The Drugs (Labeling and Packing) Rules, 1986

The Drug Rules (Labeling and Packaging), 1986

1. Short title and beginning:
(1) These rules may be called Drug Rules (labeling and packaging). 1986
2. They will enter into force when the one-year period expires from their publication in the Official Gazette.
3. Definitions: - In these rules, unless there is something disgusting in the subject or context;
(a) Non-patented international name means the name of the medication as recommended by the World Health Organization or any other name that may be notified by the federal Government in the official bulletin; (b) Pharmacopoeia means a publication mentioned in subsection (ii) of clause (2) of section (3) of the 1976 Drug Act (XXXI of 1976).
(c) Pharmacopoeia name "means the name of a drug as mentioned in the pharmacopoeia."
(d) "Program" means a program of these rules;
(e) “Registered medical practitioners” are medical practitioner registered or provincially registered under the Medical and Dental Council Ordinance of 1962 (XXXII of 1962).

(3) Form of labeling: The following data must appear printed or written in inedible ink in a visible way on the label of the innermost container of the medicine and also in which said container is packaged, namely:

(a) The registered name of the drug;
(b) If the registered name is a proprietary name, immediately after the registered name, the international non-proprietary name, and if said non-proprietary name is not known, the pharmacopoeial name or any other name, if any, approved by the board of registration for this purpose in a visible way;
(c) The non-patented international name of the pharmacopoeic name of the generic name, and if that name is not known, the chemical name of each active ingredient of a drug with weight. Added by SRC 1122 (i) 86 dated 23‐19‐1986 Manual of Drug Laws or measures in the metric system, or the number of activity units as the cause can be, expressed: -

(i) In the case of oral liquid preparations in terms of content by specified volume, the volume is indicated in the armed forces;
(ii) In the case of liquid parenteral preparations ready for administration in terms of armies or percentage by volume or dose. Provided that in the case of a preparation contained in a vial, it is sufficient if the ingredients are shown on the label or packaging attached to any package in which said vial is issued for sale.
(iii) In the case of drugs in solid form intended for parenteral administration in terms of weight or unit per milligram or gram or per container.
(iv) In the case of tablets, capsules, pills or other units, as the case may be; Y
(v) In the case of other preparations in terms of percentage by weight or volume or unit per gram or milliliter, as the case may be;

(d) Name and principal place of business of the manufacturer
(e) The drug manufacturing license number.
(f) The medication registration number.
(g) The expiration date.
(h) Urdu version of the following namely;
(i) Name of the medication
(ii) dosage; Y
(iii) instructions;
(i) The date of manufacture of the distinctive lot number and the maximum retail price;

Provided that in the case of a medicine packaged in a strip of paper or blister or aluminum foil or contained in a blister with a capacity of not more than two milliliters or in a blister containing a sterile suture or ligation and said blister or foil Aluminum be placed in another package and also in the case of printed folding tubes, it will be sufficient to provide the information on the outer packaging containing such strips, sheets, blisters or ampules. As long as the registration board can allow the relaxation of any of these conditions.

4. Labeling of medicines for internal use: -
The label on the packaging of a medicinal product intended for internal use, except a medicinal product contained in a strip or foil or blister or folding tube, in addition to the details required under rule 3, must be visibly worn.

(i) If it contains a substance specified in the schedule; "will be sold by prescription from a registered doctor only" must write on pack and;
(ii) If it contains not less than three percent by volume and alcohol, a statement indicating the amount of alcohol in terms of average percentage by volume of absolute alcohol in the finished product.
5. Labeling of drugs for external use only: ‐The label of a container of ointment, cream,liniment, lotion, antiseptic or any medication for external application must, in addition to the particular thing that must be given under rule 3, carry In a visible place conduct: -

(i) The words "For external use only" and;
6. Labeling of the doctor's sample: -
The label of a container of each medicine intended to be distributed to the medical profession as a free sample must, in addition to the details required under these rules, bear the words "Sample of a doctor that is not for sale", which will be printed or stamped in excess. Provided that if the medicine is packaged in a strip of paper or blister or aluminum foil or contained in a blister with a capacity of no more than three milliliters or in a folding tube, it will be to label the outer packaging only with those words.

7. Labeling of medicines for government supply: -
The label of a container of each medicine intended for supply to any government agency, including an autonomous agency or a semi-governmental agency, must do so. When complying with the other labeling requirements of these rules, carry the words or mark that says "Government supply" or any other word or mark that may be required by the agency in question.

8. Labeling of medicinal products for veterinary use: -
The label of a medicine container for veterinary use should visibly bear the words "For veterinary use only"

9. Transparent outer wrap that does not require labeling:-
Nothing in these rules should be deemed to require the labeling of any;
transport cover, wrapper, case or other cover used solely for the purpose of packing, transporting or delivering a medication.

10. Labeling of non-sterile surgical ligation and suture: -
Each container and each wrapper that contains a surgical ligation or suture, other than a certified ligation or suture to be sterile and suitable for surgical use without further sterilization, must carry a label or that will be printed or written in an indelible way in an ink red the word "Non-sterile surgical ligation / suture, should not be used for operations on the human body unless properly sterilized."

11. Use of letters to indicate specifications: -
Subject to these rules, the letters "P. P", "Ph. I", "Eur. P", "B. P", "B.P.C" and "U.S.N.F". must be printed or written with indelible ink on the label to indicate that the drug is manufactured in accordance with the specifications established in the Pakistan Pharmacopoeia, the International Pharmacopoeia, the European Pharmacopoeia, the United States Pharmacopoeia, the British Pharmacopoeia, Codex British Pharmaceutical Products or the United States National Form, as the case may be.

12. Packaging of finished medicines: - Each ready-to-use finished medicine will be packaged in containers intended for retail sale to a hospital, clinic or any other similar institution.

13. Labeling of medicines manufactured for export: -
The indications contained in rules 3 to 12 shall apply to a medicine manufactured for export, the label on the package or container that has been adopted to meet the specific requirements of the country to which the medicine is exported. The label on the package or container of said medicine must carry the following data in a visible place in the innermost container in which it is packaged, namely:

(i) The name of the drug
(ii) Name and principal place of business of the manufacturer and;
iii) Lot number of the date of manufacture of the medicine and the expiration date. Provided that in the case of a medicine packaged in strips of paper or foil or blister or contained in ampules of a capacity of no more than two milliliters or in printed folding tubes, except for the expiration date, it will be sufficient if these Data are given on the outer packaging that contains such strips, sheets, blisters, blisters or tubes.

14. Exemption: -

These rules should not apply with respect to a drug prepared for treatment, either after or without dilution and is supplied by a person authorized to sell prescription drugs to a registered doctor.
Provided the label contains the following data:
(i) The name and address of the drug providers;
(ii) The patient's name;
(iii) The number that represents the serial number of the entries in the recipe register.
(iv) If the medicine is for internal use, the dose
(v) If the medicine is for external use and does not contain a substance specified in the schedule, the words "For external use only" and;
(vi) If the medication is for external use and contains a substance specified in the schedule, the words "Poison for external use only" THE PROGRAM THAT A RETAILER WILL SELL IN THE PRESCRIPTION OF REGISTERED MEDICAL PRACTICANTS.

1. C.N.C. stimulants
2. Drugs that affect uterine motility.
3. Drugs that inhibit hormonal production.
4. Hormones and other steroidal preparations,