S. R. O. 1118 (I)/82, dated 7th November, 1982: The following draft of the Drugs (Labelling and Packing) Rules, 1982, which it is proposed to make in exercise of the power conferred by Section 43 of the Drugs Act, 1976 (XXXI of 1976), is published, as required by sub-section (3) of the said section, for the information of all persons likely to be affected thereby and notice is hereby given that the draft will be taken into consideration after thirty days of its publication in the official Gazette.
1. Short title and commencement (1) These rules may be called the Drugs (Labelling and Packing) Rules,.1982.
(2) They shall come into force on such date as the Federal Government may, by notification in the official Gazette, appoint.
2. Definitions: in these rules. unless there is anything repugnant in the subject or context :-
(a) “Act” means the Drugs Act, 1976 (XXXI of 1976);
(b) “international non-proprietary name” means the name of a drug as recommended by the World Health Organization or such other name as may be notified by the Federal Government in the official Gazette;
(c) “pharmacopoeia” means a publication mentioned in sub-clause (ii) of clause (z) of Section 3;
(d) “pharmacopoeiel name” means the name of a drug as mentioned in any pharmacopoeia;
(e) schedule” means a schedule to these rules;
(f) section” means a section of the Act; and
(g) “registered medical practitioner” means a medical practitioner registered or provisionally registered under the Medical and Dental Council Ordinance, 1962 (XXXI of’1962).
3. Manner of Labelling: The following particulars shall appear either in print or in writing in indelible ink in a conspicuous manner on the label of the innermost container of a drug and also on the covering in which container is packed, namely :-
(a) The registered name of the drug;
(b) if the registered name is a proprietary name, then immediately following the registered name, the international non-proprietary name, end if no such non-proprietary name is known, the pharmacopoeial name or any other name, if any, approved by the Registration Board for this purpose, in letters of the same size as that of the registered name;
(c) the international non-proprietary name or the pharmacopoeial name or the generic name, and if no such name is known, the chemical name, of each active ingredient of the drug with weight or measure in international system, or the number of units of activity, as the case may be, expressed :–
(i) in the case of oral liquid preparations, in the terms of contents per specified volume, the volume being indicated in milliliter;
(ii) in the case of liquid parenteral preparations ready for administration, in terms of milliliter or percentage by volume or dose:
Provided that in the case of a preparation contained in ampoule, it should be sufficient if the ingredients are shown on the label or wrapper affixed to any package in which such ampoule is issued for sale;
(iii) in the case of drudge in solid form intended for parenteral administration, in terms of weight or unitage, per milligram or gram or per container;
(iv) in the case of tablets, capsules, pills and the like, in terms of the contents per tablet, capsule, pill or other unit, as the case may be; and
(v) in the case of other preparations, in terms of percentage by weight or volume or unitage, per gram or milliliter, as the case may be:
Provided that this clause shall not apply to a pharmacopoeial preparation where the composition of such preparation is specified in the pharmacopoeia concerned;
(d) the name and principal place of business of the manufacturer;
(e) the drug manufacturing licence number;
(f) the drug registration number; and
(g) the distinctive batch number, date Of manufacture, date of expiry and the retail price:
(h) Provided that in the case of a drug packed in a strip of paper or foil or contained in an ampoule of a capacity of not more than three milliliters or in an ampoule containing a sterile suture or ligature, and such strip. foil or ampoule is placed in another package, and also in the cape of printed collapsible tubes, it shall be sufficient to give the information on the outer package containing such strip, foil, ampoule or tube:
Provided that in case of an imported drug, the Registration Board may allow relaxation of any of these conditions.
4. Labelling of drugs for internal use: The label of a container of a drug meant for internal use except a drug contained in a strip or foil or collapsible tube, shall, in addition to the particulars required to be given under rule 3 bear :–
(i) if it contains a substance specified in Schedule A, the words “To be sold on prescription only”; and
(ii) if it contains not less than three per cent by volume of alcohol, e statement giving the quantity of alcohol in terms of average percentage by volume of absolute alcohol in the finished product,
5. Labelling of drugs for external use only: The label of a container of liniment, lotion, liquid, anti-septic or any other drug for external application shall in addition to the particulars required to be given under rule 3, been :–
(i) the words “For external use only”; and
(ii) if the drug contains a substance specified in Schedule A, the words “Poison; for external use only”.
6. Labelling of physician’s samples: The label of a container of every drug intended for distribution in the medical profession as free sample shall, in addition to the particulars required to be given under these rules, bear the words “Physician’s sample: Not for sale” which shall be overprinted or stamped:
Provided that if the drug is packed in a strip of paper or foil or contained in an ampoule of a capacity of not more than three milliliters or in a collapsible tube, it shall be sufficient to label the outer packing only with the said words.
7. Labelling of drugs of Government supply: The label of a container of every drug intended for the supply to any Government agency shall, while complying with the other labelling requirements of these rules, bear the words or mark reading “Government Supply”, or such other words or mark as are required by the agency concerned.
8. Labelling of drugs for veterinary use: The label of a container of drug for veterinary use shall bear the words “For veterinary use only”.
9. Outer transparent wrapper not to require labelling: Nothing in these rules shall be deemed to require the labelling of any transparent cover, wrapper, case or other covering used solely for the purpose of packing, transport or delivery of a drug.
10. Labelling of non-sterile surgical ligature and suture: Every container of, and every wrapper enclosing, a surgical ligature or suture, other than a ligature or suture certified to be sterile and fit for surgical use without further sterilisation, shall bear a label on which shall be printed or written in a conspicuous manner in indelible red ink the words “Non-sterile surgical ligature/suture: Not to be used for operations upon human body unless fully sterilized”
11. Use of letters to indicate specifications: Subject to these rules, the letters “P. P.’,, “Ph. I”, “Eur. P”, “U.S. P.”, “B. P.”, “B. P. C.”, “U.S. N. F.”, shall be printed or written in indelible ink on the label to indicate that the drug is manufactured in accordance with the specifications set out in the Pakistan Pharmacopoeia, International Pharmacopoeia, European Pharmacopoeia, United States Pharmacopoeia, British Pharmacopoeia, British Pharmaceutical Codex or the United States National Formulary, as the case may be.
12. Packing of finished drugs: Each finished drug ready for use shall be packed in containers intended for retail sale or for sale to a hospital, dispensary, clinic or any other such institution.
13. Marking of each tablet or bottle cap: Each uncoated tablet with an average weight of more than one hundred milligrams, and the cap of each bottle containing any drug shall bear a mark of identification of the manufacturer or the product.
14. Exemptions: These rules shall not be applicable in respect of a drug–
(a) manufactured or imported before the coming into force of these rules;
(b) manufactured for export the label on the package or container of which is adopted to meet the specific requirements of the law of the country to which the drug is to be exported and bears the following particulars at a conspicuous place on the innermost container in which the drug is packed and on every other covering in which that container is packed, namely :–
(j) he name of the drug;
(ii) the name and principal place of business of the manufacturer; and
(iii) batch number of the drug, date of manufacture and, where applicable, the date of expiry:
Provided that in the case of a drug packed in strips of paper or foils or contained in ampoules of a capacity of not more than three milliliters or in printed collapsible tubes, it shall be sufficient if these particulars are given on the outer packing containing such strips, foils, ampoules or tubes; and
(c) made up ready for treatment, whether after or without dilution, and is supplied by a person licensed to sell drugs on the prescription of a private registered medical practitioner or a registered medical practitioner serving in a hospital, dispensary, clinic or such other institution:
Provided that the label bears the. following particulars, namely:
(i) the name and address of the supplier of the drug;
(ii the name of the patient;
(iii the number representing the serial number of the entries in the prescription registers;
(iv) if the drug is for internal use, the dose;
(v) if the drug is for external use and does no! contain a substance specified in Schedule A, the words “For external use only”; and
(vi) if the drug is for external use and contains a substance specified in Schedule A, the words “Poison: For external use.
TO BE SOLD BY A RETAILER ON THE PRESCRIPTION OF REGISTERED MEDICAL PRACTITIONER
1. Anti-coagaulants and Co-agulants.
3. Antiparkisenism Drugs.
4. Chemotherapeutic Drugs for Neo plastic diseases,
5. Chemotherapeutic agents for the treatment of microbial diseases excluding subphadiazine and non-antibiotic anti T. B. drugs.
6. C.N.S. Stimulants.
7. Drags affecting uterine motility,
8. Drugs inhibiting hormonal production.
9. Hormones and other steroidal preparation excluding preparations for external and topical use.
10. Narcotic dregs as per convention on Narcotic Drugs, 1961.
11. Psychotropic substances mentioned as per Convention on Psychotropic Substances, 1971.