suppliers of materials;
(f) the approval and monitoring of contract manufacturers;
(h) the designation and monitoring of storage conditions for materials and products;
(i) the retention of records;
(j) the monitoring of compliance with GMP requirements;
(k) the inspection, investigation, and taking of samples, in order to monitor factors that may affect product quality.
4.8 The head of the production department has the following responsibilities–
(a) to ensure that products are produced and stored according to the appropriate documentation in order to obtain the required quality;
(b) to approve the instructions relating to production operations, including the inprocess controls, and to ensure strict implementation;
(c) to ensure that the production records are evaluated and signed by a designated person before they are made available to the quality control department;
(d) to check the maintenance of the department, premises, and equipment;
(e) to ensure that the appropriate process validations and calibrations of the control equipment are performed and recorded and the reports made available;
(f) to ensure that the required initial and continuing training of production personnel is carried out and adapted according to need.
4.9 The head the of quality control department has the following responsibilities–
(a) to approve or reject starting materials, packaging materials, and intermediate, bulks, and finished products;
(b) to evaluate batch records;
(c) to ensure that all necessary testing is carried out;
(d) to approve sampling instructions, specifications, test methods, and other quality control procedures;
(e) to approve and monitor analyses carried out under contract;
(f) to check the maintenance of the department, premises and equipment;
(g) to ensure that the appropriate validations, including those of analytical procedures, and calibrations of control equipment are done;
(h) to ensure that the required initial and continuing training of quality control personnel is carried out and adapted according to need.
Other duties of the quality control department are summarised in section 3.7-3.10
Training:
4.10 The manufacturer should provide training in accordance with a written programme for all the personnel whose duties take them into production areas or into control laboratories (including the technical, maintenance, and cleaning personnel), and for other personnel whose activities could affect the quality of the product.
4.11 Besides basic training on the theory and practice of GMP, newly recruited personnel should receive training appropriate to the duties assigned to them. Continuing training should also be given, and its practical effectiveness should be periodically assessed. Training programmes should be available, approved by the head of either production or quality control, as appropriate. Training records should be maintained.
4.12 Personnel working in areas where contamination is a hazard, e.g., clean areas or areas where highly active, toxic, infectious, or sensitizing materials are handled, should be given specific training.
4.13 The concept of quality assurance and all the measures capable of improving its understanding and implementation should be fully discussed during the training sessions.
4.14 Visitors or untrained personnel should preferably not be taken into the production and quality control areas. If this is unavoidable, they should be given information in advance, particularly about personal hygiene and the prescribed protective clothing. They should be closely supervised.
Personnel Hygiene:
4.15 All personnel, prior to and during employment, as appropriate, should undergo health examinations. Personnel conducting visual inspections should undergo periodic eye examinations.
4.16 All personnel should be trained in the practices of personal hygiene. A high level of personal hygiene should be observed by all those concerned with manufacturing processes. In particular, personnel should be instructed to wash their hands before entering production area. Signs to this effect should be posted and instructions observed.
4.17 Any person shown at any time to have an apparent illness or open lesions that may adversely affect the quality of products should not be allowed to handle starting materials, packaging materials, in-process materials, or drug products until the condition is no longer judged to be a risk.
4.18 All employees should be instructed and encouraged to report to their immediate supervisor any conditions (relating to plant, equipment, or personnel) that they consider may adversely affect the products.
4.19 Direct contact should be avoided between the operators' hands and starting materials, primary packaging materials, and intermediate or bulk product.
4.20 To ensure protection of the product from contamination, personnel should wear clean body coverings appropriate to the duties they perform, including appropriate hair covering. Used clothes, if reusable, should be stored in separate closed containers until properly laundered and, if necessary disinfected or sterilised.
4.21 Smoking, eating, drinking, chewing, and keeping plants, food, drink, smoking material, and personnel medicines should not be permitted in production, laboratory, and storage areas or in any other area where they might adversely influence product quality.
4.22 Personal hygiene procedures including the use of protective clothing should apply to all persons entering production areas, whether they are temporary or full time employees or non-employees - e.g., contractors' employees, visitors, senior managers, and inspectors.
CHAPTER 5
PREMISES AND EQUIPMENT
Principle:
5.0 Premises must be located, designed, constructed, adapted, and maintained to suit the operations to be carried out. Their layout and design must aim to minimise the risk of errors and permit effective cleaning and maintenance in order to avoid cross-contamination, build-up of dust or dirt, and in general, any adverse effect on the quality of products.
General:
5.1 Premises should be situated in an environment that, when considered together with measures to protect the manufacturing process, presents minimum risk of causing any contamination of material or products.
5.2 Premises used for the manufacture of drug products should be suitably designed and constructed to facilitate good sanitation.
5.3 Premises should be carefully maintained, and it should be ensured that repair and maintenance operations do not present any hazard to the quality of products. Premises should be cleaned and, where applicable, disinfected according to the detailed written procedures.
5.4 Electrical supply, lighting, temperature, humidity, and ventilation should be appropriate and such that they do not adversely affect, directly or indirectly, either the pharmaceutical products during their manufacture and storage, or the accurate functioning of equipment.
5.5 Premises should be designated and equipped so as to afford maximum protection against entry of insects or other animals.
Production area:
5.6 In order to minimise the risk of a serious medical hazard due to cross-contamination, dedicated and self-contained facilities must be available for the production of particular pharmaceutical products, such as highly sensitizing materials (e.g., penicillin) or biological preparations (e.g., live microorganisms). The production of certain products, such as some antibiotics, hormones, cytotoxic substances, highly active pharmaceutical products, and non-pharmaceutical products, should not be conducted in the same facilities. The manufacture of technical poisons, such as pesticides and herbicides, should not be allowed in the premises used for the manufacture of pharmaceutical products.
5.7 Premises should be laid out in such a way as to allow the production to take place in areas connected in a logical order corresponding to the sequence of the operations and to the requisite cleanliness levels.
5.8 The adequacy of the working and in-process storage space should permit the orderly and logical positioning of equipment and materials so as to minimise the risk of confusion between different pharmaceutical products or their components, to avoid cross-contamination, and to minimise the risk of omission or wrong application of any of the manufacturing or control steps.
5.9 Where starting and primary packaging materials and intermediate or bulk products are exposed to the environment, interior surfaces (walls, floors, and ceilings) should be smooth and free from cracks and open joints, should not shed particulate matter, and should permit easy and effective cleaning and, where appropriate, disinfection.
5.10 Pipework, light fittings, ventilation points, and other services should be designed and sited to avoid the creation of recesses that are difficult to clean. As far as possible, for maintenance purposes, they should be accessible from outside the manufacturing areas.
5.11 Drains should be of adequate size and equipped to prevent back-flow. Open channels should be avoided, if they are necessary they should be shallow to facilitate cleaning and disinfection.
5.12 Production areas should be effectively ventilated, with air-control facilities (including control of temperature and, where necessary, humidity and filtration) appropriate to the products handles, to the operations undertaken, and to the external environment. These areas should be regularly monitored during production and non-production periods to ensure compliance with their design specifications.
5.13 Premises for the packaging of pharmaceutical products should be specifically designed and laid out so as to avoid mix-ups or cross-contamination.
5.14 Production areas should be well lit, especially where visual on-line controls are carried out.
Storage areas:
5.16 Storage areas should be of sufficient capacity to allow orderly storage of various categories of materials and products: starting and packaging materials, intermediates, bulk and finished products, products in quarantine, and released, rejected, returned, or recalled products.
5.17 Storage areas should be designed or adapted to ensure good storage conditions. In particular, they should be clean and dry and maintained within acceptable temperature limits. Where special storage conditions are required (e.g., temperature, humidity) these should be provided, checked, and monitored.
5.18 Receiving and dispatch bays should protect materials and products from whether, Reception areas should be designed and equipped to allow containers of incoming materials to be cleaned if necessary before storage.
5.19 Where quarantine status is ensured by storage in separate areas, these areas must be clearly marked and their access restricted to authorised personnel. Any system replacing the physical quarantine should give equivalent security.
5.20 There should be a separate sampling area for starting materials. If sampling is performed in the storage area, it should be conducted in such a way as to prevent contamination or cross-contamination.
5.21 Segregation should be provided for the storage of rejected, recalled, or returned materials or products.
5.22 Highly active materials, narcotics, other dangerous drugs, and substances presenting special risks of abuse, fire, or explosion should be stored in safe and secure areas.
5.23 Printed packaging materials are critical to the conformity of the pharmaceutical product to its labelling, and special attention should be paid to the safe and secure storage of these materials.
Weighing areas:
5.24 The weighing of starting materials and the estimation of yield by weighing should be carried out in separate weighing designed for that use, for example with provisions for dust control.
Quality control area:
5.25 Quality control laboratories should be separated from production areas. Areas where biological, microbiological, or radio-isotope test methods are employed should be separated from each other.
5.26 Control laboratories should be designed to suit the operations to be carried out in them. Sufficient space should be given to avoid mix-ups and cross-contamination. There should be adequate suitable storage space for samples, reference standards (with cooling), and records.
5.27 The design of the laboratories should take into account the suitability of construction materials, prevention of fumes, and ventilation. Separate air-handling units and other provisions are needed for biological, microbiological, and radio-isotope laboratories.
5.28 A separate room should be allocated for instruments to protect them against electrical interference, vibration, contact with excessive moisture, other external factors and to isolate the instruments.
Ancillary areas:
5.29 Rest and refreshment rooms should be separate from other areas.
5.30 Facilities for changing and storing clothes and for washing and toilet purposes should be easily accessible and appropriate for the number of users. Toilets should not communicate directly with production or storage areas.
5.31 Maintenance workshops should be separate from production areas. Whenever parts and tools are stored in the production area, they should be kept in rooms or lockers reserved for that use.
5.32 Animal houses should be well isolated from other areas, with separate entrance (animal access) and air-handling facilities.
Equipment:
5.33 Equipment must be located, designed, constructed, adapted, and maintained to suit the operations to be carried out. The layout and design of equipment must aim to minimise the risk of errors and permit effective cleaning and maintenance in order to avoid cross-contamination, build-up of dust or dirt, and, in general, any adverse effect on the quality of products.
5.34 Equipment should be installed in such a way as to minimise any risk of error or contamination.
5.35 Fixed pipe-work should be clearly labelled to indicate the contents and, where applicable, the direction of flow.
5.36 All service piping and devices should be adequately marked and special attention paid to the provision of non-interchangeable connections or adapters for dangerous gases and liquids.
5.37 Balances and other measuring equipment of an appropriate range and precision should be available for production and control operations and should be calibrated on a scheduled basis.
5.38 Production equipment should be designed, located, and maintained to serve its intended purpose.
5.39 Production equipment should be designed so that it can be easily and thoroughly cleaned on a scheduled basis.
5.40 Control-laboratory equipment and instruments should be suited to the testing procedures undertaken.
5.41 Washing and cleaning equipment should be chosen and used so as not to be a source of contamination.
5.42 Production equipment should not present any hazard to the products. The parts of the production equipment that come into contact with the product must not be reactive, additive, or absorptive to an extent that would affect the quality of the product.
5.43 Defective equipment should, be removed from production and quality control areas, where this is not possible, it should be clearly labelled as defective.
Equipment cleaning and use log:
5.44 A written record of major equipment cleaning, maintenance (except routine maintenance such as lubrication and adjustments), and use shall be included in individual equipment logs that show the date, time, product, and lot number of each batch processed.
5.45 If equipment is dedicated to manufacture of one product, then individual equipment logs are not required, provided that lots or batches of such product follow in numerical sequence.
5.46 In cases where dedicated equipment is employed, the records of cleaning, maintenance, and use shall be part of the batch record. The persons performing and double-checking the cleaning and maintenance shall date or initial the log indicating that the work was performed. Entries in the log shall be in chronological order.
CHAPTER 6
DOCUMENTATION
Principle:
Good documentation is an essential part of the quality assurance system and, as such, should be related to all aspects of Good Manufacturing Practice. Its aims are to define the specifications for all materials and methods of manufacture and control. This is to ensure that all personnel concerned with manufacture know what to do and when to do it. It is also necessary to ensure that authorised persons have all the information necessary to decide whether or not to release a batch of drug for sale, and to provide an audit trail that will permit investigation of the history of any suspected defective batch. The design and use of documents depends upon the manufacturer.
General:
6.1 Documents should be designed, prepared, reviewed, and distributed with care. They should comply with the relevant parts of the manufacturing and marketing authorisations.
6.2 Documents should be approved, signed, and dated by appropriate authorised persons. No document should be changed without authorisation.
6.3 Documents should have unambiguous contents: the title, nature, and purpose should be clearly stated. They should be laid out in an orderly fashion and be easy to check. Reproduced documents should be clear and legible. The reproduction of working documents from master documents must not allow any error to be introduced through the reproduction process.
6.4 Documents should be regularly reviewed and kept up to date. When a document has been revised, a system should exist to prevent an advertent use of the superseded version.
6.5 Where documents require the entry of data, these entries should be clear, legible, and indelible. Sufficient space should be provided for such entries.
6.6 Any alteration made to a document should be signed and dated; the alteration should permit the reading of the original information. Where appropriate, the reason for the alteration should be recorded.
6.7 Records should be made or completed when any action is taken and in such a way that all-significant activities concerning the manufacture of pharmaceutical products are traceable. Records and associated standard operating procedures should be retained for at least one year after the expiry date of the finished product.
6.8 Data may be recorded by electronic data processing systems or by photographic or other reliable means. Master formulae and detailed standard operating procedures relating to the system in use should be available and the accuracy of the records should be checked, If documentation is handled by electronic data-processing methods, only authorised persons should be able to enter or modify data in the computer, and there should be a record of changes and deletions; access should be restricted by passwords or other means and the entry of critical data should be independently checked. Batch records electronically stored should be protected by back-up transfer on magnetic tape, microfilm, paper print-outs, or other means. It is particularly important that, during the period of retention, the data are readily available.
Documents required:
Labels:
6.9 Labels applied to containers, equipment, or premises should be clear, unambiguous, and in the company's agreed format. It is often helpful in addition to the wording on the labels to use colours to indicate status (for example: quarantined, accepted, rejected, or clean).
6.10 Labelling should identify all finished drug products, as required by the Pharmaceutical and Poisons Act * and its respective regulations, bearing at least the following information–
(a) the name of the drug product;
(b) a list of the active ingredients (if applicable, with the International Non-proprietary Names), showing the amount of each present, and a statement of the net contents, e.g., number of dosage units, weight, or volume;
(c) the batch number assigned by the manufacturer;
(d) the expiry date in an uncoded form;
(e) any special storage conditions or handling precautions that may be necessary;
(f) directions for use, and warnings and precautions that may be necessary; and
(g) the name and address of the manufacturer or the company or the person responsible for placing the product on the market.
6.11 For reference standards, the label or accompanying document should indicate concentration, date of manufacture, expiry date, date the closure is first opened. and storage conditions, where appropriate.
Specifications and testing procedures:
6.12 Testing procedures described in documents should be validated in the context of available facilities and equipment before they are adopted for routine testing.
6.13 There should be appropriately authorised and dated specifications, including tests on identity, content, purity, and quality, for starting and packaging materials and finished products; where appropriate, they should also be available for intermediate or bulk products. Specifications for water, solvents, and reagents (e.g., acids and bases) used in production should be included.
6.14 Each specification should be approved and maintained by the quality control department. Specifications for starting materials, intermediates and bulk and finished products refer to sections 5.18-5.23 of these guidelines.
6.15 Periodic revisions of specifications may be necessary to comply with new editions of the Tanzania National formulary or other official compendia.
6.16 Pharmacopoeias, reference standards, reference spectra, and other reference materials should be available in the quality control laboratory.
Specifications for starting and packaging materials:
6.17 Specifications for starting and primary or printed packaging materials should provide, if applicable, a description of the materials, including–
(a) the designated name (if applicable, the International Non-proprietary Name) and internal code reference;
(b) the reference, if any, to a pharmacopoeia monograph; and
(c) qualitative and quantitative requirements with acceptance limits.
6.18 Other data may be added to the specification, such as:
(a) the supplier and the original producer of the materials;
(b) a specimen of printed materials;
(c) directions for sampling and testing, or a reference to procedures.
6.19 Packaging material should conform to specifications, with emphasis placed on the compatibility of the material with the drug product it contains. The material should be examined for critical and major physical defects and as well as for the correctness of identity markings.
6.20 Documents describing testing procedures should state the required frequency for re-assaying each starting material, as determined by its stability.
Specifications for intermediate and bulk products:
6.21 Specifications for intermediate and bulk products should be available if these are purchased or dispatched, or if data obtained from intermediate products are used in evaluation of finished product. The specifications should be similar to specifications for starting materials or for finished products, as appropriate.
Specifications for finished products:
6.22 Specifications for finished products should include–
(a) the designated name of the product and the code reference where applicable;
(b) the designated name(s) of the active ingredients(s) (if applicable, the International Non-proprietary Name(s));
(c) the formula or a reference to the formula;
(d) the description of the dosage form and package details;
(e) directions for sampling and testing or a reference to procedures;
(f) the qualitative and quantitative requirements, with acceptance limits;
(g) the storage conditions and precautions, where applicable; and
(h) the shelf life.
Master formula:
6.23 A formally authorised master formula should exist for each product and batch size to be manufactured.
6.24 The master formula should include–
(a) the name of the product, with a product reference code relating to its specification;
(b) a description of the dosage form, strength of the product, and batch size;
(c) a list of all starting materials to be used (if applicable, with the International Non-proprietary Names), with the amount of each, described using the designated name and a reference that is unique to that material (mention should be made of any substance that may disappear in the course of processing);
(d) a statement of expected final yield with the acceptable limits, and of relevant intermediate yields, where applicable;
(e) a statement of the processing location and the principal equipment to be used;
(f) the methods, or reference to methods, to be used for preparing the critical equipment, e.g., cleaning (especially after a change in product), assembling, calibrating, sterilising;
(g) detailed stepwise processing instructions (e.g., checks on materials, pretreatments, sequence for adding materials, mixing times, temperatures);
(h) the instruction for any in-process controls with their limits–
(i) where necessary, the requirements for storage of the products, including the container, the labelling and any special storage condition; and
(ii) any special precautions to be observed.
Packaging Instructions:
6.25 Formally authorised packaging instructions should exist for each product, pack size, and type. These should normally include, or make reference to–
(a) the name of the product;
(b) a description of its pharmaceutical form, strength and method of application where applicable;
(c) the pack size expressed in terms of the number, weight, or volume of the product in the final container;
(d) a complete list of all the packaging materials required for a standard batch size, including quantities, sizes, and types, with the code or reference number relating to the specifications for each packaging material;
(e) where appropriate, an example or reproduction of the relevant printed packaging materials and specimens, indicating where the batch number and expiry date of the product have been marked;
(f) special precautions to be observed, including a careful examination of the packaging area and equipment in order to ascertain the line clearance before operations begin;
(g) a description of the packaging operation, including any significant subsidiary operations, and equipment to be used; and
(h) details of in-process controls with instructions for sampling and acceptance limits.
Batch processing records:
A batch processing record should be kept for each batch processed. It should be based on the relevant parts of the currently approved master formula. The method of preparation of such records should be designed to avoid transcription errors.
6.26 Before any processing begins, a check should be made that the equipment and workstation are clear of previous products, documents, or materials not required for the planned process, and that the equipment is clean and suitable for use. This check should be recorded.
6.27 During processing, the following information should be recorded at the time each action is taken, and after completion the record should be dated and signed by the person responsible for the processing operations:
(a) the name of the product;
(b) the number of the batch being manufactured;
(c) dates and times of commencement, of significant intermediate stages, and of completion of production;
(d) the name of the person responsible for each stage of production;
(e) the initials of the operator(s) of different significant steps of production and where appropriate, of the person(s) who checked each of these operations (e.g., weighing);
(f) the batch number and / or analytical control number and the quantity of each starting material actually weighed including the batch number and amount of any recovered or reprocessed material added);
(g) any relevant processing operation or event and the major equipment used;
(h) the in-process controls performed, the initials of the person(s) carrying them out, and the results obtained;
(i) the amount of product obtained at different and pertinent stages of manufacture (yield), together with comments or explanations for significant deviations from the expected yield; and
(j) notes on special problems including details, with signed authorisation for any deviation from the master formula.
Batch packaging records:
6.28 A batch packaging record should be kept for each batch or part hatch processed. It should be based on the relevant parts of the packaging instructions, and the method of preparing such records should be designed to avoid transcription errors.
6.29 Before any packaging operation begins, checks should be made that the equipment and work station are clear of previous products, documents, or materials not required for the planned packaging operations, and that equipment is clean and suitable for use. These checks should be recorded.
6.30 The following information should be recorded at the time each action is taken, and the date and the person responsible should be clearly identified by signature or electronic password:
(a) the name of the product, the batch number, and the quantity of bulk product to be packed, as well as the batch number and the planned quantity of finished product that will be obtained, the actually obtained, and the reconciliation;
(b) the date(s) and time(s) of the packaging operations;
(c) the name of the responsible person carrying out the packaging operations;
(d) the initials of the operators of the different significant steps;
(e) the checks made for identity and conformity with the packaging instructions, including the results of in-process controls;
(f) details of packaging operations carried out, including references to equipment and the packaging lines used, and, when necessary, the instructions for keeping the product unpacked or a record of returning product that has not been packaged to the storage area;
(g) whenever possible, samples of the printed packaging materials used, including specimens bearing the batch number, expiry date, and any additional overprinting;
(h) notes on any special problems, including details of any deviation from the packaging instructions, with written authorisation by an appropriate person; and
(i) the quantities and reference number or identification of all printed packaging materials and bulk product issued, used, destroyed, or returned to stock and the quantities of product obtained to permit an adequate reconciliation.
Standard operating procedures and records:
6.31 There should be standard operating procedures and records for the receipt of each delivery of starting material and primary and printed packaging material.
6.32 The records of the receipts should include:
(a) the name of the material on the delivery note and the containers;
(b) the "in-house" name and/ or code of material if different from (a) above;
(c) the date of receipt;
(d) the supplier's name and, if possible, manufacturer's name;
(e) the manufacturer's batch or reference number;
(t) the total quantity and number of containers received;
(g) the batch number assigned after receipt; and
(h) any relevant comment (e.g., state of the containers).
6.33 There should be standard operating procedures for the internal labelling, quarantine, and storage of starting materials, packaging materials, and other materials, as appropriate.
6.34 Standard operating procedures should be available for each instrument and piece of equipment and placed in close proximity to the equipment.
6.35 There should be standard operating procedures for sampling, which specify the person(s) authorised to take samples.
6.36 The sampling instructions should include–
(a) the method of sampling and the sampling plan;
(b) the equipment to be used;
(c) any precautions to be observed to avoid contamination of the material or any deterioration in its quality;
(d) the amount(s) of sample(s) to be taken;
(e) instructions for any required subdivision of the sample;
(f) the type of sample container(s) to be used, and whether they are for aseptic sampling or for normal sampling;
(g) any specific precautions to be observed, especially in regard to the sampling of sterile or noxious material.
6.37 There should be a standard operating procedure describing the details of the batch (lot) numbering system, with the objective of ensuring that each batch of intermediate, bulk, or finished product is identified with a specific batch number.
6.38 The standard operating procedures for batch numbering that is applied to the processing stage and to the respective packaging stage should be related to each other.
6.39 The standard operating procedure for batch numbering should assure that the same batch numbers will not be repeatedly used; this applies also to reprocessing.
6.40 Batch-number allocation should be immediately recorded, e.g., in a logbook. The record should include date of allocation, product identity, and size of batch.
6.41 There should be written procedures for testing materials and products at different stages of manufacture, describing the methods and equipment to be used. The tests performed should be recorded.
6.42 Analysis records should include at least the following data–
(a) the name of the material or product and, where applicable, dosage form;
(b) the batch number and, where appropriate, the manufacturer and/or supplier;
(c) references to the relevant specifications and testing procedures;
(d) test results, including observations and calculations, and reference to any specifications (limits);
(e) dates of testing;
(f) the initials of persons who performed the testing;
(g) the initials of the persons who verified the testing and the calculations, where appropriate; and
(h) a clear statement of release or rejection (or other status decision) and the dated signature of the designated responsible person.
6.43 Written release and rejection procedures should be available for materials and products, and in particular for the release for sale of the finished product by an authorised person.
6.44 Complete records of distribution should be maintained of the distribution of each batch of drug in a manner that will facilitate its recall if necessary. Such records should be retained for at least 1 year after expiry date of the batch, and shall include the name and address of the consignee, the date and quantity shipped, and the lot or control numbers identifying the batch of drug.
6.45 Standard operating procedures and associated records of actions taken or, where appropriate, conclusions reached should be available for–
(a) equipment assembly and validation;
(b) analytical apparatus and calibration;
(c) maintenance, cleaning and sanitation;
(d) personnel matters including qualification, training, clothing, and hygiene;
(e) environmental monitoring;
(f) pest controls;
(g) complaints;
(h) recalls; and
(i) returns.
6.46 Logbooks should be kept with major and critical equipment and should record, as appropriate, any validations, calibrations, maintenance, cleaning, or repair operations, including dates and the identity of the people who carried these operations out.
6.47 The use of major and critical equipment and the areas where products have been processed should be appropriately recorded in chronological order.
6.48 There should be written procedures assigning responsibility for sanitation and describing in sufficient detail the cleaning schedules methods, equipment, and materials to be used and facilities to be cleaned. Such written procedures should be followed.
Records and reports:
6.49 Any production, control, or distribution record that is required to be maintained in compliance with this part and is specifically associated with a batch of a drug product shall be retained for at least 1 year after the expiry date of the batch.
6.50 Records shall be maintained for all components, drug product containers, closures, and labelling for at least 1 year after the expiration date of the last lot of drug product incorporating the component or using the container, closure, or labelling.
6.51 All records required under this part, or copies of such records, shall be readily available for authorised inspection during the retention period at the establishment where the activities described in such records occurred. These records shall be subject to photocopying or other means of reproduction as part of such inspection.
6.52 Records required under this part may be retained either as original records or as true copies such as photocopies, microfilm, microfiche, or other accurate reproductions of the original records. Where reduction techniques such as microfilming are used suitable reader and photocopying equipment shall be readily available.
6.53 Written records required by this part shall be maintained so that data therein can be used for evaluating, at least annually, the quality standards of each drug product to determine the need for changes in drug product specifications or manufacturing or control procedures.
Distribution records:
6.54 Distribution records shall contain the name and strength of the product and description of the dosage form, name and address of the consignee, date and quantity shipped, and the lot or control of the drug product. For compressed medical gas products, distribution records are not required to contain lot or control numbers.
Complaint files:
6.55 Written procedures describing the handling of all written and oral complaints regarding a drug product shall be established and followed.
Returned drug products:
6.56 Procedures for the holding, testing and reprocessing of returned drug products shall be in writing and shall be followed.
Drug product salvaging:
6.57 Drug products that have been subjected to improper storage conditions including extremes in temperature, humidity, smoke. fumes, pressure, age, or radiation due to natural disasters, fires, accidents, or equipment failures shall not be salvaged and returned to the market.
6.58 Whenever there is a question whether drug products have been subjected to such conditions, salvaging operations may be conducted only if there is:
(a) Evidence from laboratory tests and assays (including animal tests where applicable) that the drug products meets all applicable standards of identity, strength, quality, and purity;
(b) Evidence from inspection of the premises that the drug products and their associated packaging were not subjected to improper storage conditions as a result of a disaster or accident.
i. Organoleptic examinations shall be acceptable only as supplemental evidence that the drug products meet appropriate standards of identity, strength, quality, and purity.
ii. Records including name, lot number, and disposition shall be maintained for drug products subject to this section.
Batch envelope:
General:
6.59 The purpose of batch envelope is to file all relevant manufacturing / quality control documents relating to a particular drug product lot. The batch envelope serves as an official record of the manufacture, filling, labelling and packaging of each product and the in-process testing and results obtained prior to release and any testing after release of the drug product. A procedure outlining the responsibilities of personnel in the preparation of batch envelope must be written and followed.
Contents of the batch envelope:
6.60 The batch envelope of any product should contain the completed originals of the following documents–
(a) manufacturing order;
(b) standard manufacturing procedure;
(c) material requisitions / materials returns to store;
(d) product yield statement;
(e) quality assurance profile;
(f) manufacturing quality control chart;
(g) fill - label - packing order;
(h) inspection start-up check list;
(i) record of inspection;
(j) fill quality control chart;
(k) packaging materials usage analysis;
(l) finished goods to store transfer note.
Control of the batch envelope:
6.61 The batch envelope should be held at all times by the quality control manager under lock and should not be given to other departments without his authority. Records shall be kept for at least 1 year after expiry of the drug product.
File sample retention:
6.62 A policy with the objective of establishing uniformity and procedure for the retention of file samples must be written and followed. The procedure must apply to samples of raw materials, finished pharmaceutical products, ethical veterinary and animal health products manufactured in Tanzania.
6.63 The procedure must cover the following areas:
(a) sample size;
(b) retention period;
(c) retention area;
(d) size;
(e) storage conditions;
(f) location;
(g) records;
(h) accessibility;
(i) responsibility.
CHAPTER 7
PRODUCTION
Principle:
Production operations must follow clearly defined procedures in accordance with manufacturing and marketing authorisations, with the objective of obtaining products of the requisite quality.
General:
7.1 All handling of materials and products, such as receipt and quarantine, sampling, storage, labelling, dispensing, processing, packaging, and distribution should be done in accordance with written procedures or instructions and must be recorded.
7.2 Any deviation from instructions or procedures should be avoided as far as possible. If deviations occur, they should be approved in writing by a designated person, with the involvement of the quality control department.
7.3 Checks on yields and reconciliation of quantities should be carried out as necessary to ensure that there are no discrepancies outside acceptable limits.
7.4 Operations on different products should not be carried out simultaneously or consecutively in the same room unless there is no risk of mix-up or cross-contamination.
7.5 At all times during processing, all materials, bulk containers, major items of equipment, and where appropriate the rooms used should be labelled or otherwise identified with an indication of the product or material being processed, its strength, and the batch number. Where applicable, this indication must also mention the stage of production.
7.6 Access to production areas should be restricted to authorised personnel.
7.7 Non-medicinal products should not be produced in areas or with equipment destined for the production of pharmaceutical products.
7.8 In-process controls are mostly performed within the production area. They should not carry any risk for the quality of the product.
Prevention of cross-contamination and bacterial contamination in production:
7.9 When dry materials and products are used in production, special precautions should be taken to prevent the generation and dissemination of dust.
7.10 Contamination of starting material or of a product by another material or product should be avoided. This risk of accidental cross-contamination arises from the uncontrolled release of dust, gases, vapours, sprays, or organisms from materials and products in process, from residues on equipment, from intruding insects, and from operators' clothing or skin. The significance of this risk varies with the type of contaminant and of the product being contaminated. Among the most hazardous contaminants are highly sensitizing materials, biological preparations such as living organisms, certain hormones, cytotoxic substances, and other highly active materials. Products in which contamination is likely to be most significant are those administered by injection or applied to open wounds and those given in large doses and/or over a long time.
7.11 Cross-contamination should be avoided by appropriate technical or organisational measures such as–
(a) production should take place in segregated areas (this is required for products such as penicillin, live vaccines, live bacterial preparations and certain other biological preparations);
(b) providing appropriate airlocks, pressure differentials, and air extraction;
(c) minimising the risk of contamination caused by re-circulation or re-entry of untreated or insufficiently treated air;
(d) wearing protective clothing in areas where products with special risk of cross-contamination are processed;
(e) using cleaning and decontamination procedures of known effectiveness, as ineffective cleaning of equipment is a common source of cross-contamination;
(f) using a "closed system" of production;
(g) testing for residues;
(h) using cleanliness status labels on equipment.
7.12 Measures to prevent cross-contamination and their effectiveness should be checked periodically according to standard operating procedures.
7.13 Production areas where susceptible products are processed should undergo periodic microbiological monitoring.
Processing operations:
7.14 Before any processing operation is started, steps should be taken to ensure that the work area and equipment are clean and free from any starting materials, products, product residues, labels, or documents not required for the current operation.
7.15 Any necessary in-process controls and environmental controls should be carried out and recorded.
7.16 Means should be instituted of indicating failures of equipment or of services (e.g., water, gas) to equipment. Defective equipment should be withdrawn from use until the defect has been rectified. Production equipment should be cleaned according to detailed written procedures and stored only under clean and dry conditions.
7.17 Containers for filling should be cleaned before filling. Attention should be given to avoiding and removing any contaminants such as glass fragments and metal particles.
7.18 Any deviation from the expected yield should be recorded and investigated.
7.19 Checks should be carried out to ensure that pipelines and other pieces of equipment used for the transportation of products from one area to another are connected in a correct manner.
7.20 Pipelines used for conveying distilled or deionized water and, other water-pipes should be sanitized according to written procedures that detail the action limits for microbiological contamination and the measures to be taken.
7.21 Measuring, weighing, recording, and control equipment and instruments should be serviced and calibrated at pre-specified intervals and records maintained. To ensure satisfactory functioning, instruments should be checked daily or prior to use for performing analytical tests. The date of calibration and servicing and the date when re-calibration is due should be clearly indicated.
7.22 Repair and maintenance operations should not present any hazard to the quality of the products.
Packaging operations:
7.23 When the programme for packaging operations is being set up, particular attention should be given to minimising the risk of cross-contamination, mix-ups, or substitutions. Different products should not be packaged in close proximity unless there is physical segregation.
7.24 Before packaging operations are begun, steps should be taken to ensure that the work area, packaging lines, printing machines, and other equipment are clean and free from any products, materials, or documents previously used and not required for the current operation. The line clearance should be performed according to an appropriate checklist and should be recorded.
7.25 The name and batch number of the product being handled should be displayed at each packaging station or line.
7.26 Filling and sealing should be followed as quickly as possible by labelling. If labelling is delayed, appropriate procedures should be applied to ensure that no mix-ups or mislabelling can occur.
7.27 The correct performance of any printing (code numbers, expiry dates, etc.) done separately or in the course of the packaging should be checked and recorded. Attention should be paid to printing by hand, which should be rechecked at regular interval.
7.28 Special care should be taken when cut labels are used and when overprinting is carried out off-line, and in hand-packaging operations. Roll-feed labels are normally preferable to cut labels in helping to avoid mix-ups. On-line verification of all labels by automated electronic means is helpful in preventing mix-ups, but checks should be made to ensure that any electronic code readers, label counters, or similar devices are operating correctly.
7.29 Printed and embossed information on packaging materials should be distinct and resistant to fading or erasing.
7.30 On-line control of the product during packaging should include at least the checks on–
(a) the general appearance of the packages;
(b) whether the packages are complete;
(c) whether the correct products and packaging materials are used;
(d) whether the overprinting is correct;
(e) the correct functioning of line monitors.
Samples taken away from the packaging line should not be returned.
7.31 Products that have been involved in an unusual event during packaging should be reintroduced into the process only after special inspection, investigation, and approval by authorised personnel involving the quality control department. A detailed record should be kept of this operation.
7.32 Any discrepancy observed during reconciliation of the amount of bulk product and printed packaging materials and the number of units produced should be investigated and satisfactorily accounted for before release.
7.33 Upon completion of a packaging operation any unused batch-coded packaging materials should be destroyed and the destruction recorded. A documented procedure should be followed if uncoded printed materials are returned to stock.
Materials:
Principle:
7.34 The main objective of a pharmaceutical plant is to produce finished products for patients' use from a combination of materials (active, auxiliary, packaging). Special attention should be given to the materials as such.
General:
7.35 All incoming materials and finished products should be quarantined immediately after receipt or processing, until they are released for use or distribution.
7.36 All materials and products should be stored under the appropriate conditions established by the manufacturer and in an orderly fashion to permit batch segregation and stock rotation by a first-in, first-out rule.
Starting materials:
7.37 The purchase of starting materials is an important operation that should involve staff who have a particular and through knowledge of the products and suppliers.
7.38 Starting materials should be purchased only from suppliers named in the relevant specification and, where possible, directly from the producer. It is also recommended that the specifications established by the manufacturer for the starting materials be discussed with the suppliers. It is of benefit that all aspects of the production and control of the starting material in question, including handling, labelling, and packaging requirements as well as complaints and rejection procedures, are discussed between the manufacturer and the supplier.
7.39 For each consignment, the containers should be checked for integrity of package and seal and for correspondence between the order, the delivery note, and the supplier's labels.
7.40 All incoming materials should be checked to ensure that the consignment corresponds to the order. Containers should be cleaned where necessary and labelled, with the prescribed data.
7.41 Damage to containers and any other problem that might adversely affect the quality of a material should be recorded and reported to the quality control department and investigated.
7.42 If one delivery of material is made up of different batches, each batch must be considered as separate for sampling, testing, and release.
7.43 Starting materials in storage area should be appropriately labelled. Labels should bear at least the following information–
(a) the designated name of the product and the internal code reference where applicable;
(b) the batch number(s) given by the supplier and on receipt by the manufacturer, if any;
(c) where appropriate, the status of the contents (e.g., on quarantine, on test, released, rejected, returned, recalled);
(d) where appropriate, an expiry date or a date beyond which re-testing is necessary.
7.44 There should be appropriate procedures or measures to ensure the identity of the contents of each container of starting material. Bulk containers from which samples have been drawn should be identified.
7.45 Only starting materials released by quality control department and within their shelf-life should be used.
7.46 Starting materials should be dispensed only by designated persons, following a written procedure, to ensure that the correct materials are accurately weighed or measured into clean and properly labelled containers.
7.47 Each dispensed material and its weight or volume should be independently checked and the check recorded.
7.48 Materials dispensed for each batch of the final product should be kept together and conspicuously labelled as such.
Packaging Materials:
7.49 The purchase, handling, and control of primary and printed packaging materials shall be as for starting materials.
7.50 Particular attention should be paid to printed packaging materials. They should be stored in secure conditions so as to exclude the possibility of unauthorised access. Cut labels and other loose printed materials should be stored and transported in separate closed containers so as to avoid mix-ups. Packaging materials should be issued for use only by designated personnel following an approved and documented procedure.
7.51 Each delivery or batch of printed or primary packaging material should be given a specific reference number or identification mark.
7.52 Outdated or obsolete primary packaging material or printed packaging material should be destroyed and its disposal recorded.
7.53 All products and packaging materials to be used should be checked on delivery to the packaging department for quantity, identity, and conformity with the packaging instructions.
Intermediate and bulk products:
7.54 Intermediate and bulk products should be kept under appropriate conditions.
7.55 Intermediate and bulk products purchased as such should be handled on receipt as though they were starting materials.
Finished Products:
7.56 Finished products should be held in quarantine until their final release, after which they should be stored as usable stock under conditions established by the manufacturer.
7.57 The evaluation of finished products and the documentation necessary for release of a product for sale are described in Chapter 8, "Quality Control".
Rejected and recovered materials:
7.58 Rejected materials and products should be clearly marked as such and stored separately in restricted areas. They should either be returned to the suppliers, or, where appropriate, reprocessed or destroyed. Whatever action is taken should be approved by the authorised personnel and recorded.
7.59 The reprocessing of rejected products should be exceptional. It is permitted only if the quality of the final product is not affected, if the specifications are met, and it is done in accordance with a defined and authorised procedure after evaluation of the risks involved. A record should be kept of the reprocessing. A reprocessed batch should be given a new batch number.
7.60 The introduction of all or part of earlier batches, conforming to the required quality, into a batch of the same product at a defined stage of manufacture should be authorised beforehand. This recovery should be carried out in accordance with a defined procedure after evaluation of the risks involved, including any possible effect on shelf-life. The recovery should be recorded.
7.61 The need for additional testing of any finished product that has been reprocessed, or into which a recovered product has been incorporated, should be considered by the quality control department.
Recalled products:
7.62 Recalled products should be identified and stored separately in a secure area until a decision is taken on their fate. The decision should be made as soon as possible.
Returned goods:
7.63 Products returned from the market should be destroyed unless it is certain that their quality is satisfactory; they may be considered for resale, relabelling, or bulking with a subsequent batch only after they have been critically assessed by quality control department in accordance with a written procedure. The nature of the product, any special storage conditions it requires, its condition and history, and the time elapsed since it was issued should all be taken into account in this assessment. Where any doubt arises over the quality of the product, it should not be considered for re-issue or re-use. Any action taken should be appropriately recorded.
Waste materials:
7.64 Provision should be made for the proper and safe storage of waste materials awaiting disposal. Toxic substances and flammable materials should be stored in suitably designed, separate, and enclosed cupboards.
7.65 Waste material should not be allowed to accumulate. It should be collected in suitable receptacles for removal to collection points outside the buildings and disposed of safely and in a sanitary manner at regular and frequent intervals.
Miscellaneous:
7.66 Rodenticides, insecticides, fumigating agents, and sanitizing materials should not be permitted to contaminate equipment, starting materials, packaging materials, in-process materials, or finished products.
Component, drug product container, closure, and labelling records:
7.67 These records shall include the following–
(a) the identity and quantity of each shipment of each lot of components, drug product containers, closures, and labelling; the name of the supplier;
(b) the supplier's lot number(s) if known;
(c) the receiving code;
(d) the date of receipt;
(e) the name and location of the prime manufacturer if different from the supplier, shall be known;
(f) the results of tests or examination performed;
(g) the conclusions derived therefrom;
(h) an individual inventory record of each component, drug product container, and closure and, for each component, a reconciliation of the use of each lot of such component;
(i) the inventory record shall contain sufficient information to allow determination of any batch or lot of drug product associated with the use of each component, drug product container, and closure;
(j) documentation of examination and review of labels and labelling for conformity with established specifications;
(k) the disposition of rejected components, drug product containers, closure, and labelling.
Master production and control records:
7.68 To assure uniformity from batch to batch, master production and control records for each drug product, including each batch size thereof, shall be prepared, dated, and signed (full signature, handwritten) by one person and independently checked, dated, and signed by a second person.
7.69 The preparation of master production and control records shall be described in a written procedure and such written procedure shall be followed.
Batch production and control records:
7.70 Batch production and control records shall be prepared for each Batch of drug product produced and shall include complete information relating to the production and control of each batch. These records shall include–
(a) an accurate reproduction of the appropriate master production or control record, checked for accuracy, dated, and signed;
(b) documentation that each significant step in the manufacture, processing, packing, or holding of the batch was accomplished, including;
(c) dates;
(d) identity of individual major equipment and lines used;
(e) specific identification of each batch of component or in-process material used;
(f) weights and measures of components used in the course of processing;
(g) in process and laboratory control results;
(h) inspection of the packaging and labelling area before and after use;
(i) a statement of the actual yield and a statement of the percentage of theoretical yield at appropriate phases of processing;
(j) complete labelling control records, including specimens or copies of all labelling used;
(k) description of drug product containers and closures;
(l) any sampling performed;
(m) identification of the persons performing and directly supervising or checking each significant steps in the operations;
(n) any investigation made;
(o) results of examinations made.
CHAPTER 8
QUALITY CONTROL
Principle:
Quality control is concerned with sampling, specifications, and testing as well as with the organisation, documentation, and release procedures that ensure that the necessary and relevant tests are carried out, and that materials are not released for use, nor products released for sale or supply, until their quality has been judged satisfactory. Quality control is not confined to laboratory operations, but must be involved in all decisions that may concern the quality of the product. The independence of quality control from production is fundamental.
General:
Control of starting materials and intermediate, bulk, and finished products:
8.1 All tests should follow the instructions given in the relevant written test procedure for each material or product. The result should be checked by the supervisor before the material or product is released or rejected.
8.2 Samples should be representative of the batches of material from which they are taken in accordance with the approved written procedure.
8.3 Sampling should be carried out so as to avoid contamination or other adverse effects on quality. The containers that have been sampled should be marked accordingly and carefully resealed after sampling.
8.4 Care should be taken during sampling to guard against contamination or mix-up of, or by, the material being sampled. All sampling equipment that comes into contact with the material should be clean. Particularly hazardous or potent materials require special precautions.
8.5 Sampling equipment should be cleaned and, if necessary sterilised before and after each use and stored separately from other laboratory equipment.
8.6 Each sample container should bear a label indicating–
(a) the name of the sampled material;
(b) the batch or lot number;
(c) the number of the container from which the sample has been taken;
(d) the signature of the person who has taken the sample; and
(e) the date of sampling.
Test requirements:
8.7 Starting and Packaging materials
Before releasing a starting or packaging material for use, the quality control manager should ensure that the materials have been tested for conformity with specifications for identity, strength, purity, and other quality parameters.
8.8 An identity test should be conducted on a sample from each container of starting material. Each batch (lot) of printed packaging materials must be examined following receipt.
8.9 In lieu of testing by the manufacturer, a certificate of analysis may be accepted from the supplier, provided that the manufacturer establishes the reliability of the supplier's analysis through appropriate periodic validation of the supplier's test results and through on-site audits of the supplier's capabilities. Certificates must be originals (not photocopies). Certificates must contain the following information–
(a) identification of the issuing supplier, signature of the competent official, and statement of his or her qualifications;
(b) the name and batch number of the material tested;
(c) a statement of specifications and methods used; and
(d) a statement of test results obtained and the date of testing.
8.10 In-process control
In-process control records should be maintained and form part of the batch records.
8.11 Finished Products
For each batch of drug product there should be an appropriate laboratory determination of satisfactory conformity to its finished product specification prior to release.
8.12 Products failing to meet the established specifications or any other relevant quality criteria should be rejected. Reprocessing may be performed, if feasible, but the reprocessed product should meet all specifications and other quality criteria prior to its acceptance and release.
Production record review:
8.13 Production and control records should be reviewed and any divergence or failure of a batch to meet its specifications should be thoroughly investigated. The investigation should, if necessary, extend to other batches of the same product and other products that may have been associated with the specific failure or discrepancy. A written record of the investigation should be made and should include the conclusion and follow-up action.
8.14 Retention samples from each batch of finished product should be kept for at least one year after expiry date. Finished products should be kept in their final packaging and stored under the recommended conditions. If exceptionally large packages are produced, smaller samples might be stored in appropriate containers. Samples of active starting materials should be retained for at least one year beyond the expiry date of the last batch of finished product in which the material was used. Other starting materials (other than solvents, gases, and water) should be retained for a minimum of two years if their stability allows. Retention samples of materials and products should be of a size sufficient to permit at least two full re-examinations.
Stability Studies:
8.15 The quality control department should evaluate the quality and stability of finished pharmaceutical products, and when necessary, of starting materials and intermediate products.
8.16 The quality control department should establish expiry dates and shelf-life specifications on the basis of stability tests related to storage conditions.
8.17 A written programme for ongoing stability determination should be developed and implemented to include elements such as–
(a) a complete description of the drug involved in the study;
(b) the complete testing parameters and methods describing all tests for potency, purity, and physical characteristics and documented evidence that these tests indicate stability;
(c) provision for the inclusion of a sufficient number of batches;
(d) the testing schedule for each drug;
(e) provision for special storage conditions;
(f) provision for adequate sample retention; and
(g) a summary of all the data generated, including the evaluation and the conclusion of the study.
8.18 Stability should be determined prior to marketing and following any significant changes in process, equipment, packaging materials, etc.
Reagents and culture media:
8.19 All reagents and culture media should be recorded upon receipt or preparation.
8.20 Reagents made up in the laboratory should be prepared according to written procedures and appropriately labelled. The label should indicate the concentration, standardisation factor, shelf-life, the date when re-standardisation is due, and the storage conditions. The label should be signed and dated by the person preparing the reagent.
8.21 Both positive and negative controls should be applied to verify the suitability of culture media. The size of the inoculum used in positive controls should be appropriate to the sensitivity required.
Reference standards:
8.22 Reference standards should be available in the form of official reference standards. Reference standards prepared by the producer should be tested, released, and then stored in the same way as official standards. They should be kept under the responsibility of a designated person in a secure area.
8.23 Official reference standards should be used only for the purpose described in the appropriate monograph.
8.24 Secondary or working standards may be established by the application of appropriate tests and checks at regular intervals to ensure standardisation. All in-house reference standards should be based on official reference standards.
8.25 All reference standards should be stored and used in a manner that will not adversely affect their quality.
CHAPTER 9
CONTRACT MANUFACTURE AND ANALYSIS
Principle:
Contract production and analysis must be correctly defined, agreed, and controlled in order to avoid misunderstandings that could result in a product or work and analysis of unsatisfactory quality. There must be a written contract between the contract giver and the contract acceptor which clearly establishes the duties of each party. The contract must clearly state the way in which the authorised person, in releasing each batch of product for sale or issuing the certificate of analysis, exercises his or her full responsibility.
General:
9.1 All arrangements for contract manufacture and analysis, including any proposed changes in technical or other arrangements, should be in accordance with the marketing authorisation for the product concerned.
9.2 There should be a written contract covering the manufacture and/or analysis arranged under contract and any technical arrangements made in connection with it.
9.3 The contract should permit the contract giver to audit the facilities of the contract acceptor.
The contract giver:
9.4 The contract giver is responsible for assessing the competence of the contract acceptor in successfully carrying out the work or tests required and for ensuring by means of the contract that the principles of GMP described in this guide are followed.
9.5 The contract giver should provide the contract acceptor with all the information necessary to carry out the contracted operations correctly in accordance with the marketing authorisation and any other legal requirements. The contract giver should ensure that the contract acceptor is fully aware of any problems associated with the product, work or tests that might pose a hazard to premises, equipment, personnel, other materials, or other products.
9.6 The contract giver should ensure that all processed products and materials delivered by the contract acceptor comply with their specifications or that the product has been released by the authorised person(s).
The contract acceptor:
9.7 The contract acceptor must have adequate premises, equipment, knowledge, and experience and competent personnel to carry out satisfactorily the work ordered by the contract giver. Contract manufacture may be undertaken only by a manufacturer who holds a manufacturing authorisation.
9.8 The contract acceptor should not pass to a third party any of the work entrusted to him or her under the contract without the contract giver's prior evaluation and approval of the arrangements. Arrangements made between the contract acceptor and any third party should ensure that the manufacturing and analytical information is made available in the same way as between the original contract giver and contract acceptor.
9.9 The contract acceptor should refrain from any activity that may adversely affect the quality of the product manufactured and/or analysed for the contract giver.
The contract:
9.10 A contract should be drawn up between the contract giver and the contract acceptor that specifies their respective responsibilities relating to the manufacture and control of the product. Technical aspects of the contract should be drawn up by competent persons suitably knowledgeable in pharmaceutical technology, analysis, and GMP. All arrangements for production and analysis must be in accordance with the marketing authorisation and agreed by both parties.
9.11 The contract should specify the way in which the authorised person releasing the batch for sale ensures that each batch has been manufactured in, and checked for, compliance with the requirements of the marketing authorisation.
9.12 The contract should describe clearly who is responsible for purchasing, testing, and releasing materials and for undertaking production and quality controls, including in-process controls, and who has responsibility for sampling and analysis.
9.13 Manufacturing, analytical, and distribution records and reference samples should be kept by, or be available to, the contract giver. Any records relevant to assessing the quality of a product in the event of complaints or a suspected defect must be accessible and specified in the defect/recall procedures of the contract giver.
9.14 The contract should describe the handling of starting materials. intermediate and bulk products if they are rejected. It should also describe the processing of information if analysis shows that the tested product must be rejected.
CHAPTER 10
COMPLAINTS AND PRODUCT RECALL
Principle:
All complaints and other information concerning potentially defective products must be carefully reviewed according to written procedures.
Complaints:
10.1 A person responsible for handling the complaints and deciding the measures to be taken should be designated, together with sufficient supporting staff to assist him or her. If this person is different from the authorised person, the latter should be made aware of any complaint, investigation, or recall.
10.2 There should be written procedures describing the action to be taken, including the need to consider a recall, in the case of a complaint concerning a possible product defect.
10.3 Any complaint concerning a product defect should be recorded with all the original details and thoroughly investigated. The person responsible for quality control should be involved in the study of such problems.
10.4 If a product defect is discovered or suspected in a batch, consideration should be given to whether other batches should be checked in order to determine whether they are also affected. In particular, other batches that may contain reprocessed product from the defective batch should be investigated.
10.5 Where necessary, appropriate follow-up action, possibly including product recall, should be taken after investigation and evaluation of the complaint.
10.6 All the decisions and measures taken as a result of a complaint should be recorded and referenced to the corresponding batch records.
10.7 Complaint records should be regularly reviewed for any indication of specific or recurring problems that require attention and might justify the recall of marketed products.
10.8 The Pharmacy Board should be informed if a manufacturer is considering action following possibly faulty manufacture, product deterioration, or any other serious quality problems with a product.
10.9 Written records involving a drug product shall be maintained until at least 1 year after the expiration date of the drug product, or 1 year after the date that the complaint was received, whichever is longer.
10.10 The written record shall include the following information: The name and strength of the drug product, lot number, name of complainant, nature of complaint, and reply to complaint.
10.11 Where an investigation under section 10.4 of these guidelines is conducted, the written record shall include the findings of the investigation and follow-up. The record of the investigation shall be maintained at the factory where the investigation occurred for at least 1 year after the expiration date of the drug product, or 1 year after the date that the investigation was concluded whichever is longer.
10.12 Where an investigation under section 10.4 of these guidelines is not conducted, the written record shall include the reason that an investigation was found not to be necessary and the name of the responsible person making such a determination.
Product recalls:
10.13 There should be a system to recall from the market, promptly and effectively, products known or suspected to be defective.
10.14 A person responsible for the execution and co-ordination of recalls should be designated, as well as sufficient staff to handle all aspects of the recalls with the appropriate degree of urgency. This person should be independent of the sales and marketing organisation. If this person is different from the authorised person, the latter should be made aware of any recall operation.
10.15 There should be established written procedures, regularly checked and updated, for the organisation of any recall activity. Recall operations should be capable of being initiated promptly at least down to the level of the hospital or retail Pharmacy.
10.16 All competent authorities of all countries to which a given product may have been distributed should be promptly informed of any intention to recall the product because it is, or is suspected of being, defective.
10.17 The distribution records should be readily available to the person(s) responsible for recalls, and they should contain sufficient information on wholesalers and directly supplied customers (including, for exported products, those who have received samples for clinical tests and medical samples) to permit an effective recall.
10.18 The progress of the recall process should be recorded and a final report issued, including a reconciliation between the delivered and recovered quantities of the products.
10.19 The effectiveness of the arrangements for recalls should be evaluated from time to time.
10.20 An instruction should be included to store recalled products in a secure segregated area while their fate is decided.
CHAPTER 11
SELF-INSPECTION AND QUALITY AUDITS
Principle:
The purpose of self-inspection is to evaluate the manufacturer's compliance with GMP in all aspects of production and quality control. The self-inspection programme should be designed to detect any shortcomings in the implementation of GMP and to recommend the necessary corrective actions. Self-inspections should be performed routinely, and may be, in addition, performed on special occasions, e.g. in case of product recalls or repeated rejections, or when an inspection by the health authorities is announced. The team responsible for self-inspection should consist of personnel who can evaluate the implementation of GMP objectively; all recommendations for corrective action should be implemented. The procedure for self-inspection should be documented, and there should be an effective follow-up programme.
Items for self-inspection:
11.1 Written instructions for self-inspection should be established to provide a minimum and uniform standard of requirements. These may include questionnaires on GMP covering at least the following items:
(a) personnel;
(b) premises including personnel facilities;
(c) maintenance of buildings and equipment;
(d) storage of starting materials and finished products;
(e) equipment;
(f) production and in-process controls;
(g) quality control;
(h) documentation;
(i) sanitation and hygiene;
(j) validation and revalidation programmes;
(k) calibration of instruments or measurement systems;
(l) recall procedures;
(m) complaints management;
(n) labels control;
(o) results of previous self-inspections and any corrective action taken.
Self-inspection team:
11.2 Management should appoint a self-inspection team from local staff who are expert in their own fields and familiar with GMP. The members of the team may be appointed from inside or outside the company.
Frequency of self-inspection:
11.3 The frequency at which self-inspections are conducted will depend on company requirements.
Self-inspection report:
11.4 A report should be made at the completion of a self-inspection. The report should include:
(a) self-inspection results;
(b) evaluation and conclusions;
(c) recommended corrective actions.
Follow-up action:
11.5 The company management should evaluate both the self-inspection report and the corrective actions as necessary.
Quality audit:
11.6 It is necessary to supplement self-inspections with a quality audit. A quality audit consists of an examination and assessment of all or part of a quality system with the specific purpose of improving it. A quality audit should be conducted by outside or independent specialists or a team designated by the management for this purpose. Such audits should also be extended to suppliers and contractors. (see Chapter 9 Contract Manufacture and analysis).
Suppliers' audits:
11.7 The quality control department should have responsibility together with other relevant departments for approving suppliers who can reliably supply starting and packaging materials that meet established specifications.
11.8 Before suppliers are approved and included in the specifications they should be evaluated. The evaluation should take into account a supplier's history and the nature of the materials to be supplied. If an audit is required, it should determine the supplier's ability to conform to GMP standards for active pharmaceutical ingredients.
CHAPTER 12
MANUFACTURE OF STERILE MEDICINAL PRODUCTS
Principle:
The manufacture of sterile preparations has special requirements in order to minimise risks of microbiological contamination, and of particulate and pyrogen contamination. Much depends on the skill, training and attitudes of the personnel involved. Quality Assurance bears a particularly great importance, and this manufacture must strictly follow carefully established and validated methods of preparation and procedures.
Explanation:
These guidelines do not replace any of the sections in chapter two to eleven but stress specific points for the manufacture of sterile preparations to minimise the risks of microbiological, particulate, and pyrogen contamination.
General:
12.1 The production of sterile preparations should be carried out in clean areas, entry to which should be through airlocks for personnel and/or for goods. Clean areas should be maintained to an appropriate standard of cleanliness and supplied with air that has passed through filters of an appropriate efficiency.
12.2 The various operations of component preparation (containers and closures), product preparation, filling, and sterilisation should be carried out in separate areas within the clean area.
12.3 Clean area for the production of sterile products are classified according to the required characteristics of the air, in grades A, B, C, and D (see Table 1)
Table 1:
Air classification system for manufacture of sterile products
Maximum number of particles permitted per m3 equal to or above | |||
Grade | 0.5 - 5m3 | 5m3 | Maximum number of viable micro-organisms permitted per m3 |
A | 3500 | none | Less than 1 |
B | 3500 | none | 5 |
C | 350000 | 2000 | 100 |
D | 3500000 | 20000 | 500 |
It should be noted that:
• Laminar-airflow systems should provide a homogeneous air speed of about 0.30m/s for vertical flow and about 0.45m/s for horizontal flow but precise air speeds will depend on the type of equipment.
• In order to reach the B, C, and D air grades, the number of air changes should generally be higher than 20 per hour in a room with a good airflow pattern and appropriate HEPA (high-efficiency particulate air) filters.
• Low values for contaminants are reliable only when a large number of air samples are taken.
• The guidance given for the maximum permitted number of particles corresponds approximately to the United States Federal Standard 209E (1992) as follows: Class 100 (grades A and B), Class 10000 (grade C), and Class 100000 (grade D). And to British standard 3829 (adopted by the British Pharmacopoeia and the United States Pharmacopoeia).
It may not always be possible to demonstrate conformity with particular all standards at the point of fill when filling is in progress, owing to the generation of particles or droplets from the product itself.
12.4 Each manufacturing operation requires an appropriate air cleanliness level in order to minimise the risks of particulate or microbial contamination of the product or materials being handled. Section 12.5 gives the minimum air grades required for different manufacturing operations: The particulate and microbiological conditions given in Table 1 should be maintained in the zone immediately surrounding the product whenever the product is exposed to the environment. These conditions should also be achieved throughout the background environment if no personnel are present in the processing area, and if the standards fall for any reason it should be possible to recover the conditions after a short "clean-up" period. The utilisation of absolute-barrier technology and automated systems to minimise human interventions in processing areas can produce significant advantages in ensuring the sterility of manufactured products. When such techniques are used, the recommendations in these supplementary guidelines, particularly those relating to air quality and monitoring, still apply, with appropriate interpretation of the terms "workstation" and "environment".
Manufacture of sterile preparations:
12.5 Manufacturing operations are here divided into three categories: first those in which the preparation is sealed in its final container and terminally sterilised: second, those in which the preparation is sterilised by filtration; and third, those in which the preparation can be sterilised neither by filtration nor terminally and consequently must be produced from sterile starting materials in an aseptic way. Area grades as specified in sections 12.6 to 12.8. must be selected by the manufacturer on the basis of validation runs (e.g. sterile media fills).
Terminally sterilised products:
12.6 Solutions should be prepared in a grade C environment in order to give low microbial and particulate counts, suitable for immediate filtration and sterilisation. For parenterals, filling should be done in a laminar-airflow workstation (grade A) in a grade C environment. The preparation of other sterile products, e.g. ointments, creams, suspensions, and emulsions, and filling of containers should be done in grade C environment before terminal sterilisation.
Sterile filtered products:
12.7 The handling of starting materials and the preparation of solutions should be done in a grade C environment. After sterile filtration, the product must be handled and dispensed into containers under aseptic conditions in a grade A or B area with grade B or C background respectively.
12.8 The handling of starting materials and all further processing should be done in a grade A or B area with a grade B or C background respectively.
Personnel:
12.9 Only the minimum number of personnel required should be present in clean areas; this is particularly important during aseptic processes. Inspections and controls should be conducted from outside the areas as far as possible.
12.10 All personnel (including those concerned with cleaning and maintenance) employed in such areas should receive regular training in disciplines relevant to the correct manufacture of sterile products, including reference to hygiene and to the basic elements of microbiology. When outside staff who have not received such training (e.g., building or maintenance contractors) need to be brought in, particular care should be taken over their supervision.
12.11 Staff who have been engaged in the processing of animal-tissue materials or of cultures of micro-organisms other than those used in the current manufacturing process should not enter sterile-product areas unless rigorous and clearly defined decontamination procedures have been followed.
12.12 High standards of personal hygiene and cleanliness are essential, and personnel involved in the manufacture of sterile preparations should be instructed to report any condition that may cause the shedding of abnormal numbers or types of contaminants; periodic health checks for such conditions are desirable. Actions to be taken about personnel who could be introducing undue microbiological hazard should be decided by a designated competent person.
12.13 Outdoor clothing should not be brought into the clean areas, and personnel entering the changing rooms should already be clad in standard factory protective garments. Changing and washing should follow a written procedure.
12.14 The clothing and its quality has to be adapted to the process and the workplace, and worn in such a way as to protect the product from contamination.
12.15 Wrist-watches and jewellery should not be worn in clean areas, and cosmetics that can shed particles should not be used.
12.16 Clothing should be appropriate to the air grade of the area where the personnel will be working. The description of clothing required for each grade is given below.
Grade D: The hair and, where appropriate, beard should be covered. Protective clothing and appropriate shoes or overshoes should be worn. Appropriate measures should be taken to avoid any contamination coming from outside the clean area.
Grade C: The hair and, where appropriate, beard should be covered. A single or two-piece trouser suit, gathered at the wrists and with a high neck, and appropriate shoes or overshoes should be worn. The clothing should shed virtually no fibres or particulate matter.
Grade B: Headgear should totally enclose the hair and, where appropriate, beard; it should be tucked into the neck of the suit; a face mask should be worn to prevent the shedding of droplets; sterilised non-powdered rubber or plastic gloves and sterilised or disinfected footwear should be worn; trouser-bottoms should be tucked inside the footwear and garment sleeves into the gloves. The protective clothing should shed virtually no fibres or particulate matter and should retain particles shed by the body.
12.17 For every worker in a grade B room, clean sterilised protective garments should be provided at each work session, or at least once a day if monitoring results justify it. Gloves should be regularly disinfected during operations, and masks and gloves should be changed at least at every working session. The use of disposable clothing may be necessary.
12.18 Clothing used in clean areas should be laundered or cleaned in such a way that it does not gather additional particulate contaminants that can later be shed. Separate laundry facilities for such clothing are desirable. If fibres are damaged by inappropriate cleaning or sterilisation there will be an increased risk of shedding particles and should therefore not be used. Washing and sterilisation should follow standard operating procedures.
Premises:
12.19 All premises should as far as possible be designed to avoid the unnecessary entry of supervisory or control personnel. Grade B areas should be designed so that all operations can be observed from outside.
12.20 In clean areas, all exposed surfaces should be smooth, impervious, and unbroken in order to minimise the shedding or accumulation of particles or micro-organisms and to permit the repeated application of cleaning agent and disinfectants, where used.
12.21 To reduce the accumulation of dust and to facilitate cleaning there should be no uncleanable recesses and a minimum of projecting ledges, shelves, cupboards, and equipment. Doors should be carefully designed to avoid uncleanable recesses; sliding doors are undesirable for this reason.
12.22 False ceilings should be sealed to prevent contamination from the space above them.
12.23 Pipes and ducts should be installed so that they do not create recesses that are difficult to clean.
12.24 Sinks and drains should be avoided wherever possible and should be excluded from areas where aseptic operations are carried out. Where installed they should be designed, located, and maintained so as to minimise the risks of microbial contamination; they should be fitted with effective, easily cleanable traps with air breaks to prevent back-flow. Any floor channel should be open and easily cleanable and be connected to drains outside the area in a manner that prevents ingress of microbial contaminants.
12.25 Changing rooms should be designed as airlocks and used to provide separation of the different stages of changing, so minimising microbial and particulate contamination of protective clothing. They should be effectively flushed with filtered air. The use of separate changing rooms (or entering and leaving clean areas is desirable. Hand-washing facilities should be provided only in the changing rooms, not in areas where aseptic work is done.
12.26 Airlock doors should not be opened simultaneously. An interlocking system and a visual and/or audible warning system should be operated to prevent the opening of more than one door at a time.
Equipment:
12.27 A filtered air supply should maintain a positive pressure relative to surrounding areas under all operational conditions and flush the area effectively. Particular attention should be paid to the protection of the zone of greatest risk, that is, the immediate environment to which the product and the cleaned components in contact with it are exposed. The various recommendations regarding air supplies and pressure differentials may need to be modified in order to contain materials such as pathogenic, highly toxic, radioactive, or live viral or bacterial materials. Decontamination facilities and the treatment of air leaving a clean area may be necessary for some operations.
12.28 It should be demonstrated that airflow patterns do not present a contamination risk, for example care should be taken to ensure that airflows do not distribute particles from a particle-generating person, operation, or machine to a zone of higher product risk.
12.29 A warning system should be included to indicate failure in the air supply. An indicator of pressure difference should be fitted between areas where this difference is important and the pressure difference should be regularly recorded.
12.30 Consideration should be given to restricting unnecessary access to critical filling areas, e.g. grade A-filling zones, by the use of a physical barrier.
12.31 A conveyor belt should not pass through a partition between a clean area B and a processing area of lower air cleanliness, unless the belt itself is continuously sterilised (like in a sterilising tunnel).
12.32 Equipment used for processing sterile products should be chosen such that it can be effectively sterilised by steam or dry heat or other methods.
12.33 Equipment fittings and services should be designed and installed so that operations, maintenance, and repairs can be carried out outside the clean area. Equipment that has to be taken apart for maintenance should be re-sterilised after complete re-assembly.
12.34 When equipment maintenance is carried out within the clean area, clean instruments and tools should be used, and the area should be cleaned and disinfected before processing recommences.
12.35 All equipment; including sterilisers, air-filtration systems, and water-treatment systems including stills, should be subject to planned maintenance, validation, and monitoring; its approved use following maintenance work should be documented.
12.36 Water-treatment plants should be designed, constructed, and maintained so as to ensure the reliable production of water of an appropriate quality. They should not be operated beyond their designed capacity. Water should be produced, stored, and distributed in a manner that prevents microbial growth - for example, by constant circulation at 80ºC or not more than 4ºC.
Sanitation:
12.37 The sanitation of clean areas is particularly important. They should be cleaned frequently and thoroughly in accordance with a written programme approved by the quality control department. Where disinfectants are used, more than one type should be employed, with periodic alterations. Monitoring should be regularly undertaken in order to detect the emergence of resistant strains of micro-organisms. In view of its limited effectiveness, ultraviolet light should not be used as a substitute for chemical disinfection.
12.38 Disinfectants and detergents should be monitored for microbial contamination; dilutions should be kept in previously cleaned containers and should not be stored for long periods unless sterilised. Partly emptied containers should not be topped up.
12.39 Fumigation of clean areas is necessary for reducing microbiological contamination in inaccessible places.
12.40 Clean areas should be monitored at planned intervals during operations by means of microbial counts of air and surfaces; where aseptic operations are performed, monitoring should be frequent to ensure that the environment is within specifications. The results of monitoring should be considered when batches are assessed for approval. Air particulate quality should also be evaluated on a regular basis. Additional monitoring is desirable even when there are no production operations, e.g., after validation of systems, cleaning, and fumigation.
Processing:
12.41 Precautions to minimise contamination should be taken during all processing stages, including the stages before sterilisation.
12.42 Preparations containing live microbiological organisms should not be made or containers filled in areas used for the processing of other pharmaceutical products; however, vaccines of dead organisms or of bacterial extracts may be dispensed into containers, after validated inactivation and validated cleaning procedures, in the same premises as other sterile pharmaceutical products.
12.43 The use of nutrient media that support microbial growth in trials to simulate aseptic operations (sterile media fills; "broth fills") is a valuable part of overall validation of an aseptic process. Such trials should have the following characteristics–
(a) they should simulate as closely as possible actual operations, taking into account such factors as complexity of operations, number of personnel working, and length of time;
(b) the medium or media selected should be capable of growing a wide spectrum of micro-organisms, including those that would be expected to be found in the filling environment;
(c) they should include a sufficient number of units of production to give a high degree of assurance that low levels of contamination, if present would be detected.
It is recommended that at least 1,000 units of production be included in each broth-fill trial. The target should be zero growth and anything above 0.1 % of units contaminated should be considered unacceptable. Any contamination should be investigated. Broth fills should be repeated at regular intervals, and whenever there is an alteration in the product, premises, equipment, or process warrants revalidation.
12.44 Care should be taken that validations do not harm the processes.
12.45 Water sources, water-treatment equipment, and treated water should be monitored regularly for chemicals, biological contamination, and contamination with endotoxins to ensure that the water complies with the specifications appropriate to its use. Records should be maintained of the results of the monitoring and of any action taken.
12.46 Activities in clean areas, especially when aseptic operations are in progress, should be kept to a minimum, and the movement of personnel should be controlled and methodical, to avoid excessive shedding of particles and organisms due to over-vigorous activity. The ambient temperature and humidity should not be uncomfortably high because of the nature of the garments worn.
12.47 Microbiological contamination of starting materials should be minimal, and the "bio-burden" should be monitored before sterilisation. Specifications should include requirements for microbiological quality.
12.48 The presence of containers and materials liable to generate fibres should be minimised in clean areas and avoided completely when aseptic work is in progress.
12.49 Components, bulk-product containers, and equipment should be handled after the final cleaning process in such a way that they are not re-contaminated. The stage of processing of components, bulk-product containers, and equipment should be properly identified.
12.50 The interval between the washing and drying and the sterilisation of components, bulk-product containers, and equipment, as well as between sterilisation and use, should be as short as possible and subject to a time-limit appropriate to the validated storage conditions.
12.51 The time between the start of the preparation of a solutions and its sterilisation or filtration through a bacteria-retaining filter should be as short as possible. A maximum permissible time should be set for each product that takes into account its composition and the prescribed method of storage.
12.52 Any gas that is used to purge a solution or blanket a product should pass through a sterilising filter.
12.53 The microbiological contamination of products ("bio-burden") should be minimal prior to sterilisation. There should be a working limit on contamination immediately before sterilisation that is related to the efficiency of the method to be used and the risk of pyrogens. All solutions, in particular large-volume parenterals, should be passed through a micro-organism-retaining filter immediately before the filling process. Where aqueous solutions are held in sealed vessels, any pressure-release outlets should be protected, e.g., by hydrophobic microbial air filters.
12.54 Components, bulk-product containers, equipment, and any other articles required in a clean area where aseptic work is in progress should be sterilised and, passed into the area through double-ended sterilisers sealed into the wall. Other procedures that achieve the same end of not introducing contamination (e.g. triple wrapping) may be acceptable in exceptional circumstances.
12.55 The efficiency of any new processing procedure should be validated, and the validation should be repeated at regular intervals thereafter or when change is made in the process or equipment.
Sterilisation:
12.56 Sterilisation can be achieved by moist or dry heat, by ethylene oxide (or other suitable gaseous sterilising agent), by filtration with subsequent aseptic filling of sterile final containers, or by irradiation with ionising radiation (but not with ultraviolet radiation unless the process is thoroughly validated). Each method has its particular applications and limitations. Where possible and practicable, heat sterilisation is the method of choice.
12.57 All sterilisation processes must be validated. Particular attention should be given when the adopted sterilisation method is not in accordance with pharmacopoeial or other established standard or when it is used for a preparation that is not a simple aqueous or oily solution. In any case, the sterilisation process must be in accordance with the marketing and manufacturing authorisations.
12.58 Before any sterilisation process is adopted, its suitability for the product and its efficacy in achieving the desired sterilising conditions in all parts of each type of load to be processed should be demonstrated. This work should be repeated at scheduled intervals, at least annually, and whenever significant modifications have been made to the equipment. Records should be maintained of the results.
12.59 Biological indicators should be considered only as an additional method for monitoring the sterilisation. If they are used, strict precautions should be taken to avoid transferring microbial contamination from them.
12.60 There should be a clear means of differentiating products that have not been sterilised from those that have. Each basket, tray, or other carrier of products or components should be clearly labelled with the name of the material, its batch number, and an indication of whether or not it has been sterilised. Indicators such as autoclave tape may be used, where appropriate, to indicate whether or not a batch (or sub-batch) has passed through a sterilisation process, but not to give an indication that the lot is, in fact sterile.
Sterilisation by heat:
12.61 Each sterilisation cycle should be recorded by appropriate equipment with suitable accuracy and precision, e.g., on a time/ temperature chart with a suitably large scale. The temperature should be recorded from a probe at the coolest part of the load or loaded chamber, this point having been determined during the validation; the temperature should be checked against a second independent temperature probe located at the same position. The chart, or a photocopy of it, should form part of the batch record. Chemical or biological indicators may also be used but should not take the place of physical controls.
12.62 Sufficient time must be allowed for the whole of the load to reach the required temperature before measurement of the sterilising time is started. This time must be determined for each type of load to be processed.
12.63 After the high-temperature phase of a heat sterilising cycle, precautions should be taken against contamination of a sterilised load during cooling. Any cooling fluid or gas in contact with the product should be sterilised, unless it can be shown that any leaking container would not be approved for use.
Sterilisation by moist heat:
12.64 Sterilisation by moist heat is suitable only for water-wettable materials and aqueous solutions. Both temperature and pressure should be used to monitor the process. The temperature recorder should normally be independent of the controller, and there should be an independent temperature indicator, the reading from which should be routinely checked against the chart recorder during the sterilising period. For sterilisers fitted with a drain at the bottom of the chamber, it is necessary to record the temperature at this position, throughout the sterilisation period. There should be regular leak tests on the chamber when a vacuum phase is part of the cycle.
12.65 The items to be sterilised, other than products in sealed containers, should be wrapped in a material that allows removal of air and penetration of steam but prevents recontamination after sterilisation. All parts of the load should be in contact with water or saturated steam at the required temperature for the required time.
12.66 Care should be taken to ensure that steam used for sterilisation is of suitable quality and does not contain additives at a level that could cause contamination of the product or equipment.
Sterilisation by dry heat:
12.67 The process used for sterilisation by dry heat should include air circulation within the chamber and the maintenance of a positive pressure to prevent the entry of non-sterile air. If air is supplied, it should be passed through a micro-organism-retaining filter. Where this process of sterilisation by dry heat is also intended to remove pyrogens, challenge tests using endotoxins should be done as part of the validation.
Sterilisation by radiation:
12.68 Radiation sterilisation is used mainly for the sterilisation of heat-sensitive materials and products. Many pharmaceutical products and some packaging materials are radiation-sensitive, so this method is permissible only when the absence of deleterious effect on the product has been confirmed experimentally. Ultraviolet irradiation is not an acceptable method for terminal sterilisation.
12.69 If radiation sterilisation is carried out by an outside contractor, the manufacturer has the responsibility of ensuring that the requirements are met, and that the sterilisation process is validated. The responsibilities of the radiation plant operator (e.g., for the right dose) should be specified.
12.70 During the sterilisation procedure the radiation dose should be measured. For this purpose, dosimeters that are independent of dose rate should be used, giving a quantitative measurement of the dose received the product itself. Dosimeters should be inserted in the load in sufficient number, and close enough together to ensure that there is always a dosimeter in the chamber. Where plastic dosimeters are used, they should be used within the time-limit of their calibration. Dosimeter absorbencies should be read within a short period after exposure to radiation. Biological indicators may be used only as an additional control. Radiation-sensitive colour discs may be used to differentiate between packages that have been subjected to irradiation and those that have not; they are not indicators of successful sterilisation. The information obtained should constitute part of the batch record.
12.71 Validation procedures should ensure that consideration is given to the effect of variations in the density of the packages.
12.72 Handling procedures should prevent any mix-up between irradiated and non-irradiated materials. Each package should carry a radiation-sensitive indicator to show whether or not it has been subjected to radiation treatment.
12.73 The total radiation dose should be administered within a predetermined time span.
Sterilisation by ethylene oxide:
12.74 Various gases and fumigants may be used for sterilisation. Ethylene oxide should be used only when other method is practicable. During process validation it should be shown that the gas has no damaging effect on the product and that the conditions and time allowed for degassing are such as to reduce any residual gas and reaction products to defined acceptable limits for the type of product or material. These limits should be incorporated into the specifications.
12.75 Direct contact between gas and microbial cells is essential; precautions should be taken to avoid the presence of organisms likely to be enclosed in material such as crystals or dried protein. The nature and quantity of packaging materials can significantly affect the process.
12.76 Before exposure to the gas, materials should be brought into equilibrium with the humidity and temperature required by the process. The time required for this should be balanced against the opposing need to minimise the time before sterilisation.
12.77 Each sterilisation cycle should be monitored with suitable biological indicators, using the appropriate number of test pieces distributed throughout the load. The information obtained should form part of the batch record.
12.78 Biological indicators should be stored and used according to the manufacturer's instructions, and their performance checked by positive controls.
12.79 For each sterilisation cycle, records should be made of the time taken to complete the cycle, of the pressure, temperature, and humidity within the chamber during the process, and of the gas concentration. The pressure and temperature should be recorded throughout the cycle on a chart. The records should form part of the batch record.
12.80 After sterilisation, the load should be stored in a controlled manner under ventilated conditions to allow residual gas and reaction products to fall to the defined level. This process should be validated.
Filtration of pharmaceutical products that cannot be sterilised in their final container:
12.81 Whenever possible, products should be sterilised in the final container, preferably by heat sterilisation. Certain solutions and liquids that cannot be sterilised in the final container can be filtered through a sterile filter of nominal pore size 0.22µm (or less), or with at least equivalent micro-organism-retaining properties, into a previously sterilised container. Such filters can remove bacteria and moulds, but not all viruses or mycoplasmas. Consideration should be given to complementing the filtration process with some degree of heat treatment.
12.82 Owing to the potential additional risks of the filtration method as compared with other sterilisation processes, a double filter layer or second filtration via a further sterilised micro-organism-retaining filter immediately prior to filling may be advisable. The final sterile filtration should be carried out as close as possible to the filling point.
12.83 Filters that shed fibres should not be used. The use of asbestos-containing filters should be absolutely excluded.
12.84 The integrity of the filter should be checked by an appropriate method such as a bubble point test immediately after each use (it is also useful to test the filter this way before use). The time taken to filter a known volume of bulk solution and the pressure difference to be used across the filter should be determined during validation and any differences from this should be noted and investigated. Results of these checks should be recorded in the batch record.
12.85 The same filter should not be used for more than one working day.
12.86 The filter should not affect the product by removal of ingredients from it or by release of substances into it.
Finishing of sterile products:
12.87 Containers should be closed by appropriately validated methods. Samples should be checked for integrity according to appropriate procedures.
12.88 Containers sealed under vacuum should be sampled and the samples tested for maintenance of that vacuum after an appropriate predetermined period.
12.89 Filled containers of parenteral products should be inspected individually. When inspection is done visually, it should be done under suitable and controlled conditions of illumination and background. Operators doing the inspection should pass regular eyesight checks, with spectacles if worn, and be allowed frequent breaks from inspection. Where other methods of inspection are used, the process should be validated and the performance of the equipment checked at intervals.
Quality control:
12.90 Samples taken for sterility testing should be representative of the whole of the batch but should in particular include samples taken from parts of the batch considered to be most at risk of contamination, for example:
(a) For products that have been filled aseptically, samples should include containers filled at the beginning and end of the batch and after any significant interruption of work;
(b) For products that have been heat sterilised in their final containers, consideration should be given to taking samples from the potentially coolest part of the load.
12.91 The sterility test applied to the finished product should be regarded only as the last in a series of control measures by which sterility is assured and should be interpreted only in conjunction with the environmental and batch processing records.
12.92 Batches failing an initial sterility test should not be released on the basis of a second test unless an investigation into the type of organism found, and into the environmental and batch processing records involved, show that the original test was invalid.
12.93 For injectable products, consideration should be given to monitoring the water and the intermediate and finished product for endotoxins, using an established pharmacopoeial method that has been validated for each type of product. For large-volume infusion solutions, such monitoring of water or intermediates should always be done, in addition to any tests required by the marketing authorisation (Pharmacy Board) on the finished product. When a sample fails a test, the cause of failure should be investigated and remedial action taken. The investigation and remedial action must be recorded.
(Section 58)
[1st May, 1999]
G.Ns. Nos.
25 of 2001
93 of 2002
WHEREAS section 58 of the Pharmaceutical and Poisons Act * requires the Minister, upon recommendation of the Board, by order in the Gazette to prohibit and control the manufacture, importation or sale of any drug.
AND WHEREAS the Board has recommended to the Minister the list of registered human drugs to be gazetted for public awareness.
NOW THEREFORE, the public is hereby notified as follows–
1. This Order may be cited as the Pharmaceuticals and Poisons (Human Drugs List) (Notification) Order.
2. [Omitted.]
3. No person shall be allowed to circulate any drug which is not in the drug list specified in the Schedule to this Order.
4. Notwithstanding the provisions of this Order, the registration unless it is earlier cancelled shall remain valid for five years from the date of issuing registration certificates, and shall be subject to payment of annual retention fees.
5. Any person who contravenes or fails to comply with this Order commits an offence punishable under the Pharmaceutical and Poisons Act *.
SCHEDULE
REGISTERED HUMAN DRUGS LIST
Registration Number | Product Name | Active Ingredients | Strength | Manufacturer |
Registrant | A. Menarini Industrie Farmaceutiche Riunite s.r.l - ITALY | |||
1 TAN 00,1759 M01A AMI | Fastum Gel | A.Menarini Manufacturing Logistics and Services s.r.l - ITALY |
||
Ketoprofen Ph.Eur | 2.5%w/w | |||
2 TAN 00,1760 M01A AMI | Fastum Capsules | A.Menarini Manufacturing Logistics and Services s.r.l - ITALY |
||
Ketoprofen BP | 50mg | |||
Registrant | Albert David Limited - INDIA | |||
3 TAN 00,1957 P01B ADL | Aldezol Injection | Albert David Limited - INDIA |
||
Metronidazole USP | 0.5%w/v | |||
4 TAN 00,1958 J01K ADL | Cipad Injection | Albert David Limited - INDIA |
||
Ciprofloxacin USP | 0.2%w/v | |||
Registrant | Alcon Cusi, S.A. - SPAIN | |||
5 TAN 00,1761 S01G ALC | Cusicrom 4% Eye Drops | Alcon Cusi, S.A. - SPAIN |
||
Sodium Cromoglycate Ph.Eur | 40mg/ml | |||
6 TAN 00,1537 V07A ALC | Opti-Free Multiaction Solution | Alcon Cusi, S.A. - SPAIN |
||
Polyquad | 0.001% | |||
7 TAN 00,1538 S01E ALC | Cusimolol 0.5% Ear Drops | Alcon Cusi, S.A. - SPAIN |
||
Timolol Ph.Eur | 0.5%w/v | |||
8 TAN 00,1762 S01D ALC | Cusimolol 0.25% Eye Drops | Alcon Cusi, S.A. - SPAIN |
||
Timolol Ph.Eur | 2.5mg/ml | |||
9 TAN 00,1539 V07A ALC | Opti-Free Express Solution | Alcon Cusi, S.A. - SPAIN |
||
Al-6289 | 0.0005%w/v | |||
Polyquad | 0.001%w/v | |||
10 TAN 00,1540 S01D ALC | Cusicrom 2% Eye Drops | Alcon Cusi, S.A. - SPAIN |
||
Sodium Cromoglycate Ph.Eur | 20mg/ml | |||
11 TAN 00,1541 V07A ALC | Opti-Free Supercleans | Alcon Cusi, S.A. - SPAIN |
Registration Number | Product Name | Active Ingredients | Strength | Manufacturer |
Soluble Pancreatin USP | 1.700AU | |||
12 TAN 00,1959 S03D ALC | Cusiviral Eye Ointment | Alcon Cusi, S.A. - SPAIN |
||
Acyclovir Ph.Eur | 5% w/w | |||
13 TAN 00,1763 S01A ALC | Oftalmolosa Chloramphenicol Eye Ointment | Alcon Cusi, S.A. - SPAIN |
||
Chloramphenicol Ph.Eur | 10mg/g | |||
14 TAN 00,1960 S03A ALC | Chloramphenicol 0.5% Eye Drops | Alcon Cuai, S.A. - SPAIN |
||
Chloramphenicol Ph.Eur | 5mg/ml | |||
Registrant | Amman Pharmaceutical Industries Co.- JORDAN | |||
15 TAN 00,1542 R01A AMM | Decozal 0.05% Nasal Drops | Amman Pharmaceutical Industries - JORDAN |
||
Xylometazoline HCl BP | 0,5mg/ml | |||
16 TAN 00,1543 S01A AMM | Otocol Ear Drops | Amman Pharmaceutical Industries - JORDAN |
||
Chloramphenicol BP | 5%w/v | |||
Benzocaine BP | 5%w/v | |||
17 TAN 00,1544 S01D AMM | Apimol 0.25% Eye Drops | Amman Pharmaceutical Industries - JORDAN |
||
Timolol Maleate BP | 0.25mg/ml | |||
18 TAN 00,1545 R01A AMM | Decozal 0.1% Nasal Drops | Amman Pharmaceutical Industries - JORDAN |
||
Xylometazoline HCl BP | 0.1mg/ml | |||
19 TAN 00,1546 S02D AMM | Dewax Ear Drops | Amman Pharmaceutical Industries - JORDAN |
||
Dosucate Sodium BP | 5,0mg | |||
20 TAN 00,1547 S01D AMM | Apicarpin 4% Eye Drops | Amman Pharmaceutical Industries - JORDAN |
||
Pilocarpine HCl BP | 40mg/ml |
Registration Number | Product Name | Active Ingredients | Strength | Manufacturer |
21 TAN 00,1548 S01D AMM | Apimol 0.5% Eye Drops | Amman Pharmaceutical Industries - JORDAN |
||
Timolol Maleate BP | 0.5mg/ml | |||
Registrant | AstraZeneca UK Limited - U.K | |||
22 TAN 00,1764 N02A ASZ | Diprivan 1%w/v IV Injection | Fresenius Kabi AB - SWEDEN |
||
Propofol | 1%w/v | |||
23 TAN 00,1549 C01D ASZ | Plendil 5mg Tablets | AstraZeneca AB - SWEDEN |
||
Felodipine Ph.Eur | 5mg | |||
24 TAN 00,1550 C01D ASZ | Plendil 10mg Tablets | AstraZeneca AB - SWEDEN |
||
Felodipine Ph.Eur | 10mg | |||
25 TAN 00,1765 A02C ASZ | Losec Mups Tablets | AstraZeneca AB - SWEDEN |
||
Omeprazole | 20mg | |||
Registrant | Aurochem Laboratories - INDIA | |||
26 TAN 00,1766 D01A AUC | Kandicide-V Tablets | Aurochem Laboratories - INDIA |
||
Clotrimazole USP | 100mg | |||
Registrant | Aventis Pasteur S.A. - FRANCE | |||
27 TAN 00,1767 J07A AVE | Oral Polio Vaccine | Aventis Pasteur - FRANCE |
||
Poliomyelitis Virus Type 2 | 100,000 | |||
Poliomyelitis Virus Type 3 | 600,000 | |||
Poliomyelitis Virus Type 1 | 1,000,000 | |||
Registrant | Beta Healthcare International Ltd - KENYA | |||
28 TAN 00,1551 N02B BEH | Betafen Syrup | Beta Healthcare International Ltd - KENYA |
||
Ibuprofen BP | 100mg/5ml | |||
29 TAN 00,1768 P01B BEH | Betaquine Tablets | Beta Healthcare International Ltd - KENYA |
||
Amodiaquine USP | 200mg |
Registration Number | Product Name | Active Ingredients | Strength | Manufacturer |
Registrant | Biodeal Laboratories Ltd - KENYA | |||
30 TAN 00, 1552 J01B BIO | Biophenicol Suspension | Biodeal Laboratories Ltd - KENYA |
||
Chloramphenicol Palmitate BP | 125mg/5ml | |||
31 TAN 00,1553 J01H BIO | Biocillin Dry Syrup | Biodeal Laboratories Ltd - KENYA |
||
Ampicillin Trihydrate BP | 143.75mg/5ml |
|||
32 TAN 00,1554 D01B BIO | Clomzole Cream | Biodeal Laboratories Ltd - KENYA |
||
Clotrimazole BP | 1g/100g | |||
Registrant | Blue Cross Laboratories Ltd - INDIA | |||
33 TAN 00,1555 J01K BLU | Bluspar Tablets | Blue Cross Laboratories Ltd - INDIA |
||
Sparfloxacin BP | 200mg | |||
34 TAN 00,1556 V03A BLU | Ekon D.T Tablets | Blue Cross Laboratories Ltd - INDIA |
||
Cetrizine Dihydrochloride BP | 10mg | |||
35 TAN 00,1557 A02B BLU | Omepren 20 Capsules | Blue Cross Laboratories Ltd - INDIA |
||
Omeprazole BP | 20mg | |||
36 TAN 00,1769 A03D BLU | Meftal Spas Tablets | Blue Cross Laboratories Ltd - INDIA |
||
Mefenamic Acid BP | 10mg | |||
37 TAN 00,1558 D07X BLU | Sonaderm GM Cream | Blue Cross Laboratories Ltd - INDIA |
||
Gentamycin Sulphate BP | 0.10%w/w | |||
Clobetasol Propionate BP | 0.05%w/w | |||
Chlorocresol BP | 0.10%w/w | |||
Miconazole Nitrate BP | 2.00%w/w | |||
38 TAN 00,1559 R05C BLU | Tusq Tablets | Blue Cross Laboratories Ltd - INDIA |
||
Guaifenesin USP | 100.00mg | |||
{mprestriction ids="1,2,3"} | Phenylpropanolamine HCl | 25.00mg | ||
Bromhexine HCl BP | 8.00mg | |||
Chlorpheniramine maleate BP | 2.00mg | |||
Paracetamol BP | 450.00mg | |||
39 TAN 00,1961 M01A BLU | Meftal-250 Tablets | Blue Cross Laboratories Ltd - INDIA |
||
Mefenamic Acid BP | 250mg |
Registration Number | Product Name | Active Ingredients | Strength | Manufacturer |
Registrant | Chemical Industries Development - EGYPT | |||
40 TAN 00,1770 A11A CHE | Fruital Syrup | Chemical Industries Development - EGYPT |
||
Vitamin C BP | 50mg/5ml | |||
Nicotinamide BP | 12.5mg/5ml | |||
Vitamin A BP | 5000iu/5ml | |||
Vitamin B1 BP | 1,5mg/5ml | |||
Vitamin B2 BP | 1,5mg/5ml | |||
Vitamin B6 BP | 1mg/5ml | |||
Vitamin E BP | 2.5mg/5ml | |||
Vitamin D2 BP | 1000iu/5ml | |||
41 TAN 00,1560 N03A CHE | Tegral 200mg Tablets | Chemical Industries Development - EGYPT |
||
Carbamazepine BP | 200mg | |||
42 TAN 00,1561 R03A CHE | Cidophylline Injection | Chemical Industries Development - EGYPT |
||
Aminophylline BP | 250mg/10ml | |||
43 TAN 00,1962 S01A CHE | Optocetine Eye Drops | Chemical Industries Development - EGYPT |
||
Chloramphenicol BP | 0.5g/100ml | |||
Registrant | Chinoin Pharmaceutical & Chemical Works - HUNGARY | |||
44 TAN 00,1562 V03A CHI | Enzaprost F Injection | Chinoin Pharmaceutical & Chemical Works - HUNGARY |
||
Dinoprost | 5mg/ml | |||
Registrant | Cipla Ltd., - INDIA | |||
45 TAN 00,1563 D06A CIP | Cefadur 125 DT Tablets | Cipla Ltd - INDIA |
||
Cefadroxil | 125mg | |||
46 TAN 00,1564 J01D CIP | Cefadur 125 Rediuse | Cipla Ltd - INDIA |
||
Cefadroxil | 125mg/5ml | |||
47 TAN 00,1565 J05C CIP | Stavir-30 Capsules | Cipla Ltd - INDIA |
||
Stavudine | 30mg | |||
48 TAN 00,1566 J05A CIP | Duovir Tablets | Cipla Ltd - INDIA |
Registration Number | Product Name | Active Ingredients | Strength | Manufacturer |
Zidovudine USP | 300mg | |||
Lamivudine | 150mg | |||
49 TAN 00,1567 J05C CIP | Stavir-40 Capsules | Cipla Ltd - INDIA |
||
Stavudine | 40mg | |||
50 TAN 00,1568 D01A CIP | Zinoral Shampoo | Cipla Ltd - INDIA |
||
Ketoconazole USP | 2%w/v | |||
51 TAN 00,1569 V03A CIP | Alerid - D ER Tablets | Cipla Ltd - INDIA |
||
Cetirizine Dihydrochloride | 5mg | |||
Pseudoephedrine HCl | 120mg | |||
52 TAN 00,1570 A11H CIP | Vitamin E Capsules | Cipla Ltd - INDIA |
||
Alpha Tocopheryl Acetate USP | 400mg | |||
53 TAN 00,1571 N05A CIP | Risnia-2 Tablets | Cipla Ltd - INDIA |
||
Risperidone | 2mg | |||
54 TAN 00,1572 P01A CIP | Entosec Tablets | Cipla Ltd - INDIA |
||
Secnidazole | 1000mg | |||
55 TAN 00,1573 J05A CIP | Acivir-400 DT Tablets | Cipla Ltd - INDIA |
||
Acyclovir USP | 400mg | |||
56 TAN 00,1574 N03A CIP | Selerin-5 Tablets | Cipla Ltd - INDIA |
||
Selegiline HCl USP | 5mg | |||
57 TAN 00,1575 N05A CIP | Risnia-1 Tablets | Cipla Ltd - INDIA |
||
Risperidone | 1mg | |||
58 TAN 00,1576 J05A CIP | Acivir Cream | Cipla Ltd - INDIA |
||
Acyclovir BP | 5%w/w | |||
59 TAN 00,1577 J05A CIP | Acivir-200 DT Tablets | Cipla Ltd - INDIA |
||
Acyclovir USP | 200mg | |||
60 TAN 00,1771 B01A CIP | Warf-5 Tablets | Cipla Ltd - INDIA |
||
Warfarin Sodium | 5mg | |||
61 TAN 00,1772 D01B CIP | Forcan I.V. Injection | Cipla Ltd - INDIA |
Registration Number | Product Name | Active Ingredients | Strength | Manufacturer |
Fluconazole | 2mg/ml | |||
Registrant | Curacid America Corporation - U.S.A. | |||
62 TAN 00,1963 D02A CUR | Sencil Dermal Ointment | Apex International - U.S.A/ In Africa manufactured by NMD - NIGERIA |
||
Cod Liver Oil | 10%w/w | |||
White Petrolatum | 30%w/w | |||
63 TAN 00,1964 D02A CUR | Sencil Proctological Ointment | Apex International - U.S.A/ In Africa manufactured by NMD - NIGERIA |
||
White Petrolatum | 36.5%w/w | |||
Cod Liver Oil | 13.5%w/w | |||
64 TAN 00,1965 G02C CUR | Sencil Vaginal Ointment | Apex International - U.S.A/ In Africa manufactured by NMD - NIGERIA |
||
Cod Liver Oil | 10%w/w | |||
White Petrolatum | 15%w/w | |||
65 TAN 00,1966 D02A CUR | Sencil Paediatric Ointment | Apex International - U.S.A/ In Africa manufactured by NMD - NIGERIA |
||
White Petrolatum | 30%w/w | |||
Cod Liver Oil | 10%w/w | |||
Registrant | Dafra Pharma N.V - BELGIUM | |||
66 TAN 00,1967 P01B DAF | Artemether 80mg/ml Injection | Rotexmedica GMBH - GERMANY |
||
B - Artemether | 80mg/ml | |||
67 TAN 00,1968 P01B DAF | Artemether Paediatric 20mg/ml Injection | Rotexmedica GMBH - GERMANY |
||
B - Artemether | 20mg/ml | |||
Registrant | E. Merck (India) Limited - INDIA | |||
68 TAN 00,1969 A11H EME | Evion 200 Capsule | E. Merck (India) Limited - INDIA |
||
Vitamin E Acetate USP | 200mg | |||
69 TAN 00,1970 A11B EME | Neurobion Forte Injection | E. Merck (India) Limited - INDIA |
||
Nicotinamide BP | 100mg/2ml |
Registration Number | Product Name | Active Ingredients | Strength | Manufacturer |
Cyanocobalamine BP | 1000mcg/2ml |
|||
Pyridoxine HCl BP | 100mg/2ml | |||
Thiamine HCl BP | 100mg/2ml | |||
D-Panthenol BP | 50mg/2ml | |||
Registrant | EIPICO - EGYPT | |||
70 TAN 00,1578 D07A EIP | Betaderm Cream | EIPICO - EGYPT |
||
Betamethasone BP | 100mg | |||
71 TAN 00,1579 D07A EIP | Betaderm Ointment | EIPICO - EGYPT |
||
Betamethasone BP | 0.1%w/w | |||
72 TAN 00,1580 A03C EIP | Epirax Tablets | EIPICO - EGYPT |
||
Clidinium Bromide USP | 2.5mg | |||
Chlordiazepoxide USP | 5mg | |||
73 TAN 00,1581 P02X EIP | Permax Oral Suspension | EIPICO - EGYPT |
||
Mebendazole USP | 20mg/ml | |||
74 TAN 00,1773 A02A EIP | Mucogel Syrup | EIPICO - EGYPT |
||
Dried Aluminium Hydroxide | 8.1g/100ml | |||
Magnesium Hydroxide USP | 2g/100ml | |||
Oxethazaine BP | 2g/100ml | |||
Registrant | Eli Lilly Italia S.p.A - ITALY | |||
75 TAN 00,1582 J01D ELI | Ceclor Capsules | Eli Lilly Italia S.p.A - ITALY |
||
Cefaclor Ph.Eur | 500mg | |||
Registrant | Elys Chemical Industries Ltd - KENYA | |||
76 TAN 00,1774 M01A ELY | Hedapan Tablets | Elys Chemical Industries Ltd - KENYA |
||
Paracetamol | 250mg | |||
Aspirin | 300mg | |||
Caffeine | 30mg | |||
77 TAN 00,1775 P01B ELY | Quinine Sulphate Tablet | Elys Chemical Industries Ltd - KENYA |
||
Quinine Sulphate BP | 300mg |
Registration Number | Product Name | Active Ingredients | Strength | Manufacturer |
78 TAN 00,1583 P01B ELY | Quinaquin liquid mixture | Elys Chemical Industries Ltd - KENYA |
||
Quinine Bisulphate BP | 50mg/5ml | |||
79 TAN 00,1776 D01B ELY | Grisefulvin Tablets | Elys Chemical Industries Ltd - KENYA |
||
Griseofulvin BP | 500mg | |||
80 TAN 00,1584 J01F ELY | Erythromycin Dry Syrup | Elys Chemical Industries Ltd - KENYA |
||
Erythromycin Ethylsuccinate | 125mg/5ml | |||
81 TAN 00,1585 M01A ELY | Mifupen Tablets | Elys Chemical Industries Ltd - KENYA |
||
Acetylsalicylic Acid BP | 350mg | |||
Caffeine BP | 30mg | |||
82 TAN 00,1586 D01A ELY | Candistat Cream | Elys Chemical Industries Ltd - KENYA |
||
Clotrimazole | 1%w/w | |||
83 TAN 00,1777 P01X ELY | Elyzole Chewable Tablets | Elys Chemical Industries Ltd - KENYA |
||
Albendazole USP | 200mg | |||
84 TAN 00,1778 D07A ELY | Elycort Cream | Elys Chemical Industries Ltd - KENYA |
||
Hydrocortisone BP | 1%w/w | |||
85 TAN 00,1779 J01H ELY | Cloxacillin Capsules | Elys Chemical Industries Ltd - KENYA |
||
Cloxacillin BP | 250mg | |||
86 TAN 00,1780 H02A ELY | Prednisolone Tablets | Elys Chemical Industries Ltd - KENYA |
||
Prednisolone BP | 5mg | |||
87 TAN 00,1781 J01C ELY | Elyclox Capsules | Elys Chemical Industries Ltd - KENYA |
||
Cloxacillin BP | 250mg | |||
Ampicillin BP | 250mg | |||
88 TAN 00,1782 J01H ELY | Elypen Tablets | Elys Chemical Industries Ltd - KENYA |
||
Phenoxymethyl penicillin BP | 250mg | |||
89 TAN 00,1783 P02X ELY | Elyzole Suspension | Elys Chemical Industries Ltd - KENYA |
||
Albendazole BP | 200mg/5ml | |||
90 TAN 00,1784 N02B ELY | Elymol 500mg Tablets | Elys Chemical Industries Ltd - KENYA |
||
Paracetamol BP | 500mg |
Registration Number | Product Name | Active Ingredients | Strength | Manufacturer |
91 TAN 00,1785 R02A ELY | Chestcof Syrup | Elys Chemical Industries Ltd - KENYA |
||
Peppermint Oil BP | 0.135ml/100m |
|||
Glycyrrhiza BP | 1ml/100ml | |||
Aniseed Oil BP | 0.05ml/100ml |
|||
Ipecacuanha Liquid Extract | 0.075ml/100m |
|||
Tincture of Capsicum BPC | 1ml/100ml | |||
Menthol BP | 45mg/100ml | |||
92 TAN 00,1786 P01A ELY | Elogyl Tablets | Elys Chemical Industries Ltd - KENYA |
||
Metronidazole BP | 200mg | |||
93 TAN 00,1787 D01A ELY | Fungistin Suspension | Elys Chemical Industries Ltd - KENYA |
||
Nystatin BP | 100,000 I.U | |||
94 TAN 00,1788 P01B ELY | Emoquin Tablets | Elys Chemical Industries Ltd - KENYA |
||
Amodiaquine USP | 200mg | |||
95 TAN 00,1789 M01A ELY | Indomethacin Capsules | Elys Chemical Industries Ltd - KENYA |
||
Indomethacin BP | 25mg | |||
96 TAN 00,1790 A02A ELY | Stomacid Tablets | Elys Chemical Industries Ltd - KENYA |
||
Magnesium Trisilicate BP | 250mg | |||
Dried Aluminium Hydroxide | 120mg | |||
97 TAN 00,1791 M01A ELY | Ibufen Tablets | Elys Chemical Industries Ltd - KENYA |
||
Ibuprofen BP | 200mg | |||
98 TAN 00,1792 M01A ELY | Aspirin Tablets | Elys Chemical Industries Ltd - KENYA |
||
Aspirin BP | 300mg | |||
99 TAN 00,1971 A11E ELY | Vitamin B Complex Tablets | Elys Chemical Industries Ltd - KENYA |
||
Nicotinamide BP | 16.5mg | |||
Riboflavin BP | 1.1mg | |||
Thiamine HCl BP | 1.1mg | |||
100 TAN 00,1793 D07X ELY | Elyclob-G Cream | Elys Chemical Industries Ltd - KENYA |
||
Gentamycin Sulphate BP | 0.1w/w |
Registration Number | Product Name | Active Ingredients | Strength | Manufacturer |
Beclomethasone Dipropionate | 0.025%w/w | |||
Clotrimazole BP | 1.0%w/w | |||
101 TAN 00,1794 A03B ELY | Bukol Tablets | Elys Chemical Industries Ltd - KENYA |
||
Hyoscine Butylbromide BP | 10mg | |||
102 TAN 00,1795 D01A ELY | Fungistat Cream | Elys Chemical Industries Ltd- KENYA |
||
Miconazole Nitrate BP | 2%w/w | |||
103 TAN 00,1796 D07A ELY | Elyvate Ointment | Elys Chemical Industries Ltd - KENYA |
||
Betamethasone Valerate BP | 0.1%w/w | |||
104 TAN 00,1797 C03C ELY | Frusemide Tablets | Elys Chemical Industries Ltd - KENYA |
||
Frusemide BP | 40mg | |||
105 TAN 00,1798 J01F ELY | Elocin Tablets | Elys Chemical Industries Ltd - KENYA |
||
Erythromycin BP | 250mg | |||
106 TAN 00,1972 J01C ELY | Elymox Capsule | Elys Chemical Industries Ltd - KENYA |
||
Amoxycillin BP | 250mg | |||
107 TAN 00,1799 J01A ELY | Doxycycline Capsules | Elys Chemical Industries Ltd - KENYA |
||
Doxycycline HCl BP | 100mg | |||
108 TAN 00,1800 R05A ELY | Cold-Flu Capsules | Elys Chemical Industries Ltd - KENYA |
||
Paracetamol BP | 400mg | |||
Chlorpheniramine Maleate BP | 4mg | |||
Phenylephrine HCI BP | 5mg | |||
Caffeine BP | 30mg | |||
109 TAN 00,1801 D07A ELY | Elyvate Cream | Elys Chemical Industries Ltd - KENYA |
||
Betamethasone BP | 0.1%w/w | |||
110 TAN 00,1973 P02X ELY | Vumtrex Tablets | Elys Chemical Industries Ltd - KENYA |
||
Levamisole BP | 40mg | |||
111 TAN 00,1974 J01A ELY | Elytetra Ointment | Elys Chemical Industries Ltd - KENYA |
||
Tetracycline HCl BP | 3%w/w | |||
112 TAN 00,1975 R03A ELY | Ventosal-4 Tablets | Elys Chemical Industries Ltd - KENYA |
Registration Number | Product Name | Active Ingredients | Strength | Manufacturer |
Salbutamol BP | 4mg | |||
113 TAN 00,1976 D04A ELY | Chlorpheniramine Maleate 4mg Tablets | Elys Chemical Industries Ltd - KENYA |
||
Chlorpheniramine Maleate | 4mg | |||
114 TAN 00,1977 M02A ELY | Nauma Pain Balm | Elys Chemical Industries Ltd - KENYA |
||
Menthol BP | 4.5%w/w | |||
Methyl Salicylate BP | 10%w/w | |||
Turpentine Oil BP | 2%w/w | |||
Eucalyptus Oil BP | 5%w/w | |||
Camphor BP | 5%w/w | |||
Clove Oil BP | 1%w/w | |||
Registrant | Emcure Pharmaceuticals Ltd - INDIA | |||
115 TAN 00,1802 J01K EMC | Augpen 625 Tablets | Svizera Labs - INDIA |
||
Clavulanate Potassium USP | 125mg | |||
Amoxycillin Trihydrate USP | 500mg | |||
116 TAN 00,1803 J01K EMC | Augpen 375 Tablets | Svizera Labs - INDIA |
||
Clavulanate Potassium USP | 125mg | |||
Amoxycillin Trihydrate USP | 250mg | |||
Registrant | FDC Limited - INDIA | |||
117 TAN 00,1804 J01K FDC | Allercrom Eye Drops | FDC Limited - INDIA |
||
Cromolyn Sodium USP | 2%w/v | |||
118 TAN 00,1805 S01 D FDC | Norzen Eye/Ear Drops | FDC Limited - INDIA |
||
Norfloxacin USP | 0.3%w/v | |||
119 TAN 00,1806 S01D FDC | Moisol Eye Drops | FDC Limited - INDIA |
||
Hydroxypropyl Methyl | 0.7%w/v | |||
120 TAN 00,1807 S01D FDC | Zoxan Eye/Ear Drops | FDC Limited - INDIA |
||
Ciprofloxacin Hydrochloride | 0.3%w/v | |||
121 TAN 00,1808 A07C FDC | Electral Forte | |||
Sodium Chloride BP | 3.5gm/30g |
Registration Number | Product Name | Active Ingredients | Strength | Manufacturer |
Potassium Chloride BP | 1.5g/30g | |||
Trisodium Citrate BP | 2.9g/30g | |||
Citric Acid BP | 1.24g/30g | |||
Sodium Benzoate BP | 0.0195g/30g | |||
Saccharin Sodium BP | 0.15g/30g | |||
Glucose BP | 20g/30g | |||
122 TAN 00,1809 J05A FDC | Ocuvir-800 Tablets | FDC Limited - INDIA |
||
Acyclovir BP | 800mg | |||
123 TAN 00,1810 J05A FDC | Ocuvir-400 Tablets | FDC Limited - INDIA |
||
Acyclovir BP | 400mg | |||
124 TAN 00,1811 N02C FDC | Flunarin Tablets | FDC Limited - INDIA |
||
Flunarizine BP | 10mg | |||
125 TAN 00,1978 S01D FDC | Pilocar 2% Eye Drops | FDC Limited - INDIA |
||
Pilocarpine Nitrate USP | 2%w/v | |||
126 TAN 00,1979 S01D FDC | Ocuflur Eye Drops | FDC Limited - INDIA |
||
Flurbiprofen Sodium USP | 0.03%w/v | |||
Registrant | Flamingo Pharmaceuticals Limited - INDIA | |||
127 TAN 00,1587 J01H FLA | Amoxycillin Capsules | Flamingo Pharmaceuticals Limited - INDIA |
||
Amoxycillin Trihydrate BP | 250mg | |||
128 TAN 00,1588 J01H FLA | Medidox Capsules | Flamingo Pharmaceuticals Limited - INDIA |
||
Doxycycline HCl BP | 100mg | |||
129 TAN 00,1589 J01F FLA | Erycin - 500 Tablets | Flamingo Pharmaceuticals Limited - INDIA |
||
Erythromycin Stearate BP | 500mg | |||
130 TAN 00,1590 P01B FLA | Nopyrin Tablets | Flamingo Pharmaceuticals Limited - INDIA |
||
Pyrimethamine USP | 25mg | |||
Sulphadoxine USP | 500mg | |||
131 TAN 00,1591 D01B FLA | Medfulvin 500 Tablets | Flamingo Pharmaceuticals Limited - INDIA |
||
Griseofulvin BP | 500mg |
Registration Number | Product Name | Active Ingredients | Strength | Manufacturer |
132 TAN 00,1592 P01B FLA | Quinine Dihydrochloride Injection | Flamingo Pharmaceuticals Limited - INDIA |
||
Quinine Dihydrochloride BP | 60mg/ml | |||
133 TAN 00,1812 J01E FLA | Embatrim 480 Tablets | Flamingo Pharmaceuticals Limited - INDIA |
||
Cotrimoxazole BP | 480mg | |||
134 TAN 00,1593 J01F FLA | Aziflam Capsules | Flamingo Pharmaceuticals Limited - INDIA |
||
Azithromycin USP | 200mg | |||
135 TAN 00,1594 J01F FLA | Lincomycin Tablets | Flamingo Pharmaceuticals Limited - INDIA |
||
Lincomycin BP | 500mg | |||
136 TAN 00,1595 D01B FLA | Ketarin Tablets | Flamingo Pharmaceuticals Limited - INDIA |
||
Ketoconazole USP | 200mg | |||
137 TAN 00,1813 J05A FLA | Herpevir Tablets | Flamingo Pharmaceuticals Limited - INDIA |
||
Aciclovir BP | 200mg | |||
138 TAN 00,1596 P01A FLA | Tricogyn 500 Tablets | Flamingo Pharmaceuticals Limited - INDIA |
||
Tinidazole USP | 500mg | |||
139 TAN 00,1597 J01K FLA | Kefurox 750mg Injection | Flamingo Pharmaceuticals Limited - INDIA |
||
Sterile Cefuroxime USP | 750mg/vial | |||
140 TAN 00,1598 A01B FLA | Glibetics Tablets | Flamingo Pharmaceuticals Limited - INDIA |
||
Glibenclamide BP | 5mg | |||
141 TAN 00,1599 N02B FLA | Diclopar Tablets | Flamingo Pharmaceuticals Limited - INDIA |
||
Paracetamol BP | 500mg | |||
Diclofenac Sodium BP | 50mg | |||
142 TAN 00,1600 P02X FLA | Benzole Tablets | Flamingo Pharmaceuticals Limited - INDIA |
||
Albendazole USP | 200mg | |||
143 TAN 00,1601 J01K FLA | Cardion Injection | Flamingo Pharmaceuticals Limited - INDIA |
||
Vancomycin HCl USP | 500mg/vial | |||
144 TAN 00,1602 J01H FLA | Oxal Capsules | Flamingo Pharmaceuticals Limited - INDIA |
||
Oxacillin USP | 500mg |
Registration Number | Product Name | Active Ingredients | Strength | Manufacturer |
Registrant | German Remedies Ltd - INDIA | |||
145 TAN 00,1980 R03A GER | Deriphyllin Syrup | German Remedies - INDIA |
||
Theophylline BP | 14.0mg/5ml | |||
Etofylline BP | 46.5mg/5ml | |||
146 TAN 00,1981 R03A GER | Deriphyllin Tablets | German Remedies - INDIA |
||
Theophylline BP | 23mg | |||
Etofylline BP | 77mg | |||
147 TAN 00,1982 R03A GER | Deriphyllin Injection | German Remedies - INDIA |
||
Etofylline BP | 84.7mg/ml | |||
Theophylline BP | 25.3mg/ml | |||
148 TAN 00,1983 R03A GER | Deriphyllin Retard 150 Tablets | German Remedies - INDIA |
||
Etofylline BP | 115mg | |||
Theophylline BP | 35mg | |||
149 TAN 00,1984 R03A GER | Deriphyllin Retard 300 Tablets | German Remedies - INDIA |
||
Theophylline BP | 69mg | |||
Etofylline BP | 231mg | |||
Registrant | Glaxo Wellcome (Kenya) Limited - KENYA | |||
150 TAN 00,1985 J01K GLA | Septrin Tablets | Glaxo Wellcome (Kenya) Limited - KENYA |
||
Trimethoprim | 80mg | |||
Sulphamethoxazole | 400mg | |||
151 TAN 00,1603 D07X GLA | Betnovate Ointment | Glaxo Wellcome (UK) Operations Ltd - U.K. |
||
Betamethasone Valeriate BP | 0.1%w/w | |||
152 TAN 00,1606 JO5A GLA | Ziagen Oral Solution | Glaxo Wellcome Research & Development - U.K |
||
Abacavir Sulphate | 200mg/ml | |||
153 TAN 00,1607 JO5A GLA | Ziagen Tablets | Glaxo Wellcome Research & Development - U.K |
||
Abacavir Sulphate | 300mg |
Registration Number | Product Name | Active Ingredients | Strength | Manufacturer |
154 TAN 00,1604 A02B GLA | Pylorid Tablets | Glaxo Wellcome (Kenya) Limited - KENYA |
||
Ranitidine Bismuth Citrate | 400mg | |||
155 TAN 00,1605 J01D GLA | Fortum 250mg Injection | Glaxo Wellcome (UK) Operations Limited - U.K. |
||
Ceftazidime Pentahydrate | 250mg | |||
156 TAN 00,1814 N02A GLA | Tracrium Injection | Glaxo Wellcome (UK) Operations Limited - U.K. |
||
Atracurium Besylate BP | 10mg/ml | |||
157 TAN 00,1815 J01D GLA | Zinnat Tablets | Glaxo Wellcome (UK) Operations Limited - U.K. |
||
Cefuroxime BP | 500mg | |||
158 TAN 00,1816 D04A GLA | Piriton Tablets | Glaxo Wellcome (Kenya) Limited - KENYA |
||
Chlorpheniramine maleate BP | 4mg | |||
159 TAN 00,1817 J01D GLA | Zinnat Tablets | Glaxo Wellcome (UK) Operations Limited - U.K. |
||
Cefuroxime BP | 125mg | |||
160 TAN 00,1818 J01D GLA | Zinnat Tablets | Glaxo Wellcome (UK) Operations Limited - U.K. |
||
Cefuroxime BP | 250mg | |||
Registrant | Glenmark Pharmaceuticals Ltd - INDIA | |||
161 TAN 00,1819 D01A GLE | Candid-TV Suspension | Glenmark Pharmaceuticals Ltd - INDIA |
||
Selenium Sulfide USP | 2.5%w/v | |||
Clotrimazole USP | 1%w/v | |||
162 TAN 00,1820 D01A GLE | Supirocin Ointment | Glenmark Pharmaceuticals Ltd - INDIA |
||
Mupirocin USP | 2%w/w | |||
163 TAN 00,1821 D01A GLE | Keto Plus Shampoo | Glenmark Pharmaceuticals Ltd - INDIA |
||
Ketoconazole BP | 2%w/v | |||
Zinc Pyrithione | 1%w/v | |||
164 TAN 00,1822 D07A GLE | Supricort Cream | Glenmark Pharmaceuticals Ltd - INDIA |
||
Fluocinolone Acetonide BP | 0.025%w/w | |||
165 TAN 00,1823 P03A GLE | Liceoma Lotion | Glenmark Pharmaceuticals Ltd - INDIA |
||
Lindane USP | 1%w/w |
Registration Number | Product Name | Active Ingredients | Strength | Manufacturer |
166 TAN 00,1824 D07X GLE | Supricort-N Cream | Glenmark Pharmaceuticals Ltd - INDIA |
||
Fluocinolone Acetonide BP | 0.025%w/w | |||
Neomycin Sulphate BP | 0.5%w/w | |||
Registrant | Intas Pharmaceuticals Ltd - INDIA | |||
167 TAN 00,1608 C01D INT | Nilol Tablets | Intas Pharmaceuticals Ltd - INDIA |
||
Atenolol BP | 50mg | |||
Nifedipine USP | 20mg | |||
168 TAN 00,1609 J01A INT | Doxytas Capsules | Intas Pharmaceuticals Ltd - INDIA |
||
Doxycycline HCl BP | 100mg | |||
169 TAN 00,1610 M01A INT | Intaflam Tablets | Intas Pharmaceuticals Ltd - INDIA |
||
Paracetamol BP | 325mg | |||
Ibuprofen BP | 400mg | |||
170 TAN 00,1611 N05A INT | Amitone-25 Tablets | Intas Pharmaceuticals Ltd - INDIA |
||
Amitriptyline BP | 25mg | |||
171 TAN 00,1612 N04A INT | Melozine-100 Tablets | Intas Pharmaceuticals Ltd - INDIA |
||
Thioridazine HCl USP | 100mg | |||
172 TAN 00,1613 N04A INT | Melozine-25 Tablets | Intas Pharmaceuticals Ltd - INDIA |
||
Thioridazine HCl USP | 25mg | |||
173 TAN 00,1614 P02A INT | Inta-Praziquantel Tablets | Intas Pharmaceuticals Ltd - INDIA |
||
Praziquantel USP | 600mg | |||
174 TAN 00,1825 J01F INT | Binimycin Tablets | Intas Pharmaceuticals Ltd - INDIA |
||
Erythromycin Stearate BP | 250mg | |||
175 TAN 00,1826 J01F INT | Lomitas Tablets | Intas Pharmaceuticals Ltd - INDIA |
||
Lomefloxacin HCl | 400mg | |||
176 TAN 00,1827 C01K INT | Amtas-10 Tablets | Intas Pharmaceuticals Ltd - INDIA |
||
Amlodipine Besylate | 10mg |
Registration Number | Product Name | Active Ingredients | Strength | Manufacturer |
Registrant | International Dispensary Association - Netherlands | |||
177 TAN 00,1615 A03B IDA | Hyoscine 10mg Tablets | Pharmamed Limited - MALTA |
||
Hyoscine Butylbromide Ph.Eur | 10mg | |||
178 TAN 00,1828 J04A IDA | Ethambutol 400mg Tablets | Pharmamed Limited - MALTA |
||
Ethambutol HCl Ph.Eur | 400mg | |||
179 TAN 00,1829 J04A IDA | Isoniazid 100mg Tablets | Pharmamed Limited - MALTA |
||
Isoniazid BP | 100mg | |||
180 TAN 00,1830 PO1B IDA | Quinine Dihydrochloride 600mg Injection | Pharmamed Limited - MALTA |
||
Quinine Dihydrochloride | 600mg/2ml | |||
181 TAN 00,1986 N04C IDA | Diazepam 10mg Injection | Pharmamed Limited - MALTA |
||
Diazepam BP | 10mg/2ml | |||
182 TAN 00,1831 N04A IDA | Chlorpromazine 25mg Tablets | Pharmamed Limited - MALTA |
||
Chlorpromazine Ph.Eur | 25mg | |||
183 TAN 00,1832 J01A IDA | Doxycycline 100mg Tablets | Pharmamed Limited - MALTA |
||
Doxycycline | 100mg | |||
184 TAN 00,1833 R03A IDA | Ephedrine HCl 30mg Tablets | Pharmamed Limited - MALTA |
||
Ephedrine HCl Ph.Eur | 30mg | |||
185 TAN 00,1834 R03A IDA | Aminophylline 250mg Injection | Pharmamed Limited - MALTA |
||
Aminophylline BP | 250mg | |||
186 TAN 00,1835 D08A IDA | Povidone Iodine 10% Solution | Purna Pharmaceuticals - BELGIUM |
||
Povidone Iodine Ph.Eur | 10%w/w | |||
187 TAN 00,1987 P03A IDA | Benzyl Benzoate Emulsion | Purna Pharmaceuticals - BELGIUM |
||
Benzyl Benzoate BP | 25%w/v | |||
Registrant | IPCA Laboratories Limited - INDIA | |||
188 TAN 00,1616 R03A IPC | Broncofol - P - Tablets | IPCA Laboratories Ltd - INDIA |
||
Ephedrine HCl BP | 11mg | |||
Theophylline BP | 120mg | |||
189 TAN 00,1836 J01D IPC | Stericef 500mg Injection | IPCA Laboratories Ltd - INDIA |
Registration Number | Product Name | Active Ingredients | Strength | Manufacturer |
Ceftriaxone USP | 500mg | |||
190 TAN 00,1617 J01D IPC | Stericef 1g Injection | IPCA Laboratories Ltd - INDIA |
||
Ceftriaxone USP | 1g/vial | |||
191 TAN 00,1618 J01K IPC | Roxeptin-Kid Tablets | IPCA Laboratories Ltd - INDIA |
||
Roxithromycin BP | 50mg | |||
192 TAN 00,1619 P01B IPC | Larimef Tablets | IPCA Laboratories Ltd - INDIA |
||
Mefloquine HCl BP | 250mg | |||
193 TAN 00,1620 M01A IPC | Nimica Suspension | IPCA Laboratories Ltd - INDIA |
||
Nimesulide | 50mg/5ml | |||
194 TAN 00,1621 A11A IPC | Ipcavite-M Drops | IPCA Laboratories Ltd - INDIA |
||
Vitamin B1 BP | 1mg | |||
Vitamin D3 USP | 400 I.U | |||
Vitamin C BP | 50mg | |||
Vitamin B6 BP | 1mg | |||
Vitamin A USP | 500 I.U | |||
Niacinamide BP | 10mg | |||
D-Panthenol USP | 2.5mg | |||
Riboflavin Phosphate BP | 1mg | |||
195 TAN 00,1837 B04A IPC | Simlo-10 Tablets | IPCA Laboratories Ltd - INDIA |
||
Simvastatin USP | 10mg | |||
196 TAN 00,1622 B04A IPC | Simlo-20 Tablets | IPCA Laboratories Ltd - INDIA |
||
Simvastatin USP | 20mg | |||
197 TAN 00,1838 A04A IPC | Periset-4 Tablets | IPCA Laboratories Ltd - INDIA |
||
Ondansetron | 4mg | |||
198 TAN 00,1623 A04A IPC | Periset-8 Tablets | IPCA Laboratories Ltd - INDIA |
||
Ondansetron | 8mg | |||
199 TAN 00,1839 C01E IPC | Presartan-50 Tablets | IPCA Laboratories Ltd - INDIA |
||
Losartan Potassium | 50mg |
Registration Number | Product Name | Active Ingredients | Strength | Manufacturer |
200 TAN 00,1840 P02X IPC | Nemozole Tablets | IPCA Laboratories Ltd - INDIA |
||
Albendazole USP | 400mg | |||
Registrant | Ivee Aqua Epz Ltd - KENYA | |||
201 TAN 00,1624 S01D IVE | Ivytimol Eye Drops | Ivee Aqua Epz Ltd - KENYA |
||
Timolol BP | 5mg/ml | |||
202 TAN 00,1625 S02A IVE | Ivychlornicol Ear Drops | Ivee Aqua Epz Ltd - KENYA |
||
Chloramphenicol BP | 50mg/ml | |||
Registrant | Janssen Pharmaceutica (Pty) Ltd - R.S.A | |||
203 TAN 00,1626 D01A JAN | Gyno-Daktarin Vaginal Capsules | Janssen Pharmaceutical (PTY) Ltd - RSA |
||
Miconazole Nitrate Ph.Eur | 400mg | |||
Registrant | Kampala Pharmaceutical Industries (1996) Ltd - UGANDA | |||
204 TAN 00,1627 D01A KMP | Camston Cream | Kampala Pharmaceutical Industries (1996) Ltd-Uganda |
||
Clotrimazole USP | 1%w/w | |||
Registrant | Karnataka Antibiotic and Pharmaceuticals Ltd - INDIA | |||
205 TAN 00,1628 J01H KRA | Sterile Penicillin G Benzatine 2.4 Mega | Karnataka Antibiotic And Pharmaceuticals Ltd - INDIA |
||
Sterile Penicillin G Benzatine | 2.4mega |
|||
206 TAN 00,1629 J01H KRA | P.P.F Injection 0.4 mega | Karnataka Antibiotic And Pharmaceuticals Ltd - INDIA |
||
Fortified Procaine Benzyl | 0.4mega |
|||
Registrant | Kela Laboratoria N.V - BELGIUM | |||
207 TAN 00,1630 B03 A KEL | Gestiferrol Tablets | Kela Laboratoria N.V- BELGIUM |
||
Ferrous Fumarate Ph.Eur | 200mg |
|||
Folic Acid Ph.Eur | 500mcg |
Registration Number | Product Name | Active Ingredients | Strength | Manufacturer |
Registrant | Kleva Ltd - GREECE | |||
208 TAN 00,1841 M02A KLE | Vilonit Emulgel | Kleva Ltd - GREECE |
||
Diclofenac Sodium | 1%w/w | |||
209 TAN 00,1842 J01K KLE | Ginorectol Tablets | Kleva Ltd - GREECE |
||
Ciprofloxacin Ph.Eur | 500mg | |||
210 TAN 00,1843 C01D KLE | Nafordyl Tablets | Kleva Ltd - GREECE |
||
Lisinopril USP | 20mg | |||
211 TAN 00,1844 A02B KLE | Tupast Tablets | Kleva Ltd - GREECE |
||
Ranitidine Ph.Eur | 150mg | |||
Registrant | Kopran Limited - INDIA | |||
212 TAN 00,1845 A02B KOP | Kocef-250 Powder for Injection | Kopran Limited - INDIA |
||
Sterile Ceftriaxone Sodium | 250mg | |||
213 TAN 00,1846 J01D KOP | Kocef-500 Powder for Injection | Kopran Limited - INDIA |
||
Sterile Ceftriaxone Sodium | 500mg | |||
214 TAN 00,1847 J01D KOP | Kocef-1000 Powder for Injection | Kopran Limited - INDIA |
||
Sterile Ceftriaxone Sodium | 1000mg | |||
215 TAN 00,1848 M01A KOP | Nemil-OS Tablets | Kopran Limited - INDIA |
||
Nimesulide | 100mg | |||
216 TAN 00,1849 M01A KOP | Nemil Suspension | Kopran Limited - INDIA |
||
Nimesulide | 50mg/5ml | |||
217 TAN 00,1850 J01C KOP | Ampicloxa-500 Capsules | Kopran Limited - INDIA |
||
Cloxacillin BP | 250mg | |||
Ampicillin BP | 250mg | |||
218 TAN 00,1851 J01F KOP | Eryko Dry Syrup | Kopran Limited - INDIA |
||
Erythromycin USP | 125mg/5ml | |||
219 TAN 00,1852 J01F KOP | Eryko-250 Tablets | Kopran Limited - INDIA |
||
Erythromycin Stearate BP | 250mg |
Registration Number | Product Name | Active Ingredients | Strength | Manufacturer |
220 TAN 00,1853 J01H KOP | Ampik Syrup | Kopran Limited - INDIA |
||
Ampicillin BP | 125mg/5ml | |||
Registrant | Kun Woong Pharmaceutical Company Ltd - KOREA | |||
221 TAN 00,1631 J05A KUN | Acyclovir Tablets | Kun Woong Pharmaceutical Company Ltd - KOREA |
||
Acyclovir BP | 200mg | |||
222 TAN 00,1632 J01K KUN | Cipro Tablets | Kun Woong Pharmaceutical Company Ltd - KOREA |
||
Ciprofloxacin USP | 500mg | |||
Registrant | Laboratories & Allied Ltd - KENYA | |||
223 TAN 00,1854 V04A LAA | Labstatin V Tablets | Laboratories & Allied Ltd - KENYA |
||
Nystatin | 100,000 IU | |||
224 TAN 00,1855 V04A LAA | Aminophylline Tablets | Laboratories & Allied Ltd - KENYA |
||
Aminophylline BP | 100mg | |||
225 TAN 00,1856 V04A LAA | Lecotrim Tablets | Laboratories & Allied Ltd - KENYA |
||
Sulphamethoxazole BP | 400mg | |||
Trimethoprim BP | 80mg | |||
226 TAN 00,1988 P02X LAA | Natoa Tablets | Laboratories & Allied Ltd - KENYA |
||
Mebendazole BP | 100mg | |||
227 TAN 00,1989 R03A LAA | Gifol Tablets | Laboratories & Allied Ltd - KENYA |
||
Theophylline BP | 120mg | |||
Ephedrine HCl BP | 11mg | |||
228 TAN 00,1857 HO2A LAA | Hycorum Injection | Laboratories & Allied Ltd - KENYA |
||
Hydrocortisone Sodium USP | 133.7mg | |||
229 TAN 00,1858 S01A LAA | Racycline Eye Ointment | Laboratories & Allied Ltd - KENYA |
||
Tetracycline HCl BP | 1%w/w | |||
230 TAN 00,1859 M01A LAA | Rheumac Gel | Laboratories & Allied Ltd - KENYA |
||
Diclofenac Sodium BP | 1%w/w |
Registration Number | Product Name | Active Ingredients | Strength | Manufacturer |
231 TAN 00,1860 N02B LAA | Aspirin Tablets | Laboratories & Allied Ltd - KENYA |
||
Aspirin BP | 300mg | |||
232 TAN 00,1861 D07A LAA | Hycorum Cream | Laboratories & Allied Ltd - KENYA |
||
Hydrocortisone BP | 1.0g | |||
233 TAN 00,1862 D07A LAA | Labesten Pessaries | Laboratories & Allied Ltd - KENYA |
||
Clotrimazole BP | 100mg | |||
234 TAN 00,1863 J01C LAA | Axylin Capsules | Laboratories & Allied Ltd - KENYA |
||
Cloxacillin Sodium BP | 250mg | |||
Ampicillin Trihydrate BP | 250mg | |||
235 TAN 00,1864 J01A LAA | Doxycycline Capsules | Laboratories & Allied Ltd - KENYA |
||
Doxycycline BP | 100mg | |||
236 TAN 00,1865 J03B LAA | Lecotrim Suspension | Laboratories & Allied Ltd - KENYA |
||
Trimethoprim BP | 40mg/5ml | |||
Sulphamethoxazole BP | 200mg/5ml | |||
237 TAN 00,1866 J01H LAA | Lacillin Dry Syrup | Laboratories & Allied Ltd - KENYA |
||
Ampicillin BP | 125mg/5ml | |||
238 TAN 00,1867 D01A LAA | Labecten Cream | Laboratories & Allied Ltd - KENYA |
||
Clotrimazole BP | 1.0%w/w | |||
239 TAN 00,1868 N04C LAA | Phenorbarbitone Tablets | Laboratories & Allied Ltd - KENYA |
||
Phenorbarbitone BP | 30mg | |||
240 TAN 00,1869 J01K LAA | Labstatin Oral Suspension | Laboratories & Allied Ltd - KENYA |
||
Nystatin USP | 100,000 | |||
241 TAN 00,1870 J01H LAA | Lacillin Capsules | Laboratories & Allied Ltd - KENYA |
||
Ampicillin Trihydrate BP | 250mg | |||
242 TAN 00,1871 J01F LAA | Erocin Tablets | Laboratories & Allied Ltd - KENYA |
||
Erythromycin Stearate BP | 400mg | |||
243 TAN 00,1872 J01F LAA | Kemoxyl 250 Capsules | Laboratories & Allied Ltd - KENYA |
||
Amoxycillin Trihydrate BP | 250mg |
Registration Number | Product Name | Active Ingredients | Strength | Manufacturer |
244 TAN 00,1873 P01A LAA | Tynazole 500mg Tablets | Laboratories & Allied Ltd - KENYA |
||
Tinidazole BP | 500mg | |||
245 TAN 00,1874 N02B LAA | Dentamol Tablets | Laboratories & Allied Ltd - KENYA |
||
Acetaminophen USP | 500mg | |||
246 TAN 00,1875 A02A LAA | Baby Gripe Mixture | Laboratories & Allied Ltd - KENYA |
||
Sodium Citrate BP | 0.5g/100ml | |||
Sodium Bicarbonate BP | 1.2g/100ml | |||
Aniseed Oil BP | 0.12g/100ml | |||
Strong Ginger Tincture BP | 0.5g/100ml | |||
Registrant | Laboratories for Applied Biology Ltd - ENGLAND | |||
247 TAN 00,1633 S02D LBA | Cerumol Ear Drops | Laboratories For Applied Biology Ltd - ENGLAND |
||
Arachis Oil (Peanut Oil) BP | 574mg/ml | |||
Paradichlorobenzene BP | 20mg/ml | |||
Chlorbutanol BP | 50mg/ml | |||
Registrant | Laboratories SmithKline & French, S.A - FRANCE | |||
248 TAN 00,1990 P01B LAB | Halfan Suspension | Laboratories Smith Kline & French, S.A - FRANCE |
||
Halofantrine HCl | 100mg/5ml | |||
Registrant | Laboratories Synthelabo - FRANCE | |||
249 TAN 00,1634 R02A LBS | Rhinathiol 2% Syrup | Synthelabo Groupe - FRANCE |
||
Carbocisteine Ph.Eur | 2g/100ml | |||
250 TAN 00,1635 R02A LBS | Rhinathiol 5% Syrup | Synthelabo Groupe - FRANCE |
||
Carbocisteine Ph.Eur | 5g/100ml | |||
Registrant | Lilly S.A. Pty Ltd - SPAIN | |||
251 TAN 00,1636 C01L LIL | CYNT Tablets | Lilly S.A. Pty Ltd - SPAIN |
Registration Number | Product Name | Active Ingredients | Strength | Manufacturer |
Moxonidine | 0,3mg | |||
Registrant | Lincoln Pharmaceuticals Ltd - INDIA | |||
252 TAN 00,1991 M01A LIN | Vivian Gel | Lincoln Pharmaceuticals Ltd - INDIA |
||
Diclofenac Sodium BP | 1.00%w/w | |||
Methyl Salicylate BP | 10%w/w | |||
Menthol BP | 5.0w/w | |||
Linseed Oil BP | 3.0%w/w | |||
253 TAN 00,1992 P01B LIN | Linquine-F Injection | Lincoln Parenterals Pvt Ltd - INDIA |
||
Quinine Dihydrochloride BP | 300mg/ml | |||
254 TAN 00,1993 J01F LIN | L-Genta Injection | Lincoln Parenterals Pvt Ltd - INDIA |
||
Gentamycin BP | 80mg/2ml | |||
255 TAN 00,1994 J01H LIN | Ampicillin Sodium for Injection | Lincoln Parenterals Pvt Ltd - INDIA |
||
Ampicillin Sodium BP | 500mg/vial | |||
256 TAN 00,1995 N02A LIN | Vivian Injection | Lincoln Parenterals Pvt Ltd - INDIA |
||
Diclofenac Sodium BP | 25mg/ml | |||
257 TAN 00,1996 D07A LIN | Lincosone Cream | Lincoln Pharmaceuticals Ltd - INDIA |
||
Neomycin Sulphate BP | 0.5%w/w | |||
Beclomethasone Dipropionate | 0.025%w/w | |||
Clotrimazole BP | 1.0%w/w | |||
258 TAN 00,1997 D07A LIN | Lincoderm Cream | Lincoln Pharmaceuticals Ltd - INDIA |
||
Gentamycin (as sulphate) BP | 1.0mg/g | |||
Chinoform BP | 10mg/g | |||
Tolnaftate BP | 10mg/g | |||
Betamethasone Valerate BP | 0.61mg/g | |||
259 TAN 00,1998 D01A LIN | Clotrilin Cream | Lincoln Pharmaceuticals Ltd - INDIA |
||
Clotrimazole BP | 2%w/w | |||
260 TAN 00,1999 J01A LIN | Teterous-250 Capsules | Lincoln Pharmaceuticals Ltd - INDIA |
||
Tetracycline HCl BP | 250mg |
Registration Number | Product Name | Active Ingredients | Strength | Manufacturer |
261 TAN 00,2000 J03C LIN | Dermofulvin Tablets | Lincoln Pharmaceuticals Ltd - INDIA |
||
Griseofulvin BP | 500mg | |||
262 TAN 00,2001 N02B LIN | Vivian - 50 Tablets | Lincoln Pharmaceuticals Ltd - INDIA |
||
Diclofenac Sodium BP | 50mg | |||
263 TAN 00,2002 N01B LIN | Lignocaine 2% Injection | Lincoln Pharmaceuticals Ltd - INDIA |
||
Lignocaine HCl BP | 20mg/ml | |||
264 TAN 00,2003 M01A LIN | Nam Tablets | Lincoln Pharmaceuticals Ltd - INDIA |
||
Nimesulide | 100mg | |||
265 TAN 00,2004 J01B LIN | Chloramphenicol Sodium Succinate For Injection | Lincoln Pharmaceuticals Ltd - INDIA |
||
Chloramphenicol Sodium | 1g/vial | |||
266 TAN 00,2005 D06A LIN | Silvo Cream | Lincoln Pharmaceuticals Ltd - INDIA |
||
Chlorhexidine Gluconate | 0.2%w/w | |||
Silver Sulphasalazine USP | 1%w/w | |||
267 TAN 00,2006 P01B LIN | Maratab Tablets | Lincoln Pharmaceuticals Ltd - INDIA |
||
Amodiaquine BP | 200mg | |||
268 TAN 00,2007 A11E LIN | Vitamin B-Complex Injection 10ml | Lincoln Pharmaceuticals Ltd - INDIA |
||
Pyridoxine HCl BP | 1mg/10ml | |||
Thiamine HCl BP | 10mg/10ml | |||
Vitamin B2 5-Phosphate BP | 1.5ml/10ml | |||
Niacinamide BP | 50mg/10ml | |||
D-Panthenol USP | 4mg/10ml | |||
269 TAN 00,2008 M01B LIN | Hydrocortisone Sodium Succinate Injection | Lincoln Pharmaceuticals Ltd - INDIA |
||
Hydrocortisone Sodium | 100mg/vial | |||
270 TAN 00,2009 J01K LIN | Ceepro - 500 Tablets | Lincoln Pharmaceuticals Ltd - INDIA |
||
Ciprofloxacin HCl BP | 500mg | |||
Registrant | Marck Parenterals (India) Limited - INDIA | |||
271 TAN 00,1876 B05B MAR | Glucose Intravenous Infusion | Marck Parenterals (India) Limited - INDIA |
||
Glucose Anhydrous BP | 50gm/Lts |
Registration Number | Product Name | Active Ingredients | Strength | Manufacturer |
272 TAN 00,1877 B05B MAR | Compound Sodium Intravenous Infusion | Marck Parenterals (India) Limited - INDIA |
||
Sodium Lactate BP | 6.00gm/Lts | |||
Potassium Chloride BP | 0.40gm/Lts | |||
Calcium Chloride BP | 0.27gm/Lts | |||
Sodium Lactate USP | 3.20gm/Lts | |||
273 TAN 00,1878 B05B MAR | Sodium Chloride Intravenous Solution | Marck Parenterals (India) Limited - INDIA |
||
Sodium Chloride BP | 0.009g/1000 | |||
274 TAN 00,1879 B05B MAR | Sodium Chloride & Glucose Intravenous Infusion | Marck Parenterals (India) Limited - INDIA |
||
Glucose Anhydrous BP | 0.0500kg/100 | |||
Sodium Chloride BP | 0.00110kg/10 |
|||
Registrant | Medley Pharmaceuticals Ltd - INDIA | |||
275 TAN 00,1880 A09A MED | Xymex Drops | Medley Pharmaceuticals Ltd - INDIA |
||
Papain USP | 0.60mg/ml | |||
Sodium Citrate BP | 40mg/ml | |||
Citric Acid Monohydrate BP | 0.8mg/ml | |||
Weak Ginger Tincture BP | 0.024ml | |||
Cinnamon Oil BP | 0.0024ml | |||
Pepsin BP | 10mg/ml | |||
Registrant | Medochemie Ltd - CYPRUS | |||
276 TAN 00,1637 M01A MDC | Aponil Tablets | Medochemie Ltd - CYPRUS |
||
Nimesulide Ph.Eur | 100mg | |||
277 TAN 00,1638 J01D MDC | Medomycin Capsules | Medochemie Ltd - CYPRUS |
||
Doxycycline Hyclate Ph.Eur | 100mg | |||
278 TAN 00,1639 J01D MDC | Medolexin Capsules 25mg | Medochemie Ltd - CYPRUS |
||
Cefalexin Ph.Eur | 250mg | |||
279 TAN 00,1640 J02A MDC | Medoflucon Capsules | Medochemie Ltd - CYPRUS |
||
Fluconazole Ph.Eur | 150mg | |||
280 TAN 00,1881 J01A MDC | Medovir 200 Tablets | Medochemie Ltd - CYPRUS |
Registration Number | Product Name | Active Ingredients | Strength | Manufacturer |
Aciclovir Ph.Eur | 200mg | |||
281 TAN 00,1882 J01H MDC | Pamecil 250 Capsules | Medochemie Ltd - CYPRUS |
||
Ampicillin Trihydrate Ph.Eur | 250mg | |||
282 TAN 00,1883 P02A MDC | Bermoxel Tablets | Medochemie Ltd - CYPRUS |
||
Praziquantel Ph.Eur | 600mg | |||
283 TAN 00,1884 N03A MDC | Taver Tablets | Medochemie Ltd - CYPRUS |
||
Carbamazepine BP | 200mg | |||
284 TAN 00,2010 A07D MDC | Vacontil Capsule | Medochemie Ltd - CYPRUS |
||
Loperamide HCl Ph.Eur | 2mg | |||
285 TAN 00,2011 J01H MDC | Moxilen Capsules | Medochemie Ltd - CYPRUS |
||
Amoxycillin (as trihydrate) | 250mg | |||
Registrant | Medopharm - INDIA | |||
286 TAN 00,1641 J02A MEP | Edocid-P Tablets | Medopharm - INDIA |
||
Aluminium Hydroxide BP | 500mg | |||
287 TAN 00,1642 C01K MEP | M-Dopa Tablets | Medopharm - INDIA |
||
Methyldopa BP | 250mg | |||
288 TAN 00,1643 A11G MEP | Mirafolic Tablets | Medopharm - INDIA |
||
Folic Acid BP | 5mg | |||
289 TAN 00,1644 D04A MEP | Medomine Tablets | Medopharm - INDIA |
||
Chlorpheniramine Maleate BP | 4mg | |||
290 TAN 00,1885 A02A MEP | Digicid Tablets | Medopharm - INDIA |
||
Dried Aluminium Hydroxide | 120mg | |||
Magnesium Trisilicate BP | 250mg | |||
Registrant | Memphis Co. For Pharm. & Chem. Ind. - EGYPT | |||
291 TAN 00,1645 D011 MEM | Neo-Meladinine F.R. Tablets | Memphis Co. For Pharm. & Chem. Ind. - EGYPT |
||
Ammoidin USP | 10mg |
Registration Number | Product Name | Active Ingredients | Strength | Manufacturer |
292 TAN 00,1646 H02A MEM | Dopagon Tablets | Memphis Co. For Pharm. & Chem. Ind. - EGYPT |
||
Bromocriptine Mesylate BP | 2.5mg | |||
Registrant | Mepha Ltd - SWITZERLAND | |||
293 TAN 00,1647 P01B MES | Plasmotrim - 200 Rectocaps | Mepha Ltd - SWITZERLAND |
||
Artesunate | 200mg | |||
294 TAN 00,1648 P01B MES | Plasmotrim 200 Lactab | Mepha Ltd - SWITZERLAND |
||
Artesunate | 200mg | |||
295 TAN 00,1649 J05A MES | Aviral- 400 Tablets | Mepha Ltd - SWITZERLAND |
||
Acyclovir BP | 400mg | |||
296 TAN 00,1650 J05A MES | Aviral- 200 Tablets | Mepha Ltd - SWITZERLAND |
||
Acyclovir BP | 200mg | |||
297 TAN 00,1651 D11 MES | Dolobene Gel | Mepha Ltd - SWITZERLAND |
||
Heparin Sodium USP | 0.33g | |||
Dimethylsulfoxide USP | 15mg | |||
D-Panthenol BP | 2.5g | |||
298 TAN 00,1652 J05A MES | Aviral-800 Tablets | Mepha Ltd - SWITZERLAND |
||
Acyclovir BP | 800mg | |||
299 TAN 00,1653 M01A MES | Olfen-75 SR Depotabs | Mepha Ltd - SWITZERLAND |
||
Diclofenac Sodium BP | 75mg | |||
300 TAN 00,1886 A02B MES | Gasec-20 Gastrocaps | Mepha Ltd - SWITZERLAND |
||
Omeprazole Ph.Eur | 20mg | |||
Registrant | Mepha, Lda. Investigacao, Desenvolvimento e Fabricacao Farmaceutica - PORTUGAL |
|||
301 TAN 00,2012 J01H MES | Mesporin-250 Injection | Labesfal, Laboratorios Almiro SA - PORTUGAL |
||
Ceftriaxone Ph.Eur | 250mg/vial | |||
302 TAN 00,2013 J01D MES | Mesporin-500 IM Injection | Labesfal, Laboratorios Almiro SA - PORTUGAL |
Registration Number | Product Name | Active Ingredients | Strength | Manufacturer |
Ceftriaxone Ph.Eur | 500mg | |||
303 TAN 00,2014 J01D MES | Mesporin-1000 IV Injection | Labesfal, Laboratorios Almiro SA - PORTUGAL |
||
Ceftriaxone Ph.Eur | 1000mg/10ml |
|||
304 TAN 00,2015 J01K MES | Bactiflox 250 Lactab | Sofarimex Industria Quimica e Farmaceutica Lda - PORTUGAL |
||
Ciprofloxacin Ph.Eur | 250mg | |||
305 TAN 00,2016 J01K MES | Mesporin-1000 IM Injection | Labesfal, Laboratories Almiro SA - PORTUGAL |
||
Ceftriaxone Ph.Eur | 1000mg | |||
306 TAN 00,2017 J01K MES | Bactiflox-500 Lactab | Sofarimex Industria Quimica e Farmaceutica Lda - PORTUGAL |
||
Ciprofloxacin Ph.Eur | 500mg | |||
307 TAN 00,2018 J01K MES | Bactiflox 750 Labtab | Sofarimex Industria Quimica e Farmaceutica Lda - PORTUGAL |
||
Ciprofloxacin Ph.Eur | 750mg | |||
Registrant | Missionpharma International Project Services A/S - DENMARK |
|||
308 TAN 00,1654 N04A MIP | Chlorpromazine Tablets | Medicamen Biotech Ltd - INDIA |
||
Chlorpromazine BP | 25mg | |||
309 TAN 00,1655 C06A MIP | Propranolol Tablets | Medicamen Biotech Ltd - INDIA |
||
Propranolol BP | 40mg | |||
310 TAN 00,1656 A11C MIP | Vitamin A Capsules | Strides Arcolab Ltd - INDIA |
||
Vitamin A BP | 100, 000IU | |||
Registrant | Morningside Pharmaceuticals Ltd - U.K | |||
311 TAN 00,1657 M01A MOR | Diclo 25 Tablets | Camden Industries (M) SDN BHD - MALAYSIA |
||
Diclofenac Sodium BP | 25mg | |||
312 TAN 00,1658 M01A MOR | Pixicam 20 Capsule | Camden Industries (M) SDN BHD - MALAYSIA |
Registration Number | Product Name | Active Ingredients | Strength | Manufacturer |
Piroxicam BP | 20mg | |||
313 TAN 00,1659 M01A MOR | Diclo 50 Tablets | Camden Industries (M) SDN BHD - MALAYSIA |
||
Diclofenac Sodium BP | 50mg | |||
314 TAN 00,1660 A02B MOR | Cimetidine 400 Capsules | Camden Industries (M) SDN BHD - MALAYSIA |
||
Cimetidine USP | 400mg | |||
315 TAN 00,1661 C06A MOR | Pronolol 40 Tablets | Camden Industries (M) SDN BHD - MALAYSIA |
||
Propranolol HCl BP | 40mg | |||
316 TAN 00,1662 J01A MOR | Doxicap Capsules | Varichem LTD - ZIMBABWE |
||
Doxycycline HCl BP | 100mg | |||
317 TAN 00,2019 R03A MOR | Buto-Asma Aerosol | Laboratorio Aldo-Union S.A. - SPAIN |
||
Salbutamol Ph.Eur | 100mcg/Puff | |||
Registrant | N. V. Organon - THE NETHERLANDS | |||
318 TAN 00,1887 M02A ORG | Esmeron Injection | N.V.Organon, Oss - THE NETHERLANDS |
||
Rocuronium Bromide | 100mg/10ml | |||
Registrant | Norton Healthcare Limited - U.K. | |||
319 TAN 00,1663 R03A NOR | Salamol 2.5mg Steri-neb | Norton (Waterford) Limited - IRELAND |
||
Salbutamol Sulphate BP | 2.5mg | |||
320 TAN 00,1664 N04C NOR | Lorazepam Tablets | Norton (Waterford) Limited - IRELAND |
||
Lorazepam BP | 1mg | |||
321 TAN 00,1665 M01A NOR | Piroxicam Capsules | Norton (Waterford) Limited - IRELAND |
||
Piroxicam BP | 20mg | |||
322 TAN 00,2020 L02B NOR | Tamoxifen Tablets | Norton (Waterford) Limited - IRELAND |
||
Tamoxifen BP | 20mg |
Registration Number | Product Name | Active Ingredients | Strength | Manufacturer |
Registrant | Novartis Pharma AG - SWITZERLAND | |||
323 TAN 00,1666 N02B NOP | Cataflam Tablets | Novartis Pharma AG - SWITZERLAND |
||
Diclofenac Potassium | 50mg | |||
Registrant | Novartis Pharma Services Inc. - SWITZERLAND | |||
324 TAN 00,1667 A16 NOP | Zelmac Tablets | Novartis Pharma Stein AG - SWITZERLAND |
||
Tegaserod | 6mg | |||
Registrant | Novo Nordisk A/S - DENMARK | |||
325 TAN 00,2021 A10B NOV | Novo Norm 0.5 Tablets | Novo Nordisk A/S - DENMARK |
||
Repaglidine | 0.5mg | |||
Registrant | Panacea Biotec Limited - INDIA | |||
326 TAN 00,1668 PO1A PAN | Giro Tablets | Panacea Biotec Limited - INDIA |
||
Ornidazole | 500mg | |||
327 TAN 00,2022 A11H PAN | Alphadol Capsules | Panacea Biotec Limited - INDIA |
||
Alfacalcidol BP | 0.25mcg | |||
328 TAN 00,2023 M01A PAN | Nimulid-DS Tablets | Panacea Biotec Limited - INDIA |
||
Nimesulide | 200mg | |||
329 TAN 00,2024 MO1A PAN | Nimulid-ND Kid Tablets | Panacea Biotec Limited - INDIA |
||
Nimesulide | 50mg | |||
Registrant | Pfizer Laboratories (Pty) Ltd - REPUBLIC OF SOUTH AFRICA |
|||
330 TAN 00,1888 M02A PFI | Fasigyn Tablets | Laboratoire Pfizer - FRANCE |
||
Tinidazole Ph.Eur | 500mg | |||
331 TAN 00,1669 S01D PFI | Visine Eye Drops | Pfizer Canada Inc. - Canada |
||
Tetrahydrozoline HCl USP | 7.5mg/15ml | |||
332 TAN 00,1670 M01A PFI | Feldene Capsules | Pfizer Laboratories (Pty) Ltd - R.S.A. |
||
Piroxicam USP | 10mg | |||
333 TAN 00,1671 M01A PFI | Feldene Capsules | Pfizer Laboratories (Pty) Ltd - R.S.A. |
Registration Number | Product Name | Active Ingredients | Strength | Manufacturer |
Piroxicam USP | 20mg | |||
Registrant | Pharmacia & Upjohn - ITALY | |||
334 TAN 00,2025 G02A PHA | Prostin E2 Vaginal Tablets | Pharmacia & Upjohn - BELGIUM |
||
Dinoprostone Ph.Eur | 3mg | |||
335 TAN 00,2026 H02A PHA | Solu Medrol Sterile Powder for Injection | Pharmacia & Upjohn - BELGIUM |
||
Methyl Prednisolone USP | 40mg/vial | |||
336 TAN 00,2027 H02A PHA | Solu Medrol Sterile Powder for Injection | Pharmacia & Upjohn - BELGIUM |
||
Methyl Prednisolone USP | 125mg/vial | |||
337 TAN 00,1672 D10A PHA | Dalacin T Topical Solution | Pharmacia & Upjohn - BELGIUM |
||
Clindamycin Phosphate USP | 10mg/ml | |||
338 TAN 00,1889 B02A PHA | Cyclokapron 500mg Tablets | Pharmacia & Upjohn - BELGIUM |
||
Tranexamic Acid Ph.Eur | ||||
339 TAN 00,1890 B02A PHA | Cyklokapron Injection | Pharmacia & Upjohn - BELGIUM |
||
Tranexamic Acid Ph.Eur | ||||
Registrant | ||||
340 TAN 00,1891 J01C RAN | Enhancin Suspension | Ranbaxy Laboratories Ltd - INDIA |
||
Potassium Clavulanate | 62.5mg/5ml | |||
Amoxycillin Trihydrate USP | 250mg/5ml | |||
341 TAN 00,2028 J01C RAN | Enhancin Suspension | Ranbaxy Laboratories Ltd - INDIA |
||
Clavulanic Acid | 31.25mg/5ml | |||
Amoxycillin USP | 125mg/5ml | |||
342 TAN 00,2029 J01F RAN | Crixan Tablets | Ranbaxy Laboratories Ltd - INDIA |
||
Clarithromycin USP | 250mg | |||
Registrant | Regal Pharmaceuticals Ltd - KENYA | |||
343 TAN 00,1673 J01H REG | Uniamp Capsules | Regal Pharmaceuticals Ltd - KENYA |
||
Ampicillin Trihydrate BP | 250mg | |||
344 TAN 00,1674 J01H REG | Uniamp Syrup | Regal Pharmaceuticals Ltd - KENYA |
Registration Number | Product Name | Active Ingredients | Strength | Manufacturer |
Ampicillin Trihydrate BP | 125mg/5ml | |||
345 TAN 00,1675 A02A REG | Magnomint Tablets | Regal Pharmaceuticals Ltd - KENYA |
||
Magnesium Trisilicate BP> | 250mg | |||
Aluminium Hydroxide BP | 125mg | |||
Registrant | Remedica Ltd - CYPRUS | |||
346 TAN 00,1676 C03D REM | Ovamit 50 Tablets | Remedica Ltd - CYPRUS |
||
Clomifene Citrate BP | 50mg | |||
347 TAN 00,1677 C01D REM | Spirolon 25 FC Tablets | Remedica Ltd - CYPRUS |
||
Spironolactone BP | 25mg | |||
348 TAN 00,1678 C06A REM | Velorin 50 Tablets | Remedica Ltd - CYPRUS |
||
Atenolol BP | 50mg | |||
349 TAN 00,1679 C06A REM | Velorin 100 Tablets | Remedica Ltd - CYPRUS |
||
Atenolol BP | 100mg | |||
350 TAN 00,1680 GO4A REM | Nalidixic Acid 500mg Tablets | Remedica Ltd - CYPRUS |
||
Nalidixic Acid BP | 500mg | |||
351 TAN 00,1681 C01E REM | Epsitoron 25 Tablets | Remedica Ltd - CYPRUS |
||
Captopril BP | 25mg | |||
352 TAN 00,1682 D01A REM | Mycoril Cream 1% | Remedica Ltd - CYPRUS |
||
Clotrimazole BP | 1%w/w | |||
353 TAN 00,1683 L02B REM | Novofen 10 Tablets | Remedica Ltd - CYPRUS |
||
Tamoxifen BP | 10gm | |||
354 TAN 00,1892 A12A REM | Calcium Lactate 300mg Tablets | Remedica Ltd - CYPRUS |
||
Calcium Lactate BP | 300mg | |||
355 TAN 00,1893 A07D REM | Loperium 2 Tablets | Remedica Ltd - CYPRUS |
||
Loperamide HCl BP | 2mg | |||
356 TAN 00,1894 C06A REM | Emforal 40 FC Tablets | Remedica Ltd - CYPRUS |
||
Propranolol BP | 40mg |
Registration Number | Product Name | Active Ingredients | Strength | Manufacturer |
357 TAN 00,1895 A02B REM | Raniplex 150 Tablets | Remedica Ltd - CYPRUS |
||
Ranitidine BP | 150mg | |||
358 TAN 00,1896 N02B REM | Remethan 100R Tablets | Remedica Ltd - CYPRUS |
||
Diclofenac Sodium BP | 100mg | |||
359 TAN 00,1897 H02A REM | Perazone 0.5 Tablets | Remedica Ltd - CYPRUS |
||
Dexamethazone BP | 0.5mg | |||
360 TAN 00,1898 C01E REM | Korandil 5 Tablets | Remedica Ltd - CYPRUS |
||
Enalapril Maleate USP | 5mg | |||
361 TAN 00,2030 M01A REM | Roxitan 20 Capsules | Remedica Ltd - CYPRUS |
||
Piroxicam BP | 20mg | |||
Registrant | Rivopharm S.A - SWITZERLAND | |||
362 TAN 00,2031 R03A RIV | Rivofen 1mg Tablets | Rivopharm S.A. - SWITZERLAND |
||
Ketotifen | 1mg | |||
363 TAN 00,2032 C01E RIV | Rivtopril 25mg Tablets | Rivopharm S.A. - SWITZERLAND |
||
Captopril Ph.Eur | 25mg | |||
364 TAN 00,2033 C01E RIV | Rivtopril 50mg Tablets | Rivopharm S.A. - SWITZERLAND |
||
Captopril Ph.Eur | 50mg | |||
365 TAN 00,2034 N03A RIV | Rivolepsin 200mg Tablets | Rivopharm S.A. - SWITZERLAND |
||
Carbamazepine BP | 200mg | |||
Registrant | Rolab (Pty) Ltd - SOUTH AFRICA | |||
366 TAN 00,1684 A10B ROL | Glibenclamide 5 Tablets | Novartis South Africa (Pty) Ltd - R.S.A. |
||
Glibenclamide BP | 5mg | |||
367 TAN 00,1685 A10B ROL | Rolab Metformin Tablets | Novartis Pharma Stein AG - SWITZERLAND |
||
Metformin HCl BP | 500mg |
Registration Number | Product Name | Active Ingredients | Strength | Manufacturer |
Registrant | Rotexmedica GMBH - GERMANY | |||
368 TAN 00,1686 N01B ROT | Lidocaine Injection BP 2% | Rotexmedica GMBH - GERMANY |
||
Lidocaine HCl BP | 20mg/ml | |||
369 TAN 00,1687 N01A ROT | Ketamine Hydrochloride Injection USP | Rotexmedica GMBH - GERMANY |
||
Ketamine Hydrochloride USP | 50mg/ml | |||
370 TAN 00,1688 N05B ROT | Fluphenazine Decanoate Injection USP 25mg/ml | Rotexmedica GMBH - GERMANY |
||
Fluphenazine Decanoate USP | 25mg/ml | |||
371 TAN 00,1689 H01B ROT | Oxytocin Injection BP 5 Units | Rotexmedica GMBH - GERMANY |
||
Oxytocin BP | 5iu/ml | |||
Registrant | Sanofi Winthrop AMO - FRANCE | |||
372 TAN 00,1690 M01A SAN | Paracetamol Tablets | Sanofi Winthrop - U.K. |
||
Paracetamol Ph.Eur | 500mg | |||
Registrant | Scan Pharma - DENMARK | |||
373 TAN 00,1691 A11A SCA | Pregnatal Tablets | Scan Pharma - DENMARK |
||
Folic Acid BP | 0.5mg | |||
Ferrous Fumarate BP | 65mg | |||
Calcium BP | 130.0mg | |||
Zinc Oxide BP | 7.5mg | |||
Vitamin E BP | 15iu | |||
Potassium BP | 0.75mg | |||
Vitamin A Acetate BP | 3000iu | |||
Iodine BP | 75mcg | |||
Manganese BP | 0.25mg | |||
Copper BP | 1.0mg | |||
Vitamin C BP | 45mg | |||
Calcium Pantothenate BP | 2.5mg | |||
Vitamin B2 BP | 1.5mg | |||
Vitamin D3 BP | 200iu | |||
Magnesium BP | 500mg | |||
Vitamin B1 BP | 1.5mg |
Registration Number | Product Name | Active Ingredients | Strength | Manufacturer |
Nicotinamide BP | 10mg | |||
Vitamin B6 BP | 2.5mg | |||
Vitamin B12 BP | 4.0mg | |||
Registrant | SEDICO Pharmaceutical Co. - EGYPT | |||
374 TAN 00,1692 J01H SED | Flucamox 250mg Capsules | SEDICO Pharmaceutical Co - EGYPT |
||
Amoxycillin BP | 125mg | |||
Flucloxacillin BP | 125mg | |||
Registrant | Serum Institute of India - INDIA | |||
375 TAN 00,2035 N03A SER | Diphtheria Tetanus and Pertussis vaccine adsorbed | Serum Institute of India - INDIA |
||
B. Pertussis | 30 IU | |||
Tetanus Toxoid | 40 IU | |||
Diphtheria Toxoid | 30 IU | |||
Registrant | Shalina Laboratories Pvt. Ltd. - INDIA | |||
376 TAN 00,2036 R03A SHA | Aminophylline Injection | Kilitch Drugs Ltd - INDIA |
||
Aminophylline BP | 250mg/10ml | |||
377 TAN 00,1899 J01A SHA | Ampi Injection | Kilitch Drugs Ltd - INDIA |
||
Ampicillin Sodium BP | 1000mg/vial | |||
378 TAN 00,2037 B12A SHA | Calcium Gluconate Injection | Kilitch Drugs Ltd - INDIA |
||
Calcium Gluconate BP | 1g/10ml | |||
379 TAN 00,2038 N04B SHA | Dizapam Injection | Kilitch Drugs Ltd - INDIA |
||
Diazepam BP | 10mg/2ml | |||
380 TAN 00,2039 J01K SHA | Gentamycin Injection | Kilitch Drugs Ltd - INDIA |
||
Gentamycin Sulphate BP | 40mg/2ml | |||
381 TAN 00,1900 J01B SHA | Misocol Injection | Kilitch Drugs Ltd - INDIA |
||
Chloramphenicol Sodium | 1000mg/vial | |||
382 TAN 00,2040 S01A SHA | Misocol Eye Drops | Kilitch Drugs Ltd - INDIA |
||
Chloramphenicol BP | 0.5%w/v |
Registration Number | Product Name | Active Ingredients | Strength | Manufacturer |
383 TAN 00,1901 A11H SHA | Pyridox Injection | Kilitch Drugs Ltd - INDIA |
||
Pyridoxine HCl BP | 200mg/2ml | |||
384 TAN 00,2041 P01B SHA | Quinishal Injection | Kilitch Dugs Ltd - INDIA |
||
Quinine Dihydrochloride BP | 500mg/2ml | |||
385 TAN 00,2042 S03C SHA | Shaldex Eye/Ear drops | Kilitch Drugs Ltd - INDIA |
||
Neomycin Sulfate BP | 0.5%w/v | |||
Dexamethazone Sodium | 0.1 %w/v | |||
386 TAN 00,2043 J01C SHA | Shalpen Injection | Kilitch Drugs Ltd - INDIA |
||
Fortified Procaine Penicillin | 3.6gm/Vial | |||
387 TAN 00,1902 A11D SHA | Vitamin B1 Injection | Kilitch Drugs Ltd - INDIA |
||
Thiamine Hydrochloride BP | 100mg/ml | |||
388 TAN 00,1903 A11A SHA | Trishal Forte Injection | Kilitch Drugs Ltd - INDIA |
||
Cyanocobalamine BP | 1mg/ml | |||
Pyridoxine Hydrochloride BP | 55mg/ml | |||
Thiamine Hydrochloride BP | 55mg/ml | |||
Registrant | Shin Poong Pharmaceutical Co., Ltd. - KENYA | |||
389 TAN 00,1693 A02B SHI | Famtine Tablets | Shin Poong Pharmaceutical Co Ltd - KOREA |
||
Famotidine USP | 20mg | |||
390 TAN 00,1694 D01A SHI | Ribatra Ointment | Shin Poong Pharmaceutical Co Ltd - KOREA |
||
Ribavirin USP | 30mg | |||
Bacitracin USP | 400i.u | |||
391 TAN 00,1695 A10B SHI | Glipizide Tablets | Shin Poong Pharmaceutical Co Ltd - KOREA |
||
Glipizide USP | 5mg | |||
392 TAN 00,2044 M01A SHI | Rosiden Dispersible Tablets | Shin Poong Pharmaceutical Co Ltd - KOREA |
Registration Number | Product Name | Active Ingredients | Strength | Manufacturer |
Piroxicam USP | 20mg | |||
393 TAN 00,1696 J01D SHI | Shincef 750mg Injection | Shin Poong Pharmaceutical Co Ltd - KOREA |
||
Cefuroxime USP | 750mg/vial | |||
Registrant | SmithKline Beecham Consumer Healthcare - KENYA | |||
394 TAN 00,1697 N02B SKB | Panadol Extra Tablets | SmithKline Beecham Consumer Healthcare - KENYA |
||
Caffeine Ph.Eur | 65mg | |||
Paracetamol Ph.Eur | 500mg | |||
395 TAN 00,1698 R06A SKB | Coracten Tablets | SmithKline Beecham International - U.K. |
||
Nifedipine Ph.Eur | 10mg | |||
396 TAN 00,1699 N02B SKB | Panadol Ya Watoto Tablets | SmithKline Beecham Consumer Healthcare - KENYA |
||
Paracetamol USP | 80mg | |||
397 TAN 00,1700 J01C SKB | Ampiclox Neonatal Drops | SmithKline Beecham Pharmaceuticals - U.K. |
||
Cloxacillin Sodium BP | 30mg | |||
Ampicillin Trihydrate BP | 60mg | |||
398 TAN 00,1701 J01C SKB | Floxapen Injection | SmithKline Beecham Pharmaceuticals - U.K. |
||
Flucloxacillin BP | 250mg/Vial | |||
399 TAN 00,1702 J01C SKB | Augmentin Tablets 375mg | SmithKline Beecham International - U.K. |
||
Amoxycillin Trihydrate Ph.Eur | 250mg | |||
Potassium Clavulanate Ph.Eur | 125mg | |||
400 TAN 00,1703 J01C SKB | Augmentin Suspension 156mg/5ml | SmithKline Beecham International - U.K. |
||
Amoxycillin Trihydate Ph.Eur | 125mg/5ml | |||
Potassium Clavulanate Ph.Eur | 30mg/5ml | |||
401 TAN 00,1704 J01C SKB | Augmentin Injection 1.2g | SmithKline Beecham International - U.K. |
||
Amoxycillin Trihydrate Ph.Eur | 1g/Vial | |||
Potassium Clavulanate Ph.Eur | 200mg/Vial |
Registration Number | Product Name | Active Ingredients | Strength | Manufacturer |
402 TAN 00,1705 J01C SKB | Augmentin Injection 600mg | SmithKline Beecham International - U.K. |
||
Amoxycillin Trihydrate Ph.Eur | 500mg | |||
Potassium Clavulanate Ph.Eur | 100mg | |||
403 TAN 00,1706 B03A SKB | Fefol Spansule Capsules | SmithKline Beecham International - U.K. |
||
Folic Acid BP | 0.5mg | |||
Ferrous Sulphate BP | 150mg | |||
404 TAN 00,1707 D06A SKB | Bactroban Ointment | SmithKline Beecham Pharmaceuticals - U.K. |
||
Mupirocin Calcium BP | 2%w/w | |||
405 TAN 00,1708 J01H SKB | Amoxil Syrup 250mg/5ml | SmithKline Beecham Pharmaceuticals - U.K. |
||
Amoxycillin BP | 250mg/5ml | |||
406 TAN 00,1709 J01C SKB | Ampiclox Injection | SmithKline Beecham Pharmaceuticals - U.K. |
||
Ampicillin BP | 50mg | |||
Cloxacillin BP | 25mg | |||
407 TAN 00,1710 J01C SKB | Amoxil Capsules | SmithKline Beecham Pharmaceuticals - U.K. |
||
Amoxycillin Ph.Eur | 250mg | |||
408 TAN 00,1711 J01C SKB | Amoxil 500mg Capsules | SmithKline Beecham Pharmaceuticals - U.K. |
||
Amoxycillin Ph.Eur | 250mg | |||
409 TAN 00,1712 J01C SKB | Amoxil Suspension | SmithKline Beecham Pharmaceuticals - U.K. |
||
Amoxycillin BP | 125mg/5ml | |||
410 TAN 00,1713 J01C SKB | Ampiclox Capsules | SmithKline Beecham Pharmaceuticals - U.K. |
||
Ampicillin Ph.Eur | 250mg | |||
Cloxacillin Ph.Eur | 250mg | |||
411 TAN 00,1714 J01H SKB | Ampiclox Syrup | SmithKline Beecham Pharmaceuticals - U.K. |
||
Cloxacillin Ph.Eur | 125mg/5ml | |||
Ampicillin Ph.Eur | 125mg/5ml | |||
412 TAN 00,1904 P02X SKB | Zentel Tablets | SmithKline Beecham Laboratoires Pharmaceutiques - FRANCE |
||
Albendazole | 200mg |
Registration Number | Product Name | Active Ingredients | Strength | Manufacturer |
413 TAN 00,1905 A02A SKB | Andrews Liver Salts Regular Powder | Smithkline Beecham Consumer Healthcare - KENYA |
||
Magnesium Sulphate USP | 0.88g/5g | |||
Sodium Bicarbonate USP | 2.28g/5g | |||
Registrant | SmithKIine Beecham International - KENYA | |||
414 TAN 00,2045 P02X SKB | Zentel Suspension | SmithKline Beecham Laboratories Pharmaceutiques - FRANCE |
||
Albendazole USP | 2%w/v | |||
Registrant | Solvay Pharmaceutical B.V. - Netherlands | |||
415 TAN 00,1715 V03A SOL | Betaserc Tablets | Solvay Pharmaceutical B.V. - THE NETHERLANDS |
||
Betahistine Dihydrochloride | 8mg | |||
Registrant | SR Pharma - UNITED KINGDOM | |||
416 TAN 00,1956 J07A SRP | Mycobacterium Vaccae Vaccine | Centre for Applied Microbiology and Reserch - U.K. |
||
Inactivated Mycobacterium | SRL 172 | |||
Registrant | SSL International PLC - U.K | |||
417 TAN 00,1906 R05C SSL | Adult Meltus Expectorant | SSL International - U.K |
||
Purified Honey BP | 0.5mg | |||
Guaiphenesin BP | 100mg | |||
Sucrose BP | 1.75mg | |||
Cetylpyridinium Chloride BP | 2.5mg | |||
Registrant | Stafford Miller Ltd. - ENGLAND | |||
418 TAN 00,1716 V07A STA | Corega Bio Tablets | Stafford Miller Ltd - ENGLAND |
||
Polyvinylpyrrolidone | 31.249%w/w | |||
Citric Acid Granular USP | 17.671%w/w |
|||
Sodium Carbonate anhydrous | 9.6%w/w |
Registration Number | Product Name | Active Ingredients | Strength | Manufacturer |
419 TAN 00,1717 V07A STA | Corega Extradent Tablets | Stafford Miller Ltd - ENGLAND |
||
White high | 30.08%w/w | |||
Blue high | 27.26%w/w | |||
Citric acid | 18.92%w/w | |||
420 TAN 00,1718 V07A STA | Sensodyne Daily Fluoride Mouth Rinse | Stafford Miller Ltd - ENGLAND |
||
Sodium Fluoride BP | 0.05%w/w | |||
Registrant | Statens Serum Institute - DENMARK | |||
421 TAN 00,1907 R05C STS | Mycobacterium Avium Sensitin | Statens Serum institute - DENMARK |
||
Mycobacteria Sensitin | 1mcg/ml | |||
Registrant | Sterop Laboratories - BELGIUM | |||
422 TAN 00,2046 C01A STE | Digoxin 0.25mg Tablets | Sterop Laboratories - DENMARK |
||
Digoxin Ph. Eur | 0.25mg | |||
423 TAN 00,2047 V03A STE | Fercayl Injection | Sterop Laboratories - BELGIUM |
||
Iron Dextran BP | 100mg/2ml | |||
424 TAN 00,2048 M01A STE | Diclofenac Sodium Injection | Sterop Laboratories - BELGIUM |
||
Diclofenac Sodium Ph.Eur | 75mg/3ml | |||
425 TAN 00,2049 M01A STE | Prednisolone Tablets | Sterop Laboratories - BELGIUM |
||
Prednisolone Ph.Eur | 5mg | |||
426 TAN 00,2050 N02B STE | Chlorpromazine 50mg/2ml Injection | Sterop Laboratories - BELGIUM |
||
Chlorpromazine | 50mg | |||
427 TAN 00,2051 P01B STE | Quinine Tablets | Sterop Laboratories - BELGIUM |
||
Quinine Sulphate BP | 300mg | |||
428 TAN 00,2052 J01K STE | Gentamicin Injection | Sterop Laboratories - BELGIUM |
||
Gentamycin BP | 80mg/2ml | |||
429 TAN 00,2053 A02B STE | Cimetidine 400mg Tablets | Sterop Laboratories - BELGIUM |
||
Cimetidine Ph. Eur | 400mg | |||
430 TAN 00,2054 J01K STE | Sterostatine Vaginal Tablets | Sterop Laboratories - BELGIUM |
Registration Number | Product Name | Active Ingredients | Strength | Manufacturer |
Nystatin Ph. Eur | 100,000 IU | |||
431 TAN 00,2055 N04B STE | Diazepam | Sterop Laboratories - BELGIUM |
||
Diazepam BP | 10mg | |||
432 TAN 00,2056 P01B STE | Malastop Tablets | Sterop Laboratories - BELGIUM |
||
Sulfadoxine Ph.Eur | 500mg | |||
Pyrimethamine Ph.Eur | 25mg | |||
Registrant | Sun Pharmaceutical Industries Ltd - INDIA | |||
433 TAN 00,1719 M01A SUN | Muvera 7.5 Tablets | Sun Pharmaceutical Industries Ltd - INDIA |
||
Meloxicam BP | 7.5mg | |||
434 TAN 00,1908 C06A SUN | Cardivas 12.5 Tablets | Sun Pharmaceutical Industries Ltd - INDIA |
||
Carvedilol | 12.5mg | |||
435 TAN 00,1909 C06A SUN | Muvera 15 Tablets | Sun Pharmaceutical Industries Ltd - INDIA |
||
Meloxicam BP | 15mg | |||
436 TAN 00,1910 A02B SUN | Pantocid Tablets | Sun Pharmaceutical Industries Ltd - INDIA |
||
Pantoprazole USP | 40mg | |||
437 TAN 00,1911 A02B SUN | Pantocid I.V. Injection | Sun Pharmaceutical Industries Ltd - INDIA |
||
Pantoprazole USP | 40mg/ml | |||
438 TAN 00,1912 R03A SUN | Cetrizet D Tablets | Sun Pharmaceutical Industries Ltd - INDIA |
||
Pseudoephedrine HCl BP | 120mg | |||
Cetrizine HCl BP | 5mg | |||
439 TAN 00,1913 P01A SUN | Dazolic Tablets | Sun Pharmaceutical Industries Ltd - INDIA |
||
Ornidazole | 500mg | |||
Registrant | Tablets (India) Ltd - INDIA | |||
440 TAN 00,2057 A11B TAB | Estyplex-5 Injection | Tablets (India) Ltd - INDIA |
||
Dexpanthenol USP | 5mg/ml | |||
Pyridoxine HCl BP | 4mg/ml | |||
Riboflavin BP | 4mg/ml | |||
Nicotinamide BP | 20mg/ml | |||
Thiamine HCl BP | 5mg/ml |
Registration Number | Product Name | Active Ingredients | Strength | Manufacturer |
441 TAN 00,2058 M01A TAB | Profundin Tablets | Tablets (India) Ltd - INDIA |
||
Ibuprofen BP | 200mg | |||
442 TAN 00,2059 P01A TAB | Trichogyl-200 Tablets | Tablets (India) Ltd - INDIA |
||
Metronidazole BP | 200mg | |||
Registrant | The Alexandria Co. For Pharmaceuticals & Chemicals Industries - EGYPT |
|||
443 TAN 00,1720 R03A TAC | Salbovent Forte Tablets | The Alexandria Co. For Pharmaceuticals & Chemicals Industries - EGYPT |
||
Salbutamol BP | 4mg | |||
444 TAN 00,1721 S01A TAC | Ocusul 10% Eye Drops | The Alexandria Co. For Pharmaceuticals & Chemicals Industries - EGYPT |
||
Sulphacetamide Sodium BP | 10g/100ml | |||
445 TAN 00,1722 M01A TAC | Romalex Injection | The Alexandria Co. For Pharmaceuticals & Chemicals Industries - EGYPT |
||
Diclofenac Sodium BP | 75mg/3ml | |||
446 TAN 00,1914 H02A TAC | Dexonium Injection | The Alexandria Co. For Pharmaceuticals & Chemicals Industries - EGYPT |
||
Dexamethazone Sodium | 440mg/100ml |
|||
447 TAN 00,1723 N01B TAC | Mepecaine Cartridges | The Alexandria Co. For Pharmaceuticals & Chemicals Industries - EGYPT |
||
Mepivacaine HCl USP | 54mg/1.8ml | |||
448 TAN 00,1724 N01B TAC | Mepecaine-L Cartridges | The Alexandria Co. For Pharmaceuticals & Chemicals Industries - EGYPT |
||
Levonordefrin HCl | 6mg/100ml | |||
Mepivacaine HCl USP | 2000mg/100m |
|||
Registrant | The Arab Drug Company - EGYPT | |||
449 TAN 00,2060 D01A TAD | Candistan Vaginal Tablets | The Arab Drug Company - EGYPT |
||
Clotrimazole BP | 100mg |
Registration Number | Product Name | Active Ingredients | Strength | Manufacturer |
450 TAN 00,1725 R03A TAD | Vental Inhaler | The Arab Drug Company - EGYPT |
||
Salbutamol | 0.1mg/Puff | |||
451 TAN 00,1726 R03A TAD | Beclosone Inhaler | The Arab Drug Company - EGYPT |
||
Beclomethasone Dipropionate | 10mg | |||
452 TAN 00,1727 D01A TAD | Candistan Vaginal Cream | The Arab Drug Company - EGYPT |
||
Clotrimazole | 3mg/150g | |||
453 TAN 00,1728 B01A TAD | B12 Depot Injection | The Arab Drug Company - EGYPT |
||
Hydroxocobalamin Acetate | 1mg/ml | |||
454 TAN 00,2061 A11A TAD | Halorange Vit. Emulsion | The Arab Drug Company |
||
Vitamin D USP | 0.268mg/ml | |||
Vitamin A Palmitate USP | 69.01mg/ml | |||
Vitamin C USP | 1.09mg/ml | |||
455 TAN 00,1729 G03H TAD | Clomiphene Tablets | The Arab Drug Company - EGYPT |
||
Clomiphene Citrate Ph.Eur | 50mg | |||
Registrant | The Mentholatum Company Limited - U.K | |||
456 TAN 00,1915 R04A TMC | Mentholatum Balm | The Mentholatum Company Limited - U.K. |
||
Menthol BP | 1.35%w/w | |||
Methyl Salicylate BP | 0.33%w/w | |||
Camphor BP | 9.00%w/w | |||
457 TAN 00,1916 M02A TMC | Deep Heat Rub | The Mentholatum Company Limited - U.K. |
||
Turpentine Oil BP | 1.47%w/w | |||
Methyl Salicylate BP | 12.80w/w | |||
Menthol BP | 5.91%w/w | |||
Eucalyptus Oil BP | 1.97w/w | |||
458 TAN 00,1917 M02A TMC | Deep Heat Spray | CLL Industries Ltd - U.K |
||
Ethyl Salicylate BP | 5%w/w | |||
Methyl Nicotinate BP | 1.6%w/w | |||
Methyl Salicylate BP | 1%w/w | |||
2-Hydroxyethyl Salicylate BP | 5%w/w |
Registration Number | Product Name | Active Ingredients | Strength | Manufacturer |
Registrant | Unichem Laboratories Limited - INDIA | |||
459 TAN 00,2062 J01K UNI | Evaflox 400mg Tablets | Unichem Laboratories Limited - INDIA |
||
Ofloxacin USP | 400mg | |||
460 TAN 00,2063 J01K UNI | Evaflox 200mg Tablets | Unichem Laboratories Limited - INDIA |
||
Ofloxacin USP | 200mg | |||
461 TAN 00,2064 C01E UNI | Losar 50 Tablets | Unichem Laboratories Limited - INDIA |
||
Losartan Potassium | 50mg | |||
Registrant | USV Limited - INDIA | |||
462 TAN 00,1730 A10B USV | Glizide Tablets | USV Limited - INDIA |
||
Gliclazide BP | 80mg | |||
Registrant | Vital Healthcare PVT. Ltd - INDIA | |||
463 TAN 00,2065 A11B VIT | Vitamin B Complex Injection | Vital Healthcare PVT.Ltd - INDIA |
||
D-Panthenol USP | 1mg/ml | |||
Nicotinamide BP | 10mg/ml | |||
Pyridoxine HCl BP | 1mg/ml | |||
Thiamine HCl BP | 10mg/ml | |||
Riboflavin Sodium Phosphate | 0.5mg/ml | |||
464 TAN 00,2066 N02B VIT | Diclofenac Sodium Injection BP | Vital Healthcare PVT.Ltd - INDIA |
||
Diclofenac Sodium BP | 25mg/ml | |||
465 TAN 00,2067 J01G VIT | Gentamycin Injection BP | Vital Healthcare PVT.Ltd - INDIA |
||
Gentamycin Sulphate BP | 80mg/2ml | |||
466 TAN 00,2068 H02A VIT | Dexamethazone Injection | Vital Healthcare PVT.Ltd - INDIA |
||
Dexamethazone Phosphate | 4mg/ml | |||
467 TAN 00,2069 D04A VIT | Provita Injection | Vital Healthcare PVT.Ltd - INDIA |
||
Promethazine BP | 25mg/ml | |||
468 TAN 00,2070 G02A VIT | Vitocin Injection | Vital Healthcare PVT.Ltd - INDIA |
||
Oxytocin BP | 5IU/ml |
Registration Number | Product Name | Active Ingredients | Strength | Manufacturer |
Registrant | Wallace Pharmaceuticals Ltd - INDIA | |||
469 TAN 00,1731 A03D WAL | Colimex Tablets | Wallace Pharmaceuticals Ltd - INDIA |
||
Paracetamol | 500mg | |||
Dicyclomine HCl | 20mg | |||
Registrant | Win-Medicare Limited - INDIA | |||
470 TAN 00,1732 G04B WIN | Hepa-Merz Tablets | Win Medicare Limited - INDIA |
||
Pancreatin BP | 100mg | |||
L-Ornithine L-aspartate USP | 150mg | |||
471 TAN 00,1733 G04B WIN | Herpa-Merz Infusion | Win Medicare Limited - INDIA |
||
L-Ornithine L-aspartate | 0,5g/ml | |||
472 TAN 00,1918 G04A WIN | Udihep Tablets | Win Medicare Limited - INDIA |
||
Ursodeoxycholic Acid BP | 150mg | |||
473 TAN 00,1919 A02B WIN | Zapacid-30 Capsules | Win Medicare Limited - INDIA |
||
Lansoprazole | 30mg | |||
Registrant | Wockhardt Limited - INDIA | |||
474 TAN 00,1734 C03B WOC | Mannitol IV Infusion | Wockhardt Limited - INDIA |
||
Mannitol BP | 20%w/v | |||
475 TAN 00,1735 B03A WOC | Ferich Syrup | Wockhardt Limited - INDIA |
||
Ferric Ammonium Citrate | 250mg | |||
Folic Acid | 0.5mg | |||
Cyanocobalamine | 5mcg | |||
Sorbitol Solution (70%) | 1500mg | |||
476 TAN 00,1736 B05B WOC | Sodium Chloride & Dextrose I.V. Infusion | Wockhardt Limited - INDIA |
||
Sodium Chloride BP | 0.9g/100ml | |||
Anhydrous Glucose BP | 5.0g/100ml | |||
477 TAN 00,1737 N02B | Proxyvon Capsules | Wockhardt Limited - INDIA |
Registration Number | Product Name | Active Ingredients | Strength | Manufacturer |
Acetaminophen BP | 400mg | |||
Dextropropoxyphen HCl BP | 65mg | |||
478 TAN 00,1738 B04A WOC | Pro-HDL 20 Tablets | Wockhardt Limited - INDIA |
||
Lovastatin USP | 20mg | |||
479 TAN 00,2071 J01D WOC | Bestum 500 Injection | Wockhardt Limited - INDIA |
||
Ceftazidime USP | 500mg | |||
480 TAN 00,2072 J0ID WOC | Bestum 1g Injection | Wockhardt Limited - INDIA |
||
Ceftazidime USP | 1g/vial | |||
481 TAN 00,2073 J01D WOC | Bestum 250 Injection | Wockhardt Limited - INDIA |
||
Ceftazidime USP | 250mg | |||
482 TAN 00,1920 A03D WIN | Spasmoproxyvon Capsules | Wockhardt Limited - INDIA |
||
Dextrapropoxyphen HCl BP | 65mg | |||
Acetamnophen USP | 400mg | |||
Dicyclomine HCl BP | 10mg | |||
483 TAN 00,1739 J0ID WOC | Zetaxim 500 mg Injection | Wockhardt Limited - INDIA |
||
Sterile Cefotaxime USP | 500mg/vial | |||
Registrant | Wyeth South Africa (Pty) Ltd - SOUTH AFRICA | |||
484 TAN 00,1740 N03A WYE | Artane 2 Tablets | Pharma-Q (PTY) Ltd - SOUTH AFRICA |
||
Trihexyphenidyl HCl USP | 2mg | |||
Registrant | Zeneca Pharmaceuticals - U.K | |||
485 TAN 00,1741 C01L ZEN | Zestorestic Tablets | Zeneca - U.K. |
||
Lisinopril USP | 20mg | |||
Hydrochlorothiazide Ph.Eur | 12.5mg | |||
Registrant | Zenufa Laboratories Group S.A - U.K | |||
486 TAN 00,1921 A02A ZNU | Zenegene TM Suspension | Aurochem Laboratories - INDIA |
||
Magnesium Hydroxide Paste | 250mg | |||
Aluminium Hydroxide Paste | 250mg |
Registration Number | Product Name | Active Ingredients | Strength | Manufacturer |
Simethicone USP | 50 mg | |||
487 TAN 00,1922 A02A ZNU | Ampizen-250 Capsules | Aurochem Laboratories - INDIA |
||
Ampicillin BP | 250mg | |||
488 TAN 00,1742 B05B ZNU | Sodium Chloride & Glucose IV Infusion BP 500ml | Albert David Limited - INDIA |
||
Glucose Anhydrous BP | 5g/100ml | |||
Sodium Chloride BP | 0.9g/100ml | |||
489 TAN 00,1923 J01E ZNU | Zentrim Tablets | Aurochem Laboratories - INDIA |
||
Sulphamethoxazole BP | 400mg | |||
Trimethoprim BP | 80mg | |||
490 TAN 00,1924 J01E ZNU | Zenogesic Capsules | Aurochem Laboratories - INDIA |
||
Indomethacin BP | 25mg |
(Section 58)
[1st September, 2000]
G.N. No. 26 of 2001
WHEREAS Section 58 of the Pharmaceutical and Poisons Act * requires the Minister, upon recommendation of the Board, by Order published in the Gazette to prohibit and control the manufacture, importation, supply, circulation or sale of any drug.
AND WHEREAS the Board has recommended to the Minister to publish a list of Notified Human Drugs allowed to circulate in the Country to be Gazetted for public awareness.
NOW THEREFORE, the public is hereby notified as follows:
1. This Order may be cited as the Human Pharmaceuticals and Poisons (List of Human Notified Drugs) Order.
2. [Omitted.]
3. No person shall be allowed to Circulate any Human Drug in the country which is not in the drug list to this Schedule from the 1st day of January, 2001.
4. Notwithstanding the provisions of paragraph (3) the notification shall remain valid for five years from the date of issuing this order unless registered.
5. Any person who contravenes or fails to comply with this Order shall be guilty of an offence punishable under the Pharmaceutical and Poisons Act *.
6. Revocation
[Revokes the Pharmaceuticals and Poisons (Human Drugs List) (Notification) Order *].
SCHEDULE
LIST OF NOTIFIED DRUGS
AJANTA PHARM LTD - Mauritius | |||||
1 | 0057A12A AJA |
| Calcium gluconate | 500mg | TABLETS |
2 | 0070N04B AJA | MINDWEL | Haloperidol | 1.5mg | TABLETS |
3 | 0071N04B AJA | MINDWEL | Haloperidol | 2mg | TABLETS |
4 | 0072N04B AJA | MINDWEL | Haloperidol | 5mg | TABLETS |
5 | 0082A03A AJA | METNOVO | Metoclopramide | 10mg | TABLETS |
6 | 010N05A AJA |
| Chlorpromazine | 25mg | TABLETS |
7 | 0102B03B AJA |
| Folic Acid | 5mg | TABLETS |
|
|
|
|
| |
AVENTIS PHARMA - France |
| ||||
|
| BRAND NAME | GENERIC NAME | STRENGTH | DOSAGE |
8 | 3373B01A RHO | LOVENOX | Enoxaparine | 40mg | INJECTION |
9 | 3374B01A RHO | CLEXANE | Enoxaparine | 80mg | INJECTION |
10 | 3384N01A RHO | HALOTHANE | Halothane | 250ml | INHALER |
11 | 3389M01A RHO | ORUCOTE | Ketoprofen | 100mg | TABLETS |
12 | 3395R06A RHO | PHENERGAN | Promethazine HCl | 25mg/ml | INJECTION |
13 | 3398J01F RHO | ROVAMYCIN | Spiramycin | 500mg | TABLETS |
|
|
|
|
| |
|
| AVENTIS PASTEUR - France |
| ||
| Notification No. | BRAND NAME | GENERIC NAME | STRENGTH | DOSAGE FORM |
14 | 4703J07A AVP | Oral poliomyelitis vaccine | Type 1 Poliomyelitis Virus | NLT 1,000,000 CCID 50 | ORAL SOLUTION |
|
|
| Type 2 Poliomyelitis Virus | NLT 100,000 CCID 50 | |
|
|
| Type 3 Poliomyelitis Virus | NLT 600,000 CCID 50 | |
15 | 4704J07A AVP | Anti tetanus serum | Fragments of Equine anti-Tetanus Immunoglobulins | 1500 IU/ml | SOLUTION FOR INJECTION |
16 | 4705J07A AVP | Tetavax vaccine | Purified Tetanus Toxoid | 40 IU | SUSPENSION FOR INJECTION |
17 | 4706J07A AVP | Meningococcal A + C Vaccine | Freeze-Dried Polysaccharide of N. meningitidis Group A | 50mcg | SOLUTION FOR INJECTION |
|
|
| Freeze-Dried Polysaccharide of N. meningitidis Group C | 50mcg | |
18 | 4707J07A AVP | Typhim Vi | Purified Capsular vi Polysaccharide of S. typhae | 0.025mg | SUSPENSION FOR INJECTION |
19 | 4708J07A AVP | Act - HIB vaccine | Haemophilus Influenzae Type B Polysaccharide | 10mcg/0.5ml | SOLUTION FOR INJECTION |
20 | 4709J07A AVP | Stamaril | Yellow Fever Virus (17D Strain) | NLT 1,000 mouse LD 50 | SOLUTION FOR INJECTION |
21 | 4710J07A AVP | Monotest (Purified tuberculin) | Concentrated PPD Purified Tuberculin | 300,000 IU | FREEZE DRIED POWDER |
22 | 4711J07A AVP | Rudivax (Rubella) Vaccine | Attenuated Live Rubella Virus (Wistar RA 27/3 M strain) | NLT 1,000 CCID | SUSPENSION FOR INJECTION |
23 | 4712J07A AVP | Pasteur Ipser Africa | Purified anti Bitis Gabonica Serum | QS neutralize 25LD50(mini) | SUSPENSION FOR INJECTION |
|
|
| Purified anti Bitis Lachesis Serum | QS neutralize 25LD50(mini) | |
|
|
| Purified anti Echis Carinatus Serum | QS neutralize 25LD50(mini) | |
|
|
| Purified anti Naja Haje Serum | QS neutralize 25LD50(mini) | |
|
|
| Purified anti Naja Meloneuca Serum | QS neutralize 25LD50(mini) | |
Purified anti Naja Nigrocollis Serum | QS neutralize 25LD50(mini) |
List of Notified Drugs | |||||
|
|
| Purified anti Dendroaspis Serums | QS neutralize 25LD50(mini) | |
24 | 4713J07A AVP | Verorab | Freeze - Dried Rabies Vaccines | 2.5 IU | SUSPENSION FOR INJECTION |
25 | 4714J07A AVP | Rouvax (Schwarz strain) | Hyperattenuated Live Measles Virus (Schwarz Strain) | 1.000 CCID 50 | SUSPENSION FOR INJECTION |
26 | 4715J07A AVP | DTP | Purified Diphtheria Toxoid | NLT 30 IU | SUSPENSION FOR INJECTION |
|
|
| Purified Tetanus Toxoid | NLT 60 IU | |
|
|
| Bordetella Pertussis | NLT 4 IU | |
27 | 4716J07A AVP | BCG vaccine | Living Bovine Tubercle Bacillus(Bacillus Calmette-Guerin) | NLT | SOLUTION FOR INJECTION |
28 | 4717J07A AVP | Anti rabies serum | Anti Rabies Serum | NLT 200 IU | LYOPHILISED POWDER |
|
|
|
|
| |
|
| BAYER AG - Germany |
| ||
| Notification No. | BRAND NAME | GENERIC NAME | STRENGTH | DOSAGE FORM |
29 | 0139P02X BAY | YOMESAN | Niclosamide | 0.5mg | TABLETS |
30 | 0142J02A BAY | ACTRON | Ketoprofen | 25mg | TABLETS |
|
|
|
|
| |
|
| BELTA PHARMA - Italy |
| ||
| Notification No. | BRAND NAME | GENERIC NAME | STRENGTH | DOSAGE FORM |
31 | 0147S01B BEL |
| Dexamethazone | 0.1%w/v | DROPS |
|
|
| Neomycin | 0.35%w/v | |
32 | 0151S01D BEL |
| Timolol | 0.5%w/v | DROPS |
33 | 0152D01A BEL |
| Nystatin | 100,000iu/ml | SUSPENSION |
|
|
| Silver Sulphadiazine | 1%w/w | |
34 | 0153D08A BEL |
| Chlorhexidine Gluconate | 0.2%w/w | CREAM |
|
|
|
|
| |
|
| BLUE CROSS - Mumbai, India |
| ||
| Notification No. | BRAND NAME | GENERIC NAME | STRENGTH | DOSAGE FORM |
35 | 0250J01D BLU | BLUECEF TM | Cefotaxime | 250mg | INJECTION |
36 | 0280M01A BLU | MINICAM GEL | Piroxicam | 0.5%w/w | GEL |
37 | 0285B03A BLU | REDITONE PLUS | Ferrous Fumarate | 300mg | CAPS |
|
|
| Vitamin B12 | 15mcg | |
|
|
| Ascorbic Acid (Vit C) | 75mg | |
|
|
| Folic Acid | 1.5mg | |
|
|
| Zinc Sulphate | 40mg | |
38 | 0288A02A BLU | ULTRACAINE | Aluminium Hydroxide | 400mg | GEL |
|
|
| Magnesium Hydroxide | 400mg | |
|
|
| Delidocaine | 10mg | |
|
|
| Simethicon | 50mg | |
39 | 0289G01A BLU | TINICIDE | Tinidazole | 500mg | PESSARIES |
|
|
| Clotrimazole | 200mg | |
|
|
|
|
|
|
List of Notified Drugs | |||||
BRISTOL MYER - SQUIBB - France | |||||
Notification No. | BRAND NAME | GENERIC NAME | STRENGTH | DOSAGE FORM |
|
40 | 0310J02A BRI | FUNGIZONE | Amphotericin B | 50mg | INTRAVENOUS |
COX PHARMACEUTICALS - UK | |||||
Notification No. | BRAND NAME | GENERIC NAME | STRENGTH | DOSAGE FORM |
|
41 | 0869C03A COX | Bendrofluazide | 5mg | TABLETS |
|
E. MERCK (INDIA) LTD - Mumbai, India | |||||
Notification No. | BRAND NAME | GENERIC NAME | STRENGTH | DOSAGE |
|
42 | 0959V06D EME | ELECTROBION | Sodium Chloride | 3.5gm | POWDER |
Potassium Chloride | 1.5gm | ||||
Trisodium Citrate | 2.9gm | ||||
Dextrose | 20gm | ||||
43 | 0963A11E EME | POLYBION | Thiamine (Vit B1) | 2mg/5ml | SYRUP |
Pyridoxine (Vit B6) | 0.75mg/5ml | ||||
Nicotinamide | 15mg/5ml | ||||
Riboflavine (Vit B2) | 2.5mg/5ml | ||||
D-Panthenol | 3mg/5ml | ||||
Cyanocobalamine (Vit B12) | 2mcg/5ml | ||||
44 | 0964A11E EME | POLYBION | Thiamine (Vit B1) | 10mg | INJECTION |
Pyridoxine (Vit B6) | 4mg | ||||
Nicotinamide | 40mg | ||||
Riboflavine (Vit B2) | 4mg | ||||
D-Panthenol | 6mg | ||||
Cyanocobalamine (Vit B12) | 8mcg | ||||
45 | 0967A11D EME | NEUROBION | Thiamine (Vit B1) | 100mg | INJECTION |
Pyridoxine (Vit B6) | 100mg | ||||
Cyanocobalamine (Vit B12) | 1000mcg | ||||
46 | 0969N02B EME | COSOME | Dextromethorphan HBR | 10mg/5ml | SYRUP |
Phenylpropanolamine HCl | 25mg/5ml | ||||
Chlorpheniramine Maleate | 4mg/5ml | ||||
47 | 0970R05C EME | COSOME | Bromhexine HCl | 8mg/5ml | SYRUP |
Phenylpropanolamine HCl | 25mg/5ml | ||||
Chlorpheniramine Maleate | 4mg/5ml | ||||
48 | 0971B03A EME | ANEMIDOX | Ferrous Fumarate | 360mg/5ml | SYRUP |
Calcium Carbonate | 200mg/5ml | ||||
Ascorbic Acid (Vit C) | 75mg/5ml | ||||
Folic Acid | 1.5mg/5ml |
List of Notified Drugs | |||||
Cyanocobalamine (Vit B12) | 15mcg/5ml | ||||
Ergocalciferol (Vit D3) | 400iu/5ml | ||||
EGYPTIAN INTERNATIONAL PHARMACEUTICAL INDUSTRIES CO. S.A.E |
|||||
Notification No. | BRAND NAME | GENERIC NAME | STRENGTH | DOSAGE |
|
49 | 1021N03A EIP | CARBAZEN | Carbamazepine | 100mg | TABLETS |
50 | 1022N05A EIP | Haloperidol | 1.5mg | TABLETS |
|
51 | 1023N05A EIP | Haloperidol | 5mg | TABLETS |
|
52 | 1024N05A EIP | Haloperidol | 10mg | TABLETS |
|
53 | 1025N05B EIP | EPIVAL | Diazepam | 2mg | TABLETS |
54 | 1026N05B EIP | EPIVAL | Diazepam | 5mg | TABLETS |
55 | 1027N05B EIP | EPIVAL | Diazepam | 10mg | INJECTION |
56 | 1028D06A EIP | Neomycin Sulphate | 5mg | OINTMENT |
|
57 | 1029D06A EIP | Bacitracin | 500iu | ||
58 | 1031D07C EIP | Dexamethazone Sodium | 8mg | INJECTION |
|
59 | 1032D07C EIP | EPIZOLONE DEPOT | Methylprednisolone | 40mg/ml | INJECTION |
60 | 1034D07C EIP | Prednisolone | 5mg | TABLET |
|
61 | 1035A02A EIP | MUCOGEL | Aluminium Hydroxide | 8.1gm/5ml | SUSPENSION |
Magnesium Hydroxide | 2gm/5ml | ||||
Oxethazaine | 0.2gm/5ml | ||||
62 | 1055R06A EIP | DIPHEN INF | Diphenhydramine HCl | 7mg/5ml | SYRUP |
Sodium Citrate | 28.5mg/5ml | ||||
Menthol | 0.55mg/5ml | ||||
63 | 1059B12C EIP | FERRO - FOL CAP | Ferrous Sulphate | 150mg | CAPS |
ELI LILLY - Italy | |||||
Notification No. | BRAND NAME | GENERIC NAME | STRENGTH | DOSAGE FORM |
|
64 | 1118A10A ELI | HUMAN L | Humulin L | 100iu | INJECTION |
65 | 1119A10A ELI | HUMAN 70/30 | Humulin 70/30 | 100iu | INJECTION |
66 | 1134A10A ELI | HUMAN 70/30 | Humulin 70/30 | 40iu | INJECTION |
F. HOFFMANN - LA ROCHE LTD - Switzerland | |||||
Notification No | BRAND NAME | GENERIC NAME | STRENGTH | DOSAGE FORM |
|
67 | 1207V03A ROC | ANEXATE | Flumazenil | 0.5mg/10ml | INJECTION |
68 | 1212A11H ROC | BEPANTHEN | Dexpanthenol | 5%w/w | CREAM |
69 | 1215N05C ROC | DORMICUM | Midazolam | 7.5mg | TABLETS |
70 | 1216N05C ROC | DORMICUM | Midazolam | 5mg/5ml | INJECTION |
71 | 1217N05C ROC | DORMICUM | Midazolam | 15mg/3ml | INJECTION |
72 | 1222L01B ROC | Fluorouracil | 25mg/ml | INJECTION |
List of Notified Drugs | |||||
73 | 1223J05C ROC | INVIRASE | Saquinavir | 200mg | TABLETS |
74 | 1224J05C ROC | HIVID | Zalciatabine | 0.75mg | TABLETS |
75 | 1225B02B ROC | KONAKION | Phytomenadione | 1mg/1ml | INJECTION |
76 | 1226B02B ROC | KONAKION | Phytomenadione | 10mg/1ml | INJECTION |
77 | 1228N05B ROC | LEXOTANIL | Bromazepam | 1.5mg | TABLETS |
78 | 1229N05B ROC | LEXOTANIL | Bromazepam | 3.0mg | TABLETS |
79 | 1240M01A ROC | NAPROSYN EC | Naproxen | 500mg | TABLETS |
80 | 1241H03B ROC | NEOMACAZOLE | Carbimazole | 5mg | TABLETS |
81 | 1243A11G ROC | REDOXON | Ascorbic Acid (vitamin C) | 1000mg | TABLETS |
82 | 1246N03A ROC | RIVOTRIL | Clonazepam | 0.5mg | TABLETS |
83 | 1252N05C ROC | ROHYPNOL | Flunitrazepam | 2mg | TABLETS |
84 | 1254N01A ROC | TORADOL | Ketorolac | 30mg | TABLETS |
85 | 1258N05B ROC | VALIUM | Diazepam | 5mg | TABLETS |
GLENMARK PHARMACEUTICALS LTD - Mumbai, India |
|||||
Notification No | BRAND NAME | GENERIC NAME | STRENGTH | DOSAGE FORM |
|
86 | 1689D08A GLE | LICEOMA | Benzene Hexachloride | 1%w/v | LOTION |
87 | 1690A02A GLE | RELCER | Aluminium Hydroxide | 6000mg | GELL |
Magnesium Trisilicate | 80mg | ||||
Simethicone | 100mg | ||||
Deglycyrrhizinated Liquorice | 400mg | ||||
88 | 1695D01A GLE | CANDID TV | Clotrimazole | 1%w/v | LOTION |
Selenium Disulphide | 2.5%w/v | ||||
89 | 1698A12C GLE | MARKLYTE | Sodium Chloride | 3.5gm | POWDER |
Sodium Bicarbonate | 2. 5gm | ||||
Potassium Chloride | 1.5gm | ||||
90 | 1699D07A GLE | SUPRICORT | Flucinolone Acetonide | 0.03%w/v | LOTION |
91 | 1700D07A GLE | SUPRICORT | Flucinolone Acetonide | 0.03%w/w | CREAM |
92 | 1702D07A GLE | SUPRICORT- N | Flucinolone Acetonide | 0.03%w/v | LOTION |
Neomycin Sulphate | 0.5%w/v | ||||
GRUNENTHAL GmbH - Germany | |||||
Notification No. | BRAND NAME | GENERIC NAME | STRENGTH | DOSAGE FORM |
|
93 | 1811N02A GRU | TRAMAL | Tramadol HCl | 100mg | SUPPOSITORIES |
94 | 1812N02A GRU | TRAMAL | Tramadol HCl | 100mg/2ml | INJECTION |
95 | 1813N02A GRU | TRAMAL | Tramadol HCl | 50mg | DROPS |
96 | 1814N02A GRU | TRAMAL RETARD | Tramadol HCl | 100mg | CAPS |
List of Notified Drugs | |||||
H.N. NORTON & CO. LTD - UK | |||||
Notification No. | BRAND NAME | GENERIC NAME | STRENGTH | DOSAGE FORM |
|
97 | 1858N05B HNT | Chlordiazepoxide | 10mg | CAPS |
|
98 | 1868C03D HNT | Spironolactone | 25mg | TABLETS |
|
99 | 1888A10B HNT | Metformin | 850mg | TABLETS |
|
100 | 1896N05B HNT | Lorazepam | 1mg | TABLETS |
|
101 | 1897N05B HNT | Lorazepam | 2.5mg | TABLETS |
|
102 | 1903C07A HNT | Metoprolol | 50mg | TABLETS |
|
INTAS PHARMACEUTICALS LTD - Ahemedabad, India |
|||||
Notification No. | BRAND NAME | GENERIC NAME | STRENGTH | DOSAGE FORM |
|
103 | 1996R03A INT | KETOVENT | Kitotifen | 1mg | TABLETS |
104 | 2002M01A INT | INDOINTA | Indomethacin | 25mg | CAPS |
Hydrochlorothiazide | 12.5mg | ||||
105 | 2022C02D INT | ENAPRIL LT/HT | Enalapril Maleate | 10mg | TABLETS |
Hydrochlorothiazide | 25mg | ||||
106 | 2023C01D INT | MONIT-10 | Isosorbide 5 Mononitrate | 10mg | TABLETS |
107 | 2024C01D INT | MONIT-20 | Isosorbide 5 Mononitrate | 20mg | TABLETS |
108 | 2025C01D INT | MONIT-OD | Isosorbide 5 Mononitrate | 50mg | TABLETS |
109 | 2033C02C INT | TERAPRESS | Terazosin HCl | 1mg | TABLETS |
110 | 2034C02C INT | TERAPRESS | Terazosin HCl | 2mg | TABLETS |
111 | 2035C02C INT | TERAPRESS | Terazosin HCl | 5mg | TABLETS |
112 | 2036A08A INT | LOTIN | Lovastatin | 10mg | TABLETS |
113 | 2037A08A INT | LOTIN | Lovastatin | 20mg | TABLETS |
114 | 2041N05A INT | MEGATIL | Chlorpromazine HCl | 25mg | TABLETS |
115 | 2042N05A INT | MEGATIL | Chlorpromazine HCl | 50mg | TABLETS |
116 | 2043N05A INT | MEGATIL | Chlorpromazine HCl | 100mg | TABLETS |
117 | 2044N05A INT | MEGATIL | Chlorpromazine HCl | 200mg | TABLETS |
118 | 2045N05A INT | TRANCODOL | Haloperidol | 5mg | TABLETS |
119 | 2046N05A INT | TRANCODOL | Haloperidol | 10mg | TABLETS |
120 | 2047N05A INT | NEOCALM | Trifluoperazine | 5mg | TABLETS |
121 | 2048N05A INT | NEOCALM | Trifluoperazine | 10mg | TABLETS |
122 | 2049N05A INT | MELOZINE | Thioridazine HCl | 10mg | TABLETS |
123 | 2050N05A INT | MELOZINE | Thioridazine HCl | 25mg | TABLETS |
124 | 2051N05A INT | MELOZINE | Thioridazine HCl | 50mg | TABLETS |
125 | 2052N05A INT | MELOZINE | Thioridazine HCl | 100mg | TABLETS |
126 | 2053N05A INT | MELOZINE | Thioridazine HCl | 200mg | TABLETS |
127 | 2054N05A INT | FLUNIL | Fluoxetine | 20mg | CAPS |
128 | 2055N06A INT | AMITONE-25 | Amitriptyline | 25mg | TABLETS |
List of Notified Drugs | |||||
129 | 2056N06A INT | DEPSOL-25 | Imipramine HCl | 25mg | TABLETS |
130 | 2057N06A INT | CLONIL | Clomipramine HCl | 10mg | TABLETS |
131 | 2058N06A INT | CLONIL | Clomipramine HCl | 25mg | TABLETS |
132 | 2059N06A INT | CLONIL | Clomipramine HCl | 50mg | TABLETS |
133 | 2060N06A INT | CLONIL | Clomipramine HCl | 100mg | TABLETS |
134 | 2061N06A INT | CLONIL | Clomipramine HCl | 200mg | TABLETS |
135 | 2062N06A INT | DOXIN | Doxepine HCl D | 10mg | CAPS |
136 | 2063N06A INT | DOXIN | Doxepine HCl D | 25mg | CAPS |
137 | 2064N06A INT | DOXIN | Doxepine HCl D | 75mg | CAPS |
138 | 2065N05A INT | INTALITH | Lithium Carbonate | 150mg | TABLETS |
139 | 2066N05A INT | INTALITH | Lithium Carbonate | 300mg | TABLETS |
140 | 2067N05A INT | INTALITH | Lithium Carbonate | 450mg | TABLETS |
141 | 2068N03A INT | ZEN RETARD | Carbamazepine | 200mg | TABLETS |
142 | 2069N03A INT | ZEN RETARD | Carbamazepine | 400mg | TABLETS |
143 | 2070N03A INT | Phenobarbitone | 30mg | TABLETS |
|
144 | 2071N03A INT | Phenobarbitone | 60mg | TABLETS |
|
145 | 2072N03A INT | Phenytoin Sodium | 50mg | TABLETS |
|
146 | 2073N03A INT | Phenytoin Sodium | 100mg | TABLETS |
|
147 | 2074J01K INT | OFLOX-200 | Ofloxacin | 200mg | TABLETS |
148 | 2076J01K INT | LOMITAS | Lomefloxacin | 400mg | TABLETS |
149 | 2077M01A INT | KELAC | Ketorolac Tromethamine | 10mg | TABLETS |
150 | 2079N05A INT | RISDONE | Risperidone | 1mg | TABLETS |
151 | 2080N05A INT | RISDONE | Risperidone | 2mg | TABLETS |
152 | 2081N05A INT | RISDONE | Risperidone | 3mg | TABLETS |
153 | 2082N05A INT | RISDONE | Risperidone | 4mg | TABLETS |
154 | 2083N05A INT | SKIZORIL | Clozapine | 25mg | TABLETS |
155 | 2084N05A INT | SKIZORIL | Clozapine | 100mg | TABLETS |
156 | 2085P03A INT | ANTADICT | Disulfiram | 250mg | TABLETS |
157 | 2090N02A INT | NALTIMA | Naltrexone HCl | 50mg | TABLETS |
158 | 2091N04C INT | ZOPICLON | Zopiclon | 7.5mg | TABLETS |
159 | 2092C04A INT | PENTOX | Pentoxifyline | 400mg | TABLETS |
160 | 2093N04A INT | SELGIN | Selegiline HCl | 5mg | TABLETS |
161 | 2094N04A INT | BEXOL | Trihexyphendyl HCl | 2mg | TABLETS |
162 | 2111A11H INT | Pyridoxine | 5mg | TABLETS |
|
163 | 2115D06A INT | Oxytetracycline | 50mg/ml | INJECTION |
|
164 | 2116A03A INT | Metoclopramide | 5mg/ml | INJECTION |
|
165 | 2117A02B INT | FACID | Famotidine | 10mg/ml | INJECTION |
166 | 2120N05A INT | TRANCODOL | Haloperidol | 5mg/ml | INJECTION |
|
List of Notified Drugs | |||||
IPCA LABORATORIES LIMITED Mumbai, India | |||||
Notification No. | BRAND NAME | GENERIC NAME | STRENGTH | DOSAGE FORM |
|
167 | 2169D04A IPC | PECTYLFN - C | Diphenhydramine HCl | 114mg/5ml | LIQUID |
Sodium Citrate | 57mg/5ml | ||||
Menthol | 1.1mg/5ml | ||||
168 | 2170A03A IPC | PERINORM | Metoclopramide HCl | 10mg | TABLETS |
169 | 2171A03A IPC | PERINORM LIQUID | Metoclopramide HCl | 5mg/5ml | LIQUID |
IVEON LABORATORIES - Mumbai, India | |||||
Notification No. | BRAND NAME | GENERIC NAME | STRENGTH | DOSAGE FORM |
|
170 | 2190A12C IVO | IVELOTE - E | Dextrose | 5gm | INFUSION |
Sodium Chloride | 0.5gm | ||||
Sodium Acetate | 0.64gm | ||||
Potassium Chloride | 0.075gm | ||||
Calcium Chloride | 0.052gm | ||||
Magnesium Chloride | 0.031gm | ||||
Sodium Citrate | 0.075gm | ||||
Sodium Metabisulphite | 20mg | ||||
171 | 2191A12C IVO | IVELOTE - G | Dextrose | 5.0gm | INFUSION |
Sodium Chloride | 0.37gm | ||||
Potassium Chloride | 0.13gm | ||||
Sodium Sulphate | 15mg | ||||
Ammonium Chloride | 0.37gm | ||||
172 | 2193A12C IVO | IVELOTE - P | Dextrose | 5.0gm | INFUSION |
Dibasic Potassium Phosphate | 0.026gm | ||||
Sodium Acetate | 0.32gm | ||||
Potassium Chloride | 0.13gm | ||||
Magnesium Chloride | 0.031gm | ||||
Sodium Metabisulphite | 0.021gm | ||||
173 | 2194A12C IVO | IVELOTE - R | Dextrose | 5.0gm | INFUSION |
Sodium Chloride | 0.088gm | ||||
Sodium Acetate | 0.33mg | ||||
Potassium Chloride | 0.12gm | ||||
Calcium Chloride | 0.055gm | ||||
Magnesium Chloride | 0.31gm | ||||
Sodium Metabisulphite | 0.028gm | ||||
Sodium Lactate | 1.87gm | ||||
174 | 2195G01A IVO | IVEMEZOLE D | Metronidazole | 0.2gm | INFUSION |
Dextrose | 5gm |
List of Notified Drugs | |||||
175 | 2196G01A IVO | Metronidazole | 0.5gm | INFUSION |
|
Sodium Chloride | 0.8mg | ||||
176 | 2197B05B IVO | Mannitol | 20gm | INFUSION |
|
KOPRAN - Mumbai, India | |||||
Notification No. | BRAND NAME | GENERIC NAME | STRENGTH | DOSAGE FORM |
|
177 | 2284J01D KOP | BID KID | Cefadroxil | 125mg | TABLETS |
178 | 2285J01D KOP | BID KID | Cefadroxil | 250mg | TABLETS |
179 | 2302C02D KOP | HAIREX | Minoxidil | 20mg/60ml | SYRUP |
180 | 2303R03A KOP | KETOTIF | Ketotifen | 1mg | TABLETS |
181 | 2304R03A KOP | KETOTIF | Ketotifen | 1mg/ml | SYRUP |
182 | 2312N04C KOP | KOZEPAM | Diazepam | 5mg | TABLETS |
183 | 231SC01E KOP | LISIR | Lisinopril | 5mg | TABLETS |
184 | 2316C01E KOP | LISIR | Lisinopril | 10mg | TABLETS |
185 | 2337J01K KOP | SOLOFLOX | Lomefloxacin | 400mg | TABLETS |
KORUS PHARMACEUTICALS LTD - Korea | |||||
Notification No. | BRAND NAME | GENERIC NAME | STRENGTH | DOSAGE FORM |
|
186 | 2352J01D KOR | Cefuroxime | 750mg | INJECTION |
|
187 | 2354J01D KOR | Cephradine | 500mg | TABLETS |
|
188 | 2359G04A KOR | Ofloxacin | 100mg | TABLETS |
|
MEDOPHARM - Chennai, India | |||||
Notification No. | BRAND NAME | GENERIC NAME | STRENGTH | DOSAGE FORM |
|
189 | 2741A02A MEP | Aluminium Hydroxide | 500mg | TABLETS |
|
190 | 2742A02A MEP | Aluminium Hydroxide | 120mg | TABLETS |
|
Magnesium Trisilicate | 250mg | ||||
Peppermint Oil | 0.003ml | ||||
191 | 2747C01A MEP | Digoxin | 0.25mg | TABLETS |
|
192 | 2748C01A MEP | Dipyridamol | 25mg | TABLETS |
|
193 | 2754M01A MEP | Indomethacin | 25mg | CAPS |
|
194 | 2755M01A MEP | Indomethacin | 50mg | CAPS |
|
195 | 2758N02B MEP | Acetaminophen | 120mg/5ml | SUSPENSION |
|
196 | 2759N05A MEP | Amitriptyline HCl | 25mg | TABLETS |
|
197 | 2760N05A MEP | Amitriptyline HCl | 50mg | TABLETS |
|
198 | 2761N04C MEP | Chlordiazepoxide | 5mg | TABLETS |
|
199 | 2762N04C MEP | Chlordiazepoxide | 10mg | TABLETS |
|
200 | 2763N04B MEP | Chlorpromazine HCl | 25mg | TABLETS |
|
201 | 2764N04B MEP | Chlorpromazine HCl | 50mg | TABLETS |
List of Notified Drugs | |||||
202 | 2765N04B MEP | Chlorpromazine HCl | 100mg | TABLETS |
|
203 | 2766N04C MEP | Diazepam | 2mg | TABLETS |
|
204 | 2767N04C MEP | Diazepam | 5mg | TABLETS |
|
205 | 2768N04C MEP | Diazepam | 10mg | TABLETS |
|
206 | 2769N04B MEP | Haloperidol | 5mg | TABLETS |
|
207 | 2770N04B MEP | Haloperidol | 10mg | TABLETS |
|
208 | 2771N04C MEP | Phenobarbitone | 15mg | TABLETS |
|
209 | 2772N04B MEP | Phenobarbitone | 30mg | TABLETS |
|
210 | 2773N03A MEP | Carbamazepine | 200mg | TABLETS |
|
211 | 2774N04B MEP | Prochlorperazine Maleate | 5mg | TABLETS |
|
212 | 2775N04B MEP | Prochlorperazine Maleate | 25mg | TABLETS |
|
213 | 2776R06A MEP | Promethazine HCl | 10mg | TABLETS |
|
214 | 2777R06A MEP | Promethazine HCl | 25mg | TABLETS |
|
215 | 2778A03A MEP | Metoclopramide HCl | 10mg | TABLETS |
|
216 | 2779R06A MEP | Chlorpheniramine Maleate | 4mg | TABLETS |
|
217 | 2782A10B MEP | Tolbutamide | 500mg | TABLETS |
|
218 | 2785C03A MEP | Hydrochlorothiazide | 25mg | TABLETS |
|
219 | 2786C03A MEP | Hydrochlorothiazide | 50mg | TABLETS |
|
220 | 2810P02A MEP | Diethyl Carbamazine | 50mg | TABLETS |
|
221 | 2812A11H MEP | Riboflavine (Vit B2) | 2mg | TABLETS |
|
222 | 2813A11H MEP | Riboflavine (Vit B2) | 3mg | TABLETS |
|
223 | 2814A11H MEP | Riboflavine (Vit B2) | 5mg | TABLETS |
|
224 | 2815A11H MEP | Riboflavine (Vit B2) | 10mg | TABLETS |
|
225 | 2816A11H MEP | Thiamine (Vit B1) | 10mg | TABLETS |
|
MERCK SHARP & DOHME - Netherland | |||||
Notification No. | BRAND NAME | GENERIC NAME | STRENGTH | DOSAGE FORM |
|
226 | 2818M01A MER | INDOCID | Indomethacin | 25mg | CAPS |
227 | 2819M01A MER | INDOCID | Indomethacin | 25mg | GEL |
228 | 2820M01A MER | INDOCID | Indomethacin | 50gm | GEL |
229 | 2821D01A MER | MINTEZOL | Thiabendazole | 500mg/5ml | SUSPENSION |
230 | 2822D01A MER | MINTEZOL | Thiabendazole | 500mg | TABLETS |
231 | 2823C03D MER | MODURETIC | Amiloride HCl | 5mg | TABLETS |
Hydrochlorothiazide | 50mg | ||||
232 | 2828N04A MER | SINEMET | Carbidopa | 10mg | TABLETS |
Levodopa | 100mg | ||||
233 | 2829N04A MER | SINEMET | Carbidopa | 25mg | TABLETS |
Levodopa | 250mg | ||||
234 | 2830N06A MER | TRYPTIZOL | Amitriptyline HCl | 25mg | TABLETS |
List of Notified Drugs | |||||
235 | 2831N06A MER | TRYPTIZOL | Amitriptyline HCl | 50mg | TABLETS |
236 | 2832C07A MER | TIMOPTOL | Timolol | 0.25%w/v | EYE DROPS |
237 | 2834C07A MER | BLOCADREN | Timolol Maleate | 10mg | TABLETS |
238 | 2836C01E MER | CORENITEC | Enalapril | 20mg | TABLETS |
Hydrochlorothiazide | 12.5mg | ||||
239 | 2837L01D MER | COSMOGEN LYOVAC | Dactinomycin | 0.5mg | INJECTION |
240 | 2839J05C MER | CRIXIVAN | Indinavir Sulphate | 200mg | CAPS |
241 | 2840J05C MER | CRIXIVAN | Indinavir Sulphate | 400mg | CAPS |
242 | 2841N02B MER | DOLOBID | Diflunisal | 250mg | TABLETS |
243 | 2842M05A MER | FOSAMAX | Alendronate Sodium | 10mg | TABLETS |
244 | 2843M05A MER | FOSAMAX | Alendronate Sodium | 40mg | TABLETS |
245 | 2844C01E MER | HYZZAR | Losartan K | 50mg | TABLETS |
Hydrochlorothiazide | 12.5mg | ||||
2845M01A MER | INDOCID | Indomethacin | 75mg | CAPS |
|
246 | 2646M01A MER | INDOCID | Indomethacin | 100mg | SUPPOSITORIES |
247 | 2847C07A MER | MODUCREN | Timolol | 20mg | TABLETS |
Hydrochlorothiazide | 5mg | ||||
Amiloride | 5mg | ||||
248 | 2848A02B MER | PEPDINE | Famotidine | 20mg/5ml | INJECTION |
249 | 2850R06A MER | PERIACTIN | Cyproheptadine HCl | 4mg | TABLETS |
250 | 2851L02B MER | PROSCAR | Finasteride | 5mg | TABLETS |
251 | 2852J04A MER | RIFAMYCINE | Rifamycin | 1%w/v | DROPS |
252 | 2853J01K MER | TIENAM | Imipenem | 250mg | INJECTION |
Cilastatin Sodium | 250mg | ||||
253 | 2854J01K MER | TIENAM | Imipenem | 500mg | INJECTION |
Cilastatin Sodium | 500mg | ||||
254 | 2855C07A MER | TIMOPTOL XE 0.25% | Timolol | 0.25%w/v | DROPS |
255 | 2857S01A MER | TRUSOPT OPTH. | Dorzolamide HCl | DROPS |
|
256 | 2858A09A MER | ZOCOR | Simvastatin | 10mg | TABLETS |
257 | 2859A09A MER | ZOCOR | Simvastatin | 20mg | TABLETS |
N.V. SCHERING S.A. - Germany | |||||
Notification No. | BRAND NAME | GENERIC NAME | STRENGTH | DOSAGE FORM |
|
258 | 2893D07A SCH | NERISONE | Diflucortolone Valerate | 0.1%w/w | CREAM |
259 | 2896G03A SCH | NORISTERRAT | Norethisterone Enanhate | 200mg | INJECTION |
260 | 2898G03A SCH | PRIMOLUT - N | Norethisterone | 5mg | TABLETS |
261 | 2904V03A SCH | ULTRAVIST 300 | Iopromide | 0.623gm | SOLUTION |
262 | 2908G03A SCH | NORIGYNON | Norethisterone | 50mg | INJECTION |
Estradiol Valerate | 5mg |
List of Notified Drugs | |||||
263 | 2909D07A SCH | ADVANTAN | Methylprednisolone | 0.1%w/w | CREAM |
264 | 2910D07A SCH | ADVANTAN | Methylprednisolone | 0.1%w/w | OINTMENT |
265 | 2911D07A SCH | ADVANTAN FATTY | Methylprednisolone | 0.1%w/w | OINTMENT |
ORGANON INTERNATIONAL BV - Netherland | |||||
Notification No. | BRAND NAME | GENERIC NAME | STRENGTH | FORMULATION |
|
266 | 3178A14A ORG | DECA DURABOLIN | Nandrolone Decanoate | 25mg | INJECTION |
267 | 3179A14A ORG | DECA DURABOLIN | Nandrolone Decanoate | 50mg | INJECTION |
268 | 3180A14A ORG | DECA DURABOLIN | Nandrolone Phenylproprionate | 25mg | INJECTION |
269 | 3184N06A ORG | TOLVON | Mianserin | 30mg | |
270 | 3185A01A ORG | ORADEXON | Dexamethazone | 5mg | INJECTION |
Ethinyloestradiol | 50mcg | ||||
PANACEA BIOTEC Ltd - New Delhi, India | |||||
Notification No. | BRAND NAME | GENERIC NAME | STRENGTH | DOSAGE FORM |
|
271 | 3190AO2A PAN | ANTACID | Aluminium Hydroxide | 250mg | TABLETS |
Magnesium Trisilicate | 500mg | ||||
272 | 3193N05B PAN | Diazepam | 5mg | TABLETS |
|
273 | 3194N05B PAN | Diazepam | 10mg | TABLETS |
|
274 | 3197M01A PAN | INDOPAN | Indomethacin | 25mg | CAPS |
275 | 3198M01A PAN | CILAMIN | Penicillamine | 150mg | CAPS |
276 | 3199M01A PAN | CILAMIN | Penicillamine | 250mg | CAPS |
277 | 3202M01A PAN | AIRYFEN-1 | Ketotifen | 1mg | TABLETS |
278 | 3203M01A PAN | AIRYFEN | Ketotifen | 1mg/5ml | SYRUP |
279 | 3225L01A PAN | ONCOLYTE | Cyclophosphamide | 50mg | TABLETS |
280 | 3226L01X PAN | PANIMUN | Cyclosporine | 50mg/5ml | SOLUTION |
281 | 3229A07D PAN | SUPRILOP | Loperamide | 2mg/5ml | SYRUP |
282 | 3238N04A PAN | Carbidopa | 10mg | TABLETS |
|
Levodopa | 100mg | ||||
283 | 3239N04A PAN | Carbidopa | 25mg | TABLETS |
|
Levodopa | 100mg | ||||
284 | 3240N04A PAN | Carbidopa | 50mg | TABLETS |
|
Levodopa | 200mg | ||||
285 | 3241N04A PAN | ELDOPAN | Selegiline | 5mg | TABLETS |
286 | 3242J04A PAN | Cycloserine | 25mg | CAPS |
|
287 | 3252B05A PAN | ALBUPAN | Albumin | 100ml | INFUSION |
288 | 3253C01B PAN | PANARONE | Amiodarone HCl | 100mg | TABLETS |
289 | 3254C01B PAN | PANARONE | Amiodarone HCl | 200mg | TABLETS |
290 | 3255C01D PAN | DITRATE - SR | Isosorbide Dinitrate | 20mg | CAPS |
List of Notified Drugs | |||||
291 | 3256C01D PAN | DITRATE - SR | Isosorbide Dinitrate | 40mg | CAPS |
292 | 3257C01D PAN | DITRATE | Isosorbide Dinitrate | 5mg | TABLETS |
293 | 3258C01D PAN | DITRATE | Isosorbide Dinitrate | 10mg | TABLETS |
294 | 3262V03A PAN | NITROCURE | Nitroglycerin | 25mg | INJECTION |
295 | 3264G03G PAN | FERTOPHENE | Clomiphene Citrate | 50mg | TABLETS |
298 | 3267A06A PAN |
| Bisacodyl | 5mg | TABLETS |
|
|
|
|
| |
|
| PFIZER LABORATORIES LIMITED - Kenya | |||
| Notification No. | BRAND NAME | GENERIC NAME | STRENGTH | DOSAGE FORM |
297 | 3286N05B PFI | VISTARIL | Hydroxyzine HCl | 50mg | TABLETS |
298 | 3287P02X PFI | COMBANTRIN | Pyrantel Pamoate | 125mg | TABLETS |
299 | 3288P02X PFI | COMBANTRIN | Pyrantel Pamoate | 250mg/5ml | SUSPENSION |
300 | 3293D01B PFI | DIFLUCAN | Fluconazole | 2mg/ml | INJECTION |
301 | 3295D01B PFI | DIFLUCAN | Fluconazole | 50mg/5ml | SUSPENSION |
302 | 3298C04A PFI | MINIPRESS | Prazosin | 1mg | TABLET |
303 | 3299C04A PFI | MINIPRESS | Prazosin | 2mg | TABLET |
304 | 3300C04A PFI | MINIPRESS | Prazosin | 5mg | TABLET |
305 | 3303J01A PFI | TERRA- | Oxytetracycline | 1%w/w | E/E SUSPENSION |
|
|
| Hydrocortisone | 0.5%w/v | |
|
|
| Polymyxin B | 10,000iu | |
306 | 3304S02A PFI | TERRAMYCIN OTIC | Oxytetracycline | 0.5%w/v | DROPS |
|
|
| Benzocaine | 5%w/v | |
|
|
| Polymyxin B | 10.000iu | |
307 | 3305J01A PFI | TERRAMYCIN | Oxytetracycline | 250mg | CAPS |
|
|
|
|
| |
|
| RANBAXY LABORATORIES LTD - New Delhi, India |
|||
| Notification No. | BRAND NAME | GENERIC NAME | STRENGTH | DOSAGE FORM |
308 | 3330J01D RAN | KEFLOXIN | Cefadroxil | 250mg | CAPS |
309 | 3333J01D RAN | KEFLOXIN | Cefadroxil | 250mg/5ml | SYRUP |
|
|
|
|
| |
|
| REMEDICA LTD - Cyprus |
| ||
| Notification No. | BRAND NAME | GENERIC NAME | STRENGTH | DOSAGE FORM |
310 | 3353G03G REM |
| Clomiphene Citrate | 50mg | TABLETS |
311 | 3354C03D REM |
| Spironolactone | 25mg | TABLETS |
|
|
|
|
| |
|
| ROTEXMEDICA - UK |
| ||
| Notification No. | BRAND NAME | GENERIC NAME | STRENGTH | DOSAGE |
312 | 3457B01A ROT |
| Heparin | 5000IU/ml | INJECTION |
313 | 3458A01A ROT |
| Dexamethazone Sodium Phosphate | 4mg/ml | INJECTION |
List of Notified Drugs | |||||
314 | 3461V03A ROT |
| Hydrocortisone Succinate | 100mg | INJECTION |
315 | 3467G02A ROT |
| Oxytocin | 5IU/ml | INJECTION |
316 | 3473N05A ROT |
| Fluphenazine Decanoate | 25mg/ml | INJECTION |
317 | 3482B02B ROT |
| Phytomenadione | 10mg/ml | INJECTION |
|
|
|
|
| |
| SCHERING PLOUGH PRODUCTS - New Jersey, USA |
||||
| Notification No. | BRAND NAME | GENERIC NAME | STRENGTH | DOSAGE FORM |
318 | 3543D07C PLO | CELESTODERM V GARAMYCIN | Gentamycin | 0.1%w/w | OINTMENT |
|
|
| Betamethasone | 0.1%w/w | |
319 | 3544D06A PLO | TINADERM | Gentamycin | 10mg | LOTION |
|
|
| Tolnaftate | 1mg | |
320 | 3545D01APLO | LOTRIDERM | Clotrimazole | 1%w/w | CREAM |
|
|
| Betamethasone | 0.05%w/w | |
321 | 3548H02B PLO | CELESTAMINE | Betamethasone | 0.25mg | TABLETS |
|
|
| Dexchlorpheramine | 2mg | |
322 | 3555D01A PLO | DIPROSALIC | Betamethasone | 0.64mg | LOTION |
|
|
| Salicylic Acid | 20mg | |
323 | 3556D06A PLO | QUADRIDERM | Betamethasone | 0.5mg | CREAM |
|
|
| Tolnaftate | 10mg | |
|
|
| Gentamycin | 1mg | |
|
|
| Iodochlorhydroxyquin | 10mg | |
324 | 3557D06A PLO | CELESTODERM V GARAMYCIN | Gentamycin | 01%w/w | CREAM |
|
|
| Betamethasone | 0.1%w/w | |
325 | 3558D06A PLO | TINADERM | Gentamycin | 10mg | CREAM |
|
| Tolnaftate | 1mg | ||
|
|
|
|
| |
|
| SMITHKLINE BEECHAM INTERNATIONAL - UK |
|||
| Notification No. | BRAND NAME | GENERIC NAME | STRENGTH | DOSAGE FORM |
326 | 3975J01C SBI | AMPICLOX INJECTION | Ampicillin | 37.5mg | INJECTION |
|
|
| Cloxacillin | 37.5mg | |
327 | 3981J01C SBI | AUGMENTIN | Amoxycillin | 500mg | INJECTION |
|
|
| Clavulanic Acid | 100mg | |
328 | 3982J01C SBI | AUGMENTIN | Amoxycillin | 1000mg | INJECTION |
|
|
| Clavulanic Acid | 200mg | |
329 | 3983D06A SBI | BACTROBAN | Mupurocin | 2%w/w | OINTMENT |
330 | 3984R05A SBI | CONTACT | Phenylpropanolamine | 50mg | CAPS |
331 | 3986J01H SBI | FLOXAPEN | Flucloxacillin | 250mg | CAPS |
332 | 3987J01H SBI | FLOXAPEN | Flucloxacillin | 125mg/5ml | SYRUP |
333 | 3988J01H SBI | FLOXAPEN | Flucloxacillin | 250mg | INJECTION |
334 | 3990P01B SBI | HALFAN | Halofantrine HCl | 100mg/5ml | SYRUP |
List of Notified Drugs | |||||
335 | 4008J07A SBI | ENGERIX B | Hepatitis B Vaccine | 20mcg | SUSPENSION FOR INJECTION |
336 | 4009J07A SBI | ENGERIX B | Hepatitis B Vaccine | 10mcg | SUSPENSION FOR INJECTION |
337 | 4010J07A SBI | HAVRIX 1440 | Hepatitis A Vaccine | 1440 ELISA Units | SUSPENSION FOR INJECTION |
338 | 4011J07A SBI | HAVRIX 720 | Hepatitis A Vaccine | 720 ELISA Units | SUSPENSION FOR INJECTION |
339 | 4013J07A SBI | INFANRIX VACCINE | Diphtheria Toxoid | 30 IU | SUSPENSION FOR INJECTION |
|
|
| Tetanus Toxoid | NLT 40 IU | SUSPENSION FOR INJECTION |
|
|
| Pertussis Vaccine |
| SUSPENSION FOR INJECTION |
340 | 4014J07A SBI | SEROYAT | Paroxitine | 20mg | TABLETS |
341 | 4015A04A SBI | STELAZINE 1mg | Trifluperazine HCl | 1mg | TABLETS |
342 | 4016A04A SBI | STELAZINE 2mg | Trifluperazine HCl | 2mg | TABLETS |
343 | 4017A04A SBI | STELEZINE 5mg | Trifluperazine HCl | 5mg | TABLETS |
344 | 4018A04A SBI | STELAZINE 10mg | Trifluperazine HCl | 10mg | TABLETS |
345 | 4048A02A SBI | ACTAL | Polyhydroxyaluminium Monocarbonate | 360mg | TABLETS |
346 | 4049A02A SBI | PHILLIPS MILK OF MAGNESIA | Magnesium Hydroxide | 400mg | TABLETS |
347 | 4050A02A SBI | ANDREWS LIVER SALTS | Sodium Bicarbonate | 2.28gm | POWDER |
|
|
| Magnesium Sulphate | 88gm | |
348 | 4053A02A SBI | ENO LEMON | Sodium Bicarbonate | 55.765w/w | POWDER |
|
|
| Citric Acid | 43.145w/w | |
349 | 4054N02B SBI | BEECHAMS HOT LEMON | Aspirin | 600mg | POWDER |
|
|
| Caffeine | 50mg | |
|
|
| Ascorbic Acid (Vit C) | 40mg | |
350 | 4055A11C SBI | SCOTTS EMULSION | Vitamin A | 850iu/5ml | SUSPENSION |
|
|
| Ergocalciferol (Vit D3) | 85iu/5ml | |
351 | 4056N02B SBI | COLDREX | Paracetamol | 500mg | TABLETS |
|
|
| Caffeine | 25mg | |
|
|
| Phenylephrine HCl | 5mg | |
| . |
| Terpinehydrate | 20mg | |
352 | 4060V06C SBI | ASHTON & PARSONS INFANT | Matricaria | 4mg | POWDER |
|
|
| Lactose | 126mg | |
|
|
|
|
| |
|
| STEROP Overseas - Belgium |
| ||
| Notification No. | BRAND NAME | GENERIC NAME | STRENGTH | DOSAGE FORM |
353 | 4141A03B STE |
| Atropine Sulfate | 0.5mg/ml | INJECTION |
354 | 4142A03B STE |
| Atropine | 0.25mg/ml | INJECTION |
355 | 4146N02B STE | NEVRINE | Paracetamol | 500mg | TABLETS |
|
|
| Caffeine | 50mg | |
356 | 4147N02A STE |
| Pethidine | 50mg/ml | INJECTION |
357 | 4148N02A STE |
| Pethidine | 100mg/2ml | INJECTION |
358 | 4149R03A STE |
| Adrenaline | 1mg/1ml | INJECTION |
359 | 4150R06A STE |
| Promethazine | 50mg/2ml | INJECTION |
List of Notified Drugs | |||||
360 | 4151R06A STE |
| Promethazine HCl | 25mg | TABLETS |
361 | 4152R06A STE |
| Chlorpheniramine | 10mg/2ml | INJECTION |
362 | 4153N03A STE |
| Phenobarbital | 100mg/1ml | INJECTION |
363 | 4154N03A STE |
| Phenobarbital | 200mg/2ml | INJECTION |
364 | 4155N03A STE |
| Carbamazepine | 200mg | TABLETS |
365 | 4168B03A STE |
| Iron Dextran | 100mg/2ml | INJECTION |
366 | 4169B03A STE |
| Iron Dextran | 250mg/5ml | INJECTION |
367 | 4170A11 STE |
| Vitamin K1 | 10mg/ml | INJECTION |
368 | 4171C01A STE |
| Digoxine | 0.25mg | TABLETS |
369 | 4175G02A STE |
| Ergometrine Maleate | 0.5mg/ml | INJECTION |
370 | 4176N05B STE |
| Diazepam | 10mg/2ml | INJECTION |
371 | 4177N05A STE |
| Chlorpromazine | 50mg/2ml | INJECTION |
372 | 4178N05A STE |
| Chlorpromazine HCl | 25mg | TABLETS |
373 | 4179R03B STE |
| Aminophylline | 250mg/10ml | INJECTION |
374 | 4180R03B STE |
| Aminophylline | 100mg | TABLETS |
|
|
|
|
| |
|
| SUN PHARMACEUTICALS INDUSTRIES LTD - Mumbai, India |
|||
| Notification No. | BRAND NAME | GENERIC NAME | STRENGTH | DOSAGE FORM |
375 | 4192C04A SUN | FLEXITAL | Oxypentifylline | 400mg | TABLETS |
376 | 4194J04A SUN | MESACOL | 5-Amino Salicylic Acid | 400mg | TABLETS |
377 | 4196C01D SUN | MONOTRATE | lsosorbide-5-Mononitrate | 20mg | TABLETS |
378 | 4198C01D SUN | MONOTRATE | lsosorbide-5-Mononitrate | 50mg | TABLETS |
379 | 4202N06A SUN | CLOFRANIL | Clomipramine HCl | 25mg | TABLETS |
380 | 4241N05A SUN | PRODEP | Fluoxetine HCl | 20mg | TABLETS |
381 | 4245N05A SUN | RIDAZIN | Thioridazine HCl | 50mg | TABLETS |
382 | 4246N05A SUN | RIDAZIN | Thioridazine HCl | 100mg | TABLETS |
383 | 4247N05A SUN | SEFORM | Haloperidol | 5mg | TABLETS |
384 | 4248N05A SUN | SEFORM | Haloperidol | 0.25mg | TABLETS |
385 | 4272R06A SUN | KETASMA | Ketotifen | 1mg | TABLETS |
|
|
|
|
| |
|
| UNICHEM LABORATORIES LIMITED Mumbai, India |
|||
| Notification No. | BRAND NAME | GENERIC NAME | STRENGTH | DOSAGE FORM |
386 | 4448C02D UNC | CISADE CMPS | Cisapride | 10mg | TABLETS |
|
|
| Simethicone | 125mg | |
387 | 4462J01K UNC | SULBACIN | Sultamicillin Tosylate | 375mg | TABLETS |
388 | 4467N04C UNC | TRIZAC | Fluoxetine HCl | 20mg | CAPS |
389 | 4470G03A UNC | UNIPROGESTIN | Progesterone | 25mg/ml | INJECTION |
390 | 4471G03A UNC | UNIPROGESTIN | Progesterone | 50mg/ml | INJECTION |
391 | 4472G03A UNC | UNIPROGESTIN DEPOT | Hydroprogesterone Caproate | 250mg/ml | INJECTION |
List of Notified Drugs | |||||
392 | 4473G03A UNC | UNIPROGESTIN DEPOT | Hydroprogesterone Caproate | 500mg/ml | INJECTION |
|
|
|
|
| |
|
| UNIQUE PHARMACEUTICAL LABORATORIES - Mumbai, India |
|||
| Notification No. | BRAND NAME | GENERIC NAME | STRENGTH | DOSAGE FORM |
393 | 4480N01B UNQ | LIDOGEL | Lignocaine HCl | 2%w/w | GEL |
|
|
|
|
| |
|
| WARNER LAMBERT S.A (Pty) Ltd. - R.S.A |
|||
|
| BRAND NAME | GENERIC NAME | STRENGTH | DOSAGE FORM |
394 | 4494C01E WAR | ACCUPRIL | Quinapril HCl | 5mg | TABLETS |
395 | 4496C01E WAR | ACCUPRIL | Quinapril HCl | 20mg | TABLETS |
396 | 4505A07E WAR | ANUGESIC | Pramoxine HCl | 10mg/g | OINTMENT |
397 | 4512R05C WAR | BENYLIN PAEDIATRIC | Diphenhydramine HCl | 7mg/5ml | SYRUP |
|
|
| Sodium Citrate | 28.5mg/5ml | |
|
|
| Menthol | 0.55mg/5ml | |
398 | 4515R05D WAR | BENYLIN WITH CODEINE | Diphenhydramine | 12.5mg/5ml | SYRUP |
|
|
| Ammonium Chloride | 125mg/5ml | |
|
|
| Codeine Phosphate | 10mg/5ml | |
|
|
| Menthol | 1mg/5ml | |
399 | 4519A02A WAR | GELUSIL PEPPERMINT | Aluminium Hydroxide | 250mg | TABLETS |
|
|
| Magnesium Trisilicate | 500mg | |
400 | 4537M01A WAR | KETOFLAM | Ketoprofen | 200mg | CAPS |
401 | 4542A01A WAR | LISTERINE | Thymol | 12.78mg | SOLUTION |
402 | 4548A01A WAR | ORALDINE M/WASH | Hexetidine | 15mg/15ml | SOLUTION |
403 | 4556R05E WAR | SINUTAB ND | Paracetamol | 325mg | TABLETS |
|
|
| Phenylpropanolamine | 18mg | |
404 | 4557R05E WAR | SINUTAB SA | Paracetamol | 600mg | TABLETS |
|
|
| Phenylpropanolamine | 100mg | |
|
|
| Phenyltoloxamine Citrate | 66mg | |
405 | 4560M02A WAR | SLOAN'S HEAT RUB | Capsicum | 31.319g | CREAM |
|
|
| Methyl Salicylate | 4.00mg | |
|
|
| Methyl Nicotinate | 5.879mg | |
406 | 4561M02A WAR | SLOAN'S LINIMENT | Methyl Salicylate | 31.319g | LINIMENT |
|
|
| Camphor | 4.00mg | |
|
|
| Oleoresin Capsicum | 5.879mg | |
|
|
| Oil of Turpentine | 1.2mg | |
|
|
|
|
| |
|
| WOCKHARDT PHARMACEUTICAL LTD - Gujarat, India |
|||
| Notification No. | BRAND NAME | GENERIC NAME | STRENGTH | DOSAGE FORM |
407 | 4621C02E WOC | ACEZIDE | Captopril | 25mg | TABLETS |
List of Notified Drugs | |||||
|
|
| Hydrochlorothiazide | 15mg | |
408 | 4627N02B WOC | NEPAM | Nefopam HCl | 20mg | INJECTION |
409 | 4628N02B WOC | KETOCOL | Ketorolac Tromethamine | 10mg | TABLETS |
410 | 4629N02B WOC | KETOCOL | Ketorolac Tromethamine | 30mg/ml | INJECTION |
411 | 4630N02B WOC | PROXYVON | Dextrapropoxyphen HCl | 65mg | CAPS |
Acetaminophen | 400mg | ||||
412 | 4635J03C WOC | PELOX | Pefloxacin | 400mg | INFUSION |
|
|
| Dextrose | 5mg | |
413 | 4644N02B WOC | IBUDOSS | Dextrapropoxyphen HCl | 65mg | CAPS |
|
| Ibuprofen | 400mg | ||
414 | 4645B05B WOC | PROBOFEX | Protein Hydrolysate | 300mg | CAPS |
|
|
| Ferrous Aminoate | 60mg | |
|
|
| Pyridoxine (Vit B6) | 3mg | |
|
|
| Vitamin B12 | 15mcg | |
|
|
| Folic Acid | 1.5mg | |
415 | 4653A11A WOC | OSSIDOSS | Calcium Gluconate | 300mg | TABLETS |
|
|
| Vitamin A | 1000iu | |
|
|
| Cholecalciferol (Vit D3) | 100iu | |
416 | 4654A08A WOC | FLABOLIN | Fenfluramine | 20mg | TABLETS |
417 | 4655A08A WOC | FLABOLIN | Fenfluramine | 40mg | TABLETS |
418 | 4656N02B WOC | SPASMO PROXYVON | Dextrapropoxyphen HCl | 65mg | CAPS |
|
|
| Acetaminophen | 400mg | |
|
|
| Dicyclomine HCl | 10mg | |
419 | 4657P01A WOC | WOTINEX | Tinidazole | 300mg | TABLETS |
|
|
| Diloxanide Furoate | 250mg | |
420 | 4658D08A WOC |
| Povidone Iodine | 1 %w/w | OINTMENT |
|
|
| Flucinolone | 0.025%w/w | |
421 | 4659B05B WOC |
| Dextrose | 10%w/v | INFUSION |
422 | 4663B05B WOC | ELECTRODRIP M | Potassium Chloride | 0.15gm | INFUSION |
|
|
| Dibasic Potassium Phosphate | 0.026gm | |
|
|
| Sodium Acetate | 0.32gm | |
|
|
| Magnesium Chloride | 0.031gm | |
|
| Sodium Metabisulphate | 0.021gm | ||
|
| Dextrose | 5gm | ||
423 | 4664B05B WOC | AMINODRIP | Amino Acids | 5%w/v | INFUSION |
424 | 4666B05B WOC | FUTODRIP 10 | Dextrose | 10%w/v | INFUSION |
| Fructose | 10%w/v | |||
| |||||
| WYETH SOUTH AFRICA (Pty) Ltd - South Africa |
|
List of Notified Drugs | |||||
| Notification No. | BRAND NAME | GENERIC NAME | STRENGTH | DOSAGE FORM |
425 | 4670N05B WYT | ATIVAN | Lorazepam | 1mg | TABLETS |
426 | 4671N05B WYT | ATIVAN | Lorazepam | 2.5mg | TABLETS |
427 | 4672C04A WYT | ISORDIL | Isosorbide Dinitrate | 5mg | TABLETS |
428 | 4673C04A WYT | ISORDIL | Isosorbide Dinitrate | 10mg | TABLETS |
429 | 4675G03F WYT | PREMARIN | Oestrogen | 0.625mg | TABLETS |
430 | 4676G03F WYT | PREMARIN | Oestrogen | 1.25mg | TABLETS |
(Section 58)
[1st October, 2001]
G.Ns. Nos.
27 of 2001
92 of 2002
WHEREAS section 58 of the Pharmaceutical and Poisons Act * requires the Minister, upon recommendation of the Board, by order in the Gazette to prohibit and control the manufacture, importation or sale of any drug.
AND WHEREAS the Board has recommended to the Minister the list of veterinary drugs to be gazetted for public awareness.
NOW THEREFORE, the public is hereby notified as follows:
1. This Order may be cited as the Pharmaceuticals and Poisons (Veterinary Drugs List) (Notification) Order.
2. [Omitted.]
3. No person shall be allowed to manufacture for sale, supply, import or export any drug which is not in the drug list specified in the Schedule to this Order.
4. Notwithstanding the provisions of this Order, the registration shall remain valid for five years from date of issuing registration certificates, and shall be subject to payment of annual retention fees for each year, unless it is earlier cancelled.
5. Any person who contravenes or fails to comply with this Order commits an offence punishable under the Pharmaceutical and Poisons Act *.
SCHEDULE
LIST OF REGISTERED VETERINARY DRUGS APPROVED TO CIRCULATE IN THE COUNTRY
Registration Number | Product Name | Active Ingredients | Strength | Manufacturer |
Registrant | Anglian Nutrition Products Company- U.K | |||
1 TAN 00,1925 J01A ANG | OTC 20% | Anglian Nutrition Product Company - ENGLAND |
||
Oxytetracycline HCl BP | 200mg/g | |||
2 TAN 00,1926 J01A ANG | Extra Egg Formula | Anglian Nutrition Product Company - ENGLAND |
||
Pant5othenic Acid | 4.2mg/g | |||
Nicotinamide | 11.94mg/g | |||
Vitamin B12 | 2mcg/g | |||
Vitamin B2 | 2562.5mcg/g | |||
Vitamin K | 12.5mg/g | |||
Vitamin D3 | 350 I.U/g | |||
Vitamin A | 2012.5 I.U/g | |||
Oxytetracycline HCl | 50mg/g | |||
3 TAN 00,1743 P01X ANG | Ancoban | Anglian Nutrion Product Company - ENGLAND |
||
Amprolium BP | 20%w/w | |||
4 TAN 00,1744 P02X ANG | Ivermectin 10 Injection | Anglian Nutrion Product Company - ENGLAND |
||
Ivermectin BP | 1%w/w | |||
Registrant | Ceva Sante Animale - FRANCE | |||
5 TAN 00,1927 P01X CEV | Veribin Powder | Ceva Sante Animale - FRANCE |
||
Diminazene Diaceturate | 1.05g/2.36g |
|
||
Registrant | COOPHAVET S.A - FRANCE | |||
6 TAN 00,1745 J01J COO | Peni DHS injection | Coophavet S.A. - FRANCE |
||
Dihydrostreptomycin Sulphate | 20%w/v | |||
Benzyl Penicillin Procaine | 20 miu/ml | |||
7 TAN 00,1746 J01A COO | Remacycline L.A. | Coophavet S.A. - FRANCE |
||
Oxytetracycline Ph.Eur | 20%w/v |
Registration Number | Product Name | Active Ingredients | Strength | Manufacturer |
8 TAN 00,1928 P02X COO | Vermizol L Injection | Coophavet S.A. - FRANCE |
||
Levamisole HCl Ph.Eur | 12.7%w/v | |||
9 TAN 00,2074 J01A COO | Oxytetra 5 Coophavet | Coophavet S.A. - FRANCE |
||
Oxytetracycline HCl Ph.Eur | 5%w/v | |||
10 TAN 00,1747 P02X COO | Piperazine Citrate | Coophavet S.A. - FRANCE |
||
Piperazine Citrate Ph.Eur | 100%w/w | |||
Registrant | Farvet Laboratories B.V. - HOLLAND | |||
11 TAN 00,2075 J01J FAR | Pen-Strep 20/25 Injection | Farvet Laboratories B.V. - HOLLAND |
||
Dihydrostreptomycin Ph.Eur | 250mg/ml | |||
Procaine Benzylpenicillin | 200mg/ml | |||
12 TAN 00,2076 J01A FAR | Cyclosol 200 LA Injection | Farvet Laboratories B.V. - HOLLAND |
||
Oxytetracycline Dihydrate | 216mg/ml | |||
13 TAN 00,1929 J01A FAR | Oxytetracycline 10% Injection | Farvet Laboratories B.V. - HOLLAND |
||
Oxytetracycline HCl Ph.Eur | 100mg/ml | |||
14 TAN 00,1930 J01E FAR | Fartrim Injection | Farvet Laboratories B.V. - HOLLAND |
||
Sulfamethoxazole Ph.Eur | 200mg/ml | |||
Trimethoprim Ph.Eur | 40mg/ml | |||
15 TAN 00,1931 D06A FAR | CTC-Spray | Farvet Laboratories B.V. - HOLLAND |
||
Chlortetracycline HCl Ph.Eur | 3.21g/270ml | |||
Registrant | Investigaciones Quimicas Y Farmaceuticas Y- SPAIN | |||
16 TAN 00,1932 J03C IQF | Fluquin Oral Solution | Investigaciones Quimicas Y Farmaceuticas Y - SPAIN |
||
Enrofloxacin BP | 100mg/ml | |||
17 TAN 00,1933 J03B IQF | Coridix oral water soluble powder | Investigaciones Quimicas Y Farmaceuticas Y - SPAIN |
||
Sulphamethoxypyridazine | 125mg/g |
Registration Number | Product Name | Active Ingredients | Strength | Manufacturer |
Tylosin | 30mg/g | |||
Trimethoprim | 25mg/g | |||
Registrant | Kela Laboratoria N.V- BELGIUM | |||
18 TAN 00,1748 J01J KEL | Penstrep 20/20 Injection | Kela Laboratoria N.V. - BELGIUM |
||
Procaine Benzylpenicillin | 200mg/ml | |||
Dihydrostreptomycin Ph.Eur | 200mg/ml | |||
19 TAN 00,1934 H02A KEL | Dexa-Kel 02 Injection | Kela Laboratoria N.V. - BELGIUM |
||
Dexamethazone Sodium | 2.64mg/ml | |||
20 TAN 00,1935 J01K KEL | Genta-Kel 0.5 Solution for Injection | Kela Laboratoria N.V. - BELGIUM |
||
Gentamycin Ph.Eur | 50,000 I.U/ml |
|||
21 TAN 00,1936 J01K KEL | Genta-Kel 10 Injection | Kela Laboratoria N.V. - BELGIUM |
||
Gentamycin Ph.Eur | 100,000 | |||
22 TAN 00,1937 J01K KEL | Albendazole 10 % Suspension | Kela Laboratoria N.V - BELGIUM |
||
Albendazole Ph.Eur | 100mg/ml | |||
23 TAN 00,1938 J01A KEL | Oxy-Kel 20 | Kela Laboratoria N.V - BELGIUM |
||
Oxytetracycline HCl Ph.Eur | 20%w/w | |||
Registrant | Merial South Africa (PTY) Ltd - SOUTH AFRICA | |||
24 TAN 00,1939 P02X MER | Trodax 34% Injection | Merial SAS Laboratoire De Toulouse - FRANCE |
||
Nitroxynil Eglumine BP | 58.55%m/m | |||
25 TAN 00,1940 P02X MER | Trodax 34% Injection | Merial SAS Laboratoire De Toulouse - FRANCE |
||
Nitroxynil Eglumine BP | 58.55%m/m | |||
Registrant | Norbrook Laboratories Ltd - IRELAND | |||
26 TAN 00,1749 J03B NOR | Norodine Oral Suspension | Norbrook Laboratories Ltd - NORTHERN IRELAND |
||
Sulphadiazine Ph.Eur | 45.5mg/ml | |||
Trimethoprim Ph.Eur | 9.1mg/ml |
Registration Number | Product Name | Active Ingredients | Strength | Manufacturer |
27 TAN 00,1750 J01J NOR | Pen & Strep Injection | Norbrook Laboratories Ltd - NORTHERN IRELAND |
||
Procaine Penicillin Ph.Eur | 200mg/ml | |||
Dihydrostreptomycin Ph.Eur | 250mg/ml | |||
28 TAN 00,1751 J01H NOR | Benzylpenicillin Sodium for Injection | Norbrook Laboratories Ltd - IRELAND |
||
Benzylpenicillin Sodium | 600mg/10ml | |||
29 TAN 00,1941 N01B NOR | Lignocaine & Adrenaline Injection | Norbrook Laboratories Ltd - IRELAND |
||
Adrenaline Tartrate Ph.Eur | 0.00227%w/w |
|||
Lignocaine HCl Ph.Eur | 20%w/v | |||
30 TAN 00,1942 N01B NOR | Vitesel Emulsion | Norbrook Laboratories Ltd - IRELAND |
||
Selenium (as acetate) BP | 1.5mg/ml | |||
Alpha Tocopheryl Acetate | 68mg/ml | |||
31 TAN 00,2077 J01A NOR | Alamycin-10 Injection | Norbrook Laboratories Ltd - IRELAND |
||
Oxytetracycline hydrochloride | 10%w/v | |||
32 TAN 00,1943 J03A NOR | Intradine Injection | Norbrook Laboratories Ltd - IRELAND |
||
Sulphadimidine Ph.Eur | 300 | |||
33 TAN 00,1944 J01A NOR | Alamycin Egg Chick Formula | Norbrook Laboratories Ltd - IRELAND |
||
Vitamin E BP | 0.12%w/w | |||
Vitamin D3 BP | 0.072%w/w | |||
Oxytetracycline HCl BP | 5%w/w | |||
Pantothenic Acid BP | 0.42%w/w | |||
Riboflavin Sodium Phosphate | 0.26%w/w | |||
Nicotinamide BP | 1.2%w/w | |||
Vitamin K BP | 0.072%w/w | |||
Vitamin B12 BP | 0.02%w/w | |||
Vitamin A BP | 0.4%w/w | |||
34 TAN 00,1945 J01A NOR | Alamycin LA 300 Injection | Norbrook Laboratories Ltd - IRELAND |
||
Oxytetracycline Dihydrate | 30%w/v | |||
35 TAN 00,2078 J01A NOR | Alamycin Aerosol | Norbrook Laboratories Ltd - IRELAND |
||
Oxytetracycline Hydrochloride | 3.6%w/w |
Registration Number | Product Name | Active Ingredients | Strength | Manufacturer |
36 TAN 00,1752 J03A NOR | Intradine Poultry | Norbrook Laboratories Ltd - IRELAND |
||
Sulphadimidine Ph.Eur | 33.3%w/w | |||
37 TAN 00,1753 J03A NOR | Noromectin Injection | Norbrook Laboratories Ltd - IRELAND |
||
Ivermectin Ph.Eur | 1.0%w/v | |||
38 TAN 00,1755 P02X NOR | Levacide Injection | Norbrook Laboratories Ltd - IRELAND |
||
Levamisole HCl Ph.Eur | 7.5%w/v | |||
39 TAN 00,1757 P02X NOR | Levamicide Drench | Norbrook Laboratories Ltd - IRELAND |
||
Levamisole HCl Ph.Eur | 1.5mg/ml | |||
40 TAN 00,1758 J01J NOR | PenDeStrep | Norbrook Laboratories Ltd - IRELAND |
||
Dihydrostreptomycin Sulphate | 25%w/v | |||
Procaine Penicillin Ph.Eur | 20%w/v | |||
Registrant | Phenix Pharmaceuticals N.V- BELGIUM | |||
41 TAN 00,1559 J01J PHE | Penstrep 20/20 injection | Kela Laboratoria N.V. - BELGIUM |
||
Procaine Benzylpenicillin | 200mg/ml | |||
Dihydrostreptomycin Sulphate | 200mg/ml | |||
42 TAN 00,1946 D07A PHE | Dexa 0.2 Injection | Kela Laboratoria N.V. - BELGIUM |
||
Dexamethazone Sodium | 2.64mg/ml | |||
43 TAN 00,1947 P02X PHE | Levami-Kel 7.5% Injection | Kela Laboratoria N.V. - BELGIUM |
||
Levamisole HCl Ph.Eur | 7.5%w/v | |||
44 TAN 00,1948 J01K PHE | Genta 5% Injection | Kela Laboratoria N.V. - BELGIUM |
||
Gentamycin Ph.Eur | 50,000 I.U/ml | |||
45 TAN 00,1949 J01K PHE | Genta 10% Injection | Kela Laboratoria N.V. - BELGIUM |
||
Gentamycin Ph.Eur | 100,000 | |||
46 TAN 00,2079 J01H PHE | Drycloxaphen Ointment | Kela Laboratoria N.V. - BELGIUM |
||
Cloxacillin Benzathine BP | 100mg/g | |||
47 TAN 00,2080 J01K PHE | Kanapen P Ointment | Kela Laboratoria N.V. - BELGIUM |
||
Kanamycin Ph.Eur | 10mg/g | |||
Procaine Benzylpenicillin | 30mg/g |
Registration Number | Product Name | Active Ingredients | Strength | Manufacturer |
Prednisolone Ph.Eur | 2mg/g | |||
48 TAN 00,2081 J03B PHE | Typhoprim 30% Powder | Kela Laboratoria N.V. - BELGIUM |
||
Sulfadiazine Ph.Eur | 250mg/g | |||
Trimethoprim Ph.Eur | 50mg/g | |||
49 TAN 00,1950 P02X PHE | Albendazole 10% Suspension | Kela Laboratoria N.V. - BELGIUM |
||
Albendazole Ph.Eur | 10%w/v | |||
Registrant | Univet Laboratories Ltd - IRELAND | |||
50 TAN 00,1951 J01K UNI | Terrexine oily paste | Univet Laboratories Ltd - IRELAND |
||
Kanamycin Sulphate BP | 10,000 | |||
Cephalexin Monohydrate BP | 200mg/10g | |||
51 TAN 00,1952 J01A UNI | Duocycline 10% Injection | Univet Laboratories Ltd - IRELAND |
||
Oxytetracycline Ph.Eur | 10%w/w | |||
52 TAN 00,2082 AB12A UNI | Sacrolyte Powder | Univet Laboratories Ltd - IRELAND |
||
Calcium Pantothenate Ph.Eur | 150mg/100g | |||
Sodium Chloride Ph.Eur | 6.5g/100g | |||
Sodium Citrate Ph.Eur | 4.5g/100g | |||
Potassium Chloride Ph.Eur | 2.5g/100g | |||
Potassium Dihydrogen | 1.3g/100g | |||
Thiamine HCl Ph.Eur | 75mg/100g | |||
Riboflavin Sodium Phosphate | 110mg/100g | |||
Pyridoxine HCl Ph.Eur | 40mg/100g | |||
Dextrose Monohydrate Ph.Eur | 72.68g/100g | |||
53 TAN 00,1953 J01J UNI | Pentomycin Injection | Univet Laboratories Ltd - IRELAND |
||
Procaine Penicillin Ph.Eur | 250mg/ml | |||
Dihydrostreptomycin Ph.Eur | 250mg/ml | |||
54 TAN 00,2083 A11A UNI | Multivit Injection | Univet Laboratories Ltd - IRELAND |
||
Cyanocobalamine Ph.Eur | 50mcg/ml | |||
Dexpanthenol Ph.Eur | 25mcg/ml | |||
Retinol Palmitate BP | 15,000 I.U/ml |
|||
L-Cholecalciferol Ph.Eur | 1,000 I.U/ml |
Registration Number | Product Name | Active Ingredients | Strength | Manufacturer |
Alpha Tocopheryl Acetate | 10mg/ml | |||
Thiamine HCl Ph.Eur | 10mg/ml | |||
Riboflavin Sodium Phosphate | 5mg/ml | |||
Pyridoxine HCl Ph.Eur | 3mg/ml | |||
Nicotinamide Ph.Eur | 35mg/ml | |||
55 TAN 00,1954 J01K UNI | Mycomas 10% Solution | Univet Laboratories Ltd - IRELAND |
||
Norfloxacin USP | 10%w/w | |||
56 TAN 00,2084 J01A UNI | Duocycline LA Injection | Univet Laboratories Ltd - IRELAND |
||
Oxytetracycline BP | 200mg/ml | |||
57 TAN 00,1955 P02X UNI | Univet Multidose Fluke & Worm Drench | Univet Laboratories Ltd - IRELAND |
||
Levamisole Ph.Eur | 15mg/ml | |||
Rafoxanide BP | 22.5mg/ml |
REGULATIONS
(Section 71(1))
G.N. No. 445 of 1986
1. Short title
These Regulations may be cited as the Pharmacy Board Inquiries Regulations.
2. Interpretation
In these Regulations–
"complainant", subject to the provisions of regulation 9(3), means a person who makes a complaint or gives information to the Board.
3. Complaints and information of conduct of pharmacist
When a complaint is made to or information is received by the Board or any member thereof or the Registrar that a pharmacist has been convicted of any offence or has been guilty of conduct which prima facie constitutes infamous conduct in a professional respect, the Registrar shall make a preliminary examination of the case and report to the Board in accordance with regulation 6 of these Regulations.
4. Complaints to be in writing and accompanied by statutory declaration
Where a complaint is made by a person or body charging a pharmacist with infamous conduct in a professional respect, such complaint shall be formulated in writing and addressed to the Registrar, stating the grounds thereof, and shall be accompanied by one or more statutory declarations verifying the facts of the case:
Provided that if the complaint is made by or on behalf of the government such complaint need not be accompanied by statutory declarations.
5. Contents of statutory declaration
Every statutory declaration shall state the address and description of the declarant, and where any fact stated in the declaration is not within the personal knowledge of the declarant, his information and the ground of his belief of its truth must be accurately and fully stated.
6. Preliminary examination
(1) In the course of his preliminary examination the Registrar shall have power to ask the pharmacist against whom such complaint is made or in respect of whom such information is received, as the case may be, for any explanation and may cause such further investigation to be made and such further evidence to be obtained and may obtain such advice and assistance as he thinks fit:
Provided that the Registrar may in any case in which a complaint is made or information received, and shall in any case where he asks a pharmacist for such explanation as aforesaid, supply the pharmacist with copies of the complaint or summary of the information, as the case may be, and such particulars thereof as will enable the pharmacist to make answer thereto.
(2) When he has completed his preliminary examination the Registrar shall report to the Board and the Board shall determine whether or not to hold an inquiry.
7. Procedure where no prima facie case disclosed
If the Board is of the opinion that no prima facie case for inquiry is made out against the pharmacist the Board shall direct the Registrar to inform both the pharmacist and the complainant of the Board's intention not to hold an inquiry, in which case no further proceedings before the Board shall lie in respect of that complaint or information.
8. Procedure where an inquiry is directed to be held
(1) If the Board is of the opinion that a prima facie case for inquiry is disclosed, the Board shall direct that an inquiry shall be held.
(2) If the legal member shall not sit on the Board at such inquiry the Registrar shall so inform the Attorney General (hereinafter called "the Legal Adviser"), who shall advise the Board with regard to law and procedure.
(3) The Registrar shall at least three days before an inquiry, provide each member of the Board and the Legal Adviser (if appointed) with a copy of all material documents appertaining to the inquiry which have been lodged with him.
9. Parties may be represented by advocates
(1) A complainant (if any) and the pharmacist may be represented by an advocate.
(2) If there is no complainant the Board may appoint an advocate or, with the consent of the Attorney-General, a State Attorney to present the case against the pharmacist.
(3) References to either party hereinafter in these Regulations shall be deemed to include, wherever the context so admits, their respective advocates, and references to the complainant shall be deemed to include an advocate or State Attorney appointed by the Board to present the case against the pharmacist.
10. Notification of inquiry
Where an inquiry has been directed to be held notice of the inquiry in the manner set out in Form A in the Schedule hereto shall be served on the pharmacist concerned and on the complainant by the Registrar. Such notice shall specify the charge or charges in respect of which the inquiry will be held, and inform the pharmacist and the complainant of the time and place appointed for holding the inquiry.
11. Rights of parties of documents
Either party shall, for the purpose of his defence or reply as the case may be, and upon request in writing for that purpose to the Registrar, be entitled to be supplied by the Registrar on demand, with a copy of any statutory declarations, explanation, answer or other document given or sent to the Board by or on behalf of the other party.
12. Notice to admit facts
The complainant and the pharmacist may at any time prior to the date of holding the inquiry serve upon the other a notice in writing asking him to admit in writing any facts or produce any documents which are specified in such notice, material to the complaint or defence, as the case may be.
13. Summons to witnesses
(1) A summons issued by the Chairman may be either in Form B or Form C as set out in the Schedule hereto, with such variations as circumstances may require.
(2) Witness expenses shall be at the rate currently in force for witnesses in the High Court, and shall be paid–
(a) where the witness is called by and on behalf of the Board, by the Registrar;
(b) where the witness is called by or on behalf of complainant, by the complainant; and
(c) where the witness is called by or on behalf of the pharmacist, by the pharmacist.
14. Service of notice
Service of any notice or document required by these Regulations shall be deemed to be effected–
(a) if served personally on the person to be served;
(b) if sent by registered post addressed to him at his last known address; or
(c) in the case of service of any notice or document on a complainant or the pharmacist, if sent by registered post addressed to any advocate appointed by him under Regulation 9(1) of these Regulations,
and proof that such notice or document was served personally or was so addressed and posted shall be proof of service.
15. Inquiry to be public
The place where the inquiry is held shall be open to the public so far as the same can conveniently contain them:
Provided that the Board, if it thinks fit, may at any stage of the inquiry exclude the public generally or any particular person.
16. Board to be satisfied of service of notice of inquiry procedure
At the opening of the inquiry the charge or charges shall be read and, if the pharmacist concerned is not present, the Board shall satisfy itself that notice of inquiry was duly served on him as prescribed by these Regulations.
17. Procedure during case
(1) The complainant shall open the case and produce his evidence in support thereof.
(2) The Board shall then call upon the pharmacist to state his case and produce evidence in support thereof.
(3) At the conclusion of the case by the pharmacist, the complainant may address the Board in reply:
Provided that if the pharmacist has not produced evidence in support of his case, the complainant shall not, without the special leave of the Board, make an address in reply.
18. Evidence and examination of witnesses
(1) Evidence may be taken by the Board by oral or by written statement and, if oral shall be given upon oath or affirmation administered by the Chairman or, if written, shall be in the form of an affidavit or statutory declaration.
19. Board may question witnesses
Members of the Board may, through he Chairman, put such questions to the parties or witnesses as they think desirable.
20. Adjournment and deliberations by the Board
(1) At any stage of the inquiry the Board may adjourn to consider any matter arising therefrom.
(2) At the conclusion of the hearing the Board shall deliberate in camera.
(3) No person other than a member of the Board shall be entitled to be present at any meeting of the Board during an adjournment or during its deliberations under the provisions of these Regulations:
Provided that, if the legal member shall not be sitting on the Board, the Legal Adviser shall be present.
21. Records of the inquiry
Shorthand notes of the proceedings of the inquiry, other than of the deliberations of the Board which are held in camera, may be taken by a person appointed for the purpose by the Chairman and any party who appears at the proceedings shall be entitled to inspect the transcript thereof. The Registrar shall if required, supply to any person entitled to appeal under section 66 of the Act against the decision of the Board, or to his advocate, but to no other person, a copy of the transcript. If no shorthand notes are taken, the Chairman or some member of the Board authorised by him in that behalf or the Registrar, shall take a note of the proceedings, other than of the deliberations held in camera, and the provisions of this regulation as to the inspection and taking of copies shall apply to such note.
22. Finding
The decision of the Board shall be recorded by the Chairman under his own hand and shall be announced by him in public in such terms as the Board approves.
SCHEDULE
FORMS
FORM A
NOTICE TO A REGISTERED PHARMACIST OF AN INQUIRY UNDER SECTION 14 OF THE PHARMACEUTICAL AND POISONS ACT
(Regulation 10)
On behalf of the Pharmacy Board I give you notice (that information and evidence have |
|
You are requested to answer in writing the above charge or charges and to appear before the Pharmacy Board at the above named place and time to establish any denial or defence that you may have to make and you are hereby informed that if you do not attend as required the Board may proceed to hear and decide upon the said charges in your absence. |
|
Any answer, document or other communication or application which you may desire to produce or make respecting the said charge or charges, on your defence thereto, should be addressed to me and dispatched so as to reach me not later than ............................. days before the date appointed for the hearing of this matter. |
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A copy of the Pharmacy Board Inquiries Regulations is enclosed for your information. |
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....................................................... |
FORM B
FORMS OF SUMMONS TO GIVE EVIDENCE
(Regulation 13)
In the matter of A.B. a registered/temporarily registered/provisional registered 1 pharmacist |
|
and |
|
In the matter of the Pharmaceutical and Poisons Act. |
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WHEREAS your attendance is required to give evidence on behalf of ............................... |
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Given under my hand at Dar-es-Salaam this ......................... day of ......................... 20........ |
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......................................................... |
FORM C
FORM OF SUMMONS TO PRODUCE DOCUMENT
(Regulation 13)
In the matter of C.D. a registered/temporarily registered/provisionally registered 1 pharmacist. |
|
and |
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In the matter of the Pharmaceutical and Poisons Act. |
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You are required in the above matter to ........................................................................ |
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2 (a) attend and produce personally before the Pharmacy Board on the ......................... day of ......................... 20........, at .................. o'clock in the ............... noon, the under-mentioned document(s); or |
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(b) cause to be produced to the Pharmacy Board on or before the ......................... day of ......................... 20........, at ..................... o'clock in the ................... noon, the under-mentioned document(s). |
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Given under my hand at Dar-es-Salaam this ......................... day of ......................... 20........ |
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......................................................... |
(Section 19)
G.N. No. 317 of 1986
1. Citation
These Regulations may be cited as the Recruitment and the Activities of Medical Representatives Regulations.
2. Registration as medical representative
No person may be registered as a medical representative except in accordance with these Regulations.
3. Qualification for registration
Every person applying for registration as a medical representative shall have attained an education of not lower than Form Four or its equivalent and shall, in addition have a professional training in any one or more in the following fields–
(a) Pharmaceutical assistant;
(b) Medical assistant;
(c) Staff nurse registered as grade IIA;
(d) Assistant Field Officer;
(e) Dental Assistants;
(f) Veterinary Assistant, and
shall have received vocational training offered by his employer.
4. Dissemination of information by medical representative
(1) A medical representative shall not detail, or disseminate information and literature on drugs or issue free medical samples except to–
(a) drug committees in hospitals;
(b) registered–
(i) medical officers;
(ii) dental officers;
(iii) veterinary officers;
(iv) pharmacists; and
(v) medical, dental, veterinary or pharmaceutical institutions;
(c) the Registrar.
(2) Any medical representative who contravenes or fails to comply with this regulation shall be liable to suspension or his permit may be revoked.
(Section 71(1))
[1st September, 1990]
G.N. No. 363 of 1990
PART I
PRELIMINARY PROVISIONS (regs 1-2)
1. Short title
These Regulations may be cited as the Pharmaceutical and Poisons Regulations.
2. Interpretation
(1) In these Regulations, unless the context requires otherwise–
"Act" means the Pharmaceutical and Poisons Act *;
"animal" includes bird;
"drug" includes any medicine, pharmaceutical product or therapeutic substance whether in the form of active ingredient or in the form of preparation;
"food" includes drink;
"manufacturer" means a person who is engaged in the manufacture, preparation, compounding, processing, packaging or labelling of a drug or drugs at an industrial scale;
"medicine for internal treatment of ailments" includes any medicine to be administered by parenteral injection but does not include any mouth wash, eye drops or lotion, ear drops, douche, dentifrice or similar article;
"pharmaceutical product" means any drug, medicine, medicinal preparation or therapeutic substance or other articles manufactured or prepared in any way and intended for use by man as a medicine or as a remedy used for the purpose of medical, dental or veterinary treatment;
"poison" means a pharmaceutical or chemical product included in the Poisons List referred to in section 33 of the Act;
"prescription medicine" means any pharmaceutical product required to be sold by retail only upon a prescription given by a duly qualified medical practitioner, dentist or veterinary surgeon.
(2) Any reference to the percentage of a poison contained in the substance shall, unless otherwise expressly provided, be construed as a reference–
(a) in the case of a solid, that one gramme (g) of the poison is contained in every hundred grammes of the substance; and
(b) in the case of a liquid, that one millilitre (ml) of the poison or if the poison itself is a solid, one gramme of the poison is contained in every hundred millilitres of the substance,
and so on in proportion for any greater or lesser percentage.
PART II
REGISTRATION OF PHARMACEUTICAL PRODUCTS (regs 3-8)
3. Control of manufacture, sales, import and export
Except as otherwise provided in these Regulations, no person shall manufacture, sell, supply, import or export any pharmaceutical product unless–
(a) the pharmaceutical product is registered; and
(b) the person holds the appropriate licence required and issued by the Board.
4. Registration of pharmaceutical products
(1) The Board may on application made in the form specified in the First Schedule to these Regulations, register any pharmaceutical product subject to such conditions as it may impose.
(2) Every application for registration of a pharmaceutical product shall be accompanied by the registration fee prescribed by regulation 40 of these Regulations and by such documents, items, drug samples, particulars or information as the Board may require.
(3) The Board may charge any applicant such costs as it may incur for the purpose of carrying out laboratory investigation prior to the registration of any pharmaceutical product.
(4) The registration fee and such costs as may be incurred by the Board under subregulation (3) of this Regulation shall not be refundable in the event of the application being rejected under regulation 8 of these Regulations.
(5) Any change in any document, item, drug sample, particulars or information mentioned in subregulation (2) shall be notified in writing by the applicant to the Board within fourteen days from the date of such change and shall be accompanied by the alteration fee prescribed by regulation 40 of these Regulations.
(6) Subject to regulation 8 of these Regulations, the period of registration of a pharmaceutical product shall be specified in the registration certificate issued under subregulation (8) of this regulation and where so specified the registration shall be valid until the end of the specified period.
(7) Notwithstanding the provision of subregulation (6) of this regulation, the period of registration of a pharmaceutical product may be extended upon the end of the specified period for a period of one year, provided that an annual retention fee prescribed by regulation 40 of these Regulations is paid.
(8) Upon registration of a pharmaceutical product the Registrar shall grant to the applicant a registration certificate.
(9) A registration certificate granted under this regulation shall be issued in the form set out in the First Schedule to these Regulations and shall expire after a period of one year.
(10) Any person who knowingly supplies false information to the Board in connection with his application for registration of a pharmaceutical product commits an offence.
5. Register of pharmaceutical products
(1) The Registrar shall keep and maintain a register of the pharmaceutical products registered.
(2) Subject to subregulation (1) of this regulation, the register shall contain–
(a) the name under which the product is registered;
(b) the content and quantity of the active ingredient;
(c) the name and address of the manufacturer;
(d) the name and address of the product registration certificate;
(e) the registration certificate number; and
(f) the date of issue and expiry of the registration certificate if any.
6. Declaration relating to imported products
The Board may require any person applying for the registration of any imported pharmaceutical product to furnish a written declaration made by or on behalf of the manufacturer of the pharmaceutical product that all the legal requirements governing the manufacture of such product imposed by the laws of the country of manufacture have been complied with.
7. Rejection of application for registration
The Board may without giving any reason reject any application for registration of any product.
8. Suspension or cancellation
(1) The Board may at any time and without assigning any reason, suspend or cancel the registration of any pharmaceutical product and may amend the conditions to which such registration is subject.
(2) Subject to subregulation (3) of this regulation any suspension or cancellation of registration of any product under subregulation (1) of this regulation shall similarly and at the same time affect any licence issued under these regulations relating to the product.
(3) Notwithstanding subregulation (2) of this regulation where registration granted under these Regulations relates to several registered pharmaceutical products the suspension or cancellation of the registration of any product under subregulation (1) of this regulation, shall not affect the position of other registered pharmaceutical products listed in the licence.
PART III
MANUFACTURE OF REGISTERED PHARMACEUTICAL PRODUCTS (regs 9-17)
9. Application for licence to manufacture
(1) Every application for a licence to manufacture registered pharmaceutical products, made pursuant to section 22 of the Act, shall be in the form set out in the First Schedule to these Regulations and shall be accompanied by the fee prescribed by regulation 40 of these Regulations.
(2) A licence granted under this regulation shall be issued in the form set out in the First Schedule to these Regulations and shall expire on the thirty first day of December of the year in which it is issued.
(3) A licensed manufacturer shall ensure that the personnel employed at all levels of manufacture–
(a) possess suitable qualifications required for their jobs;
(b) have adequate experience and are technically competent;
(c) are regularly trained during their employment for the purposes of keeping up to date with any advances or changes; and
(d) are medically examined regularly.
10. Premises
(1) A licensed manufacturer shall ensure that registered pharmaceutical products are manufactured, processed, packed, labelled and tested in premises which are in accordance with the standards set by the Board.
(2) Subject to subregulation (1) of this regulation, a licensed manufacturer shall ensure that–
(a) adequate storage areas are provided so that all starting, rejected or returned materials or intermediate or finished registered pharmaceutical products are adequately separated;
(b) there is a sanitation programme for the maintenance of the premises and records of the premises in good sanitary conditions and records of the performance of the programme is kept at the premises; and
(c) manufacturing premises are maintained in good sanitary conditions.
11. Plant maintenance
A licensed manufacturer shall ensure–
(a) that manufacturing and testing equipments are designed, placed and maintained in such a way so as to–
(i) be suitable for the intended use;
(ii) facilitate thorough cleaning whenever necessary;
(iii) minimise the risk of confusion or omission of any manufacturing stages; and
(b) that manufacturing operations are carried out in accordance with the World Health Organisation (WHO) standards of good manufacturing practices, rules and other requirements as may be determined by the Board.
12. Quality control
(1) A licensed manufacturer shall establish a quality control department under the supervision of a suitably qualified person to control–
(a) all materials used in manufacturing process;
(b) the quality aspect of all manufacturing steps; and
(c) the quality and stability of the finished products.
(2) For the purposes of subregulation (1) of this regulation, a licensed manufacturer shall provide such facilities as may be necessary for the quality control department to discharge its duties.
13. Inspection and maintenance of records
(1) Subject to the provisions of regulations 9, 10, 11, and 12 a licensed manufacturer shall–
(a) conduct regular inspection of his manufacturing and quality control activities; and
(b) maintain proper records of every batch of finished pharmaceutical products distributed to enable the complete and rapid recall of the product if necessary.
(2) Any person who refuses or fails to comply with the provisions of this regulation commits an offence.
14. Certification
(1) The Board may certify on any matter relating to any pharmaceutical product where such certification is required by any country importing such a product.
(2) Subject to subregulation (1) of this regulation, a fee prescribed by regulation 40 of these Regulations shall be payable for the certification.
15. Drug information sheets and labelling of containers of pharmaceutical products
(1) Every pharmaceutical product manufactured locally or imported shall be accompanied with a drug information data sheet detailing the following–
(a) its active substance bearing the International Non-proprietary Name (INN);
(b) pharmacological data describing the pharmacological effects and mechanisms of action;
(c) clinical information describing–
(i) indications;
(ii) dosage regimen and relevant pharmacokinetic data;
(iii) contraindications;
(iv) precautions and warnings;
(v) adverse effects;
(vi) drug interactions;
(vii) overdosage;
(d) pharmaceutical information describing–
(i) dosage forms;
(ii) strength of dosage form;
(iii) excipients;
(iv) storage conditions and shelf-life;
(v) description of the product and package;
(vi) name and address of manufacturers.
(2) Every container of a pharmaceutical products shall be affixed with a label bearing the following information–
(a) the International Non-proprietary Name (INN) in block letters and a trade mark name in small letters in brackets, if any;
(b) strength of dosage unit;
(c) the total number of units or volume of container;
(d) storage conditions and shelf-life;
(e) name and address of manufacturer;
(f) the word "prescription medicine" or "poison" indicating character specified in regulation 16 of these Regulations shall–
(i) be printed in red letters on a contrasting background or in letters of some other colour set against a red background;
(ii) be easily legible and either on a separate label or surrounded by a line within which there are no other words.
(3) Directions for the use of any locally manufactured pharmaceutical product shall be given in English and in Kiswahili languages.
(4) Where the container of a pharmaceutical product is labelled in accordance with the provisions of the Act and of these Regulations any outer cover or wrapper to that container used only for the purpose of delivery or transport need not be similarly labelled if it complies with the provisions of regulation 36 of these Regulations.
(5) Any person who sells any pharmaceutical product not labelled in accordance with the provisions of this regulation commits an offence.
16. Indication of character of poison
(1) Any poison specified in the Second Schedule to these Regulations shall be labelled with the words and in the manner specified in the Second Schedule to these Regulations.
(2) The words specified in the Second Schedule to these Regulations shall not be modified by the addition of any other words or marks and shall–
(a) be printed in red letters on a contrasting background or in letters of some colour set against a red background.
(b) be so printed as to be easily legible on a separate label or surrounded by a line within which there are no other words.
17. Refusal to grant licence
The Board shall not grant a licence to an applicant unless the applicant complies with the requirements of provisions under regulations 9, 10, 11, 12, 13, 15 and 16.
PART IV
CUSTODY OF POISONS (regs 18-21)
18. Containers for poisons
(1) No person shall keep, sell or consign for transport any poison unless it is contained in a container impervious to the poison and sufficiently strong to prevent leakage arising from the ordinary risks of handling and transport.
(2) Any person who refuses or fails to comply with subregulation (1) of this regulation commits an offence.
19. Safe custody of poisons
(1) No person engaged in any trade, business or profession shall knowingly have in his possession or under his control any poison, other than a substance specified in the Third Schedule to these Regulations or in Group C of Part II of the Poisons List, or a medicine prescribed for his personal use unless the following conditions are complied with at all times when the poison is not in actual use, that is to say:
(a) the poison shall be kept under lock and key in a separate room or compartment specially reserved for keeping poisons, clearly marked with the words "Poisons Only" and kept in a place apart from anything containing food or drink;
(b) the poison shall be kept in a place ordinarily accessible only to persons lawfully having access to it;
(c) the key of such room, compartment, cupboard, box or other receptacle in which poisons are kept shall be retained under the control of the person in charge of the poison.
(2) Any person in possession of any receptacle which has been used for containing any poison and which is no longer required for that purpose shall, by destruction or other means, render that receptacle innocuous.
(3) Poisons for the treatment of human ailments shall be kept on a separate shelf, or in a separate room or cupboard, from any other poisons.
(4) Any person who refuses or fails to comply with any of the provisions of this regulation commits of an offence.
20. Special provisions with respect to hospitals
(1) In any hospital, infirmary, dispensary, clinic, health centre, nursing home or other similar institution at which human ailments are treated, all medicines not in actual use shall be kept under the control of the person in charge of the institution or any fit and proper person whose duties include the responsibility for the care and issue of those poisons.
(2) In such institution–
(a) at which medicines are dispensed in a dispensing or pharmaceutical department under the charge of a person appointed in that behalf, no prescription medicine shall, except in a case of emergency, be supplied from that department for use in the wards, operating theaters or other sections of the institution except upon a written order signed by a duly qualified medical or dental practitioner or nursing officer or other qualified medical or dental practitioner or nursing officer or other qualified person in charge or a ward, theater or other section of the institution, and in any case of emergency, the written order shall be supplied as soon as possible after the prescription medicine has been supplied;
(b) the person supplying the prescription medicine shall label the container with words describing its contents and indicating that the prescription medicine is to be stored in a place reserved solely for the storage of poisons in accordance with the provisions of these Regulations.
(3) The person in charge of any such institution shall, not less than once in every year, arrange, and be responsible, for the inspection of the following–
(a) all store cupboards and other places where medicines are kept in the institution;
(b) the procedure and methods by which medicines are issued, dispensed and used in the institution; and
(c) the books and any other records of any kind kept in the institution for the purpose of recording the purchase, issue and use of medicines.
(4) The person carrying out the inspection under subregulation (3) shall be a registered pharmacist or a duly qualified medical practitioner.
(5) After carrying out the inspection, the person in question shall submit copies of his report to:
(a) the person in charge of the institution, if that person has not himself carried out the inspection;
(b) the Registrar appointed under section 6 of the Act; and
(c) the governing body of the institution.
(6) Any person who refuses or fails to comply with any of the provisions of this section commits an offence.
21. Special provisions with respect to medical representatives
(1) Any person practising as a medical representative in accordance with any provisions made under section 19 of the Act, and representing a person engaged in the manufacture, sale or supply of pharmaceutical or pharmaceutical products, may have in his possession or under his control and supply free samples of pharmaceutical or pharmaceutical products for clinical trials to persons who satisfy him that they may lawfully possess those pharmaceutical subject to subregulation (2).
(2) Every medical representative shall, within twenty four hours after supplying any pharmaceutical product enter the following particulars in a book regularly used for the purpose namely:
(a) the date on which any pharmaceutical product is supplied;
(b) the name and quantity of the pharmaceutical product supplied; and
(c) the name and address of the person to whom the pharmaceutical product is supplied.
PART V
IMPORTATION OF REGISTERED PHARMACEUTICAL PRODUCTS (regs 22-26)
22. Restriction on importation of pharmaceutical product
(1) Subject to subregulation (5) no person, other than a person issued with a licence under the provisions of this regulation, may import into the United Republic any registered pharmaceutical product.
(2) The Board may issue any of the following licences subject to such conditions it may impose–
(a) a clinical trial import licence in the form set out in the First Schedule to these Regulations authorising the licensee to import any pharmaceutical product for purposes of clinical trials notwithstanding that the product is not a registered pharmaceutical product;
(b) an import licence in the form set out in the First Schedule to these Regulations authorising the licensee to import and sell or distribute by wholesale or retail, the registered products at the set of premises specified in the licence.
(3) A clinical trial import licence shall include only one product.
(4) A clinical trial import licence shall be valid for such period, not exceeding three years from the date of issue of the licence and may be specified in the licence.
(5) Every licence shall be personal to the licensee named therein and shall not be transferable to another person.
(6) Notwithstanding the provisions of this regulation, any bona fide tourist or visitor who enters the United Republic, and a person normally resident in the United Republic, who re-enters the United Republic, may bring with him into the United Republic, such quantity of any pharmaceutical product as may be required during a period of twenty-one days for the medical treatment of himself, or any member of party travelling with him.
(7) Any person who fails or refuses to comply with the provisions of this regulation commits an offence.
23. Application for licence to import pharmaceutical product
(1) Every application for a licence to import any registered pharmaceutical product made pursuant to section 30 of the Act shall be in the form set out in the First Schedule to these Regulations and shall be accompanied by the fee prescribed by regulation 40.
(2) The applicant for any import licence of any registered pharmaceutical product shall furnish such documents, particulars or information as the Board may require.
(3) Any person who knowingly supplies false or misleading information to the Board in connection with his application for any import licence of any pharmaceutical product commits an offence.
24. Refusal of application for licence
The Board may, if it thinks fit and without assigning any reason, refuse any application for a licence.
25. Exemptions
(1) Any person who wishes to import any product for the purposes of research in a school of pharmacy or a research or training institution or in order to obtain samples for purposes of registration may on application be exempted by the Board from the provisions of regulation 3.
(2) The requirement of Regulation 3 as regards a licence to supply or manufacture does not apply to dispensing of the drug, or any acts falling within the definition of "manufacture" which is necessary for dispensing of any drug for the purpose of its being used for medical treatment by the following persons and in the following circumstances–
(a) a pharmacist or a person working under the immediate personal supervision of a pharmacist in a retail pharmacy;
(b) a person acting in the course of his duties who is employed in a hospital or dispensary maintained by the Government, voluntary agency, parastatal organisation, charity approved hospitals and registered private hospitals.
(3) A school of pharmacy or any research or training institution which intends to manufacture any product for teaching and research purposes may on application be exempted by the Board from the provisions of regulation 3.
26. Directions for recall
(1) The Board may issue such directions to any persons as it thinks necessary for the better carrying out the provisions of these Regulations and which may in particular relate to the recall of any product from the market and the disposal of any product.
(2) Any person who contravenes any directions issued by the Board under subregulation (1) of this regulation commits an offence.
PART VI
EXPORTATION OF REGISTERED PHARMACEUTICAL PRODUCTS (reg 27)
27. Restrictions of exportation of registered pharmaceutical products
(1) No person, other than an authorised local manufacturer of pharmaceutical products may export any pharmaceutical product (other than a pharmaceutical product intended for the medical treatment of himself or his family which is in the possession of the exporter at the time of export) from the United Republic.
(2) Every authorised manufacturer of registered pharmaceutical products who exports any registered pharmaceutical product shall–
(a) keep a full and accurate record of all such exports; and
(b) if the pharmaceutical product is sent by post, send it by registered or parcel post.
PART VII
DISPOSITION OF REGISTERED PHARMACEUTICAL PRODUCTS (regs 28-36)
28. Registered pharmaceutical products to be dispensed only upon prescriptions
(1) Subject to the provisions of this regulation, no person may sell by retail any registered pharmaceutical product specified as a prescription medicine in the Fourth Schedule to these Regulations 1 except on and in accordance with the terms of a prescription given by a duly qualified medical practitioner, dentist or veterinary surgeon in the form provided for by subregulation (5) of this regulation.
(2) Any person who sells any such prescription medicine in contravention of the provision of this regulation commits an offence.
(3) Notwithstanding the provisions of subregulation (1) of this regulation, where an authorised seller of prescription medicine has reasonable cause to believe that a person ordering any prescription medicine in the Fourth Schedule to these Regulations 2 is a duly qualified medical practitioner, dentist or veterinary surgeon and who is by reason of some emergency unable to furnish the prescription immediately, he may, notwithstanding that no prescription has been given, if that person undertakes to furnish him with the prescription within the twenty-four hours next following, deliver the prescription medicine ordered in accordance with directions of that person.
(4) Notwithstanding subregulation (2) of this regulation, the supply of prescription medicine shall not be repeated unless the prescription has been given.
(5) Any person by whom any undertaking referred to in subregulation (3) of this regulation has been given and who fails to deliver to the seller a prescription in accordance with the undertaking and who for the purposes of obtaining delivery of any prescription medicine under subregulation (2) of this regulation makes a statement which is to his knowledge false, commits an offence.
(6) The provisions of this regulation shall not apply to any sale referred to in subsection (1) of section 40 of the Act.
(7) For the purposes of this regulation a prescription shall–
(a) be in writing, signed and dated by the person giving it with his usual signature;
(b) specify the address of the person giving it;
(c) specify the name and address of the person for whose treatment it is given, or if the prescription is given by a veterinary surgeon, of the person in-charge of the animal to which the medicine is to be administered;
(d) have written on it, if given by a dentist, the words "for dental treatment only" or, if given by a veterinary surgeon, the words "for animal treatment only";
(e) specify the total amount of the medicine to be supplied and, except in the case of a preparation which is to be used for external treatment only, the dose to be taken.
(8) The person dispensing the prescription shall comply with the following requirements:
(a) the prescription shall not be dispensed more than once unless the prescriber has directed on it either that it may be dispensed at stated intervals or a stated number of times;
(b) if the prescription contains a direction that it may be dispensed, stated number of times or at stated intervals, it shall not be dispensed otherwise than in accordance with the directions;
(c) a prescription which contains a direction that it may be dispensed at stated number of times but no direction as to the intervals at which it may be dispensed, shall not be dispensed more than once in three days, and a prescription which contains a direction that it is to be dispensed at stated intervals but no directions to the number of time that it may be dispensed, shall not be dispensed more than three times;
(d) at the time of dispensing, where a prescription medicine has been delivered in accordance with the provisions of subregulation (2) of this regulation, on the subsequent receipt of the prescription, there shall be noted on the prescription above the signature of the prescriber, the name and address of the seller and the date which the prescription was dispensed;
(e) except in the case of a prescription which may be dispensed again, the prescription shall for a period of two years be retained and kept on the premises on which it was dispensed in such manner as to be readily available for inspection.
(9) Any person who refuses or fails to comply with the provisions of subregulation (8) of this regulation commits an offence.
29. Directions to use
(1) No person shall sell any liquid poison, other than a medicine for the treatment of human ailments, in bottles unless the bottle is labelled with the words "NOT TO BE TAKEN", and also the words "SI YA KUNYWEWA".
(2) No person shall sell any embrocation, liniment, lotion, liquid antiseptic or other liquid medicine for external application which contains a poison unless the container is labelled with the name of the article and the words, in capital letters "FOR EXTERNAL USE ONLY", and the words "NI YA KUPAKA TU".
(3) No person shall sell any hydrocyanic acid or cyanide unless the container is labelled with the words "WARNING: This container holds a poison substance and should be opened and used only by persons having expert knowledge of the precautions to be taken in its use", and the words "HATARI: Kuna sumu kali sana ndani, usifungue wala kutumia kama huna maelekezo ya Mtaalam".
(4) Any person who fails to comply with any of the provisions of this regulation commits an offence.
30. Control of licensed sellers of Part II poisons
(1) Every person dealing in Part II poisons shall be conversant with the relevant provisions of the Act and these Regulations concerning the manner of handling and otherwise dealing with those poisons.
(2) Every person intending to deal with Part II Poisons shall appear before the Registrar or his assistant who shall interview him with a view of satisfying himself that the person is conversant with the relevant provisions of the Act and the Regulations as provided under subregulation (1).
(3) The relevant provisions are those relating to the labelling of containers and articles of poisons, restrictions on sales by licensed sellers of Part II poisons, regulation relating to indication of characters of poisons containers of poisons, safe custody of poisons and direction for use, and regulation relating to transportation of poisons.
(4) The Registrar or his assistant after interviewing any person intending to deal with Part II poisons, shall recommend to the Regional Commissioner whether or not that person may be issued with a licence.
(5) The Regional Commissioner shall not issue a person with a licence unless he receives a recommendation from the Registrar or his assistant showing that the person intending to deal with Part II poisons is conversant with the relevant provisions of the Act and these Regulations concerning the manner of handling and dealing with Part II poisons.
31. Premises where Part II poisons sold to be secure
(1) A person may sell Part II poisons only in premises licensed for that purpose.
(2) The premises for selling Part II poisons shall be secure enough for the safe custody of the poisons.
(3) In the case of a seller of veterinary, agricultural and horticultural poisons and certain commonly used bulk poisons, adequate secure storage space must be available.
(4) Any set of premises which does not or fails to fulfil the requirements of this regulation shall not be granted registration.
32. No further licence in area already secured
(1) No applicant for any application for a business of Part II poisons in respect of any area already adequately served by another licence holder operating in that area shall be issued with a licence.
(2) In the case of medicinal Part II poisons, no consideration shall be given to an application for a business of medicinal Part II poisons in an area already served by public outlets.
33. Licence to be revoked in case of conviction
(1) Where a person is convicted of an offence under the Act, such conviction shall entail automatic revocation of his licence and this shall be a ground for refusal to renew the licence in the following period.
(2) No licence which has been revoked in accordance with the provisions of subregulation (1) may be renewed except with the express authority of the Board.
34. Restriction on sales by licensed sellers of Part II Poisons
(1) A licensed seller of poisons in Part II of the Poisons List shall not sell–
(a) any poisons except in a closed container as closed by the manufacturer of other person from whom the poison was obtained;
(b) any poison in Group A of Part II of the Poisons List, for which a special use is indicated, or in Group B of Part II of the Poisons List, unless in addition to the normal labelling requirements, it is labelled with a notice of the special purpose for which the poison is intended, and a warning that it must only be used for that purpose;
(c) any poison in Group B of Part II of the Poison List unless the purchaser is engaged in the trade or business of agriculture and requires the poison for the purpose of that trade or business.
(2) Any person who refuses or fails to comply with the provisions of subregulation (1) of this regulation commits an offence.
35. Restriction on sales by persons licensed to deal in poisons for mining, agricultural and horticultural purposes
(1) A person licensed to deal in poisons for mining, agricultural or horticultural purposes shall not sell–
(a) any poison, except in a closed container as closed by the manufacturer or other person from whom the poison was obtained;
(b) any poison in Group A of Part II of the Poisons List for which a special purpose is indicated, or in Group B of Part II of the Poisons List unless, in addition to the normal labelling requirements the container is labelled with a notice of the special purpose for which the poison is intended, and a warning that it must only be used for that purpose;
(c) any poison in Part I of the Poisons List, unless–
(i) its proposed purchaser is a person engaged in the trade, business or profession of mining, agriculture or horticulture and requires the poison for the purposes of his trade, business or profession; and
(ii) the sale is made by one of the persons named in the application for the licence to sell the poisons;
(iii) the poison, if it is one of the substances referred to in the Sixth Schedule to these Regulations, is, in addition to any other requirements of the Act and these Regulations, labelled in the manner described in that Schedule.
(2) Any person who refuses or fails to comply with the provisions of subregulation (1) of this regulation commits an offence.
36. Transport of poisons
(1) No person may consign for transport any poison specified in the Fifth Schedule to these Regulations, 3 unless the outside of the package is labelled conspicuously with the name or description of the poison and a notice indicating that it is to be kept separate from food and from empty food containers.
(2) No person may knowingly transport any poison specified in the Fifth Schedule to these Regulations 4 in any vehicle in which food is being transported unless the food is being transported or carried in a part of the vehicle effectively separated from that containing the poison, or is otherwise adequately protected from the risk of contamination.
(3) Any person who refuses or fails to comply with any of the provisions of this regulation commits an offence.
PART VIII
POISONS RECORDS (regs 37-40)
37. The Poisons Book
(1) The Poisons Book shall be in the form set out in the First Schedule to these Regulations.
(2) In the case of any person licensed under the provisions of section 38 of the Act as a wholesale dealer in poisons or any authorised seller of poisons having wholesale section distinct and separate from any retail shop in which complete and detailed records of the receipts and disposal of all poisons are regularly maintained, the Board may in its absolute discretion and upon such conditions as it may deem fit to impose relieve that person of the necessity to record sales by way of wholesale in the Poison Book.
38. Forms
The forms to be used in pursuance of the provisions of the Act and of these Regulations shall be those specified in the First Schedule to these Regulations.
39. Preservation of books and records
All books, prescription books and other prescribed records for purposes of sections 33, 34, 35, 36, 37, 38, 39, 40, 41, 42, 43, 44, 45 and 46, of the Act shall be preserved on the premises on which the sales recorded in them were made for a period of two years from the date on which the last entry was made in each of them.
40. Fees
The fees specified in the Seventh Schedule shall be paid in connection with matters specified against them arising under the Act.
PART IX
MISCELLANEOUS (regs 41-43)
41. General penalty
(1) Any person convicted of an offence under regulation 9, 21, 26 or 27 shall be liable to a fine not exceeding shillings 7,000 and to imprisonment for a term not exceeding 2 years.
(2) Any person convicted of an offence under any of the provisions of these Regulations, other than the provisions specified in subregulation (1) of this Regulation, shall be liable to a fine not exceeding shillings 5,000 and to imprisonment for a term not exceeding six months.
42. Revocation and appeals
(1) The Board may revoke any permit, and may refuse to grant or renew any licence, issued or issuable under these Regulations.
(2) Any person aggrieved by the revocation of a permit or a licence, or the refusal to grant or renew a licence, by the Board, may subject to the provisions of section 66 of the Act appeal to the High Court.
43. Revocation
[Revokes the Pharmaceutical and Poisons Regulations, 1980* and the Control of Part II Poisons Regulations, 1986 *.]
FIRST SCHEDULE
NEW FORMS
(Regulations 4(1), 9(1), 23(1))
(1) Application for Registration of Pharmaceutical Products. |
(2) Certificate of Drug Registration. |
(3) Register of Registered Pharmaceutical Products. |
(4) Import Licence of Registered Pharmaceutical Products |
SECOND SCHEDULE
(Regulation 16)
No. 6 – Delete "mercury, organic compounds of", when contained in aerosols.
THIRD SCHEDULE
(Regulation 19)
GROUP I
Delete the following items–
"apomorphine, brucine, coca, alkaloids of, cocaine, contarnine, gelsemium, alkaloids of, jaborandi, alkaloids of, papaverine pomegranate, alkaloids of, sabadilla, alkaloids of, stavesacre, alkaloids of, the bine, veratrum, alkaloids of, mercuric (chloride, iodide, potassium iodides, nitrate organic compounds)".
GROUP II
Antihistamine substances, their salts, their molecular compounds.
Substances being tetra-substituted N-derivatives of ethylenediamine or propylenediamine.
FOURTH AND FIFTH SCHEDULES
[Omitted.]
SIXTH SCHEDULE
LICENCE TO IMPORT REGISTERED PHARMACEUTICAL PRODUCTS
Delete "arsenical poisons, mercury (its halides, organic compounds)". |
|
THE UNITED REPUBLIC OF TANZANIA THE PHARMACY BOARD OF TANZANIA |
|
LICENCE TO IMPORT REGISTERED PHARMACEUTICAL PRODUCTS |
|
M/S ................................................................................................................................ |
|
...................................................................................................................................... |
|
This licence is valid for the import of these products on one occasion only/during the year ending 31st December, 20........ |
|
Date ....................................... | ............................................................... |
SEVENTH SCHEDULE
FEES
(Regulation 40)
(1) For a certificate of registration as a pharmacist– |
|
(a) full registration (section 8) .................................................. | Shs. 1,000/= |
(b) temporary registration (section 10) ...................................... | Shs. 2,000/= |
(c) provisional registration (section 9) ....................................... | Shs. 500/= |
(2) For the restoration of name to the register (sections 7(3) and 66(4)) | Shs. 1,000/= |
(3) For the registration of premises section 24(1)) .......................... | Shs. 20,000/= |
(4) For a wholesale dealer's licence (section 38(2)) per annum .......... | Shs. 20,000/= |
(5) For a licence to deal in mining, agricultural or horticultural | Shs. 20,000/= |
(6) For a licence to sell Part II Poisons (section 43(2)) per annum ... | Shs. 10,000/= |
(7) For a licence to manufacture drugs and medicines (section | Shs. 30,000/= |
(8) For a medical representative's permit (section 19(2)), per annum | Shs. 10,000/= |
(9) For any or all of the written examinations held under section 8 of the Act ........................................................................................... | Shs. 500/= |
(10) For each of the practical examinations held under section 8 of the Act ........................................................................................... | Shs. 1,000/= |
(11) For registration of pharmaceutical product (section 25(2))– | |
(a) foreign company ............................................................... | US$500 |
(b) local ................................................................................ | T.Shs. 20,000/= |
(12) For retention of a registered pharmaceutical product on the register (section 25(2))– | |
(a) foreign .............................................................................. | US$100 |
(b) local ................................................................................. | T.Shs. 2,000/= |
(13) For alteration of document in relation to registration of pharmaceutical product (section 25(2))– | |
(a) foreign .............................................................................. | US$10 |
(b) local ................................................................................. | T.Shs. 1,000/= |
(14) For export certification of locally manufactured pharmaceutical products (section 71)) ...................................................................... | Shs. 5,000/= |
(15) For import licence of | |
(a) drug sample for clinical trial................................................ | US$200 |
(b) registered pharmaceutical product per import licence | 2% of the value of the licence |
{/mprestriction}