The Drugs’ Act, 1940
Act
No. XXIII of 1940
(For Statement of Objects and
Reasons, see Gazette of India, 1940, Pt. V, p. 34; for Report of Select
Committee, see ibid., p. 143.
This Act has been applied to,---
(i) Baluchistan, see Notification
No. 168‑N,
dated the 17th October, 1940, Gazette of India
(ii) Phulera in the Excluded Area of
Upper Tanawal to the extent the Act is applicable in the N.‑W.F.P.,
and extended to the Excluded Area of Upper Tanawal (N.‑W.F.P.)
other than Phulera with effect from such date and subject to such modifications
as may be notified, see N.‑W.F.P. (Upper Tanawal) (Excluded
Area) Laws Regulation, 1950.
It has been extended to,---
(i) the Leased Areas of Baluchistan by the Leased Areas (Laws) Order, 1950 (G. G.
O. 3 of 1950);
(ii) the Baluchistan States Union by
the Baluchistan States Union (Federal Laws) (Extension) Order, 1953 (G. G. O. 4
of 1953), as amended;
(iii) the State of Bahawalpur by the
Bahawalpur (Extension of Federal Laws) Order,
1953 (G. G. O. 11 of 1953), as amended; and
(iv) the whole of West
Pakistan by West Pakistan Act 14 of 1958 (with effect from the
26th December, 1957).
The Act has been and shall be deemed
to have been brought into force in Gwadur with effect from the 8th September,
1958, by the Gwadur (Application of Central Laws) Ordinance, 1960 (37 of 1960),
s. 2.)
[10th April, 1940]
An Act to regulate the import,
export, manufacture, distribution and sale of drugs
(Ins. by the Drugs (Arndt.) Act,
1963 (22 of 1963), ss. 2 and 3.)
WHEREAS it is expedient to regulate
the import into, (Ins. by the Drugs (Arndt.) Act, 1963 (22 of 1963), ss. 2 and
3.)[export from,] and the manufacture, distribution and sale in, (Subs. by the
Central Laws (Statute Reform) Ordinance, 1960 (21 of 1960), s. 3 and 2nd Sch.
(with effect from the 14th October, 1955), for "the Provinces and the
Capital of the Federation" which had been subs. by A. O., 1949. for
"British India".) [Pakistan
AND WHEREAS the Legislatures of all
the Provinces have passed resolutions in terms of section 103 of the Government
of India Act, 1935, in relation to such of the above‑mentioned
matters and matters ancillary thereto as are enumerated in List II of the
Seventh Schedule to the said Act, 26 Geo. 5, c. 2;
It is hereby enacted as follows:-
CHAPTER I
INTRODUCTORY
1.
Short title, extent and commencement. (1) This Act may be called the
Drugs’ Act, 1940.
(Subs. by the Central Laws (Statute
Reform) Ordinance, 1960 (21 of 1960), s. 3 and 2nd Sch. (with effect from the
14th October, 1955), for the original sub‑section (2), as amended by A. O.,
1949.)[(2) It extends to the whole of Pakistan
(3) It shall come into force at
once; but effect only from such date(The 1st April 1947, as the date from which
Chapter III shall take effect, see Gazette of India, 1946, Pt. I, p. 1349.) as
the Central notification in the official Gazette, appoint in this Chapter IV
shall take effect in a particular Province such date as the Provincial
Government may, by like appoint(The 1st September, 1954, as the date on which
Chapter IV shall take in Baluchistan, see Gaz. of P., 1954, Pt. 1, p. 215.) in
this behalf.
2.
Application of other laws not barred. The provisions of this Act shall
be in addition to, and not in derogation of, the Dangerous Drugs Act, 1930, and
any law for the time being in force, II of 1930.
3.
Definitions. In this Act, unless there is
anything repugnant in the subject or context,‑
(a) "the Board" means the
Drugs Technical Advisory Board constituted under section 5 ;
(Subs. by the Drugs (Amdt.) Act,
1963 (22 of 1963), s. 4, for the original cl. (b).) [(b) “drug" includes,---
(i) all medicines for internal or
external use of human beings or animals, and all substances intended to be used
for or in the treatment, mitigation or prevention of diseases in human beings or
animals, not being medicines and substances exclusively used or prepared for
use in accordance with the ayurvedic, unani, homoeopathic or biochemic system
of medicine,
(ii) diagnostic, abortive and
contraceptive substances, surgical ligatures, sutures, bandages, absorbent
cotton, bacteriophages, adhesive plaster, gelatine capsules and antiseptic
solutions,
(iii) such substances (other than
food) intended to affect the structure or any function of the human body or
intended to be used for the destruction of vermins or insects which cause
disease in human beings or animals,
(iv) any substance, mentioned as
monograph in any of the editions of the British Pharmacopoeia or the British
Pharmaceutical Codex or the United States Pharmacopoeia or the National Formulary
of the United States or the International Pharmacopoeia, whether alone or in
combination with any substance exclusively used in the unani, ayurvedic,
homoeopathic or biochemic system of medicine and intended to be used for any of
the purposes mentioned in sub‑clauses (i), (ii) and (iii), and
(v) any other substance which the
Central Government may, by notification in the official Gazette, declare to be
a "drug" for the purposes of this Act ;]
(Cls. (ba), (bb) and (bc), ins. by
the Drugs (Amdt.) Act, 1963 (22 of 1963), s. 4.)[(ba) "to export"
means to take out of Pakistan
(bb) "licensing authority"
means such authority as may be prescribed;
(bc) 'manufacture,' in relation to
any drug includes any process or part or stage of process for making, altering,
ornamenting, finishing, packing, labelling, breaking up or otherwise treating
or adopting any drug with a view to its sale and distribution, but does not
include the compounding and dispensing or the packing of any drug in the ordinary
course of retail business or on a prescription of a registered medical
practitioner or dentist or of a veterinarian, and to manufacture' shall be
construed accordingly ;]
(c) "to import", with its
grammatical variations and cognate expressions, means to bring into (Subs. by
the Central Laws (Statute Reform) Ordinance, 1960 (21 of 1960), s. 3 and 2nd
Sch. (with effect from the 14th October, 1955), for "the Provinces and the
Capital of the Federation" which bad been subs. by A. O., 1949, for ''British India ".) [Pakistan
(d) "patent or proprietary
medicine" means a drug which is a remedy or prescription prepared for
internal or external use of human beings or animals, and which is not for the
time being recognised by the Permanent Commission on Biological Standardisation
of the (Subs. by Act 22 of 1963, s. 4, for "League of Nations".)
[World Health Organisation] or in the latest edition of the British
Pharmacopoeia or the British Pharmaceutical Codex or any other pharmacopoeia
authorised in this behalf by the Central Government after consultation with the
Board:
(e) "prescribed" means
prescribed by rules made under Chapter II or Chapter III (Ins. by the Drugs
(Amdt.) Act, 1963 (22 of 1963), s. 4.)[or Chapter IIIA] by the Central
Government, or under Chapter IV by the Provincial Government.
4.
Presumption as to poisonous substances. Any substance specified as
poisonous by rule made under Chapter III or Chapter IV shall be deemed to be a
poisonous substance for the purposes of Chapter III or Chapter IV, as the case
may be.
5.
The Drugs Technical Advisory Board. (1) The Central Government shall,
as soon as may be, constitute a Board (to be called the Drugs Technical
Advisory Board) to advise the Central Government (The words "and the
Provincial Governments" omitted by A. O., 1964, Art. 2 and Sch.)* * * on
technical matters arising out of the administration of this Act and to carry
out the other functions assigned to it by this Act.
(Subs. by Act, (22 of 1963), s. 5,
for the original sub‑section (2), as amended by A. O.,
1949 and the Federal Laws (Revision and Declaration) Act. 1951 (26 of 1951), s.
4 and 3rd Sch.) [(2) The Board shall consist of the following members, namely:
(i) The Director General, Health, ex‑officio,
who shall be Chairman;
(ii) The Director of the Central
Government Bureau of Laboratories, Pakistan
(iii) The Director, Central Drugs
Laboratory, ex-officio;
(iv) The Head of the Pakistan Animal
Husbandry Research Institute, ex-officio;
(v) One person directly connected
with the administration of this Act to be nominated by the Central Government;
(vi) Two persons directly connected
with the administration of this Act, one to be nominated by each Provincial
Government;
(vii) Two persons holding the
appointment of Government Analyst under this Act, one to be nominated by each
Provincial Government;
(viii) One person to be nominated by
the Central Government from amongst the professors of medicine serving in the
medical colleges affiliated to universities in Pakistan
(ix) One person to be nominated by
the Central Government from amongst the pharmaceutical chemists recommended by
the universities in Pakistan
(x) One person to be elected by the
Medical Council of Pakistan from amongst the professors of medicine serving in
the medical colleges affiliated to universities in Pakistan
(xi) One person belonging to
pharmaceutical profession to be nominated by the Central Government; and
(xii) One person to be elected by
the Central Council of the Pakistan Medical Association:
Provided that the members shall be
so elected or nominated as to secure, as far as practicable, equality in the
number of members belonging to each Province.
(2a) The meetings of the Board shall
be held alternatively in East Pakistan and West Pakistan .]
(3) The nominated and elected
members of the Board shall hold office for three years, but shall be eligible
for re‑nomination
and re‑election.
(4) The Board may, subject to the
previous approval of the Central Government, make (For the Drugs Technical
Advisory Board By‑Laws, 1963, see Gaz, of P., 1963,
Pt. 1, pp. 469‑471.) by-laws fixing a quorum and
regulating its own procedure and the conduct of all business to be transacted
by it.
(5) The Board may constitute
sub-committees and may appoint to such sub-committees for such periods, not
exceeding three years, as it may decide, or temporarily for the consideration
of particular matters, persons who are not members of the Board.
(6) The functions of the Board may
be exercised notwithstanding any vacancy therein.
(7) The Central Government shall
appoint a person to be Secretary of the Board and shall provide the Board with
such clerical and other staff as the Central Government considers necessary.
6.
The Central Drugs Laboratory. (1) The Central Government shall,
as soon as may be, establish a Central Drugs Laboratory under the control of a
Director to be appointed by the Central Government, to carry out the functions
entrusted to it by this Act or any rules made under this Chapter:---
Provided that, if the Central
Government so prescribes, the functions of the Central Drugs Laboratory in
respect of any drug or class of drugs shall be carried out at (Subs. by A. O.,
1949, for "the Central Research Institute, Kasauli, or at any
other".) [any (The word "prescribed" omitted by the Federal Laws
(Revision and Declaration) Act, 1951 (26 of 1951), s. 3 and 2nd Sch.)*]
prescribed Laboratory and the functions of the Director of the Central Drugs
Laboratory in respect of such drug or class of drugs shall be exercised by the
Director of that (The words "institute or of that other" omitted by
A. O., 1949.)* * * Laboratory, (The words "as the case may be" rep.
by Act (26 of 1951, s. 3 and 2nd Sch.)***
(2) The Central Government may, after
consultation with the Board, make rules prescribing‑‑
(a) the functions of the Central
Drugs Laboratory;
(Cls. (b) and (c) omitted by the
Drugs (Amdt.) Act, 1963 (22 of 1963), section 6.)* *
* * * *
(d) the procedure for the submission
to the said Laboratory under Chapter IV of samples of drugs for analysis or
test, the forms of the Laboratory's reports thereon and the fees payable in
respect of such reports;
(e) such other matters as may be
necessary or expedient to enable the said Laboratory to carry out its
functions;
(f) the matters necessary to be
prescribed for the purposes of the proviso to sub-section (1).
7.
The Drugs Consultative Committee. (1) The Central Government may
constitute an advisory committee to be called "the Drugs Consultative
Committee" to advise the Central Government, (The words "the
Provincial Governments" omitted by A. O., 1964, Art. 2 and Sch.)* * * and
the Drugs Technical Advisory Board on any matter tending to secure uniformity throughout
(Subs. by the Central Laws (Statute Reform) Ordinance, 1960 (21 of 1960), s. 3
and 2nd Sch., for "the Provinces" (with effect from the 14th October,
1955).) [Pakistan
(2) The Drugs Consultative Committee
shall consist of two representatives of the Central Government to be nominated
by that Government and one representative of each Provincial Government to be
nominated by the Provincial Government concerned.
(3) The Drugs Consultative Committee
shall meet when required to do so by the Central Government and shall have
power to regulate its own procedure.
8.
Standards of quality. (1) For the purposes of this
Chapter the expression "standard quality" when applied to a drug
means that the drug complies with the standard set out in the Schedule.
(2) The Central Government, after
consultation with the Board and after giving by notification in the official
Gazette not less than three months' notice of its intention so to do, may by a
like notification add to or otherwise amend the Schedule for the purposes of
this Chapter, and thereupon the Schedule shall be deemed to be amended
accordingly.
9.
Misbranded drugs. For the purposes of this Chapter a
drug shall be deemed to be misbranded,---
(a) if it is an imitation of, or
substitute for, or resembles in a manner likely to deceive, another drug, or
bears upon it or upon its label or container the name of another drug, unless
it is plainly and conspicuously marked so as to reveal its true character and
its lack of identity with such other drug; or
(b) if it purports to be the product
of a place or country of which it is not truly a product; or
(c) if it is imported under a name
which belongs to another drug; or
(d) if it is so coloured, coated,
powdered or polished that damage is concealed, or if it is made to appear of
better or greater therapeutic value than it really is; or
(e) if it is not labelled in the
prescribed manner; or
(f) if its label or container or
anything accompanying the drug bears any statement, design or device which
makes any false claim for the drug or which is false or misleading in any
particular; or
(g) if the label or container bears
the name of an individual or company purporting to be the manufacturer or
producer of the drug, which individual or company is fictitious or does not
exist.
10.
Prohibition of import of certain drugs. From such date (The 1st April,
1947, for cls. (a), (b), (c), (e) and (f), see Gazette of India, 1947, Pt. 1,
p. 189; the 1st July, 1950, for clause (d), see Gaz. of P., 1950, Pt. I, p.
25.) as may be fixed by the Central Government by notification in the official
Gazette in this behalf, no person shall import‑
(a) any drug which is not of
standard quality;
(b) any misbranded drug;
(c) any drug for the import of which
a licence is prescribed, otherwise than under, and in accordance with, such
licence;
(d) any patent or proprietary
medicine, unless there is displayed in the prescribed manner on the label or
container thereof either the true formula or list of ingredients contained in
it in a manner readily intelligible to members of the medical profession,
(Certain words omitted by the Drugs (Amdt.) Act, 1963 (22 of 1963), section
7.)* * *
(e) any drug which by means of any
statement, design or device accompanying it or by any other means, purports or
claims to cure or mitigate any such disease or ailment, or to have any such
other effect, as may be prescribed;
(f) any drug the import of which is
prohibited by rule made under this Chapter:
Provided that nothing in this
section shall apply to the import, subject to prescribed conditions, of small
quantities of any drug for the purpose of examination, test or analysis or for
personal use:
Provided further that the Central
Government may, after consultation with the Board, by notification in the
official Gazette, permit, subject to any conditions specified in the
notification, the import of any drug or class of drugs not being of standard
quality.
Explanation. The formula or list of
ingredients mentioned in clause (d) shall be deemed to be true and a sufficient
compliance with that sub‑clause if, without disclosing a full
and detailed recipe of the ingredients, it indicates correctly all potent or
poisonous substances contained therein together with an approximate statement
of the composition of the medicine.
11.
Application of law relating to sea customs and powers of Customs officers.
(1) The law for the time being in force relating to sea customs and to goods,
the import of which is prohibited by section 18 of the Sea Customs Act, 1878,
shall, subject to the provisions of section 13 of this Act, apply in respect of
drugs the import of which is prohibited under this Chapter, and officers of
Customs and officers empowered under that Act to perform the duties imposed thereby
on a Customs Collector and other officers of Customs, shall have the same
powers in respect of such drugs as they have for the time being in respect of
such goods as aforesaid, VIII of 1878.
(2) Without prejudice to the
provisions of sub‑section (1), the Customs Collector,
or any servant of the (Subs. by A. O., 1961, Art. 2 and Sch., for
"Crown" (with effect from the 23rd March, 1956).)[State] authorised
by the Provincial Government in this behalf, may detain any imported package
which he suspects to contain any drug the import of which is prohibited under
this Chapter, and shall forthwith report such detention to the Director of the
Central Drugs Laboratory and, if required by him, forward the package or
samples of any suspected drug found therein to the said Laboratory.
12.
Power of Central Government to make rules. (1) The
Central Government may, after consultation with the Board and after previous
publication by notification in the official Gazette, make rules for the purpose
of giving effect to the provisions of this Chapter.
(2) Without prejudice to the
generality of the foregoing power, such rules may,---
(a) specify the drugs or classes of
drugs for the import of which a licence is required, and prescribe the form and
conditions of such licences, the authority empowered to issue the same, and the
fees payable therefore;
(b) prescribe the methods of test or
analysis to be employed in determining whether a drug is of standard quality;
(c) prescribe, in respect of
biological and organo-metallic compounds, the units or methods of
standardisation;
(d) specify the diseases or ailments
which an imported drug may not purport or claim to cure or mitigate and such
other effects which such drug may not purport or claim to have;
(e) prescribe the conditions subject
to which small quantities of drugs, the import of which is otherwise prohibited
under this Chapter, may be imported for the purpose of examination, test or
analysis or for personal use;
(f) prescribe the places at which
drugs may be imported, and prohibit their import at any other place;
(g) require the date of manufacture
and the date of expiry of potency to be clearly and truly stated on the label
or container of any specified imported drug or class of such drug, and prohibit
the import of the said drug or class of drug after the expiry of a specified
period from the date of manufacture;
(h) regulate the submission by
importers, and the securing, of samples of drugs for examination, test or
analysis by the Central Drugs Laboratory, and prescribe the fees, if any,
payable for such examination, teat or analysis;
(i) prescribe the evidence to be
supplied, whether by accompanying documents or otherwise, of the quality of
drugs sought to be imported, the procedure of officers of Customs in dealing
with such evidence, and the manner of storage at places of import of drugs
detained pending admission;
(j) provide for the exemption,
conditionally or otherwise, from all or any of the provisions of this Chapter
and the rules made thereunder of drugs imported for the purpose only of
transport through, and export from, (Subs. by the Central Laws (Statute Reform)
Ordinance, 1960 (21 of 1960), s. 3 and 2nd Sch. (with effect from the 14th
October, 1955), for "the Provinces and the Capital of the Federation"
which had been subs. by A. O., 1949, for "British India".)[Pakistan
(k) prescribe the conditions to be
observed in the packing in bottles, packages or other containers, of imported
drugs;
(l) regulate the mode of labelling
drugs imported for sale in packages, and prescribe the matters which shall or
shall not be included in such labels;
(m) prescribe the maximum proportion
of any poisonous substance which may be added to or contained in any imported
drug, prohibit the import of any drug in which that proportion is exceeded, and
specify substances which shall be deemed to be poisonous for the purposes of
this Chapter and the rules made thereunder;
(n) require that the accepted
scientific name of any specified drug shall be displayed in the prescribed manner
on the label or wrapper of any imported, patent or proprietary medicine
containing such drug;
(o) provide for the exemption,
conditionally or otherwise, from all or any of the provisions of this Chapter
or the rules made thereunder, of any specified drug or class of drugs.
13.
Offences. (1) Whoever contravenes any of the provisions of this
Chapter or of any rule made thereunder shall, in addition to any penalty to
which he may be liable under the provision of section 11, be punishable with
imprisonment which may extend to one year, or with fine which may extend to
five hundred rupees, or with both.
(2) Whoever, having been convicted
under sub‑section
(1), is again convicted under that sub‑section shall, in addition to any
penalty as aforesaid, be punishable with imprisonment which may extend to two
years, or with fine which may extend to one thousand rupees, or with both.
14.
Confiscation. Where any offence punishable under
section 13 has been committed, the consignment of the drug in respect of which
the offence has been committed shall be liable to confiscation.
CHAPTER III
IMPORT OF DRUGS
15.
Jurisdiction. No Court
inferior to that of a (The words "Presidency Magistrate or of a"
omitted by the Pakistan Drugs Act Adaptation Order, 1948 (G. G. O. 5 of 1948),
Art. 3.)* * * magistrate of the first class shall try an offence punishable
under section 13.
[CHAPTER IIIA]
(Chapter III A (containing sections
15A, 15B and 15C), ins. by the Drugs (Amdt.) Act, 1963 (22 of 1963), s. 8.)
EXPORT of DRUGS
15A.
Prohibition of Export of drugs without licence.
(Chapter III A (containing sections 15A, 15B and 15C), ins. by the Drugs
(Amdt.) Act, 1963 (22 of 1963), s. 8.) From such date as may be fixed by the
Central Government by notification in the official Gazette in this behalf, no
person shall export any drug for the export of which a licence is prescribed,
otherwise than under, and in accordance with, such licence:
Provided that nothing in this
section shall apply to the export, subject to the prescribed conditions, of
small quantities of any drug for the purpose of examination, test or analysis
or for personal use.
15B.
Power of Central Government to make rules. ( Chapter
III A (containing sections 15A, 15B and 15C), ins. by the Drugs (Amdt.) Act,
1963 (22 of 1963), s. 8.)‑(1) The Central Government may,
after consultation with the Board and after previous publication by
notification in the official Gazette, make rules for the purpose of giving
effect to the provisions of this Chapter.
(2) Without prejudice to the
generality of the foregoing power, such rules may‑
(a) specify the drugs or classes of
drugs for the export of which a licence is required, and prescribe the form and
conditions of such licences, the authority empowered to issue the same, and the
fees payable therefore;
(b) prescribe the conditions subject
to which small quantities of drugs, the export of which is otherwise prohibited
under this Chapter, may be exported for the purpose of examination, test or
analysis or for personal use;
(c) prescribe the places at which
drugs may be exported, and prohibit their export at any other place;
(d) regulate the submission by
exporters of samples of drugs for examination, test or analysis by the Central
Drugs Laboratory, and prescribe the fees, if any, payable for such examination,
test or analysis;
(e) prescribe the evidence to be
supplied, whether by documents or otherwise, of the quality of drugs sought to
be exported.
15C.
Penalty. (Chapter IIIA (containing sections 15A, 15B and 15C), ins.
by the Drugs (Amdt.) Act, 1963 (22 of 1963), s. 8.) Whoever contravenes any of
the provisions of section 15A or of any rule made under section 15B shall be
punishable with fine which may extend to five thousand rupees.]
THE SCHEDULE
(See sections 8 and 16)
Standards to be complied with by
imported drugs and by drugs manufactured for sale, sold, stocked or exhibited
for sale, or distributed.
Class of drug.
Standard to be complied with.
1. Patent or proprietary medicines
The formula or list of ingredients
displayed m the prescribed manner on the label or container, (The words and
comma "or the formula disclosed to the Central Drugs Laboratory, as the
case may be" omitted by the Drugs (Amdt.) Act, 1963 (22 of 1963), s. 1.6.)
* * *.
2. Substances commonly known as
vaccines, sera, toxins, toxoids, anti‑toxins, and antigens and biological
products of such nature.
The standards maintained at the
National Institute for Medical Research, London ,
and such further standards of strength, quality and purity as may be
prescribed.
3. Vitamins, hormones and analogous
products.
The standards maintained at the
National Institute for Medical Research, London ,
and such further standards of strength, quality and purity as may be
prescribed.
(Entry 3 A ins. ibid.) [3A.
Substances (other than food) intended to affect the structure or any function
of the human body or intended to be used for the destruction of vermins or
insects which cause disease in human beings or animals.
Such standards as may be
prescribed.]
4. Other drugs
The standards of identity purity and
strength specified in the latest edition of the British Pharmacopoeia or the
British Pharmaceutical Codex or any other prescribed pharmacopoeia, or adopted
by the Permanent Commission on Biological Standardisation of the (Subs. ibid.,
for "League of Nations ".) [World
Health Organisation].
CHAPTER IV
MANUFACTURE, SALE
AND DISTRIBUTION of DRUGS
16.
Standards of quality. (1) For the purposes of this
Chapter the expression "standard quality" when applied to a drug
means that the drug complies with the standard set out in the Schedule.
(2) The Provincial Government (The
words "after consultation with the Board and" omitted by A. O. 1964,
Art. 2 and Sch.)* * * after giving by notification in the official Gazette not
less than three months' notice of its intention so to do, may by a like
notification add to or otherwise amend the Schedule for the purposes of this
Chapter, and thereupon the Schedule shall be deemed to be amended accordingly.
CHAPTER IV
MANUFACTURE, SALE
AND DISTRIBUTION of DRUGS
17.
Misbranded drugs. For the purposes of this Chapter a
drug shall be deemed to be misbranded‑
(a) if it is an imitation of, or
substitute for, or resembles in a manner likely to deceive, another drug, or
bears upon it or upon its label or container the name of another drug, unless
it is plainly and conspicuously marked so as to reveal its true character and
its lack of identity with such other drug; or
(b) if it purports to be the product
of a place or country of which it is not truly a product; or
(c) if it is sold, or offered or
exposed for sale, under a name which belongs to another drug; or
(d) if it is so coloured, coated,
powdered or polished that damage is concealed, or if it is made to appear of
better or greater therapeutic value than it really is; or
(e) if it is not labelled in the
prescribed manner; or
(f) if its label or container or any
thing accompanying the drug bears any statement, design or device which makes
any false claim for the drug or which is false or misleading in any particular;
or
(g) if the label or container bears
the name of an individual or company purporting to be the manufacturer or
producer of the drug which individual or company is fictitious or does not
exist.
18.
Prohibition of manufacture and sale of certain drugs.
From such date as may be fixed by the Provincial Government by notification in
the official Gazette in this behalf, no person shall himself or by any other
person on his behalf‑
(d) manufacture for sale, or sell,
or stock or exhibit for sale, or distribute‑
(i) any drug which is not of
standard quality;
(ii) any misbranded drug;
(This sub‑clause was brought into force in‑
(i) the Capital of the Federation,
with effect on and from the 1st July, 1953, see Gaz. of P., 1952, Pt. VI, p.
154.;
(ii) Sind ,
with effect from the 1st July, 1953, see Sind Govt. Gazette 1952, Pt. 1, p.
638.
(iii) East Bengal, with effect on
and from the 1st January, 1955, see Dacca Gazette, 1954, Pt. 1, p. 1218; and
(iv) Punjab ,
with effect on and from the 1st July, 1951, see Punjab Gazette, 1950, Pt. 1, p.
372.)(iii) any patent or proprietary medicine, unless there is displayed in the
prescribed manner on the label or container thereof either the true formula or
list of ingredients contained in it in a manner readily intelligible to members
of the medical profession, (The commas and certain words omitted by the Drugs
(Amdt.) Act, 1963 (22 of 1963), s. 9.)* * *.
(iv) any drug which by means of any
statement, design or device accompanying it or by any other means, purports or
claims to cure or mitigate any such disease or ailment, or to have any such
other effect as may be prescribed;
(v) any drug, in contravention of
any of the provisions of this Chapter or any rule made thereunder;
(b) sell, or stock, or exhibit for
sale, or distribute any drug which has been imported or manufactured in
contravention of any of the provisions of this Act or any rule made thereunder;
(c) manufacture for sale, or sell,
or stock or exhibit for sale, or distribute any drug, except under, and in
accordance with the conditions of, a licence issued for such purpose under this
Chapter:
Provided that nothing in this
section shall apply to the manufacture, subject to prescribed conditions, of
small quantities of any drug for the purpose of examination, test or analysis:
Provided further that the Provincial
Government may, (The words and comma "after consultation with the
Board," omitted by A. O. 1964, Art. 2 and Sch.)* by notification in the
official Gazette, permit, subject to any conditions specified in the
notification, the manufacture for sale, sale or distribution of any drug or
class of drugs not being of standard quality.
Explanation.‑The formula or list of ingredients
mentioned in sub‑clause
(iii) of clause (a) shall be deemed to be true and a sufficient compliance with
that sub‑clause if,
without disclosing a full and detailed recipe of the ingredients, it indicates
correctly all the potent or poisonous substances contained therein together
with an approximate statement of the composition of the medicine.
19.
Pleas. (1) Save as hereinafter provided in this section, it shall
be no defence in a prosecution under this Chapter to prove merely that the
accused was ignorant of the nature, substance or quality of the drug in respect
of which the offence has been committed or of the circumstances of its
manufacture or import, or that a purchaser, having bought only for the purpose
of test or analysis, has not been prejudiced by the sale.
(2) For the purposes of section 18 a
drug shall not be deemed to be misbranded or to be below standard quality only
by reason of the fact that‑
(a) there has been added thereto
some innocuous substance or ingredient because the same is required for the manufacture
or preparation of the drug as an article of commerce in a state fit for
carriage or consumption, and not to increase the bulk, weight or measure of the
drug or to conceal its inferior quality or other defects; or
(b) in the process of manufacture,
preparation or conveyance some extraneous substance has unavoidably become
intermixed with it: provided that this clause shall not apply in relation to
any sale or distribution of the drug occurring after the vendor or distributor
became aware of such intermixture.
(3) A person, not being the
manufacturer of a drug or his agent for the distribution thereof, shall not be
liable for a contravention of section 18 if he proves‑
(a) that he did not know, and could
not with reasonable diligence have ascertained, that the drug in any way
contravened the provisions of that section, and that the drug while in his
possession remained in the same state as when he acquired it; or
(b) that he acquired the drug from a
person resident in (Subs. by the Central Laws (Statute Reform) Ordinance, 1960
(21 of 1960), s. 3 and 2nd Sch. (with effect from the 14th October, 1955), for
"the Provinces and the Capital of the Federation" which had been
subs. by A. O. 1949, for "British India.)[Pakistan] under a written
warranty in the prescribed form and signed by such person that the drug does
not in any way contravene the provisions of section 18, and that the drug while
in his possession remained in the same state as when he acquired it:
Provided that a defence under clause
(b) shall be open to a person only‑
(i) if he has, within seven days of
the service on him of the summons, sent to the Inspector a copy of the warranty
with a written notice stating that he intends to rely upon it and giving the
name and address of the warrantor, and
(ii) if he proves that he has,
within the same period, sent written notice of such intention to the said
warrantor.
20.
Government Analysts. The Provincial Government may, by
notification in the official Gazette, appoint such persons as it thinks fit,
having the prescribed qualifications, to be Government Analysts for such areas
and in respect of such drugs or classes of drugs as may be specified in the
notification:
Provided that a servant of the
(Subs, by A. O., 1961, Art. 2 and Sch., for "Crown" with effect from
the 23rd March, 1956).)[State] serving under the Central Government or another
Provincial Government shall not be so appointed without the previous consent of
the Government under which he is serving.
21.
Inspectors. (1) The Provincial Government may,
by notification in the official Gazette, appoint such persons as it thinks fit,
having the prescribed qualifications, to be Inspectors for the purposes of this
Chatter within such local limits as it may assign to them respectively:---
Provided that no person who has any
financial interest in the manufacture, import or sale of drugs shall be
appointed to be an Inspector under this sub‑section.
(2) Every Inspector shall be deemed
to be a public servant within the meaning of the Pakistan Penal Code, and shall
be officially subordinate to such authority as the Provincial Government may
specify in this behalf, XLV of 1860.
22.
Powers of Inspectors. ( Subs. by the Drugs (Amdt.) Act,
1963 (22 of 1963), s. 10, for the original section 22, as amended by the
Pakistan Drugs Act Adaptation Order, 1948 (G. G. O. 5 of 1948). Art 3.)‑(1) Subject to the provisions of
section 23 and of any rules made by the Provincial Government in this behalf,
an inspector may, within the local limits for which he is appointed, and in any
other area with the permission of the licensing authority,---
(a) inspect any premises wherein any
drug is being manufactured, the plant and process of manufacture, the means
employed for standardising anal testing the drugs and all records, and
registers, relating thereto;
(b) inspect any premises wherein any
drug is being sold or is stocked or exhibited for sale or is being distributed
the storage arrangement and all relevant records and registers;
(c) take samples of any drug which
is being manufactured, or being sold or is stocked or exhibited for sale or is
being distributed;
(d) enter and search at all
reasonable times, with such assistance, if any, as he considers necessary, any
building, vessel or place, in which he has reason to believe, from personal
knowledge or from information given by any person and taken down in writing,
that an offence under this Act or any rules made thereunder, has been or is
being committed;
(e) seize such drug and all
materials used in the manufacture thereof and all other articles including
registers, cash‑memos,
invoices, bills which he has reason to believe may furnish evidence of the
commission of an offence punishable under this Act and any rules made
thereunder;
(f) call any person from the
neighbourhood to be present as witness in course of search, seizure or in
connection with any other matter where the presence of witnesses is necessary;
(g) require any person to appear
before him at any reasonable time at any proper place to give statement,
assistance or information relating to, or in connection with, the investigation
of an offence under this Act or rules made thereunder:
Provided that the exemptions under
sections 132 and 133 of the Code of Civil Procedure, 1908 shall be applicable
to requisitions for attendance under this clause, Act V of 1908;
(h) lock and seal any factory,
laboratory, shop, building, store‑house
or godown or a part thereof where any drug is, or is being, manufactured,
stored, sold or exhibited for sale without the necessary licence under this
Act, or where he has reason to believe that an offence under this Act has been
committed or may continue to be committed;
(i) forbid for a reasonable period
not exceeding three months any person in charge of any premises from removing
or disposing of any drug, article or other thing likely to be used in evidence
of the commission of an offence under this Act or any rules made thereunder;
(j) exercise such other powers as
may be necessary for carrying out the purposes of this Act or any rules made
thereunder.
(2) The provisions of the Code of
Criminal Procedure, 1898, so far as they are not inconsistent with the
provisions of this to searches and seizures made under this Chapter, Act V of
1898.
(3) If any person wilfully obstructs
an Inspector in the exercise of the powers conferred upon him by or under this
Chapter or disobeys the lawful authority of an Inspector, he shall be
punishable with imprisonment which may extend to three years, or with fine, or
with both.]
23.
Procedure of Inspectors. (Sub-section (1) omitted by the
Drugs (Amdt.) Act, 1963 (22 of 1963), 11.)*
* * *
* * *
(Subs. ibid., for the original sub‑section (2).)[(2) Where the
Inspector seizes any drug or any other article under section 22, he shall
tender a receipt therefore in the prescribed form.]
(3) Where an Inspector takes a
sample of a drug for the purpose of test or analysis, he shall intimate such
purpose in writing in the prescribed form to the person from whom he takes it
and, in the presence of such person unless he willfully absents himself, shall
divide the sample into four portions and effectively seal and suitably mark the
same and permit such person to add his own seal and mark to all or any of the
portions so sealed and marked:
Provided that where the sample is
taken from premises whereon the drug is being manufactured, it shall be
necessary to divide the sample into three portions only:
Provided further that where the drug
is made up in containers of small volume, instead of dividing a sample as
aforesaid, the Inspector may, and if the drug be such that it is likely to
deteriorate or be otherwise damaged by exposure shall, take three or four, as
the case may be, of the said containers after suitably marking the same and,
where necessary, sealing them.
(4) The Inspector shall restore one
portion of a sample so divided or one container, as the case may be, to the person
from whom he takes it, and shall retain the remainder and dispose of the same
as follows:
(i) one portion or container he
shall forthwith send to the Government Analyst for test or analysis;
(ii) the second he shall produce to
the Court before which proceedings, if any, are instituted in respect of the
drug; and
(iii) the third, where taken, he
shall send to the warrant or, if any, named under the proviso to sub‑section (3) of section 19.
(5) Where an Inspector takes any
action under (The words, letter and parenthesis "clause (c) of"
omitted. ibid.)* * * section 22,---
(a) he shall use all despatch in
ascertaining whether or not the drug contravenes any of the provisions of
section 18 and, if it is ascertained that the drug does not so contravene,
forthwith revoke the order passed under the said (Subs. by the Drugs (Amdt.)
Act, 1963 (22 of 1963), s. 11, for "clause".)[section] or, as the
case may be, take such action as may be necessary for the return of the stock
seized;
(b) if he seizes the stock of the
drug, he shall as soon as may be, inform a Magistrate and take his orders as to
the custody thereof;
(c) without prejudice to the
institution of any prosecution, if the alleged contravention be such that the
defect may be remedied by the possessor of the drug, he shall, on being
satisfied that the defect has been so remedied, forthwith revoke his order
under the said (Subs. by the Drugs (Amdt.) Act, 1963 (22 of 1963), s. 11, for
"clause".)[section].
24.
Persons bound to disclose place where drugs are manufactured or kept.
Every person for the time being in charge of any premises whereon any drug is
being manufactured or is kept for sale or distribution shall, on being required
by an Inspector so to do, be legally bound to disclose to the Inspector the
place where the drug is being manufactured or is kept, as the case may be.
25.
Reports of Government Analysts. (1) The Government Analyst to whom
a sample of any drug has been submitted for test or analysis under sub‑section (4) of section 23, shall
deliver to the Inspector submitting it a signed report in triplicate in the
prescribed form.
(2) The Inspector on receipt thereof
shall deliver one copy of the report to the person from whom the sample was
taken and another copy to the warrantor, if any, named under the proviso to sub‑section (3) of section 19, and shall
retain the third copy for use in any prosecution in respect of the sample.
(3) Any document purporting to be a
report signed by a Government Analyst under this Chapter shall be evidence of
the facts stated therein, and such evidence shall be conclusive unless the
person from whom the sample was taken or the said warrantor has; within twenty‑eight days of the receipt of a copy
of the report, notified in writing the Inspector or the Court before which any
proceedings in respect of the sample are pending that he intends to adduce
evidence in controversion of the report.
(4) Unless the sample has already
been tested or analysed in the Central Drugs Laboratory, where a person has
under subsection (3) notified his intention of adducing evidence in
controversion of a Government Analyst's report, the Court may, of its own
motion or in its discretion at the request either of the complainant or the
accused, cause the sample of the drug produced before the Magistrate under sub‑section (4) of section 23 to be sent
for test or analysis to the said Laboratory, which shall make the test or
analysis and report in writing signed by, or under the authority of, the
Director of the Central Drugs Laboratory the result thereof, and such report shall
be conclusive evidence of the facts stated therein.
(5) The cost of a test or analysis
made by the Central Drugs Laboratory under sub‑section (4) shall be paid by the
complainant or accused as the Court shall direct.
26.
Purchaser of drug enabled to obtain test or analysis.
Any person shall, on application in the prescribed manner and on payment of the
prescribed fee, be entitled to submit for test or analysis to a Government
Analyst any drug purchased by him and to receive a report of such test or
analysis signed by the Government Analyst.
27.
Penalty for manufacture, sale, etc., of drugs in contravention of this Chapter.
Whoever himself or by any other person on his behalf manufactures for sale,
sells, stocks or exhibits for sale, or distributes any drug in contravention of
any of the provisions of this Chapter or any rule made thereunder shall be
punishable with imprisonment which may extend to (Subs. by the Drugs (Amdt.)
Act, 1963 (22 of 1963), s. 12, for "one year, or with fine which may
extend to five hundred rupees,") [three years or with fine], or with both.
28.
Penalties for giving false warranty or misuse of warranty.
(1) Whoever in respect of any drug sold by him whether as principal or agent,
gives to the purchaser a false warranty that the drug does not in any way
contravene the provisions of section 18 shall, unless he proves that when he
gave the warranty he had good reason to believe the same to be true, be
punishable with imprisonment which may extend to one year, or, with fine which
may extend to five hundred rupees, or with both.
(2) Whoever applies or permits to be
applied to any drug sold, or stocked or exhibited for sale, by him, whether on
the container or label or in any other manner, a warranty given in respect of
any other drug, shall be punishable with imprisonment which may extend to one
year, or with fine which may extend to five hundred rupees, or with both.
29.
Penalty for use of Government Analyst's report for advertising.
Whoever uses any report of a test or analysis made by the Central Drugs
Laboratory or by a Government Analyst, or any extract from such report for the
purpose of advertising any drug, shall be punishable with fine which may extend
to five hundred rupees.
30.
Penalty for subsequent offences. (Subs. by the Drugs (Amdt.) Act,
1963 (22 of 1963), s. 13, for the original section 30.)‑(1) Whoever, having been convicted
of an offence under section 27, is again convicted of an offence under that
section shall be punishable with imprisonment which may extend to five years,
or with fine, or with both.
(2) Whoever, having been convicted
of an offence under section 28 or section 29, is again convicted of an offence
under either of those sections shall be punishable with imprisonment which may
extend to two years, or with fine, or with both.]
31.
Confiscation. Where any person has been convicted
under this Chapter for contravening any such provision of this Chapter or any
rule made thereunder as may be specified by rule made in this behalf, the stock
of the drug in respect of which the contravention has been made shall be liable
to confiscation.
32.
Cognisance of offences. (1) No prosecution under this
Chapter shall be instituted except by an Inspector.
(3) Nothing contained in this
Chapter shall be deemed to prevent any person from being prosecuted under any
other law for any act or omission which constitutes an offence against this
Chapter.
33.
Power of Provincial Government to make rules. (1) The
Provincial Government may, (The words "after consultation with the Board
and', omitted by A. O., 1964, Art. 2 and Sch.)* * * after previous publication
by notification in the official Gazette, make rules(For the West Pakistan Drugs
Rules, 1958, see West Pakistan Gazette, 1958, Ext., pp. 1255‑56.) for the purpose of giving
effect to the provisions of this Chapter.
(2) Without prejudice to the
generality of the foregoing power, such rules may‑
(a) provide for the establishment of
laboratories for testing and analysing drugs;
(b) prescribe the qualifications and
duties of Government Analysts and the qualifications of Inspectors;
(c) prescribe the methods of test or
analysis to be employed in determining whether a drug is of standard quality;
(d) prescribe, in respect of
biological and organo‑metallic
compounds, the units or methods of standardisation;
(e) prescribe the forms of licences
for the manufacture for sale, for the sale and for the distribution of drugs or
any specified drug or class of drugs, the form of application for such
licences, the conditions subject to which such licences may be issued, the
authority empowered to issue the same and the fees payable therefore;
(f) specify the diseases or ailments
which a drug may not purport or claim t o cure or mitigate anal such other
effects which a drug may not purport or claim to have;
(g) prescribe the conditions subject
to which small quantities of drugs may be manufactured for the purpose of
examination, test or analysis;
(h) require the date of manufacture
and the date of expiry of potency to be clearly and truly stated on the label
or container of any specified drug or class of drugs, and prohibit the sale,
stocking or exhibition for sale, or distribution of the said drug or class of
drugs after the expiry of a specified period from the date of manufacture or
after the expiry of the date of potency;
(i) prescribe the conditions to be
observed in the packing in bottles, packages and other containers of drugs, and
prohibit the sale, stocking or exhibition for sale, or distribution of drugs
packed in contravention of such conditions;
(j) regulate the mode of labelling
packed drugs, and prescribe the matters which shall or shall not be included in
such labels;
(k) prescribe the maximum proportion
of any poisonous substance which may be added to or contained in any drug,
prohibit the manufacture, sale or stocking or exhibition for sale, or
distribution of any drug in which that proportion is exceeded, and specify substances
which shall be deemed to be poisonous for the purposes of this Chapter and the
rules made thereunder;
(l) require that the accepted
scientific name of any specified drug shall be displayed in the prescribed
manner on the label or wrapper of any patent or proprietary medicine containing
such drug;
(m) prescribe the form of warranty
referred to in subsection (1) of section 19;
(n) regulate the powers and duties
of Inspectors;
(o) prescribe the forms of report to
be given by Government Analysts, and the manner of application for test or
analysis under section 26 and the fees payable therefore;
(p) specify the offences against
this Chapter or any rule made thereunder in relation to which the stock of the
drug shall be liable to confiscation under section 31;
(q) provide for the exemption,
conditionally or otherwise, from all or any of the provisions of this Chapter
or the rules made thereunder, of any specified drug or class of drugs.
34.
[Omitted.] [Protection to persons acting under
this Chapter.] Omitted by the Drugs (Amdt.) Act, 1963 (XXII of 1963), s. 14.
[CHAPTER V]
(Chapter V containing sections 35‑41, added by the Drugs (Amdt.) Act,
1963 (22 of 1963), s. 15.)
MISCELLANEOUS
35.
Sale of patent or proprietory medicines or
pharmaceutical specialities. (Chapter V containing sections 35‑41, added by the Drugs (Amdt.) Act,
1963 (22 of 1963), s. 15.) No patent or proprietary medicine or pharmaceutical
speciality or any other medicine, whether allopathic, unani, ayurvedic,
homoeopathic or biochemic, for the time being not recognised by the accepted
pharmacopoeias, shall be offered for sale to the public or advertised for such
sale, unless two samples thereof shall have been sent to the Director, Central
Drugs Laboratory, and the latter shall have determined that the medicine or
specialty is suitable or proper for use by the public.
36.
Prohibition to sell drugs in public streets, etc.
(Chapter V containing sections 35‑41,
added by the Drugs (Amdt.) Act, 1963 (22 of 1963), s. 15.) No person shall, in
any public street, highway, footpath or park or on any public transport or
conveyance, peddle, hawk or offer for sale or distribute free of charge any
medicine of pharmaceutical speciality whether allopathic, unani, ayurvedic,
homoeopathic or of any other description.
37.
Penalty. (Chapter V Containing sections 35‑41, added by the Drugs (Arndt.) Act,
1963 (22 of 1963), s. 15.) Any person who contravenes any of the provisions of
section 35 or section 36 shall be punishable with imprisonment which may extend
to two years, or with fine, or with both.
38.
Offences by Companies, etc. (Chapter V Containing sections 35‑41, added by the Drugs (Arndt.) Act,
1963 (22 of 1963), s. 15.) Where the person guilty of an offence under this Act
is a company, corporation or firm every director, partner and officer of the
company, corporation or firm with whose knowledge and consent the offence was
committed shall be guilty of the like offence.
39.
Powers to try offence summarily. (Chapter V Containing sections 35‑41, added by the Drugs (Arndt.) Act,
1963 (22 of 1963), s. 15.) Any Magistrate of the first class or any bench of
Magistrates invested with the powers of a Magistrate of the first class
empowered for the time being to try in a summary way the offences specified in
sub section (1) of section 260 of the Code of Criminal Procedure, 1898, may, on
application in this behalf being made by the prosecution, try in accordance
with the provisions contained in sections 262 to 265 of that Code, any such
offence punishable under this Act and any rules made thereunder as may be
prescribed, Act V of 1898.
40.
Special provision regarding imprisonment and fine.
(Chapter V Containing sections 35‑41,
added by the Drugs (Arndt.) Act, 1963 (22 of 1963), s. 15.) Notwithstanding
anything contained in section 32 of the Code of Criminal Procedure, 1898, it
shall be lawful for any Magistrate of the first class to pass any sentence
authorised by this Act even if such sentence exceeds his powers under section
32 of that Code, Act V of 1898.
41.
Protection to persons acting under this Act. (Chapter V Containing sections 35‑41,
added by the Drugs (Arndt.) Act, 1963 (22 of 1963), s. 15.) No suit,
prosecution or other legal proceeding shall lie against any person for anything
which is in good faith done or intended to be done under this Act or any rules
made thereunder.]
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