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The Drugs
[Labelling and Packing]
Rules, 1978
S. R. O. 1197 (I)/78, dated 5th
October, 1978: The following draft of the Drugs (Labelling and Packing) Rules, 1978,
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.
Any objection or Suggestion which may be received from any person in respect of the said
draft before the .expiry of the said period will be considered by the Federal Government.
1. Shot1: title and commencement: (1) These rules may be called the Drugs
(Labelling and Packing) Rules, 1978.
(2) They shall come into force on the 1st July, 1979.
2. Definition: In these Rules, unless there is anything repugnant in the subject or
context,--
(a) "Act" means the Drugs Act, 1976 (XXXI of 1976);
(b) "Schedule" means a Schedule to these rules; and
(c) "Registered Medical Practitioner" means a Medical Practitioner registered or
provisionally registered under the Pakistan Medical end Dental Council Ordinance (XXXI of
1962).
3. Manner of labelling: (1) Subject to the other provisions of these rules, 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 every
other covering in which the container is packed, namely :-
(i) The registered name of the drug ; if the registered name is a brand name, the
international non-proprietary name as recommended by the World Health Organization; also
in an equally conspicuous manner and if no such non-proprietary name is known, the name,
if available, in bold letters in any of the Pharmacopoeia's or other documents specified
under sub-sec. (2) of Section 3 of the Act, or any other name as may be approved by the
Registration Board for this purpose, to be written in indelible ink of any contrasting
colour in letters of equal size as that of the registered name and following immediately
after or under such brand name.
(ii) A correct statement of the contents of active ingredients given under their
international non-proprietary, pharmacopoeial or generic name and if so such name is
known, the chemical name in terms of weight or measure expressed in international System,
or the number of unit of activity, .as the case may be expressed,-
(a) in the case of oral liquid preparations, in terms of the content per single dose, the
dose being indicated in millilitres:
Provided that in the case of oral drops for infants, the contents may be expressed in
terms of millilitres irrespective of its single dose:
(b) in the case of liquid parental preparations ready for administration in term of
millilitre or percentage by volume or dose;
Provided that if the preparation is contained in ampoule, it shall be enough if the
composition is shown on the label or wrapper affixed to any package in which such ampoule
is issued for sale;
(c) in the case of drugs in solid form intended for parenteral administration, in terms of
units or weight per millgram or gram or per container;
(d) in the case of tablets, capsules, pills and the like, in term of the contents in each
tablet, capsule, pill or other units, as the case be; and
[(e) in the case of other preparations, in terms of percentage by weight or volume or in
terms of unitage per gram or milli-meter, 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 respective pharmacopoeia.
(iii) The name and principal place of business of the manufacturer.
(iv) The drug manufacturing licence number and, in the case of an imported drug,
the reference number of the permission under which the drug has been allowed to be
manufactured by the competent authority of the country of export.
(v) The drug registration number.
(vi) The distinctive batch number, the date of manufacture the date of expiry and
the retail price:
Provided that if the drug is packed in a strip of paper or foil or an ampoule of capacity
of not more than three millilitres which is placed in another package, it shall be
sufficient to give the information on the outer packing:
Provided further that in the case of printed collapsible tubes, it shall be sufficient to
give the date of manufacture, date of expiry, batch number and the retail price on the
outer packing containing the tube.
4. Labelling of drugs included in Schedules: (1) The container of a drug which is
not made up ready for treatment shall, if the drug contains a substance specified in
Schedule A, be labelled with the word "Poison"
(2) Subject to the provisions of these rules, the container of a drug meant for internal
human use shall,--
(a) if it contain a substance specified in Schedule 'A' and not in Schedule 'B', be
labelled with the word "Poison";
(b) if it contain a substance specified in Schedule 'B', be labelled with the word
"caution". It is dangerous to take this preparation except under medical
supervision";
(c) if it contains a substance specified in column I of Schedule A in a strength below
that specified in column 2 thereof, be labelled with the words "Caution: It is
dangerous to exceed the stated dose";
(d) if it contains a substance specified in Schedule C, be labelled with the words:
"Warning: To be sold by a retailer on the prescription of a registered medical
Practitioner only"; and
(e) if it contains not less than 3 per cent. by volume of alcohol, include a statement of
the quantity of the alcohol in terms of average percentage by volume of absolute alcohol
in the finished product.
(3) The word with which a container of a drug is required to be labelled under sub-rules
(1) and (2) shall,--
(a) if the drug contains a substance specified in Schedule A, either be in red lettering
or be set against a red background, and
(b) in all other cases, be on a separate label or be surrounded by a line within which
there shall be no words except the words with which the container is required to be
labelled under these rules.
5. Labelling of drugs for external use only: (1) The container of liniment, lotion,
liquid, antiseptic or any other liquid drug for external application shall be labelled
with the words "For external use only".
(2) If the drug referred to in sub-rule (1) contains a substance specified in Schedule A,
the container shall be labelled with the words "Poison: For external use only".
6. Labelling of physician's samples: Every drug intended for distribution to the
medical profession as a free sample shall, while complying with the other labelling
provisions under these rules, further bear on the label of the container the words
"Physician's Sample--NOT FOR SALE" which shall be overprinted.
7. Labelling of drugs for Government supply: Every drug intended for supply to any
Government agency shall bear a label or mark reading "Government Supply" or such
other words or marks as is required by the agency concerned.
8. Labailing of drugs for veterinary use: The container of a drug for veterinary
use shall be labelled conspicuously with the words "For veterinary use only".
9. Outer 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.
10. Labelling of non-sterile surgical ligature and suture: Every container of, and
wrapper enclosing, 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 indeliable operated ink
the words "Non-sterile surgical ligature/suture--not to be used for operations upon
human body unless efficiently sterilized".
11. Use of letter P. P., Ph. I., Eur. P., U.S. P., B. P., B. P. C., U.S.N.F., etc.:
The letters "P. P.", "Ph. I;", "Eur. P.", "U.S.
P.", "B.P.", "B.P.C.", "'U.S.N.F.", etc. shall be
entered on the label of drug only for the purposes of indicating that the drug is in
accordance with the specifications set out in the Pakistan Pharmacopoeia, International
Pharmacopoeia, Europeon Pharmacopoeia, United States Pharmacopoeia, British Pharmacopoeia,
British Pharmaceutical Codex, or United States National Formulary, as the case may be.
12. Packing of finished drugs: A 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 over 100 mg. and the cap of a bottle containing a drug shall bear a mark of
identification of the manufacture and the product,
14. Exemptions: These rules shall not apply to drugs,--
(a) 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 the following particulars appear in a conspicuous position on the innermost
container in which the drug is packed and every other covering in which that container is
packed, namely:--
(i) the 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 the date of expiry,
wherever applicable:
Provided that if a drug is packed in a strip of paper or foil or in ampoule of capacity
not more than 3 millilitres it shall be sufficient if the information is given on the
outer packing containing such strips:
Provided further that in the case of printed collapsible tubes, it shall be sufficient to
give the batch number, date of manufacture and the date of expiry, wherever applicable on
the outer packing containing such tubes; or
(b) made up ready for treatment. whether after or without dilution, and are supplied on
the prescription of a registered medical practitioner by a person licensed to sell drugs
or from a. hospital dispensary or such other institution as a clinic of a registered
medical practitioner:
Provided that the drug is labelled with the following particulars, namely :--
(a) the name end address of the supplier;
(b) the name of the patient;
(c) the number representing the serial number of the entry in the prescription register;
(d) the dose, if the drug is for internal use; and
(e) if the medicine is for external use, the words "FOR EXTERNAl. USE ONLY",
and if the drug is for external use and contains a substance specified in Schedule A, the
words "POISON" and "FOR EXTERNAL USE ONLY" in the manner prescribed in
Rule 4.
