Drug Act 1976

1. Short title, extent and commencement: (1) This Act may be called the Drugs Act, 1976.
(2) It extends to the whole of Pakistan.

(3) It shall come into force at once.
COMMENTS
Object : The act provided for the control of import, export, manufacture, sale, supply and
distribution of the drugs.
In recent years there has been a great increase in the number of objectionable advertisements
published in newspapers or magazines or otherwise relating to alleged cures for venereal
diseases, sexual stimulants and cures for certain other deadly diseases. These advertisements
tended to cause the ignorant and the unwary to resort to self-medication with harmful drugs and
appliances or to resort to quacks who indulge in such advertisements for treatment which cause
great harm. It was, therefore, considered necessary in the public interest to put a stop to such
undesirable advertisements.
The Act, it should be noted, is hot in derogation of the Dangerous Drugs Act, 1930 which still
holds the field. The Drugs Act, 1940 has of course been repealed and superseded by this Act. A
comparison of the two Acts will show that the present Act is much more exhaustive and covers a
large number of new grounds, legislation in respect of which was an imperative necessity due to
the advance of times and change of tactics by manufacturers and dealers of drugs In jointly
making the best use of their profession to their personal advantage and gain regardless of the
welfare of the nation as a whole.
Preamble : Registration under the Drugs Act, 1976 would not constitute defence against the
infringement regulated by the Patents and Designs ACT; 1911, two statutes covering different
fields and controlling distinct classes of activities. P L D 1991 Kar. 252.
Islamisation of Laws: The Drugs Act, 1976 is not repugnant to Sharia P L D 1986 F S C 29.
Investigation: The Police Officers could investigate into offences under the Drugs Act, 1976
either upon their own information or on information given under Section 154, Criminal Procedure
Code, 1898 irrespective of fact whether the informant was Drugs Inspector or someone else.
1979 P Cr. L J Note 6 at p. 4.
Offence under this Act: Offence under this Act can be investigated by Police Officer either upon
his own information or upon information given to him under Section 154 Criminal Procedure
Code. (1898). Whether informer is Drug Inspector or not No provision in this Act corresponds to
Section 196 or Section 199, Criminal Procedure Code (1898). P L J 1978 Kar. 216.
Jurisdiction : The alleged offence was committed prior to enfforcement of the Drugs Act. XXXI of
1976. The Drugs Court, had no jurisdiction to take cognizance of such offence. Offence was
committed under the Drugs Act, 1940. Provision of new law (lid not permit the Drugs Court to take
cognizance of offence committed under the Act, 1940 proceedings were illegal. Prosecution could
take steps to refer case to a Court of the competent jurisdiction. 1980 P Cr. L J 738.
Act apply to provincially Administered Tribal Areas of Balochistan: No. 80 (T.A) 13-1/91,
dated 18-2-1992. In exercise of the powers conferred by clause (3) of Article 247 of the
constitution of the Islamic Republic of Pakistan, the Governor of Balochistan with the approval of
the President is pleased to direct that the drugs Act, 1976 (XXXI of 1976) and the rules made
thereunder, as in force in the, Province of Balochistan immediately before the issue of Notification
shall apply to the Provincially Administered Tribal Areas of Balochistan.
Renewal of licence under Drugs Act, 1976 : The petitioner a licensed manufacturer of the
drugs, under, the Drugs Act, 1976 submitted t, he application for renewal of licence under new
law as required by Rules. Facts revealing petitioner having been dealt with left-handedly and
adverse action having been taken rather irresponsibly in rejecting petitioner's application. Appeal
filed by petitioner heard by Appellate Board including two such members who complained of
having not been treated with respect by petitioner and launching criminal proceedings against
petitioner through Martial Law authorities in consequence whereof petitioner arrested and
remained in jail until released on bail. The Board in circumstances. could not be said to have
acted in the manner to let justice appear to be done. Justice not only to be done but has
manifestly to appear being done. Order of the Appellate Board, not with lawful authority. The case
was remitted back to be decided keeping in view background of the case, facts as well as law. P
L. D 1978 Lah. 1249.
Admissibility of admitting expenses : Claim of assessee of sale promotion expenses in excess

of five per cent. of the turn over in violation of Rr. 12 & 35 of the Drugs (Licensing, Registration
and Advertising) Rules, 1976 Admissibility. Penalty provided by Rr. 33 & 12 of Drugs (Licensing,
Registration and Advertising) Rules, 1976, having not been provided in Income tax Law, could not
be extended to the assessee's case. Expenses incurred by the assessee, on advertising sale
promotion etc., therefore, were admissible expenses. 1995 P T D 1128.
Assessing Officer disallowed expenditure incurred excess of five per cent of turn-over on sales
promotion under R. ,33 of Drugs (Licensing, Registration and Advertising) Rules, 1976 Penalty
provided under the said rule held, could not be extended to the provisions (Income Tax
Ordinance as no such penalty had been provided in the Ordinance. 1995 P T D 577.
"Hexa-Chlorophene liquid soap"-Nature of product : Nature of product, could he gauged from

properties of compound and primary use of the product. Hexa-Chlorophene Soap", containing
0.25% of the Hexa-chlorophene and 12% solution of potassium soap, registered in the National
Pharmulary as drug and primarily used for care and treatment of skin was essentially medical
drug. Such product could not be treated as article of perfumery, cosmetic or toilet preparation
1986 M L D 63.
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 (11 of 1930), and any other law for the time
being in force.
COMMENTS
No. SO. (T.A.) 13-1/91, dated 18-2-1992.-- In exercise of the powers conferred by clause (3) of
Article 247 of the Constitution of the Islamic Republic of Pakistan, the Governor of Balochistan,
with the approval of the President is pleased to direct that the Drugs Act, 1976 (XXXI of 1976)
and the Rules made thereunder, as in force in the Province of Balochistan immediately before the
issue of Notification shall apply to the Provincially Administered tribal Areas of Balochistan.
3. Definitions: In this Act, unless there is anything repugnant in the subject or context,--
(a) "adulterated drugs" means a durg--
(i) which consists in whole or in part of any filthy, putrid or decomposed substance or which
contains any foreign matter, vermin, worm, rodent or insect; or
(ii) which has been manufactured, packed, or held under unsanitary conditions whereby it may
have been contaminated with dirt, filth or any other foreign matter or whereby it may have been
rendered injurious to health; or
(iii) the container of which releases any poisonous or deleterious substance which may render the
contents injurious to health; or
(iv) which bears or contains as an ingredient a substance other than the prescribed substance; or
(v) with which any substance has been mixed or packed so as to reduce its quality or strength or
for which any substance has been substituted wholly or in part;
(b) "Appellate Board" means the Board constituted under Section 9;

(c)"batch" means a quantity of any drug produced during a given cycle of manufacture;
(d) "batch number" means a designation printed on the label of a drug that identifies the batch
and permits the production history of the batch, including all stages of manufacture and control, to
be traced and reviewed;
(e) "Central Licensing Board" means a Board set up under Section 5;
(f) "counterfeit drug" means a drug the label' or outerpacking of which is an imitation of, or
resembles or so nearly resembles as to be calculated to deceive the label or outer-packing of a
drug of another manufacture;
(g) "drug" includes--
(i) any substance or mixture of substances that is manufactured, sold, stored, offered for sale or
represented for internal or external use in the treatment, mitigation, prevention or diagnosis of
diseases, an abnormal physical state, or the symptoms thereof in human beings or animals or the
restoration, correction, or modification of organic functions in human beings or animals, not being
a substance exclusively used or prepared for use in accordance with the ayurvedic, unani,
homoeopathic or biochemic system of treatment except those substances and in accordance with
such conditions as may be prescribed;
(ii) abortive and contraceptive substances, agents and devices, surgical ligatures, sutures,
bandages, absorbent cotton, disinfectants, bacteriophages, adhesive plasters, gelatine capsules
and antiseptic solutions;
(iii) such substances intended to be used for the destruction or repulsion of such vermin, insects,
rodents and other organism as cause, carry or transmit disease in human beings or animals or for
disinfection in residential areas or in premises in which food is manufactured, prepared or kept or
stored;
(iv) such pesticides as may cause health hazard to the public;
(v) any substance mentioned as monograph or as a preparation in the Pakistan Pharmacopoeia

or the Pakistan National Formulary or the International Pharmacopoeia or the British
Pharmacopoeia or the British Pharmaceutical Codex or the United States Pharmacopoeia or the
National Formulary of the United States, whether alone or in combination with any substance
exclusively used in the unani, ayurvedic, homoeopathic or biochemic system of treatment, and
intended to be used for any of the purposes mentioned in sub-clauses (i), (ii) and (iii), and
(vi) any other substance which the Federal Government may, by notification in the official
Gazette, declare to 'be a "drug" for the purposes of this Act;
(h) "expiry date" means the date stated on the label of a drug after which the drug is not expected
to retain its claimed efficacy, safety, quality or potency or after which it is not permissible to sell
the drug;
(i) "expert" means a specialist through university education and experience in the relevant field;
(j) "export", with its grammatical variations and cognate expressions, means to take out of
Pakistan by sea, land or air;
(k) "generic name" means the non-proprietary, scientific or official name of a drug as approved by
the Federal Government;
(l) "Government analysis" means a Federal Government Analyst or Provincial Government
Analyst appointed under Section 16;
(m) "import" with its grammatic31 variations and cognate expressions means to bring into
(n) "Inspector" means a Federal Inspector or a Provincial Inspector appointed under Section 17;
(o) "label" means a display of written, printed or graphic matter upon the immediate container, or
the outside container or wrapper of a drug package;
"Labelling" means all labels and other written, printed or graphic matter accompanying any drug;
(q) "licensing authority" means such authority as may be prescribed;
(r) "manufacture", in relation to a drug, means all operations involved in the production of the
drug, including processing, compounding, formulating, filling, packing, repacking, altering,
ornamenting, finishing and labelling with a view to its storage, 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;
(s) "misbranded drug" means a drug--
(i) which is not labelled in the prescribed manner; or

(ii) on the label or labelling of which any word, statement or other matter or information required
by the rules to appear on the label or labelling is not prominently placed with such
conspicuousness (as compared with other words, statements, designs, or devices on the label or
labelling) and in such terms as may render it likely to be read 'and understood by the ordinary
individual under customary conditions of purchase and use; or
(iii) which is not labelled with such directions for use and such warnings against use in indications
where its use may be dangerous to health, or against unsafe dosage or duration of administration
or application in such manner and form as are necessary for the protection of users or as may be
prescribed; or
(iv) the label or container of which, or anything accompanying which, bears any statement, design
or device which makes any false claim for the drug or which is false or misleading in any
particular; or
(v) which is so coloured, coated, powdered or polished that damage is concealed, or which is
made to appear of better or greater therapeutic value than it really is; or
(vi) which is manufactured according to the specifications of a particular pharmacopoeia or any
other document as may be prescribed and the label does not bear the name of that
pharmacopoeia or document;
(t) "prescribed" means prescribed by rules;
(u) "Provincial Quality Control Board" means a Board set up under Section 11;
(v) "Registration Board" means a Board set up under Section 7;
(w) "registered drug" means any drug registered under Section 7;
(x) "rules' means rules made under this Act;
(y) "Drug Court" means a Court established under Section 31;
(z) "specifications" when applied to a drug mean--
(i) such specifications as may be prescribed; or
(ii) when the specifications are not prescribed, the specifications as contained in the most recent
edition of any of the following publications, namely:-
(1) the Pakistan Pharmacopoeia;

(2) the International Pharmacopoeia;
(3) the European Pharmacopoeia;
(4) the United States Pharmacopoeia;
(5) the British Pharmacopoeia;
(6) the British Pharmaceutical Codex;
(7) the United States National Formulary; and
(8) such other publication as may be prescribed:
Provided that, if the specifications do not appear in the most recent edition of any such
publication, the specifications appearing in the next preceding edition of such publication in which
the specifications appear shall apply; or
(iii) if no specifications are either prescribed or contained in any of the publications referred to in
sub-clause (ii), the specification approved for the purpose of registration under this Act;
(z-a) "sell" means sell, offer for sale, expose for. sale, have in possession for sale and distribution
and "to sell", "sold" or "sale" shall be construed accordingly;
(z-b) "spurious drug" means a drug--
(i) which purports to be a drug but does not contain the active ingredient of that drug; or
(ii) which purports to be the product of a manufacturer, place or country of whom or of which it is
not truly a product; or
(iii) which is imported or exported or sold or offered or exposed for sale under a particular name
while actually it is another drug; or
(iv) the label of which bears the name of an individual or company purporting to be its
manufacturer or producer which individual or company is fictitious or does not exist;
(z-c) "storage" means storage for sale and "to store" or "stored" shall be construed accordingly;
and
(zz) "sub-standard drug' means a drug which is not of specifications.
COMMENTS
Sub-clause (G)--Drug The definition of drug is comprehensive enough to take not only
medicines but also substances intended to be used for or in the treatment of diseases of human
beings or animals. This artificial definition introduces distinction between medicines and
substances which are not medicines strictly so-called. The expression 'substances' or 'mixture of
substances', therefore. is something other than medicines but which are used for the treatment of
diseases of human beings or animals. The term 'drug' includes medicines for internal or external
uses 1994 C L C 114. The Oxford Concise Dictionary defines drug as "original simple medicinal
substance, organic or inorganic, used-alone or as in ingredient". The word as defined in this Act,
has, however, a much wider connotation. As per definition of the word drug as defined in the Act
any substance or mixture of substances used in the treatment, mitigation, prevention, or
diagnosis of disease in human beings or animals, or the restoration, correction, or modification of
the organic functions in human beings or animals, not being a substance exclusively used in
accordance with the Ayurvedic, Unani, Homoeopathic or Biochemic system of treatment, abortive
and contraceptive substances and devices, surgical ligatures, sutures, bandages absorbent
cotton, disinfectants, adhesive plasters, gelatine capsules, antiseptic solutions, pesticides, any
substance mentioned as monograph or as a preparation in the Pakistan Pharmacopoeia or
International or British Pharmacopoeia or United States Pharmacopoeia or formulary, whether
alone or in combination with any substance exclusively used in the Unani, Ayurvedic,
Homoeopathic or Biochemic system of treatment, and such substance as the Federal
Government may declare to be a drug for purposes of this Act shall be deemed to be a drug. It
will thus appear that it is not only the drugs that are used in the cure, prevention, mitigation, etc.,
of a disease that fall within the definition but even such articles as are used in the diagnosis,
treatment, prevention or mitigation of diseases are covered within the term.
According to the case of The State v. Abdullah Sham/m, 1987 M L D 2160, any substance
mentioned as monograph or preparation in British or Pakistan/Pharmacopoeia or National
Formulary is included in the definition of "drug". Methyl Salicylate finds mention in National
Formulary and British Pharmacopoeia. Certain preparations used in the manufacture of the
Ayurvedic or Unani medicines are no doubt excluded but all such preparations are not excluded
and such a question is purely of fact to be established by the evidence. Not only the manufacture
and sale of drugs without licence and registration is punishable offence but even there
counterfeiting is an offence. Where prima facie case was made out by the prosecution, the Trial
Court, was not justified in throwing out case without recording evidence.
Any substance mentioned as a preparation in the Pakistan National Formulary, or Pakistan

Pharmacopoeia for treatment, mitigation, prevention or diagnoses of disease being a drug would
fall under the P.T.C. Hdg. 30.03. P L D 1992 SO 455.
Basic test report of drugs not in conformity with the provision of law: Such report was
wholly without jurisdiction and incapable of being acted upon. Contention that another efficacious
remedy being available to tile respondent by reverting to the Federal Test Laboratory, was
nothing but to perpetuate the tyranny, thus, the same was repelled. No exception could be taken
to the finding of 'the Single Judge of the High Court whereby Analyst's report was set aside; and
the same was affirmed in appeal. 1992 M L D 481.
Counterfeiting drug: A drug so packed that its label or outerpacking imitates, or resembles or so
nearly resembles as to deceive and cause it to be taken as the label or outer-packing of another
manufacturer is a counterfeit drug. It is only the packing which is calculated to deceive and cause
it to be taken as the manufacture of another manufacturer which is the essence of the definition.
The quality of the drug has nothing to do with this definition.
If any substance or mixture of substances is exclusively used or prepared for use in accordance
with the Ayurvedic, Unani, Homoeopathic or Biochemic system of treatment then (unless such
substance is excepted in accordance with such conditions as may be prescribed) the same would
not be included in the definition of "Drug" occurring in Section 3 (g) (i) of the Drugs Act. 990*M L
D 1524.
Any isolated or synthesised substance mentioned as monograph or as a preparation appearing in

the several publications referred on in Section 3(g)(v) of the Drugs Act would by itself constitute a
drug and fall within the fold of the said definition clause irrespective of the fact whether the same
is used alone or in combination with any other substance exclusively used in any of the four
excepted systems of medicine in question. in the later case if intended to be used for any of the
purposes mentioned in sub-clauses (i), (ii) and (iii) of clause (g) of Section 3 of the Drugs Act. In
such category word fall such isolated or synthesised active constituents as are covered in the
publications referred to in Section 3(g) (v) of the Act, 1990 M L D 1524.
Word "medicament'--Meaning : Definition of the word "medicament" as given by the Drugs Act,
1976 would be relevant. P L D 1992 S C 455.
Adulterated drug: A drug which either in whole or in part consists of any filthy, putrid, or
decomposed substance or which contains any foreign matter, vermin, worm, rodent, or insect, or
which has been manufactured or packed or kept under unsanitary conditions rendering it likely to
be contaminated with dirt, filth or any other foreign matter and making it likely to be injurious to
health or whose container releases any poisonous or deleterious substance rendering the
contents injurious to health, or which bears or contains as an ingredient a substance other than
the prescribed substance or with which any substance has been mixed or packed so as to reduce
its quality or strength or for which any substance has been wholly or partly substituted is an
adulterated drug.
According to the case of Woodwards (Pakistan) Ltd. v. The State, 1985 P Or. L J 2064, the test
report containing finding that sample was adulterated. Test report not found to be consistent with
definition of the "adulterated drug". The test report not saying whether black particles found in test
were of foreign matter. The report not saying that contents of sample were injurious to health or
containing an ingredient or substance other than the prescribed substance. Negative remarks
about standard of sample speaking only of physical appearance and not of the quality. Physical
appearance of contents not mentioned in the definition. Number and size of particles found in
sample not given. The report found useless for comparison with specifications. The report not
made on prescribed form No. 6 and not fulfilling requirements of rule 16 of the Drugs (Federal
Inspector, Federal Drug Laboratory and-Federal Government Analysts) Rules, 1976. Such test
report, was not admissible in evidence.
Registered drug: A registered drug is one which has been registered according to the specified
rules by the Registration Board set up by the Federal Government.
Sub-clause (r)--Manufacture : The term "manufacture" includes packing, finishing and labelling
of a drug. Workers founding labelling and packing of unregistered drug, would amount to
"manufacture" for the purposes of the Drugs Act. 1983 P Cr. L J 401.
Manufacture would include process of "packing".or "re-packing" of a drug. 1983 P Cr. L J 2491.
Sub-clause (s)--Misbranded drug: A drug which is not labelled in the prescribed manner is a
misbranded drug. Similarly a drug on the label of which any word or statement is required by the
Rules to appear but does not so appear or is not prominently placed with such conspicuousness
and in such terms as may render it likely to be read and understood by the ordinary individual
under customary conditions of or purchase and use or which is not labelled with the directions for
use and such warnings against use in cases where its use may be dangerous or against unsafe
dosage or duration of administration or application or whose label or anything accompanying it
bears any statement, design or device which makes any false or misleading claim or which is so
coloured, coated, powdered, or polished, or as to conceal damage, or which is made to appear of
letter or greater therapeutic value than it really is or which does not bear the name of the
pharmacopoeia or document according to whose specifications it is manufactured is a
misbranded drug.
A drug would be deemed as misbranded when such drug is not labelled in the prescribed manner
or labelling of which is against the Rules or misleading or which is camouflaged to conceal
damage, etc., or on which the name of the pharmacopoeia under the specifications of which the
drug is manufactured is not mentioned. P L D 1992 Kar. 347.
Sub-clause (zb)--Spurious drug: A drug which purports to be a drug but does not contain the
active ingredient of that drug or which purports to be the manufacture of a person, place, or
country whose product it is not in fact, or which is imported or exported or sold or exposed for
sale under a name which actually it does not fall within that name, or where label bears fictitious
name of manufacturer Qr producer is a spurious drug.
According to the case a of Salim Siddiqui v. The State, 1987 S C M R 2100, the petitioner tried for
manufacturing spurious drug. Analysis/test not carded out by the concerned Gazetted
Government Analyst. The report of the Analyst other than Gazerted Government Analyst was
legally valueless and the complaint having no legal foundation. The accused acquitted of the
charge.
The medicine recovered from the accused which he was selling at his shop purported to be the
drug and which according to the Chemical Analyser's report contained only lactose and starch
which meant that it had no active ingredient of the drug. Held, drug in question was deregistered
and spurious drug in circumstances. P L D 1992 Quetta 67.
Sub-standard drug (zz): Sub-standard drug is a drug which does not conform to the
specification or which is not of the identity, purity, and strength specified in Pharmacopoeia or
other relevant documents.
Drugs manufactured by the respondents were declared by Analyst that the same although
conformed to the stated specifications chemically; yet did not conform to the physical
specifications being adulterated with particles and fibres. The High Court in Constitutional
jurisdiction set aside Analyst's report, Held, to hold the samples as spurious or adulterated drugs.
Analyst was required to have stated so, or to have declared the same as filthy, putrid or
decomposed or to contain vermin, worm, rodent or insect or the same had been prepared under
unsanitary conditions so as to be contaminated with dirt, filth or any foreign matter, whereby the
same could have been rendered injurious to health. Definition of adulterated durg clearly laid
down a test and a report which did not conform to provided by law could not be considered to be
valid and legal report. Analyst's report in question, when considered within the meaning of the
definition of spurious drugs, fell outside the category of that definition. Finding of the High Court in
constitutional jurisdiction was confirmed in the intra-Court appeal in circumstances. 1992 M L D
481.
Strepsils: "Strepsils" manufactured by the petitioners was a medicament and being a drug was
exempted from sales tax. Strepsils lozenges was in fact a medicinal preparation within the
meaning of the Drugs Act, 1976 and that being so, it could not be termed as sugar confectionery
and as such could not be charged for the purposes of sales tax. Ministry of Health had uniformly
pointed out that the Strepsils lozenges were used as a remedy for treatment of infections of the
mouth and throat and a valuable adjunct to the systematic treatment of tonsils and other deep
throat infections. Levy of sales tax on such product would not be justified. Circulars issued for
imposition of sales tax were declared to be without lawful authority, of no legal effect and were
quashed. 1991 C L C Note 39, p. 27.
THE DRUGS ACT

(XXXI OF 1976)
[llth May, 1976]

An Act to regulate the import, export, manufacture, storage, distribution and sale of drugs
Preamble : Whereas it is expedient to regulate the import, export, manufacture, storage,

distribution and sale of drugs:
It is hereby enacted as follows:--
CHAPTER I
Introductory
1. Short title, extent and commencement: (1) This Act may be called the Drugs Act, 1976.
(2) It extends to the whole of Pakistan.
(3) It shall come into force at once.
COMMENTS
Object : The act provided for the control of import, export, manufacture, sale, supply and
distribution of the drugs.
In recent years there has been a great increase in the number of objectionable advertisements
published in newspapers or magazines or otherwise relating to alleged cures for venereal
diseases, sexual stimulants and cures for certain other deadly diseases. These advertisements
tended to cause the ignorant and the unwary to resort to self-medication with harmful drugs and
appliances or to resort to quacks who indulge in such advertisements for treatment which cause
great harm. It was, therefore, considered necessary in the public interest to put a stop to such
undesirable advertisements.
The Act, it should be noted, is hot in derogation of the Dangerous Drugs Act, 1930 which still
holds the field. The Drugs Act, 1940 has of course been repealed and superseded by this Act. A
comparison of the two Acts will show that the present Act is much more exhaustive and covers a
large number of new grounds, legislation in respect of which was an imperative necessity due to
the advance of times and change of tactics by manufacturers and dealers of drugs In jointly
making the best use of their profession to their personal advantage and gain regardless of the
welfare of the nation as a whole.
Preamble : Registration under the Drugs Act, 1976 would not constitute defence against the
infringement regulated by the Patents and Designs ACT; 1911, two statutes covering different
fields and controlling distinct classes of activities. P L D 1991 Kar. 252.
Islamisation of Laws: The Drugs Act, 1976 is not repugnant to Sharia P L D 1986 F S C 29.
Investigation: The Police Officers could investigate into offences under the Drugs Act, 1976
either upon their own information or on information given under Section 154, Criminal Procedure
Code, 1898 irrespective of fact whether the informant was Drugs Inspector or someone else.
1979 P Cr. L J Note 6 at p. 4.
Offence under this Act: Offence under this Act can be investigated by Police Officer either upon
his own information or upon information given to him under Section 154 Criminal Procedure
Code. (1898). Whether informer is Drug Inspector or not No provision in this Act corresponds to
Section 196 or Section 199, Criminal Procedure Code (1898). P L J 1978 Kar. 216.
Jurisdiction : The alleged offence was committed prior to enfforcement of the Drugs Act. XXXI of
1976. The Drugs Court, had no jurisdiction to take cognizance of such offence. Offence was
committed under the Drugs Act, 1940. Provision of new law (lid not permit the Drugs Court to take
cognizance of offence committed under the Act, 1940 proceedings were illegal. Prosecution could
take steps to refer case to a Court of the competent jurisdiction. 1980 P Cr. L J 738.
Act apply to provincially Administered Tribal Areas of Balochistan: No. 80 (T.A) 13-1/91,
dated 18-2-1992. In exercise of the powers conferred by clause (3) of Article 247 of the
constitution of the Islamic Republic of Pakistan, the Governor of Balochistan with the approval of
the President is pleased to direct that the drugs Act, 1976 (XXXI of 1976) and the rules made
thereunder, as in force in the, Province of Balochistan immediately before the issue of Notification
shall apply to the Provincially Administered Tribal Areas of Balochistan.
Renewal of licence under Drugs Act, 1976 : The petitioner a licensed manufacturer of the
drugs, under, the Drugs Act, 1976 submitted t, he application for renewal of licence under new
law as required by Rules. Facts revealing petitioner having been dealt with left-handedly and
adverse action having been taken rather irresponsibly in rejecting petitioner's application. Appeal
filed by petitioner heard by Appellate Board including two such members who complained of
having not been treated with respect by petitioner and launching criminal proceedings against
petitioner through Martial Law authorities in consequence whereof petitioner arrested and
remained in jail until released on bail. The Board in circumstances. could not be said to have
acted in the manner to let justice appear to be done. Justice not only to be done but has
manifestly to appear being done. Order of the Appellate Board, not with lawful authority. The case
was remitted back to be decided keeping in view background of the case, facts as well as law. P
L. D 1978 Lah. 1249.
Admissibility of admitting expenses : Claim of assessee of sale promotion expenses in excess

of five per cent. of the turn over in violation of Rr. 12 & 35 of the Drugs (Licensing, Registration
and Advertising) Rules, 1976 Admissibility. Penalty provided by Rr. 33 & 12 of Drugs (Licensing,
Registration and Advertising) Rules, 1976, having not been provided in Income tax Law, could not
be extended to the assessee's case. Expenses incurred by the assessee, on advertising sale
promotion etc., therefore, were admissible expenses. 1995 P T D 1128.
Assessing Officer disallowed expenditure incurred excess of five per cent of turn-over on sales
promotion under R. ,33 of Drugs (Licensing, Registration and Advertising) Rules, 1976 Penalty
provided under the said rule held, could not be extended to the provisions (Income Tax
Ordinance as no such penalty had been provided in the Ordinance. 1995 P T D 577.
"Hexa-Chlorophene liquid soap"-Nature of product : Nature of product, could he gauged from

properties of compound and primary use of the product. Hexa-Chlorophene Soap", containing
0.25% of the Hexa-chlorophene and 12% solution of potassium soap, registered in the National
Pharmulary as drug and primarily used for care and treatment of skin was essentially medical
drug. Such product could not be treated as article of perfumery, cosmetic or toilet preparation
1986 M L D 63.
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 (11 of 1930), and any other law for the time
being in force.
COMMENTS
No. SO. (T.A.) 13-1/91, dated 18-2-1992.-- In exercise of the powers conferred by clause (3) of
Article 247 of the Constitution of the Islamic Republic of Pakistan, the Governor of Balochistan,
with the approval of the President is pleased to direct that the Drugs Act, 1976 (XXXI of 1976)
and the Rules made thereunder, as in force in the Province of Balochistan immediately before the
issue of Notification shall apply to the Provincially Administered tribal Areas of Balochistan.

stored;

the drug;

prescribed; or
particular; or

and
COMMENTS

D 1524.

adulterated drug.
misbranded drug.
charge.
481.

stored;

the drug;

prescribed; or
particular; or

and
COMMENTS

D 1524.

adulterated drug.
misbranded drug.
charge.
481.
CHAPTER 2 - Administration and Enforcement

4. Regulation and Prohibition of Import, etc. of drugs.
5. Regulation of manufacture of drugs.
6. Regulation of sale of drugs.
7. Registration of drugs.
8. Pakistan National Formulary.
9. Appellate Board.
10. Expert Committees.
11. Provincial Quality Control Board.
12. Power to fix maximum prices of drug, etc.
13. Directions to Provincial Governments.
14. Federal Drugs Laboratory and Institutes, etc.
15. Provincial Drugs Testing Laboratory.
16. Government Analysts.
17. Inspectors.
18. Powers of Inspectors.
19. Procedure for Inspectors.
20. Persons bound to disclose place where drugs are manufactured or kept.
21. Disclosure of the name of the manufacturer.
22. Reports of Government Analysts.
4. Regulation and prohibition of import, etc., of drugs: (1) The Federal Government shall regulate
the import and export. of drugs in the prescribed manner and for that purpose may make such orders
and issue such directions to the importers and exporters as it may deem fit.
(2) If in the opinion of the Federal Government the public interest so requires, the Federal
Government may, by notification in the official Gazette,--
(a) direct that a drug or a class of drugs specified in the notification, or drugs generally, shall not be
imported or exported otherwise than under the authority of 'a license issued under this Act or except
by an importer or exporter or through an indentor registered in accordance with the rules;
(b) direct that a drug or class of drugs specified in the notification shall not be imported except by an
agency of Government so specified; or
(c) prohibit the import or export of any drug or class of drugs specified in the notification.
COMMENTS
Scope: This section empowers the Federal Government to allow or disallow the import and export of
drugs and if all need to do so in accordance with a prescribed manner and subject to directions as
may be issued. The Federal Government may also direct that a licence would be required for the
export or import of a certain drug or class of drugs or that as certain drug or class of drugs should not
be imported or exported at all or that any drug or class of drugs shall be imported only by a specified
agency of Government.
Import and export of drugs is regulated by the Drugs (Import and Export) Rules 1976, printed infra.
5. Regulation of manufacture of drugs: (1) The grant of licenses to manufacture drugs shall be
regulated in accordance with such conditions and procedure as may be prescribed, by a Central
Licensing Board to be set up by the Federal Government and consisting of such representatives of
the Federal Government and the Provincial Governments as may be prescribed.
(2) The members of the Central Licensing Board shall exercise such powers, including the powers of
an Inspector, as may be prescribed.
(3) The Central Licensing Board shall make regulations to regulate the conduct of its business.
(4) Any member of the Central Licensing Board may, at any time, by writing under his hand addressed
to the Federal Government, resign his office or shall vacate his office if the Federal Government,
being of opinion that in the public interest it is necessary so to do, so directs.
(5) Subject to sub-section (4), a member of the Central Licensing Board shall hold office for the
prescribed period.
COMMENTS
Scope : This section regulates the manufacture of drugs. Manufacture of drugs requires a licence
which will be. issued subject to such conditions and procedure as may be prescribed by a Central
Licensing Board set up by the Federal Government.
Renewal of Licence-Refusal grounds un-suitable: The renewal of a licence was refused on ground
of un-suitability of building. Mere user of a portion of premises or building for residential purpose-Held-
does not render the same un-suitable for a Licensed premises and manufacturing place only required
to be separate from residential place. P L D 1978 Lah. 445.
Interpretation of section--Presumption: A manufacturer of drugs was prosecuted for offence under

section 27 of the Drugs Act, 1940 after a report had been received from the Government Analyst that
drug was not of standard quality. No copy of the report was supplied , as required under Section 25(3)
of the Act, to manufacturer. It was, therefore, contended that the manufacturer in the circumstances
could not be prosecuted for offence under section 27 of the Act. It was held, the effect of the second
part of sub-section (3) of Section 25 of the Drugs Act, 1940 is only this that the report of the
Government Analyst cannot be treated as conclusive evidence against the person, from whom the
sample was taken, where no copy of the report was supplied to him. But under the first part of sub-
section, there is presumption that the facts stated in the report are correct. This presumption, unless
rebutted 'by contrary evidence, can be a sufficient basis for the conviction of the accused. P L D 1967
Kar. 80.
6. Regulation of sale of drugs : The Provincial Governments shall regulate the sale of drugs in the
prescribed manner and may for that purpose make such orders, and issue such directions to the
importers, manufacturers, stockists, retailers or other dealers of drugs, as they may deem fit.
COMMENTS
Scope: It may be noted that Section 4 regulates the import and export of drugs, section 5 regulates
the manufacture of drugs, while this section 6 regulates the sale of drugs. The Federal Government
may make such orders and issue such directions to importers, manufacturers, stockists, retailers or
other dealers of drugs as it may deem fit in this regard.
Criteria for issuance of Licence should have logical nexus with object of law: Drug Act, 1976 Is
an independent enactment and has been promulgated for a specified purpose of regulating the sales
etc. of the Drugs, therefore, to require a person to obtain licence under the said Act, for the sale of
drugs that he should qualify an examination prescribed for a pharmacist would amount to negation of
his fundamental right as guaranteed under Article 18 of the constitution. The criteria for prescribing
terms and conditions for issuance of licence to regulate a trade or business should be such which has
logical nexus with the object of the law. P L D 1992 Lah. 415.
The provision of Rule 20, Punjab Drugs Rules, 1988, whereby any person who was not registered as
a pharmacist under the Pharmacy Act, 1967 was debarred from entering upon trade or business of
sale of drugs, was violative of the Fundamental Right under Article 18 of the' Constitution guaranteed
to a citizen to enter upon any lawful profession or business. P L D 1992 Lah. 415.
7. Registration of drugs : (1) The Federal Government shall cause all drugs to be registered in-
accordance with such conditions and procedure as may be prescribed and for that purpose set up a
Registration Board, consisting of such number of persons, possessing such qualifications, as may be
prescribed.
Explanation: In this section, "drugs" means drugs which are in the finished form ready for use.
(2) The members of the Registration Board shall exercise such powers, including the powers of an
Inspector, as may be prescribed.
(3) The Registration Board shall make regulations to regulate the conduct of its business.
(4) Any member of the Registration Board may, at any time, by writing under his hand addressed to
the Federal Government, resign .his office or shall vacate his office if the Federal Government, being
of opinion that in the public interest it is necessary so to do, so directs.
(5) Subject to sub-section (4), the members of the Registration Board shall hold office for the
prescribed period.
(6) The Federal Government shall, by notification in the official Gazette, fix the date after which no
drug which is not registered shall be allowed to be exported, imported, manufactured, stored,
distributed or sold.
(7) A person applying for the registration of a drug shall furnish such information in respect of the drug
as may be prescribed, including information relating to its efficacy, safety, and quality, or as may be
required by the Registration Board for the purpose of the evaluation of the drug.
(8) Single-ingredient drugs shall be registered generally by their generic names while compound
drugs shall be
registered generally by their proprietary names.
Explanation: In this sub-section,--

(a) "single-ingredient drugs" means drugs containing one active ingredient;
(b) "compound drugs" means drugs containing more than one active ingredient.
(9) The registration of a drug shall be subject to such conditions, if any, as the Registration Board may
specify at the time of its registration.
(10) Where the Registration Board registers a drug, it shall inform the person applying for its
registration and the Provincial Governments of its having done so and of the conditions subject to
which it has been registered.
(11) If the Registration Board, on the basis of information received or an inquiry conducted by it, is of
opinion that--
(a) the registration of a drug was procured by fraud or misrepresentation; or
(b) the circumstances in which a drug was registered no longer exist; or
(c) there has been a violation of the conditions subject to which a drug was registered; or
(d) it is necessary in the public interest so to do;
the Registration Board may, after affording to the person on whose application the drug was
registered an opportunity of showing cause against the action proposed to be taken, cancel or
suspend the registration or specify any further conditions to which the registration shall be subject and
inform such person and the Provincial Governments accordingly.
(12) The Provincial Governments shall take all such steps as may be necessary to ensure compliance
with the
conditions subject to which a drug is registered and to prevent the manufacture or sale of a drug-- .
(a) which has not been registered; or
(b) the registration of which has been cancelled or stands suspended.
COMMENTS
Registration of drugs: Registration of drugs is not automatic but subject to fulfillment of specified
conditions and satisfaction of Registration Board. 1979 P Cr. L J Note 6 at p. 4.
The Federal Government has fixed 15th August, 1977 to be the date after which no drug which is not
registered under the said Act would be allowed to be stored, distributed or sold.
Certain steps in the manufacture Of unregistered drug being carried out in the factory of the accused
immediately on day following cut-off date. Basically drug in question being manufactured by accused
long before cutoff date and even completion certificate in respect of whole consignment of such drug
issued by the Directorate of Inspection by that date. Offence committed by the accused was technical
in nature, hence nominal fine of Rs. 1,000 was imposed, in circumstances. 1983 P Cr. L J .401.
LIST OF DE-REGISTERED DRUGS
Notification No. S.R.O. 1069(I)/85, dated 24th October, 1985: Whereas in the opinion of the
Registration Board the public interest so requires and in exercise of the powers conferred by clause
(d) of sub-section (11) of Section 7 of the Drugs Act, 1976 the said Board is pleased to notify the list of
drugs that have been de-registered from time to time,
SI. Regn No. Name of the Drug(s) Name of Manufacturer Date

No.
1 003312 Nikethamide Drops. M/s. Anglo French (Pak) Ltd., 18-10-1984
Karachi.
2 003822 Vitamin A. & D Capsules. M/s. Scherer, Australia 31-10-1984
3 003609 Surgical Silk Suture with or M/s. J. Primmer, W. Do.
without Needles (4/0, 3/0, 2/0, 0, Germany.
1, 2).
4 003610 Surgical Catgut with or without M/s. J. Primmer, W. Do.
Needles(4/0, 3/0, 2/0, 0, 1, 2). Germany.
5 002525 Seven Seas Cod Liver Oil.. M/s. British Cod Liver Oils, Do.
U.K.
6 002526 Seven Seas Cod Liver Oil Do. Do.
Capsules.
7 002822 Silk Suture with or without M/s. Ledelre, U.K. Do.
Needles(4/0, 3/0, 2/0, 0, 1,. 2).
8. 004123 Cod Liver Oil Capsules. M/s. Takeda, Japan Do
9. 003585 Gentamycin Sulphate Injection M/s. Shanghai Pharma, 5-11-1984
China.
10. 004131 Kimotab Tablets. M/s. Mochida, Japan. Do.
11. 001849 Gentamycin Injection. M/s. Dai Han Chong, Korea. 5-11-1984
12. 004167 Chymotrypsin Tablets Do. Do.
13. 001280 Catgut Plain with or without M/s. Euro Sutures, W 6-11-1984
Needles(4/0, 3/0, 2/0, O, 1, 2, 3). Germany.
14. 000814 Phisohex Cream. M/s. Sterling, U.S.A. 11-11-1984
15. 000815 Weprowin Tablets. Do. Do
16. 002109 Phillips Gripe Medicine. Do. Do.
17. 002890 Fergon Tablets Do. Do.
18. 004098 Netroferol Plus Syrup. Do. Do.
19. 004099 Intergrin Capsules. Do. Do.
20. 004179 Izal Germicide Do. Do.
21. 004513 Rocal Liquid. Do. Do.
22 004600 Franol Syrup. Do. Do.
23 002562 Fish Liver Oil Capsules. M/s. Changhai Pharma, Do.
China
24. 001030 Theodrex Tablets M/s. Riker, England 20-10-1984
25. 005124 Tandalgesic Capsules. M/s. Caba-Geigy (Pak) 18-9-1984
Limited, Karachi.
26. 000638 Irgapyrin Tablets Do. Do.
27. 001370 Tanderil Cream. Do. 7-1-1985
28. 001014 Gentamycin Injection. M/s. Dong Shin, Korea. 16-4-1985
29. 001180 Vitamin A & D Capsules. M/s. Polfa, Poland. 12-2-1985
30. 002558 Tetracycline Eye Ointment. M/s. Shanghai Pharma, 5-2-1985
China.
31. 000128 Bendryl Capsules. M/s. Parke Davis & Co., 31-3-1985
Karachi.
32. 000129 Taka-Combex Capsules. Do. Do.
33. 000209 Elec Capsules. Do. Do.
34. 000207 Abdec Capsules. Do. Do.
35. 005309 Anethol Trithion Tablet. M/s. Ferozsons, Nowshera. 26-6-1985
36. 007292 Vibramycin Paediatric Drops. M/s. Pfizer Laboratories, 14-7-1985
Karachi.
37. 000475 Terramycin Paediatric Drops. Do. Do.
38. 000502 Nardelazine Tablets. M/s. Warner Lambert (Pak) 16-7-1985
Ltd., Karachi
39. 000142 Peritrate S.A Tablets. M/s. Warner Lambert (Pak) 16-7-1985
Ltd., Karachi.
40. 000144 Peritrate Tablets, Do. Do.
41 000520 Isokin T. Forte Tablets. Do. Do.
42 000334 B.G. Phos Elixir M/s. Merck Sharp & Dhome 31-7-1985
(Pak) Ltd., Karachi,
43. 000307 Cyroheptadine S/R Capsules. Do Do.
44. 000319 Indocid Suppositories. Do Do.
45. 004547 Periactin Vita Tablets. Do. Do.
46. 001682 Predinisolone Tablets. M/s. Merck Sharp & Dhome Do.
(Pak) Ltd., Karachi
47. 000333 Injection Redisol. Do. Do.
48. 001605 Tetracycline Capsules. Do. Do.
49. 001606 Tetracycline Syrup. Do. Do.
50. 000316 Tryptanol Syrup. Do. Do.
51. 002815 Haemostate Tablets. M/s. Consolidate Chemical 25-8-1985
Labs., Lahore.
52. 002816 Haemostate Injection. Do. Do.
53. 001951 Haemostop Tablets M/s. The Schazo Do.
Laboratories Ltd., Lahore.
54. 001498 Styptobion Injection. M/s, Marker Alkaloids, Quetta Do.
55. 001499 Styptobion Tablets Do. Do.
56. 003985 Hepahionta Tablets Do. Do.
57. 001939 Anaroxyl Tablets25 mg. M/s. Hormone Laboratories Do.
58. 001620 Guanimycin Suspension, M/s, Glaxo Laboratories Do.
59. 001173 Phthalylsulphathiazole Tablets. M/s. Polfa, Poland. Do.
60. 000951 Intestine Euvernil Tablets. M/s. Von Hyden, West Do.
Germany.
61. 001843 Alkaselzer Effervescent Tablets. M/s. Miles Laboratories, Do.
Australia
62. 005029 Pentafen Tablets. M/s. Lab. Chemico, Italy. Do.
63. 005165 Heomex Tablets25 m.g. M/s. Opel Laboratories, 25-8-1985

Karachi.
64. 002767 Hemestine Tablets 25 m.g. M/s. Pakistan Pharmaceutical Do.
Products Ltd., Karachi.
65. 003182 Noxyl Tablets 25 m.g. M/s. Popular Chemical Works Do.
Ltd., Lahore.
66. 001115 Phthalylsulphathiazole Tablets. M/s. Shanghai, China. Do.
67. 004259 Rutin Compound Tablets. M/s. Regent Laboratories, Do.

Karachi.
68. 003230 Rutin K. Tablets. M/s. Chas A Mendoza, Do.
Karachi.
69. 002662 Fernidol Tablets. M/s. Lepetit, Italy. Do.
70. 003385 Clotin Tablets. M/s. Hakimsons Chemical Do.

Indus. Ltd., Karachi.
71. 003906 Rutin Compound Tablets. M/s. Dosaco Laboratories, Do.
Lahore.
72. 005270 Kagulin C Tablets. M/s. Geofman Do.
Pharmaceuticals, Karachi
73. 004436 Lomofen Suspension. M/s. Searle (Pak) Ltd., Do.
Karachi.
74. 003558 Phthatylsulphathiazole Tablets. M/s. Medexport, USSR. Do.
75 004182 Rutin Compound Tablets. M/s. Cyrus Pharma, Lahore. Do.

76. 004749 Rutin Compound Tablets. M/s. Harman Pharmaceutical, Do.
Lahore.
77. 006190 Intestopen Q.A. Tablets. M/S. Sandoz (Pak) Ltd., 9-9-1985
Karachi.
78. 000127 Adroxyd Tablets. M/s. Parke Davis & CO., 30-9-1985
Karachi.
Drug "Fucidin Leo Interlullo gauze" registered as drug, being not exempt was liable for
Customs duty & Sales Tax: It is not disputed that the "Fucidin Leo Interlullo gauze" is a drug within
the meaning of Section 3 (g) of the Drugs Act XXXl of 1976. and is also registered as a drug under:
Section 7 of the said Act, but the mere registration of substances, mixtures, powders, solutions.
bandages, agents, devices as "drugs" under the Drugs Act or any other substances which the Federal
Government may be notification in the Official Gazette declare to be "drug" for the purposes of that
Act, does not mean that in the classification of medicaments (including veterinary medicaments)" as
given in heading 30.03 of the Pakistan Customs Tariff all what comes under the definition of "drug"
under the Drugs Act, 1976, will stand included. The classification of drugs for the purposes of the
Pakistan Customs Tariff is totally different. 1988 C L C 313.
Registration of a Drug under Drug Act 1976, cannot exempt from claim under Patent Act: The
contention that the drug has been registered under Drugs Act, 1976 and registration certificate under
Section -7 of the Act has been issued by the Ministry-of-Health Held, mere registration of the Drug
with the Ministry of Health under the Drugs Act cannot immunise the Defendants against claims of
aggrieved parties under the Patent and Design Act, 1911. 1987 C L C 1571.
8. Pakistan National Formulary: The Federal Government shall compile and publish in the official
Gazette Pakistan National Formulary comprising all drugs allowed to be imported, manufactured or
sold and such Formulary may be reviewed and modified from time to time.
9. Appellate Board : (1) The: Federal Government shall, in accordance with the rules, constitute an
Appellate Board for the disposal of appeals preferred by persons aggrieved by any decision of the
Central Licensing Board or the Registration Board or the Licensing Authority or a Board or Authority to
which the powers of the Federal Government under section 12 have been delegated under sub-
section (3) of that section and for revision of any such decision on its own motion.
(2) The Appellate Board shall consist of such representatives of the Federal Governments and the
Provincial Governments, including a Chairman, as the Federal Government may from time to time
appoint.
(3) Subject to sub-section (4), the Chairman and other members of the Appellate.-Board shall hold
office for the prescribed period.
(4) The Chairman or any other member of the Appellate Board may, by writing under his hand
addressed to the Federal Government, resign his office or shall vacate his office if the Federal
Government, being of opinion that in the public interest it is necessary so to do, so directs.
(5) The members of the Appellate Board shall exercise such powers, including the powers of an
(6) The Appellate Board may appoint experts for the purposes of detailed study of any specific matter
before it.
(7) The Appellate Board shall make regulations to regulate the conduct of its business.
COMMENTS
Constitutional jurisdiction, invoking of : The constitutional jurisdiction of the High Court, could not
be invoked where order of the authority was based on facts within the exclusive domain of such
authority. The alternate remedy of appeal having not been availed of by affected person, constitutional
jurisdiction could not be resorted to. 1986 C L C 1610.
10. Expert Committees: (1) The Federal Government may constitute committees of experts on
Drugs Evaluation, on Pakistan Pharmacopoeia, on Advertising and on such other matters as may be
necessary for the purposes of this Act.
(2) Each committee constituted under sub-section (1) shall consist of such members as the Federal
Government may appoint from time to time and each such member shall hold office during the
pleasure of the Federal Government.
11. Provincial Quality Control Board: (1) Each Provincial Government shall set up a Provincial
Quality Control Board consisting (3f such members, including a Chairman, as that Government may
appoint from time to time.
(2) The Chairman and other members of the Provincial Quality Control Board shall hold office during
the pleasure of the Provincial Government, on such terms and conditions as that Government may
determine.
(3) 'The provincial Government shall appoint a person to be the Secretary of the Provincial Quality
Control Board and provide the Board with such staff as the Provincial Government may consider
necessary.
(4) The Provincial Quality Control Board shall make regulations to regulate the conduct of its
business.
(5) The following shall be the powers and functions of the Provincial Quality Control Board, namely:--
(a) to inspect any premises where any drug is being or is to be, manufactured or sold and to
recommend to the appropriate authority the cancellation or suspension of the licence to manufacture
or sell drugs granted to any person who is found to be contravening, or to have contravened, any of
the provisions of this Act, or the rules;
(b) to scrutinize the reports of Provincial Inspectors in respect of contraventions of this Act and
'reports of the Government Analysts in respect of drugs Sent to them by the Provincial Inspectors for
test and analysis and issue instructions to the Inspectors to the action to be taken on such reports:
Provided that the Provincial Quality Control Board may specify the class of cases in which a Provincial
Inspector may make a complaint to the Drug Court, or take any other action, without the specific
instructions of the Board;
(c) to exercise all the powers of an Inspector under this Act and the rules; and
(d) to advise the Provincial Government on ways and means to ensure quality control of drugs
manufactured in the Province.
(6) The Provincial Quality Control Board may entrust any of its powers or functions under sub-section
(5) to any one or more of its members.
COMMENTS
No prosecution could be launched without the permission of the Quality Control Board. Permission for
prosecution should not be given by the Board in the presence of the negative report of Laboratory.
1989 P Cr. L J 566.
Sanction for prosecution granted by Board without issuing show-cause notice to accused
manufacturer would be violatire of requirement of rule 4(3)(4). Complaint lodged before Drugs Court
on basis of Such illegal sanction would be null and void. Such violation of R.4(3)(4) is a serious
illegality and not merely an omission with result that inception of proceedings before: Drugs Court on
basis of such sanction complaint would stand invalidated not nullified. Accused manufacturer in such
case would be entitled to discharge by Drugs Court in exercise of its powers under. Section 265 K Cr.
P C. N L.R 1994 Cr. J 648.
12. Power to fix maximum prices of drug, etc.: (1)

The Federal Government may, by notification in the official Gazette,--
(a)fix the maximum price at which any drug specified in the notification is to be sold; and
(b) specify a certain percentage of the profits of manufacturers of drugs which shall be utilised, in
accordance with the rules for purposes of research in drugs.
(2) For the purpose of the exercise of its powers under sub-section (1), the Federal Government may
require a manufacturer, stockist, importer, exporter, retailer or other dealer in drugs to furnish such
relevant information as may be necessary.
(3) The Federal Government may, by notification in the official Gazette, delegate any of its powers
under this section .to any Board or other authority.
13. Directions to Provincial Governments : The Federal Government may give such directions to a
Provincial Government as may appear to the Federal Government to be necessary for carrying into
execution in the Province of any of the provisions of this Act or of any rule or order made thereunder
or for maintaining supplies of drugs of standard quality at reasonable prices or for the achievement of
uniformity in respect of any matter in different parts of Pakistan.
14. Federal Drugs Laboratory and institutes etc.: The Federal Government shall, as soon as may
be, establish a Federal Drug Laboratory and may also set up such other institutes and drugs testing
and research laboratories for the purposes of this Act as may be prescribed.
15. Provincial Drugs Testing Laboratory : Each Provincial Government shall, as soon as may be,
set up a Provincial Drugs Testing Laboratory for such purposes as may be prescribed.
16. Government Analysts: The Federal Government or a Provincial Government may, by notification
in the official Gazette, appoint such persons as it thinks fit, having the prescribed qualifications, to be
the Federal Government Analysts or, as the case may be, Provincial Government Analysts, for such
areas and in respect of such drugs or classes of drugs as may be specified in the notification:
Provided that no person who has any financial interest in the manufacture, import, export or sale of
drugs shall be so appointed:
Provided further that a person serving under the Federal Government or another Provincial
Government shall not be so appointed without the previous consent of that Government.
COMMENTS
Scope : This section is not ultra vires the provisions of the Constitution as it has sufficiently, 3rotacted
the basic right of an accused to defend himself. A I R 1958 All. 865. (Under the section it is open to
the accused to rebut the report of the Analyst and the Court to reject the report when it is satisfied with
the rebuttal).
The report itself when it embodies the protocols of tests applied by the analyst would become
conclusive evidence of the results therein. A I R 1959 Cal. 427. (The official statement or account
which is the description of the experiment or clinical report is the protocol of test within the meaning of
R. 5 of the Drugs Rules.)
A report of the Analyst which simply states the result of the test but does not give the protocols at all is
not conclusive evidence of the facts stated in it. A I R 1959 All. 634. Failure to give the protocol would
seriously prejudice the accused in his defence and hence his conviction cannot be sustained. A I R
1958 All. 865. Report not containing factual data cannot be treated as conclusive evidence.
The report of the analyst becomes conclusive only when it has not been challenged according to the
procedure prescribed in the section. 1955 All. WR (HC) 328.
Chemical Examiner's opinion--Evidentiary value: The Chemical Examiner's opinion is sought for
the aid and assistance of the Court Court is, however, competent to disbelieve such report if no
plausible reasons have been put forth by the expert in support of his opinion. P L D 1992 Quetta 67
(c).
17. Inspectors : The Federal Government or a Provincial Government may, by notification in the
official Gazette, appoint such persons as it thinks fit, having the prescribed qualifications, to be
Federal Inspectors, or, as the case may be, Provincial Inspectors for the purposes of this Act within
such local limits as it may assign to them respectively:
any drug shall be appointed:
Government shall not be .so appointed without the previous consent of such Government.
COMMENTS
Drug Inspector not notified effect: Prosecution for offences under Sections 23(1), (b), 23(1)(a) (vii)
launched by an Inspector who is not notified within meaning of Section 17 should not be allowed to
sustain, such prosecution being incompetent under Section 30. 1984 Cr. L J 492.
Requirement of Drug/Inspector: Requirement about appointment of a person as Drug Inspector is

mandatory proceedings from stage of taking test upto filing of complaint by a person who is not
notified as Drug Inspector would be unwarranted. N L R 1993; Cr. L J 102(a).
A notification appointing all District Medical Officers as inspectors under the Act can be in general
terms. Failure to state in the Notification that such Medical Officers should possess qualifications laid
down in the rules will not render the notification invalid. 1955 All. WR (HC) 328.
An officer of the Public Health Department who is also a registered medical practitioner can be
appointed as ex officio inspector for the purposes of inspecting retail shops. Such an appointment is
justified by R 49, Proviso 3. AIR 1958 All, 163.
Record showing no order of' appointment of the Drugs Inspector haying been produced before the
trial Court at all and Notification issued in this behalf not indeed a notification as stipulated by section
17 of the Act. Since no prosecution can be instituted except by a properly appointed Drug Inspector,
conviction and sentence awarded to appellant, were set aside, in circumstances. 1982 P Cr. L J 48.
Complaint lodged by Inspector whose notified appointment did not conform with section 17, the
recovery not witnessed by two respectable persons of locality as required by section 103, Cr.P.C.
Circumstances not suggesting any probability of accused being convicted of any offence in the long
run. The Drug. Court accepted accused's application under section 149-A, Cr.P.C. and ordered their
acquittal. N L R 1985 Cr. L J 264.
Drug Inspectors appointment Improper--Sentence set aside :. Record showing no order of

appointment of Drug Inspector having been produced before Trial Court at all and Notification issued
in this behalf not indeed a notification as stipulated by Section 17 of Act. Since no prosecution can be
instituted except by a properly appointed Drugs Inspector, Conviction and. sentence awarded to
appellant, set aside in (circumstances. 1982 P. Or. L J 48.
18. Powers of, Inspectors : (1) Subject to the provisions of section 19 and of any rules made in this
behalf, an Inspector may, within the local limits for which he is appointed, and in any other area within
the permission of the licensing authority,-
(a) inspect any premises-wherein any drug is manufactured, the plant and process of manufacture,
the means employed for standardising and testing the drugs and all relevant records and registers;
(b) inspect any premises wherein any drug is sold or is stocked or exhibited for sale or is distributed,
the storage arrangements 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, with such assistance, if any, as he considers necessary, any building, vessel or
place, in which he has reason to believe that an offence under this Act or any rules has been or is
being committed or may continue to be committed;
(e) call any person to be present as witness in the course of search or seizure or in connection with
any other matter where the presence of witnesses is necessary;
(f) seize such drug and all materials used in the manufacture thereof and any other articles, including
registers, cash memos, invoices and bills, which he has reason to believe may furnish evidence of the
commission of an offence punishable under this Act or any rules;
(g) require any person to appear before him at any reasonable time and place to give statement,
assistance or information relating to or in connection with the investigation of an offence under this Act
or the rules:
Provided that the exemptions under Sections 132 and 133 of the Code of Civil Procedure, 1908 (Act V
of 1908), shall be applicable to requisitions for attendance under this Clause;
(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 in contravention of any
of the provisions of this Act or the rules;
(i) forbid for a reasonable period, not exceeding four weeks or such further period, which shall not be
more than three months, as the Inspector may, with. the approval of the Provincial Quality Control
Board, the Central Licensing Board, the Registration Board, or the licensing authority, as the case
may be, specify, any person in charge of any premises
from removing or dispensing of any drug, article or other thing likely to be used in evidence of the
commission of an offence under this Act or the rules; and
(j) exercise such other powers as may be necessary for carrying out the purposes of this Act or any
rules:
Provided that the powers under causes (f) to (j) shall be exercisable only by an Inspector specifically
authorised in this behalf, by an order in writing, by the Government appointing him, subject to such
conditions as may be specified in such order:
Provided further that the power under clause (h) may be exercised by an Inspector not authorised as
aforesaid where the contravention is of a provision which requires a licence to be obtained for the
manufacture, storage or sale of a drug.
(2) The provisions of the Code of Criminal Procedure, 1898 (Act V of 1898), in so far as they are not
inconsistent with the provisions of this Act, shall apply to searches and seizures made under this Act.
COMMENTS
Powers of Inspectors : The duties entrusted to the Inspectors conveniently called "Inspectors for the
purpose of inspection of retail shops" cover a wider range than mere inspection of retail shops. Such
an Inspector can, therefore, search any premises (such as the dwelling house and not only the retail
shop) in order to detect any sale of drugs in contravention of the Act, A I R 1958 All. 163.
Powers of search and seizure given to the Drugs Inspectors under Section 18(1) is not restricted to
such officers. Searches and seizures in respect of offences under section 27(1), could also be made
by the Police Officers. Police Officers in such cases, was not required to follow procedure laid down in
section 19 but to follow procedure prescribed under the Code of Criminal Procedure, 1898, Section
109. 1979 P Cr. L J Note 6 at p. 4.
Sanction of competent authority--Violation of licensing conditions--Sealing of premises: Shop

sealed by the Drugs Inspector for violation of licensing conditions for more than four weeks. Effect of
no sanction from competent authority obtained for sealing premises beyond four weeks, sealing of
premises beyond four weeks, was in contravention of provisions of section 18-H (1) and without lawful
authority, under these circumstances premises ordered to be desealed. 1988 P Cr. L J 1328.
Effect of repeal : Object of enacting section 6 of the General Clauses Act is to protect rights and
liabilities already accrued or incurred under repealed law. Drugs Act of 1976, while repealing Act of
1940 has not provided a saving clause. Complaint not made regarding alleged offence under section
18 of Act of 1940 before repeal of Act was a vested right or liability as envisaged under section 6,
could not be deemed to have accrued for enforcing same under the repealing enactment. P L D 1980
Lah. 195.
Sample of drugs was submitted by the Inspector of Drugs to Government Analyst for test and
analysis. Report of the Analyst was not received within the prescribed period of sixty days and
necessary permission of the Quality Control Board not obtained for extension of time and Inspector
was not communicating about submission of testing method to manufacturers. Report was received
after prescribed period, not conclusive and the Drugs Analyst committed violation of relevant provision
of law by submitting report without obtaining extension of time from the Board. 1984 P Cr. L J 1580.
or the rules:
rules:
COMMENTS
109. 1979 P Cr. L J Note 6 at p. 4.

Lah. 195.
19. Procedure for Inspectors: Where an Inspector seizes any drug or any other article under section
18, he shall tender a receipt therefor in the prescribed form.
(2) 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 wilfully absents himself, shall divide the sample into four portions
and effectively seal and suitably mark the same and permit such persons to add his own seal, if any,
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:
Provided further that if the contents of one container are insufficient for the laboratory test and
analysis, the Inspector may increase the number of the containers in order to make the sample
sufficient for this purpose.
(3) 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
within seven days as follows :-
(i) one portion of sample he shall send to the Government Analyst concerned for test and analysis;
(ii) the second he shall send to the chairman, Provincial Quality Control Board or the Central
Licensing Board or the Registration Board, as the case may be; and
(iii) the third, where taken, he shall send to the warrantor, if any, named under the proviso to sub-
section (3) of Section 32.
(4) Where an Inspector seizes any drug containing any filthy or putrid substance, vermin, worm,
rodent, insect or any foreign matter which is visible to the naked eye, and the sample is such that it
cannot or need not be divided, he shall effectively seal and suitably mark the same and permit the
person from whom he seizes the drug to add his own seal, if any, and mark to it and shall produce the
same before the Drug Court or the Central Licensing Board or the Registration Board, as the case
may be, before which proceedings are instituted or action is initiated in respect of the drug.
(5) Where an Inspector takes any action under section 18,--
(a) he shall as soon as practicable ascertain whether or not the drug contravenes any of the
provisions of this Act and, it is ascertained that the drug does not so contravene, he shall forthwith
revoke the order passed under the said section or, as the case may be, take such action as may be
necessary for the return of the stock seized and payment for the samples taken, under intimation to
the Board concerned;
(b) if he seizes the stock of the drug he shall, as soon as may be inform the Board concerned and
take its order as to the custody thereof:
Provided that where a Federal Inspectors not competent to take action under section 30, he shall as
soon as may be, report the matter and hand over the stock, if any, to the Provincial Inspector for
further action under this Act.
(6) The Provincial Inspector on finding any contravention of this Act shall, unless the Board otherwise
directs, always refer the case to the Provincial Quality Control
Board and seek orders as to the action to be taken in respect of such contravention.
(7) The Federal Inspector on finding any contravention of this Act for which he is authorised shall,
unless otherwise directed, always refer the case to the Central Licensing Board or the Registration
Board or any other authority as may be specified for the purpose and seek any further orders as to the
action to be taken in respect of such contravention.
COMMENTS
Analyst Report received after prescribed period not conclusive: Sample of drugs submitted by
Inspector of Drugs to Government Analysis for test and analysis. Report of analyst not received within
prescribed period of sixty days and necessary permission of Quality Control Board not obtained for
extension of time and Inspector not communicating about submission of testing method to
manufacturers. Report received after prescribed period, held, not conclusive and Drugs Analyst
committed violation of relevant provisions of law by submitting report without obtaining extension of
time from Board. 1984 P Cr. L J 1580.
The accused was charged for offence of the manufacturing drugs without obtaining registration of
such drugs in the name of firm. Action was initiated against firm only within half an hour of expiry of
date for the manufacture of drugs without registration and possibility that workers were cleaning
machines when premises raided was not ruled out. Seizure of drugs also not strictly in accordance
with law as no receipt after seizure passed on to accused in the prescribed form as required by
Section 19 of the Drugs Act. All preparations to raid premises complete before mid-night of the date
when firm still was within the permissible limits of the manufacturing drugs without registration.
Deliberate efforts were made to harass the accused in circumstances. The conviction and sentence
were set aside. 1982 P Cr. L J 175.
Directions in regard to making and submission of test reports, held, not directory but mandatory and
the Drug Court could not convict accused if directions not strictly observed and reports not submitted
in the prescribed manner. 1985 P Cr. L J 281.
20. 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, disclose to the Inspector the place
where the drug is being manufactured or is kept, as the case may be.
21. Disclosure of the name of the manufacturer: Every person, not being the manufacturer of a
drug or his agent for the distribution thereof, shall if so required by an Inspector, disclose to him the
name, address and other particulars of the manufacturer or other person from whom he acquired the
drug.
22. Reports of .Government Analysts : (1) The Government Analyst to whom a sample of any drug
has been submitted for test and analysis under sub-section (3) of section 19 shall deliver to the
Inspector submitting it a signed report in quadruplicate in the prescribed form and forward one copy
thereof to the authority as may be prescribed.
(2) The Government Analyst, as far as may be, shall submit the report referred to in sub-section (1)
within sixty days of the receipt by him of the sample of the drug and, if he is not able to do so for
reasons beyond his control, shall communicate the reasons to the Inspector in writing and shall
endorse its copy to the Board concerned who shall have the sample tested from the same or any
other Government Analyst or a Government Drug Testing Laboratory or any other Laboratory and
shall ensure the receipt of results of such test and analysis within a further period as may be
prescribed and shall make the test report available to the Inspector for further action.
(3) On receipt of the report, the Inspector shall--

(a) deliver one copy thereof to the person from whom the sample was taken;
(b) forward one copy to the warrantor, if any, named under the proviso to sub-section (3) of Section
32;
(c) forward one copy to the Board concerned for its directions as to the action to be taken on the
report; and
(d) retain the fourth copy for use in any prosecution or for any other purpose.
(4) Notwithstanding anything contained in any other law for the time being in force, any document
purporting to be a report signed by a Government analyst shall be admissible as evidence of the facts
stated therein without formal proof and such evidence shall be conclusive unless the person from
whom the sample was taken or the said warrantor has, within thirty days of the receipt of a copy of the
report notified in writing to the Inspector or the Drug Court or, as the case may be, the Central
Licensing Board or the Registration Board before which any proceedings in respect of the sample are
pending that he intends to adduce evidence in controversion of the report.
(5) Where a person has, under sub-section (4), notified his intention of adducing evidence in
controversion of a Government Analyst's report, the Drug Court or the Board concerned 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 lying with the Board concerned under sub-section (3) of section 19 to be sent for
test or analysis to the Federal Drug Laboratory or any other laboratory specified for the purpose by
the Federal Government which shall make the test or analysis and report in writing signed by, or
under the authority of the person for the time being incharge of the Federal Drug Laboratory, or, as
the case may be, such other laboratory, the result thereof and such report shall be conclusive
evidence of the facts stated therein.
(6) The cost of a test or analysis made by the Federal Drug Laboratory or other laboratory under sub-
section (5) shall be paid by the complainant or accused as the Drug Court or the Board concerned
shall direct.
COMMENTS

the drug was not of standard quality. No copy of the report was supplied, as required under section
25(3) of the Act, to manufacturer. It was, therefore, contended that the manufacturer in the
circumstances, could not be prosecuted for offence under section 27 of the Act. It was held that the
effect of the second part of sub-section (3) of section 25 of the Drugs Act, 1940, is only this that the
report of the Government Analyst cannot be treated as conclusive evidence against the person, from
whom the sample was taken, where no copy of the report was supplied to him. But under the first part
of sub-section (3) there is presumption that the facts stated in the report are correct. This
presumption, unless rebutted by contrary evidence, can be a sufficient basis for the conviction of the
accused. P L D 1967 Kar. 80.
Substandard drugs : Record not showing that after purchasing drugs from manufacturer whether the
same were stored under the conditions Paid down or stated on carton. Reasonable possibility of
sample obtained by the Drug Inspector and subsequently sent to the National Health Laboratory
having been deteriorated due to its improper storage after purchase from the manufacturers not ruled
out Accused, held, entitled to the benefit of doubt and the conviction and sentence were set aside.
1985 P Cr. I. J 281.
Mere non-compliance with section does not make report inadmissible: Sub-section (2) of section
25 of the Drugs Act. 1940 requires that a copy of the report of the Government Analyst shall be
delivered to the person from whom the sample is taken and another copy to the warrantor, if any,
named under the proviso to sub-section (3) of Section 19. Then comes sub-section (3) which makes
the report evidence of the facts stated therein and furthermore makes it 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".
It will thus be seen that the contents of the report not only prove themselves but are also considered
to be conclusive unless objection is made. Sub-section (3) of section 25 provides the consequence of
non-compliance with the provisions of sub-section (2) of the said section. Thus, if no report is supplied
all that happens is that the contents of the report do not become conclusive evidence; but they are
nevertheless evidence and rebuttable at the stage of the trial. This does not mean that at the trial the
contents of the report cannot be utilised as evidence. The intention of the legislature appears to be to
merely give an adequate opportunity to the person charged to challenge the correctness of the report.
If this has not been done, then the contents of the report become conclusive evidence. If any event,
the provisions are clear and leave no room for doubt that if the copy of the report is not supplied to the
accused, the report is, nevertheless, admissible in evidence and proves itself but its contents are not
conclusive evidence. On the other hand, if a copy has been supplied and the appellant does not raise
any objection within the time prescribed, then the report becomes conclusive evidence and cannot
even be rebutted. P L D 1973 S C 299.
Report of Public Analyst did not complete with "full protocols of tests" and silent as to how he arrived
at conclusion regarding low percentage of Tetracycline hydrochloride in sample. Order of the trial
Court rejecting application for summoning Public Analyst as witness was set aside, in circumstances.
Court further directed to summon witness to produce full protocols of tests, in the interest of justice.
1977 P Cr. L J 822.
Accused failed to challenge the Government Analyst's report within statutory period of 30 days by
notifying to any of the authorities specified in sub-section (4) of Section 22 of the Act, regarding their
such intention. Report was conclusive proof of its contents. Contention that report being silent about
full protocols was of no consequence. 1984 P Cr. L J 2007.
Potency and the state of certain drugs, was depended to some extent upon conditions in which they
were required to be stored and had actually been stored prior to test by the concerned laboratory.
1984 P Cr. L J 1580.
Analyst submitted his report beyond the period prescribed by law without obtaining extension from the
Quality Control Board. Drug Analyst committed violation of provisions of law and report sent by him
not in the prescribed form. 1985 P Cr. L J 281.
Appeal against acquittal: The accused respondents had a right to request for retesting of samples
and Section 22(5) of the Drugs Act, 1976, makes it compulsory for prosecution to send the samples
for retesting to the Federal Drugs Laboratory or any other laboratory specified for the purpose by the
Federal Government. The accused had not given up their such request and their right could not be
brushed aside on basis of their letters which did not amount to unconditional admission of guilt as
provisions of law have to be strictly followed. Letters were addressed to the Provincial Quality Control
Board and not to proper quarters. The trial Court, held, had rightly given benefit of doubt to the
accused in view of clear violation of Section 22(5) of the Drugs Act, 1976. Appeal against the acquittal
was dismissed in circumstances. 1990 P Cr. L J 865.
Finding of the Drugs Court that test report was not according to law was correct. Drugs Court had also
rightly concluded that the said report would not be conclusive as provided under Section 22(4) of the
Drugs Act. Provincial Quality Control Board had sent the sample for retesting in contravention of sub-
sections (4) and (5) of Section 22 of the Drugs Act and as such second report was illegal under such
circumstances appeal against the acquittal of the accused was dismissed. 1991 P Cr. L J 1363.
After an accused has secured acquittal from a Court, the Appellate Court will not interference until
prosecution shows conclusively that inference of guilty is irresistible and indications of error in the
judgment are clear and evidence more cogent and convincing in support of prosecution case is
available. 1991 P Cr. L J 1363.
CHAPTER II
Administration and Enforcement
COMMENTS
prescribed period.
COMMENTS

Kar. 80.
COMMENTS
prescribed.
prescribed period.
drugs shall be

opinion that--
with the
COMMENTS

No.
Karachi.
1, 2).
Needles(4/0, 3/0, 2/0, 0, 1, 2). Germany.
U.K.
Capsules.
Needles(4/0, 3/0, 2/0, 0, 1,. 2).
China.
China
Limited, Karachi.
China.
Karachi.
Karachi.
Ltd., Karachi
Ltd., Karachi.
(Pak) Ltd., Karachi
Labs., Lahore.
Germany.
Australia

Karachi.
Ltd., Lahore.

Karachi.
Karachi.

Lahore.
Karachi.

Lahore.
Karachi.
Karachi.
appoint.
before it.
COMMENTS
determine.
necessary.
business.
COMMENTS
1989 P Cr. L J 566.
P C. N L.R 1994 Cr. J 648.

COMMENTS
the rebuttal).
(c).
COMMENTS


or the rules:
rules:
COMMENTS
109. 1979 P Cr. L J Note 6 at p. 4.

Lah. 195.
or the rules:
rules:
COMMENTS
109. 1979 P Cr. L J Note 6 at p. 4.

Lah. 195.
COMMENTS
drug.

32;
report; and
shall direct.
COMMENTS

1985 P Cr. I. J 281.
1977 P Cr. L J 822.
1984 P Cr. L J 1580.
CHAPTER II
COMMENTS
prescribed period.
COMMENTS

Kar. 80.
COMMENTS
prescribed.
prescribed period.
drugs shall be

opinion that--
with the
COMMENTS

No.
Karachi.
1, 2).
Needles(4/0, 3/0, 2/0, 0, 1, 2). Germany.
U.K.
Capsules.
Needles(4/0, 3/0, 2/0, 0, 1,. 2).
China.
China
Limited, Karachi.
China.
Karachi.
Karachi.
Ltd., Karachi
Ltd., Karachi.
(Pak) Ltd., Karachi
Labs., Lahore.
Germany.
Australia

Karachi.
Ltd., Lahore.

Karachi.
Karachi.

Lahore.
Karachi.

Lahore.
Karachi.
Karachi.
appoint.
before it.
COMMENTS
determine.
necessary.
business.
COMMENTS
1989 P Cr. L J 566.
P C. N L.R 1994 Cr. J 648.

COMMENTS
the rebuttal).
(c).
COMMENTS


or the rules:
rules:
COMMENTS
109. 1979 P Cr. L J Note 6 at p. 4.

Lah. 195.
or the rules:
rules:
COMMENTS
109. 1979 P Cr. L J Note 6 at p. 4.

Lah. 195.
COMMENTS
drug.

32;
report; and
shall direct.
COMMENTS

1985 P Cr. I. J 281.
1977 P Cr. L J 822.
1984 P Cr. L J 1580.
CHAPTER II
COMMENTS
prescribed period.
COMMENTS

Kar. 80.
COMMENTS
prescribed.
prescribed period.
drugs shall be

opinion that--
with the
COMMENTS

No.
Karachi.
1, 2).
Needles(4/0, 3/0, 2/0, 0, 1, 2). Germany.
U.K.
Capsules.
Needles(4/0, 3/0, 2/0, 0, 1,. 2).
China.
China
Limited, Karachi.
China.
Karachi.
Karachi.
Ltd., Karachi
Ltd., Karachi.
(Pak) Ltd., Karachi
Labs., Lahore.
Germany.
Australia

Karachi.
Ltd., Lahore.

Karachi.
Karachi.

Lahore.
Karachi.

Lahore.
Karachi.
Karachi.
appoint.
before it.
COMMENTS
determine.
necessary.
business.
COMMENTS
1989 P Cr. L J 566.
P C. N L.R 1994 Cr. J 648.

COMMENTS
the rebuttal).
(c).
COMMENTS


or the rules:
rules:
COMMENTS
109. 1979 P Cr. L J Note 6 at p. 4.

Lah. 195.
or the rules:
rules:
COMMENTS
109. 1979 P Cr. L J Note 6 at p. 4.

Lah. 195.
COMMENTS
drug.

32;
report; and
shall direct.
COMMENTS

1985 P Cr. I. J 281.
1977 P Cr. L J 822.
1984 P Cr. L J 1580.
CHAPTER II
COMMENTS
prescribed period.
COMMENTS
Kar. 80.
COMMENTS
prescribed.
prescribed period.
drugs shall be

opinion that--
with the
COMMENTS

No.
Karachi.
1, 2).
Needles(4/0, 3/0, 2/0, 0, 1, 2). Germany.
U.K.
Capsules.
Needles(4/0, 3/0, 2/0, 0, 1,. 2).
China.
China
Limited, Karachi.
China.
Karachi.
Karachi.
Ltd., Karachi
Ltd., Karachi.
(Pak) Ltd., Karachi
Labs., Lahore.
Germany.
Australia

Karachi.
Ltd., Lahore.

Karachi.
Karachi.

Lahore.
Karachi.

Lahore.
Karachi.
Karachi.
appoint.
before it.
COMMENTS
determine.
necessary.
business.
COMMENTS
1989 P Cr. L J 566.
P C. N L.R 1994 Cr. J 648.

COMMENTS
the rebuttal).
(c).
COMMENTS


or the rules:
rules:
COMMENTS
109. 1979 P Cr. L J Note 6 at p. 4.

Lah. 195.
or the rules:
rules:
COMMENTS
109. 1979 P Cr. L J Note 6 at p. 4.

Lah. 195.
COMMENTS
drug.
32;
report; and
shall direct.
COMMENTS

1985 P Cr. I. J 281.
1977 P Cr. L J 822.
1984 P Cr. L J 1580.
9. Appellate Board : (1) The: Federal Government shall, in accordance with the rules, constitute
an Appellate Board for the disposal of appeals preferred by persons aggrieved by any decision of
the Central Licensing Board or the Registration Board or the Licensing Authority or a Board or
Authority to which the powers of the Federal Government under section 12 have been delegated
under sub-section (3) of that section and for revision of any such decision on its own motion.
(2) The Appellate Board shall consist of such representatives of the Federal Governments and
the Provincial Governments, including a Chairman, as the Federal Government may from time to
time appoint.
(3) Subject to sub-section (4), the Chairman and other members of the Appellate.-Board shall
hold office for the prescribed period.
(6) The Appellate Board may appoint experts for the purposes of detailed study of any specific
matter before it.
COMMENTS
Constitutional jurisdiction, invoking of : The constitutional jurisdiction of the High Court, could
not be invoked where order of the authority was based on facts within the exclusive domain of
such authority. The alternate remedy of appeal having not been availed of by affected person,
constitutional jurisdiction could not be resorted to. 1986 C L C 1610.
Drugs Evaluation, on Pakistan Pharmacopoeia, on Advertising and on such other matters as may
be necessary for the purposes of this Act.
(2) Each committee constituted under sub-section (1) shall consist of such members as the
Federal Government may appoint from time to time and each such member shall hold office
during the pleasure of the Federal Government.
Quality Control Board consisting (3f such members, including a Chairman, as that Government
may appoint from time to time.
(2) The Chairman and other members of the Provincial Quality Control Board shall hold office
during the pleasure of the Provincial Government, on such terms and conditions as that
Government may determine.
(3) 'The provincial Government shall appoint a person to be the Secretary of the Provincial
Quality Control Board and provide the Board with such staff as the Provincial Government may
consider necessary.
business.
(5) The following shall be the powers and functions of the Provincial Quality Control Board,
namely:--
recommend to the appropriate authority the cancellation or suspension of the licence to
manufacture or sell drugs granted to any person who is found to be contravening, or to have
contravened, any of the provisions of this Act, or the rules;
'reports of the Government Analysts in respect of drugs Sent to them by the Provincial Inspectors
for test and analysis and issue instructions to the Inspectors to the action to be taken on such
reports:
Provided that the Provincial Quality Control Board may specify the class of cases in which a
Provincial Inspector may make a complaint to the Drug Court, or take any other action, without
the specific instructions of the Board;
(6) The Provincial Quality Control Board may entrust any of its powers or functions under sub-
section (5) to any one or more of its members.
COMMENTS
No prosecution could be launched without the permission of the Quality Control Board.
Permission for prosecution should not be given by the Board in the presence of the negative
report of Laboratory. 1989 P Cr. L J 566.
manufacturer would be violatire of requirement of rule 4(3)(4). Complaint lodged before Drugs
Court on basis of Such illegal sanction would be null and void. Such violation of R.4(3)(4) is a
serious illegality and not merely an omission with result that inception of proceedings before:
Drugs Court on basis of such sanction complaint would stand invalidated not nullified. Accused
manufacturer in such case would be entitled to discharge by Drugs Court in exercise of its powers
under. Section 265 K Cr. P C. N L.R 1994 Cr. J 648.

(2) For the purpose of the exercise of its powers under sub-section (1), the Federal Government
may require a manufacturer, stockist, importer, exporter, retailer or other dealer in drugs to
furnish such relevant information as may be necessary.
(3) The Federal Government may, by notification in the official Gazette, delegate any of its
powers under this section .to any Board or other authority.
13. Directions to Provincial Governments : The Federal Government may give such directions
to a Provincial Government as may appear to the Federal Government to be necessary for
carrying into execution in the Province of any of the provisions of this Act or of any rule or order
made thereunder or for maintaining supplies of drugs of standard quality at reasonable prices or
for the achievement of uniformity in respect of any matter in different parts of Pakistan.
14. Federal Drugs Laboratory and institutes etc.: The Federal Government shall, as soon as
may be, establish a Federal Drug Laboratory and may also set up such other institutes and drugs
testing and research laboratories for the purposes of this Act as may be prescribed.
15. Provincial Drugs Testing Laboratory : Each Provincial Government shall, as soon as may
be, set up a Provincial Drugs Testing Laboratory for such purposes as may be prescribed.
16. Government Analysts: The Federal Government or a Provincial Government may, by

notification in the official Gazette, appoint such persons as it thinks fit, having the prescribed
qualifications, to be the Federal Government Analysts or, as the case may be, Provincial
Government Analysts, for such areas and in respect of such drugs or classes of drugs as may be
specified in the notification:
Provided that no person who has any financial interest in the manufacture, import, export or sale
of drugs shall be so appointed:
COMMENTS
Scope : This section is not ultra vires the provisions of the Constitution as it has sufficiently,
3rotacted the basic right of an accused to defend himself. A I R 1958 All. 865. (Under the section
it is open to the accused to rebut the report of the Analyst and the Court to reject the report when
it is satisfied with the rebuttal).
which is the description of the experiment or clinical report is the protocol of test within the
meaning of R. 5 of the Drugs Rules.)
A report of the Analyst which simply states the result of the test but does not give the protocols at
all is not conclusive evidence of the facts stated in it. A I R 1959 All. 634. Failure to give the
protocol would seriously prejudice the accused in his defence and hence his conviction cannot be
sustained. A I R 1958 All. 865. Report not containing factual data cannot be treated as
conclusive evidence.
The report of the analyst becomes conclusive only when it has not been challenged according to
the procedure prescribed in the section. 1955 All. WR (HC) 328.
Chemical Examiner's opinion--Evidentiary value: The Chemical Examiner's opinion is sought

for the aid and assistance of the Court Court is, however, competent to disbelieve such report if
no plausible reasons have been put forth by the expert in support of his opinion. P L D 1992
Quetta 67 (c).
Federal Inspectors, or, as the case may be, Provincial Inspectors for the purposes of this Act
within such local limits as it may assign to them respectively:
of any drug shall be appointed:
COMMENTS
launched by an Inspector who is not notified within meaning of Section 17 should not be allowed
to sustain, such prosecution being incompetent under Section 30. 1984 Cr. L J 492.
Requirement of Drug/Inspector: Requirement about appointment of a person as Drug Inspector

is mandatory proceedings from stage of taking test upto filing of complaint by a person who is not
terms. Failure to state in the Notification that such Medical Officers should possess qualifications
laid down in the rules will not render the notification invalid. 1955 All. WR (HC) 328.
appointed as ex officio inspector for the purposes of inspecting retail shops. Such an appointment
is justified by R 49, Proviso 3. AIR 1958 All, 163.
Record showing no order of' appointment of the Drugs Inspector haying been produced before
the trial Court at all and Notification issued in this behalf not indeed a notification as stipulated by
section 17 of the Act. Since no prosecution can be instituted except by a properly appointed Drug
Inspector, conviction and sentence awarded to appellant, were set aside, in circumstances. 1982
P Cr. L J 48.
Circumstances not suggesting any probability of accused being convicted of any offence in the
long run. The Drug. Court accepted accused's application under section 149-A, Cr.P.C. and
ordered their acquittal. N L R 1985 Cr. L J 264.

appointment of Drug Inspector having been produced before Trial Court at all and Notification
issued in this behalf not indeed a notification as stipulated by Section 17 of Act. Since no
prosecution can be instituted except by a properly appointed Drugs Inspector, Conviction and.
sentence awarded to appellant, set aside in (circumstances. 1982 P. Or. L J 48.
18. Powers of, Inspectors : (1) Subject to the provisions of section 19 and of any rules made in
this behalf, an Inspector may, within the local limits for which he is appointed, and in any other
area within the permission of the licensing authority,-
(a) inspect any premises-wherein any drug is manufactured, the plant and process of
manufacture, the means employed for standardising and testing the drugs and all relevant
records and registers;
(b) inspect any premises wherein any drug is sold or is stocked or exhibited for sale or is
distributed, the storage arrangements 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, with such assistance, if any, as he considers necessary, any building,
vessel or place, in which he has reason to believe that an offence under this Act or any rules has
been or is being committed or may continue to be committed;
(e) call any person to be present as witness in the course of search or seizure or in connection
with any other matter where the presence of witnesses is necessary;
(f) seize such drug and all materials used in the manufacture thereof and any other articles,
including registers, cash memos, invoices and bills, which he has reason to believe may furnish
evidence of the commission of an offence punishable under this Act or any rules;
assistance or information relating to or in connection with the investigation of an offence under
this Act or the rules:
Provided that the exemptions under Sections 132 and 133 of the Code of Civil Procedure, 1908
(Act V of 1908), shall be applicable to requisitions for attendance under this Clause;
where any drug is or is being manufactured, stored, sold or exhibited for sale in contravention of
any of the provisions of this Act or the rules;
(i) forbid for a reasonable period, not exceeding four weeks or such further period, which shall not
be more than three months, as the Inspector may, with. the approval of the Provincial Quality
Control Board, the Central Licensing Board, the Registration Board, or the licensing authority, as
the case may be, specify, any person in charge of any premises
(j) exercise such other powers as may be necessary for carrying out the purposes of this Act or
any rules:
Provided that the powers under causes (f) to (j) shall be exercisable only by an Inspector
specifically authorised in this behalf, by an order in writing, by the Government appointing him,
subject to such conditions as may be specified in such order:
Provided further that the power under clause (h) may be exercised by an Inspector not authorised
as aforesaid where the contravention is of a provision which requires a licence to be obtained for
the manufacture, storage or sale of a drug.
(2) The provisions of the Code of Criminal Procedure, 1898 (Act V of 1898), in so far as they are
not inconsistent with the provisions of this Act, shall apply to searches and seizures made under
this Act.
COMMENTS
Powers of Inspectors : The duties entrusted to the Inspectors conveniently called "Inspectors
for the purpose of inspection of retail shops" cover a wider range than mere inspection of retail
shops. Such an Inspector can, therefore, search any premises (such as the dwelling house and
not only the retail shop) in order to detect any sale of drugs in contravention of the Act, A I R
1958 All. 163.
Powers of search and seizure given to the Drugs Inspectors under Section 18(1) is not restricted
to such officers. Searches and seizures in respect of offences under section 27(1), could also be
made by the Police Officers. Police Officers in such cases, was not required to follow procedure
laid down in section 19 but to follow procedure prescribed under the Code of Criminal Procedure,
1898, Section 109. 1979 P Cr. L J Note 6 at p. 4.
Sanction of competent authority--Violation of licensing conditions--Sealing of premises:

Shop sealed by the Drugs Inspector for violation of licensing conditions for more than four weeks.
Effect of no sanction from competent authority obtained for sealing premises beyond four weeks,
sealing of premises beyond four weeks, was in contravention of provisions of section 18-H (1)
and without lawful authority, under these circumstances premises ordered to be desealed. 1988 P
Cr. L J 1328.
liabilities already accrued or incurred under repealed law. Drugs Act of 1976, while repealing Act
of 1940 has not provided a saving clause. Complaint not made regarding alleged offence under
section 18 of Act of 1940 before repeal of Act was a vested right or liability as envisaged under
section 6, could not be deemed to have accrued for enforcing same under the repealing
enactment. P L D 1980 Lah. 195.
necessary permission of the Quality Control Board not obtained for extension of time and
Inspector was not communicating about submission of testing method to manufacturers. Report
was received after prescribed period, not conclusive and the Drugs Analyst committed violation of
relevant provision of law by submitting report without obtaining extension of time from the Board.
1984 P Cr. L J 1580.
any rules:
this Act.
COMMENTS
1958 All. 163.

Cr. L J 1328.
1984 P Cr. L J 1580.
19. Procedure for Inspectors: Where an Inspector seizes any drug or any other article under
section 18, he shall tender a receipt therefor in the prescribed form.
(2) 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 wilfully absents himself, shall divide the sample into
four portions and effectively seal and suitably mark the same and permit such persons to add his
own seal, if any, 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:
(3) 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 within seven days as follows :-
(i) one portion of sample he shall send to the Government Analyst concerned for test and
analysis;
rodent, insect or any foreign matter which is visible to the naked eye, and the sample is such that
it cannot or need not be divided, he shall effectively seal and suitably mark the same and permit
the person from whom he seizes the drug to add his own seal, if any, and mark to it and shall
produce the same before the Drug Court or the Central Licensing Board or the Registration
Board, as the case may be, before which proceedings are instituted or action is initiated in
respect of the drug.
provisions of this Act and, it is ascertained that the drug does not so contravene, he shall
forthwith revoke the order passed under the said section or, as the case may be, take such action
as may be necessary for the return of the stock seized and payment for the samples taken, under
intimation to the Board concerned;
Provided that where a Federal Inspectors not competent to take action under section 30, he shall
as soon as may be, report the matter and hand over the stock, if any, to the Provincial Inspector
for further action under this Act.
(6) The Provincial Inspector on finding any contravention of this Act shall, unless the Board
otherwise directs, always refer the case to the Provincial Quality Control
unless otherwise directed, always refer the case to the Central Licensing Board or the
Registration Board or any other authority as may be specified for the purpose and seek any
further orders as to the action to be taken in respect of such contravention.
COMMENTS
Analyst Report received after prescribed period not conclusive: Sample of drugs submitted
by Inspector of Drugs to Government Analysis for test and analysis. Report of analyst not
received within prescribed period of sixty days and necessary permission of Quality Control
Board not obtained for extension of time and Inspector not communicating about submission of
testing method to manufacturers. Report received after prescribed period, held, not conclusive
and Drugs Analyst committed violation of relevant provisions of law by submitting report without
obtaining extension of time from Board. 1984 P Cr. L J 1580.
such drugs in the name of firm. Action was initiated against firm only within half an hour of expiry
of date for the manufacture of drugs without registration and possibility that workers were
cleaning machines when premises raided was not ruled out. Seizure of drugs also not strictly in
accordance with law as no receipt after seizure passed on to accused in the prescribed form as
required by Section 19 of the Drugs Act. All preparations to raid premises complete before mid-
night of the date when firm still was within the permissible limits of the manufacturing drugs
without registration. Deliberate efforts were made to harass the accused in circumstances. The
conviction and sentence were set aside. 1982 P Cr. L J 175.
Directions in regard to making and submission of test reports, held, not directory but mandatory
and the Drug Court could not convict accused if directions not strictly observed and reports not
submitted in the prescribed manner. 1985 P Cr. L J 281.
20. 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, disclose to the Inspector
the place where the drug is being manufactured or is kept, as the case may be.
21. Disclosure of the name of the manufacturer: Every person, not being the manufacturer of
a drug or his agent for the distribution thereof, shall if so required by an Inspector, disclose to him
the name, address and other particulars of the manufacturer or other person from whom he
acquired the drug.
22. Reports of .Government Analysts : (1) The Government Analyst to whom a sample of any
drug has been submitted for test and analysis under sub-section (3) of section 19 shall deliver to
the Inspector submitting it a signed report in quadruplicate in the prescribed form and forward one
copy thereof to the authority as may be prescribed.
(2) The Government Analyst, as far as may be, shall submit the report referred to in sub-section
(1) within sixty days of the receipt by him of the sample of the drug and, if he is not able to do so
for reasons beyond his control, shall communicate the reasons to the Inspector in writing and
shall endorse its copy to the Board concerned who shall have the sample tested from the same or
any other Government Analyst or a Government Drug Testing Laboratory or any other Laboratory
and shall ensure the receipt of results of such test and analysis within a further period as may be

(b) forward one copy to the warrantor, if any, named under the proviso to sub-section (3) of
Section 32;
report; and
purporting to be a report signed by a Government analyst shall be admissible as evidence of the
facts stated therein without formal proof and such evidence shall be conclusive unless the person
from whom the sample was taken or the said warrantor has, within thirty days of the receipt of a
copy of the report notified in writing to the Inspector or the Drug Court or, as the case may be, the
Central Licensing Board or the Registration Board before which any proceedings in respect of the
sample are pending that he intends to adduce evidence in controversion of the report.
controversion of a Government Analyst's report, the Drug Court or the Board concerned 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 lying with the Board concerned under sub-section (3) of section 19 to be
sent for test or analysis to the Federal Drug Laboratory or any other laboratory specified for the
purpose by the Federal Government which shall make the test or analysis and report in writing
signed by, or under the authority of the person for the time being incharge of the Federal Drug
Laboratory, or, as the case may be, such other laboratory, the result thereof and such report shall
be conclusive evidence of the facts stated therein.
(6) The cost of a test or analysis made by the Federal Drug Laboratory or other laboratory under
sub-section (5) shall be paid by the complainant or accused as the Drug Court or the Board
concerned shall direct.
COMMENTS
Interpretation of section--Presumption: A manufacturer of drugs was prosecuted for offence

under section 27 of the Drugs Act, 1940 after a report had been received from the Government
Analyst that the drug was not of standard quality. No copy of the report was supplied, as required
under section 25(3) of the Act, to manufacturer. It was, therefore, contended that the
manufacturer in the circumstances, could not be prosecuted for offence under section 27 of the
Act. It was held that the effect of the second part of sub-section (3) of section 25 of the Drugs Act,
1940, is only this that the report of the Government Analyst cannot be treated as conclusive
evidence against the person, from whom the sample was taken, where no copy of the report was
supplied to him. But under the first part of sub-section (3) there is presumption that the facts
stated in the report are correct. This presumption, unless rebutted by contrary evidence, can be a
sufficient basis for the conviction of the accused. P L D 1967 Kar. 80.
Substandard drugs : Record not showing that after purchasing drugs from manufacturer
whether the same were stored under the conditions Paid down or stated on carton. Reasonable
possibility of sample obtained by the Drug Inspector and subsequently sent to the National Health
Laboratory having been deteriorated due to its improper storage after purchase from the
manufacturers not ruled out Accused, held, entitled to the benefit of doubt and the conviction and
sentence were set aside. 1985 P Cr. I. J 281.
Mere non-compliance with section does not make report inadmissible: Sub-section (2) of
section 25 of the Drugs Act. 1940 requires that a copy of the report of the Government Analyst
shall be delivered to the person from whom the sample is taken and another copy to the
warrantor, if any, named under the proviso to sub-section (3) of Section 19. Then comes sub-
section (3) which makes the report evidence of the facts stated therein and furthermore makes it
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". It will thus be seen that the contents of the report
not only prove themselves but are also considered to be conclusive unless objection is made.
Sub-section (3) of section 25 provides the consequence of non-compliance with the provisions of
sub-section (2) of the said section. Thus, if no report is supplied all that happens is that the
contents of the report do not become conclusive evidence; but they are nevertheless evidence
and rebuttable at the stage of the trial. This does not mean that at the trial the contents of the
report cannot be utilised as evidence. The intention of the legislature appears to be to merely give
an adequate opportunity to the person charged to challenge the correctness of the report. If this
has not been done, then the contents of the report become conclusive evidence. If any event, the
provisions are clear and leave no room for doubt that if the copy of the report is not supplied to
the accused, the report is, nevertheless, admissible in evidence and proves itself but its contents
are not conclusive evidence. On the other hand, if a copy has been supplied and the appellant
does not raise any objection within the time prescribed, then the report becomes conclusive
evidence and cannot even be rebutted. P L D 1973 S C 299.
Report of Public Analyst did not complete with "full protocols of tests" and silent as to how he
arrived at conclusion regarding low percentage of Tetracycline hydrochloride in sample. Order of
the trial Court rejecting application for summoning Public Analyst as witness was set aside, in
circumstances. Court further directed to summon witness to produce full protocols of tests, in the
interest of justice. 1977 P Cr. L J 822.
notifying to any of the authorities specified in sub-section (4) of Section 22 of the Act, regarding
their such intention. Report was conclusive proof of its contents. Contention that report being
silent about full protocols was of no consequence. 1984 P Cr. L J 2007.
Potency and the state of certain drugs, was depended to some extent upon conditions in which
they were required to be stored and had actually been stored prior to test by the concerned
laboratory. 1984 P Cr. L J 1580.
Analyst submitted his report beyond the period prescribed by law without obtaining extension
from the Quality Control Board. Drug Analyst committed violation of provisions of law and report
sent by him not in the prescribed form. 1985 P Cr. L J 281.
Appeal against acquittal: The accused respondents had a right to request for retesting of
samples and Section 22(5) of the Drugs Act, 1976, makes it compulsory for prosecution to send
the samples for retesting to the Federal Drugs Laboratory or any other laboratory specified for the
purpose by the Federal Government. The accused had not given up their such request and their
right could not be brushed aside on basis of their letters which did not amount to unconditional
admission of guilt as provisions of law have to be strictly followed. Letters were addressed to the
Provincial Quality Control Board and not to proper quarters. The trial Court, held, had rightly given
benefit of doubt to the accused in view of clear violation of Section 22(5) of the Drugs Act, 1976.
Appeal against the acquittal was dismissed in circumstances. 1990 P Cr. L J 865.
Finding of the Drugs Court that test report was not according to law was correct. Drugs Court had
also rightly concluded that the said report would not be conclusive as provided under Section
22(4) of the Drugs Act. Provincial Quality Control Board had sent the sample for retesting in
contravention of sub-sections (4) and (5) of Section 22 of the Drugs Act and as such second
report was illegal under such circumstances appeal against the acquittal of the accused was
dismissed. 1991 P Cr. L J 1363.
Drugs Evaluation, on Pakistan Pharmacopoeia, on Advertising and on such other matters as may
be necessary for the purposes of this Act.
(2) Each committee constituted under sub-section (1) shall consist of such members as the
Federal Government may appoint from time to time and each such member shall hold office
during the pleasure of the Federal Government.
consider necessary.
business.
namely:--
reports:
COMMENTS

COMMENTS

Quetta 67 (c).
COMMENTS
P Cr. L J 48.

any rules:
this Act.
COMMENTS
1958 All. 163.

Cr. L J 1328.
1984 P Cr. L J 1580.
any rules:
this Act.
COMMENTS
1958 All. 163.

Cr. L J 1328.
1984 P Cr. L J 1580.
analysis;
COMMENTS
acquired the drug.

Section 32;
report; and
COMMENTS

consider necessary.
business.
namely:--
reports:
COMMENTS


COMMENTS

Quetta 67 (c).
COMMENTS

P Cr. L J 48.

any rules:
this Act.
COMMENTS
1958 All. 163.

Cr. L J 1328.
1984 P Cr. L J 1580.
any rules:
this Act.
COMMENTS
1958 All. 163.

Cr. L J 1328.
1984 P Cr. L J 1580.
analysis;
COMMENTS
acquired the drug.

Section 32;
report; and
COMMENTS

CHAPTER II
COMMENTS
prescribed period.
COMMENTS

Kar. 80.
COMMENTS
prescribed.
prescribed period.
drugs shall be

opinion that--
with the
COMMENTS

No.
Karachi.
1, 2).
Needles(4/0, 3/0, 2/0, 0, 1, 2). Germany.
U.K.
Capsules.
Needles(4/0, 3/0, 2/0, 0, 1,. 2).
China.
China
Limited, Karachi.
China.
Karachi.
Karachi.
Ltd., Karachi
Ltd., Karachi.
(Pak) Ltd., Karachi
Labs., Lahore.
Germany.
Australia

Karachi.
Ltd., Lahore.

Karachi.
Karachi.

Lahore.
Karachi.

Lahore.
Karachi.
Karachi.
appoint.
before it.
COMMENTS
determine.
necessary.
business.
COMMENTS
1989 P Cr. L J 566.
P C. N L.R 1994 Cr. J 648.

COMMENTS
the rebuttal).
(c).
COMMENTS


or the rules:
rules:
COMMENTS
109. 1979 P Cr. L J Note 6 at p. 4.

Lah. 195.
or the rules:
rules:
COMMENTS
109. 1979 P Cr. L J Note 6 at p. 4.

Lah. 195.
COMMENTS
drug.

32;
report; and
shall direct.
COMMENTS

1985 P Cr. I. J 281.
1977 P Cr. L J 822.
1984 P Cr. L J 1580.
CHAPTER II
COMMENTS
prescribed period.
COMMENTS

Kar. 80.
COMMENTS
prescribed.
prescribed period.
drugs shall be

opinion that--
with the
COMMENTS

No.
Karachi.
1, 2).
Needles(4/0, 3/0, 2/0, 0, 1, 2). Germany.
U.K.
Capsules.
Needles(4/0, 3/0, 2/0, 0, 1,. 2).
China.
China
Limited, Karachi.
China.
Karachi.
Karachi.
Ltd., Karachi
Ltd., Karachi.
(Pak) Ltd., Karachi
Labs., Lahore.
Germany.
Australia

Karachi.
Ltd., Lahore.

Karachi.
Karachi.

Lahore.
Karachi.

Lahore.
Karachi.
Karachi.
appoint.
before it.
COMMENTS
determine.
necessary.
business.
COMMENTS
1989 P Cr. L J 566.
P C. N L.R 1994 Cr. J 648.

COMMENTS
the rebuttal).
(c).
COMMENTS


or the rules:
rules:
COMMENTS
109. 1979 P Cr. L J Note 6 at p. 4.

Lah. 195.
or the rules:
rules:
COMMENTS
109. 1979 P Cr. L J Note 6 at p. 4.

Lah. 195.
COMMENTS
drug.

32;
report; and
shall direct.
COMMENTS

1985 P Cr. I. J 281.
1977 P Cr. L J 822.
1984 P Cr. L J 1580.
CHAPTER II

COMMENTS
prescribed period.
COMMENTS

Kar. 80.
COMMENTS
prescribed.
prescribed period.
drugs shall be

opinion that--
with the
COMMENTS

No.
Karachi.
1, 2).
Needles(4/0, 3/0, 2/0, 0, 1, 2). Germany.
U.K.
Capsules.
Needles(4/0, 3/0, 2/0, 0, 1,. 2).
China.
China
Limited, Karachi.
China.
Karachi.
Karachi.
Ltd., Karachi
Ltd., Karachi.
(Pak) Ltd., Karachi
Labs., Lahore.
Germany.
Australia

Karachi.
Ltd., Lahore.

Karachi.
Karachi.

Lahore.
Karachi.

Lahore.
Karachi.
Karachi.
appoint.
before it.
COMMENTS
determine.
necessary.
business.
COMMENTS
1989 P Cr. L J 566.
P C. N L.R 1994 Cr. J 648.

COMMENTS
the rebuttal).
(c).
COMMENTS


or the rules:
rules:
COMMENTS
109. 1979 P Cr. L J Note 6 at p. 4.

Lah. 195.
or the rules:
rules:
COMMENTS
109. 1979 P Cr. L J Note 6 at p. 4.

Lah. 195.
COMMENTS
drug.

32;
report; and
shall direct.
COMMENTS

1985 P Cr. I. J 281.
1977 P Cr. L J 822.
1984 P Cr. L J 1580.
CHAPTER II
COMMENTS
prescribed period.
COMMENTS

Kar. 80.
COMMENTS
prescribed.
prescribed period.
drugs shall be

opinion that--
with the
COMMENTS

No.
Karachi.
1, 2).
Needles(4/0, 3/0, 2/0, 0, 1, 2). Germany.
U.K.
Capsules.
Needles(4/0, 3/0, 2/0, 0, 1,. 2).
China.
China
Limited, Karachi.
China.
Karachi.
Karachi.
Ltd., Karachi
Ltd., Karachi.
(Pak) Ltd., Karachi
Labs., Lahore.
Germany.
Australia
Karachi.
Ltd., Lahore.

Karachi.
Karachi.

Lahore.
Karachi.

Lahore.
Karachi.
Karachi.
appoint.
before it.
COMMENTS
determine.
necessary.
business.
COMMENTS
1989 P Cr. L J 566.
P C. N L.R 1994 Cr. J 648.

COMMENTS
the rebuttal).
(c).
COMMENTS


or the rules:
rules:
COMMENTS
109. 1979 P Cr. L J Note 6 at p. 4.

Lah. 195.
or the rules:
rules:
COMMENTS
109. 1979 P Cr. L J Note 6 at p. 4.

Lah. 195.
COMMENTS
drug.

32;
report; and
shall direct.
COMMENTS

1985 P Cr. I. J 281.
1977 P Cr. L J 822.
1984 P Cr. L J 1580.
CHAPTER II
COMMENTS
prescribed period.
COMMENTS

Kar. 80.
COMMENTS
prescribed.
prescribed period.
drugs shall be

opinion that--
with the
COMMENTS

No.
Karachi.
1, 2).
Needles(4/0, 3/0, 2/0, 0, 1, 2). Germany.
U.K.
Capsules.
Needles(4/0, 3/0, 2/0, 0, 1,. 2).
China.
China
Limited, Karachi.
China.
Karachi.
Karachi.
Ltd., Karachi
Ltd., Karachi.
(Pak) Ltd., Karachi
Labs., Lahore.
Germany.
Australia

Karachi.
Ltd., Lahore.

Karachi.
Karachi.

Lahore.
Karachi.

Lahore.
Karachi.
Karachi.
appoint.
before it.
COMMENTS
determine.
necessary.
business.
COMMENTS
1989 P Cr. L J 566.
P C. N L.R 1994 Cr. J 648.

COMMENTS
the rebuttal).
(c).
COMMENTS


or the rules:
rules:
COMMENTS
109. 1979 P Cr. L J Note 6 at p. 4.

Lah. 195.
or the rules:
rules:
COMMENTS
109. 1979 P Cr. L J Note 6 at p. 4.

Lah. 195.
COMMENTS
drug.

32;
report; and
shall direct.
COMMENTS

1985 P Cr. I. J 281.
1977 P Cr. L J 822.
1984 P Cr. L J 1580.
CHAPTER II
COMMENTS
prescribed period.
COMMENTS

Kar. 80.
COMMENTS
prescribed.
prescribed period.
drugs shall be

opinion that--
with the
COMMENTS

No.
Karachi.
1, 2).
Needles(4/0, 3/0, 2/0, 0, 1, 2). Germany.
U.K.
Capsules.
Needles(4/0, 3/0, 2/0, 0, 1,. 2).
China.
China
Limited, Karachi.
China.
Karachi.
Karachi.
Ltd., Karachi
Ltd., Karachi.
(Pak) Ltd., Karachi
Labs., Lahore.
Germany.
Australia

Karachi.
Ltd., Lahore.

Karachi.
Karachi.

Lahore.
Karachi.

Lahore.
Karachi.
Karachi.
appoint.
before it.
COMMENTS
determine.
necessary.
business.
COMMENTS
1989 P Cr. L J 566.
P C. N L.R 1994 Cr. J 648.

COMMENTS
the rebuttal).
(c).
COMMENTS


or the rules:
rules:
COMMENTS
109. 1979 P Cr. L J Note 6 at p. 4.

Lah. 195.
or the rules:
rules:
COMMENTS
109. 1979 P Cr. L J Note 6 at p. 4.

Lah. 195.
COMMENTS
drug.

32;
report; and
shall direct.
COMMENTS

1985 P Cr. I. J 281.
1977 P Cr. L J 822.
1984 P Cr. L J 1580.
CHAPTER II
COMMENTS
prescribed period.
COMMENTS

Kar. 80.
COMMENTS
prescribed.
prescribed period.
drugs shall be

opinion that--
with the
COMMENTS

No.
Karachi.
1, 2).
Needles(4/0, 3/0, 2/0, 0, 1, 2). Germany.
U.K.
Capsules.
Needles(4/0, 3/0, 2/0, 0, 1,. 2).
China.
China
Limited, Karachi.
China.
Karachi.
Karachi.
Ltd., Karachi
Ltd., Karachi.
(Pak) Ltd., Karachi
Labs., Lahore.
Germany.
Australia

Karachi.
Ltd., Lahore.

Karachi.
Karachi.

Lahore.
Karachi.

Lahore.
Karachi.
Karachi.
appoint.
before it.
COMMENTS
determine.
necessary.
business.
COMMENTS
1989 P Cr. L J 566.
P C. N L.R 1994 Cr. J 648.

COMMENTS
the rebuttal).
(c).
COMMENTS


or the rules:
rules:
COMMENTS
109. 1979 P Cr. L J Note 6 at p. 4.

Lah. 195.
or the rules:
rules:
COMMENTS
109. 1979 P Cr. L J Note 6 at p. 4.
Lah. 195.
COMMENTS
drug.

32;
report; and
shall direct.
COMMENTS
1985 P Cr. I. J 281.
1977 P Cr. L J 822.
1984 P Cr. L J 1580.
CHAPTER II
COMMENTS
prescribed period.
COMMENTS

Kar. 80.
COMMENTS
prescribed.
prescribed period.
drugs shall be

opinion that--
with the
COMMENTS

No.
Karachi.
1, 2).
Needles(4/0, 3/0, 2/0, 0, 1, 2). Germany.
U.K.
Capsules.
Needles(4/0, 3/0, 2/0, 0, 1,. 2).
China.
China
Limited, Karachi.
China.
Karachi.
Karachi.
Ltd., Karachi
Ltd., Karachi.
(Pak) Ltd., Karachi
Labs., Lahore.
Germany.
Australia

Karachi.
Ltd., Lahore.

Karachi.
Karachi.

Lahore.
Karachi.

Lahore.
Karachi.
Karachi.
appoint.
before it.
COMMENTS
determine.
necessary.
business.
COMMENTS
1989 P Cr. L J 566.
P C. N L.R 1994 Cr. J 648.

COMMENTS
the rebuttal).
(c).
COMMENTS


or the rules:
rules:
COMMENTS
109. 1979 P Cr. L J Note 6 at p. 4.

Lah. 195.
or the rules:
rules:
COMMENTS
109. 1979 P Cr. L J Note 6 at p. 4.

Lah. 195.
COMMENTS
drug.

32;
report; and
shall direct.
COMMENTS

1985 P Cr. I. J 281.
1977 P Cr. L J 822.
1984 P Cr. L J 1580.
CHAPTER II
COMMENTS
prescribed period.
COMMENTS

Kar. 80.
COMMENTS
prescribed.
prescribed period.
drugs shall be

opinion that--
with the
COMMENTS

No.
Karachi.
1, 2).
Needles(4/0, 3/0, 2/0, 0, 1, 2). Germany.
U.K.
Capsules.
Needles(4/0, 3/0, 2/0, 0, 1,. 2).
China.
China
Limited, Karachi.
China.
Karachi.
Karachi.
Ltd., Karachi
Ltd., Karachi.
(Pak) Ltd., Karachi
Labs., Lahore.
Germany.
Australia

Karachi.
Ltd., Lahore.

Karachi.
Karachi.

Lahore.
Karachi.

Lahore.
Karachi.
Karachi.
appoint.
before it.
COMMENTS
determine.
necessary.
business.
COMMENTS
1989 P Cr. L J 566.
P C. N L.R 1994 Cr. J 648.

COMMENTS
the rebuttal).
(c).
COMMENTS


or the rules:
rules:
COMMENTS
109. 1979 P Cr. L J Note 6 at p. 4.

Lah. 195.
or the rules:
rules:
COMMENTS
109. 1979 P Cr. L J Note 6 at p. 4.

Lah. 195.
COMMENTS
drug.

32;
report; and
shall direct.
COMMENTS

1985 P Cr. I. J 281.
1977 P Cr. L J 822.
1984 P Cr. L J 1580.
CHAPTER II
COMMENTS
prescribed period.
COMMENTS

Kar. 80.
COMMENTS
prescribed.
prescribed period.
drugs shall be

opinion that--
with the
COMMENTS

No.
Karachi.
1, 2).
Needles(4/0, 3/0, 2/0, 0, 1, 2). Germany.
U.K.
Capsules.
Needles(4/0, 3/0, 2/0, 0, 1,. 2).
China.
China
Limited, Karachi.
China.
Karachi.
Karachi.
Ltd., Karachi
Ltd., Karachi.
(Pak) Ltd., Karachi
Labs., Lahore.
Germany.
Australia

Karachi.
Ltd., Lahore.

Karachi.
Karachi.

Lahore.
Karachi.

Lahore.
Karachi.
Karachi.
appoint.
before it.
COMMENTS
determine.
necessary.
business.
COMMENTS
1989 P Cr. L J 566.
P C. N L.R 1994 Cr. J 648.

COMMENTS
the rebuttal).
(c).
COMMENTS


or the rules:
rules:
COMMENTS
109. 1979 P Cr. L J Note 6 at p. 4.

Lah. 195.
or the rules:
rules:
COMMENTS
109. 1979 P Cr. L J Note 6 at p. 4.

Lah. 195.
COMMENTS
drug.

32;
report; and
shall direct.
COMMENTS

1985 P Cr. I. J 281.
1977 P Cr. L J 822.
1984 P Cr. L J 1580.
CHAPTER II
COMMENTS
prescribed period.
COMMENTS

Kar. 80.
COMMENTS
prescribed.
prescribed period.
drugs shall be
opinion that--
with the
COMMENTS

No.
Karachi.
1, 2).
Needles(4/0, 3/0, 2/0, 0, 1, 2). Germany.
U.K.
Capsules.
Needles(4/0, 3/0, 2/0, 0, 1,. 2).
China.
China
Limited, Karachi.
China.
Karachi.
Karachi.
Ltd., Karachi
Ltd., Karachi.
(Pak) Ltd., Karachi
Labs., Lahore.
Germany.
Australia

Karachi.
Ltd., Lahore.

Karachi.
Karachi.

Lahore.
Karachi.

Lahore.
Karachi.
Karachi.
appoint.
before it.
COMMENTS
determine.
necessary.
business.
COMMENTS
1989 P Cr. L J 566.
P C. N L.R 1994 Cr. J 648.

COMMENTS
the rebuttal).
(c).
COMMENTS


or the rules:
rules:
COMMENTS
109. 1979 P Cr. L J Note 6 at p. 4.

Lah. 195.
or the rules:
rules:
COMMENTS
109. 1979 P Cr. L J Note 6 at p. 4.

Lah. 195.
COMMENTS
drug.

32;
report; and
shall direct.
COMMENTS

1985 P Cr. I. J 281.
1977 P Cr. L J 822.
1984 P Cr. L J 1580.
CHAPTER 3 - Prohibitions
23. Import, manufacture and sale of drugs.
24. Control of advertisement.
25. Control of samplings.
26. Control of printing of labelling.
CHAPTER III
Prohibitions
23. Import, manufacture and sale of drug: (1) No person shall himself or by any other person on his
behalf--
(a) export, import or manufacture for sale or sell
(i) any spurious drug;
(ii) any counterfeit drug;
(iii) any misbranded drug;
(iv) any adulterated drug;
(v) any substandard drug;
(vi) any drug after its expiry date;
(vii) any drug which is not registered or is not in
accordance with the conditions of registration;
(viii) 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;
(ix) any drug if it is dangerous to health when used in the dosage or with the frequency, or, for the
duration specified, recommended or suggested in the labelling thereof; or
(x) any drug in contravention of any of the provisions of this Act or any rule;
(b) manufacture for sale any drug except under, and in accordance with the conditions of, a licence
issued under this Act;
(c) sell any drug except under, and in accordance with the conditions of, a licence issued under this
Act;
(d) import or export any drug the import or export of which is prohibited by or under this Act;
(e) import or export any drug for the import or export of which a licence is required, except under, and
in accordance with the conditions of, such licence;
(f) supply an incorrect, incomplete or misleading information, when required to furnish any information
under this Act or the rules;
(g) peddle, hawk or offer for sale any drug in a park or public street or on a highway, footpath or public
transport or conveyance;
(h) import, manufacture for sale, or sell any substance, or mixture of substances, which is not a drug
but is presented in a form or a manner which is intended or likely to cause the public to believe it to be
a drug;
(i) sell any drug without having a warranty in the prescribed form bearing the name and batch number
of the drug issued,--
(i) in the case of a drug manufactured in Pakistan, by the manufacturer holding a valid licence to
manufacture drugs and permission to manufacture that drug or by his authorised agent;
(ii) in the case of an imported drug, by the manufacturer or importer of that drug or, if the drug is
imported through an indentor by such indentor; and
(j) apply an incorrect batch number to a drug.
(2) Nothing in sub-section (1) shall apply to the manufacture or subject to prescribed conditions, of
small quantities or any drug for the purpose of clinical trial examination, test, analysis or personal use.
COMMENTS
Scope: Where drugs are stocked in a shop the presumption is that they have been stocked for sale.
Distributing includes dispensing and the Mens rea is not necessary for conviction of the accused. It is
not necessary that the accused should have known that it was an offence to stock drugs for sale
without licence. P L D 1957 Kar. 671.
The charge against the accused was under section 18(b) of the Drugs Act and therefore an essential
ingredient of the evidence was that the drugs sold by the accused were drugs which has been
manufactured by an unlicensed manufacturer. And it was in order to prove this ingredient of the
offence that the Inspector of P.W. had produced the letter of the Health Department, that the alleged
manufacturers did not have any licence to manufacture drugs. But the burden was on the prosecution
to prove that the manufacturers did not have any licence under the Drugs Act and as the accused had
taken objection to the production of this letter the prosecution should have prove it in the manner
prescribed under Section 67 of the Evidence Act. This it did not care to do. It was contended that the
letter had not been proved : Held : This submission was supported by the unanimous view of the
Supreme Court in the case of Muhammad Khattak v. S.M. Ayub, 1974 P Or, L J Note 81. Additionally
there was also no provision in the Drugs Act which could relieve the prosecution of its obligation to
prove this letter under section 67 of the Evidence Act, held the letter had not been proved.
The substandard drug for the manufacture of which the respondent herein was sought to be
prosecuted was actually manufactured by Laboratories which being a private Limited Company,
incorporated under the Companies Act, 1913, would be a 'person' in its own right within the meaning
of that expression as appearing in section 18, section 19(3) and section 27, Drug Act, 1940. By the
plain language of the said three sections, therefore, prima facie Messrs. Laboratories seemed to have
brought itself within the mischief of the law. Therefore if the prosecution had proceeded against the
said Company, in view of the bar contained in section 19, it would not be open to it to plead in defence
that it was ignorant of the nature, substance or quality of the said substandard drug or of the
circumstances in which it was manufactured. In point of fact under section 19(3), its liability would
seem to be total. And consequently upon its conviction it could under section 27 be awarded the
punishment of fine. The difficulty in the way of the appellants, however, is that no proceedings were
drawn up against the said Company. Nor indeed the Company was made a co-accused in the challan
submitted against the respondent, herein in the criminal Court. In so far as the liability of the
respondent is concerned, it would not only arise if he can be shown to have manufactured the said
substandard drugs for and on behalf of Messrs. Nawabsons Laboratories Limited, as in the nature of
things the said Company had to act through a living person. It was true that at the relevant time
respondent was the Managing Director of the said Company. But then in the challan submitted
against him in the trial Court no allegation was made that it was he who had manufactured the said
drug on behalf of the said company. Furthermore, it is common knowledge that in the hierarchy of a
Limited Company, the Managing Director was assisted by other directors as well as executives,
officers and workers. There was no reason to believe that in the case of Laboratories the system was
any different. Therefore, it would be difficult .to presume that the respondent was guilty of the
manufacture of the said substandard drug for and on behalf of the Company, just because he
happened to be its Managing Director. P L D 1978 S C 193; N L R 1978 S C 768; P L J 1978 S C
283.
Omission by the prosecution to bring on record expert's opinion in proof of the allegation that drug
allegedly recovered from accused's premises was spurious and such omission entitles the accused to
a clean acquittal even at the preliminary stage. Drug Court accepted accused's application under
section 249-A, Cr.P.C. on additional grounds that complaint was incompetently lodged and recovery
was in contravention of section 103, Cr.P.C. N L R 1985 Or. L J 266.
Prosecution on the basis of complaint of 'the Drug Inspector who is not duly notified under Section 17,
cannot be sustained in a case where recovery was not witnessed according to section 103, Cr.P.C.
The Drug Court accepted accused's application and ordered their acquittal. N L R 1985 U C 386 (2),
Where a dealer in medicines purchased drugs from a manufacturer and obtained a warranty that
there had been no contravention of this section from the manufacturer and sent a copy of warranty
with written notice to Inspector of Drugs and warrantor within 7 days of the service of .summons upon
him, it was held that in such circumstances the dealer could not be held guilty. 1973 P Cr. L J 218.
The word "building" in Schedule B, para. 2 of the Drugs (Licensing, Registering and Advertising)
Rules is synonymous with the word "premises". The word "premises" as used in various rules and the
Schedule does not mean a detached or separate building or structure. Mere use of a portion of
premises or building for residential purposes does not render it unsuitable for a licensed premises and
manufacturing place is only required to be separate from the residential place. P L D 1978 Lah. 445.
Where the applicant committed a breach of the provisions of this section and also of rule, a charge
can be framed even if the complaint does not expressly state the provision of law which has been
contravened. 1955 All. W.R. (HC) 328.
For committing an offence under this section, intention to do the guilty act which is made penal by the
statute is not required. The Act creates an absolute liability and rules out mens rea as a constituent
part of the crime. It would only affect the question of punishment. 1958-2 Mad. L Jour. 308.
The complaint against the accused for manufacturing for sale substandard Ampicillin Dry Syrup
containing 89% Ampicillin against U.S.P. limits of 90% to 120% and thus violating provisions of the
Drugs Act. The accused, however, explaining carton of drug containing instructions for its keeping in a
cool and dark place and as per WHO pamphlet loss of activity of international standard if drug stored
at temperature less than 20oC and such requirements having not been fulfilled, there appeared a
slight discrepancy in quantum of active agent. Ampicillin according to B.P. to be in a well closed
container at a temperature not exceeding 25oC but climatic conditions in Pakistan ranging from 30oC
to 40oC. Drug after the purchase remaining in normal temperature and possibility of deficiency in
contents as required by B.P. existing. The accused was given the benefit of doubt and acquitted, in
circumstances. 1979 P Cr. L J 872.
Offences falling under section 23 of the Drugs Act, being punishable up to 10 years, the prohibition
under section 497, Cr.P.C., was attracted, the offences related to clandestine sale of stolen
Government medicines as well as their genuineness, hence bail is declined. 1981 P Cr. L J 243.
Instructions against provisions of Section 23 could not be relied upon. Petitioner has referred to
Section 23 of the Drugs Act, 1976 which provide that any drug of which the expiry period had not
expired could be imported. In view of the provision of Section 23 of the Drugs Act, respondent No. 1,
could not decline permission to the petitioner company to clear any drug of which the period of expiry
had not been completed as was the present case, therefore, the reliance on the instructions as
against the express provisions of Section 23 of the Act, could not have been made. 1994 C L C 2270.
Self-contradictory order: Acquittal of the accused under section 265-K, Cr.P.C. with observation
tantamounting to punish him while the order is impugned. Petitioner was acquitted and convicted by
one and the same order being self-contradictory, petition was converted into appeal and impugned
observations were expunged. 1987 S C M R 2100.
Quashment of F.I.R. : Registration of the F.I.R. in respect of the offence was not a case classified by
the Provincial Quality Control Board. nor the Provincial Inspector had submitted a report to the said
Board Provincial Inspector had also not obtained instructions from the Provincial Quality Control
Board regarding the registration of the F.I.R. and on his own had got the same registered which act
being without lawful authority was declared to be of no legal effect. Constitutional petition was
accepted accordingly. 1994 P Cr. L J 1065.
Quashment of proceedings : Only allegation against the manufacturer being that sample pack of
drug contained 15 mi. of drug and that under R. 32 contents should have been less than 15 mi. No
allegation made to the effect that manufacturer sold physician's sample to any one in contravention of
the provisions of the Act or Rules. Nowhere in the complaint it was urged that quantity impact was
unreasonable or that unreasonably large quantity of sample was supplied to any physician or
institution. No fresh case could be permitted to be argued against the manufacturer in that behalf.
Complaint being based on erroneous view of law no case, held, was made out against the
manufacturer for violation of R. 32 which could entail any punishment under section 27(4) or 23(1)(x),
Drug Act, 1976, therefore, the proceedings were quashed. P L D 1985 Lah. 503.
The accused was proceeded against for manufacturing spurious drugs. Drug Inspector could not
identify accused who was admittedly not present at the premises in question when raid was
conducted. Two persons, apprehended on the spot exonerated accused and denied having any
acquaintance with him or having ever seen him in the premises. Disputed premises was neither
owned by the accused nor occupied by him. Lease agreement showed that premises was rented out
to someone else by the owner and the proceedings were quashed in such circumstances. 1991 P Cr.
L J 2329.
Constitutional petition concerned only with import of drugs and their clearance. Applicant
shareholder, desirous to become a party to Constitutional petition in view of disputes inter se between
shareholders of the company. Applicant's locus standi to be impleaded as a party in Constitutional
petition. Clearance of drugs being for the benefit of the company of which applicants were
shareholders, they were, therefore, neither necessary nor proper party in such proceedings. As for
applicant's dispute with other shareholders of the company regarding the affairs of the company, they
could seek remedy in accordance with law. 1994 C L C 2270(b).
Substandard drugs: Record not showing that after purchasing drugs from manufacturer whether
same were stored under the conditions laid down or stated on carton. Reasonable possibility of
having been deteriorated due to its improper storage after the purchase from manufacturers not ruled
out. Accused entitled to the benefit of doubt and the conviction and sentence were set aside. 1985 P
Or. L J 281; 1985 P Cr. L J 281.
According to the case of Fazal Elahi v. The State, 1985 P Cr. L J 268, no prosecution launched
against the company which manufactured drugs in question. Accused not shown to be acting as agent
of the company for distribution of substandard drugs. In absence of the company, accused held, could
not be prosecuted. The liability of manufacturer of the drugs and his agent for distribution thereof
would be co-extensive.
Appreciation of Evidence. Evidence on record did not show that the accused was found selling the
drugs recovered from his possession while keeping them in his shop without a licence. Drugs
recovered could be available almost in every house for daily consumption. Defence version was
believable and the possibility of false implication of accused could not be ruled out. Accused was
acquitted in circumstances. 1994 P Cr. L J 2468.
Appeal against acquittal: Explanation given by the accused for not complying with a direction of the
Secretary, Registration Board, to mention "Oleoresin of Ginger" as an ingredient on the label was
convincing. Nothing manifestly wrong or perverse was, therefore, found in the conclusion arrived at by
the trial Court, the appeal against the acquittal of the accused was consequently dismissed. P L D
1992 Kar. 347 (d).
24. Control of advertisement: No person shall himself or by any other person on his behalf
advertise, except in accordance with such conditions as may be prescribed,--
(i) any drug;
(ii) any substance used or prepared for use in accordance with the ayurvedic, unani, homoeopathic or
biochemic system of treatment or any other substance or mixture of substances as may be
prescribed;
(iii) any remedy, treatment or offer of a treatment for any disease.
Explanation: In this section, "advertise" means to make any representation by any means whatsoever
for the purpose of promoting directly or indirectly the sale or disposal of a drug, a substance or a
mixture of substances, a remedy or a 'treatment except the display of sign boards for a clinic, a
dispensary or a hospital or such other institution offering treatment.
COMMENTS
Presumption of fact : No evidence having been produced by prosecution to prove factum of

publication of advertisement in newspaper and souvenir by the accused. Accused having disputed the
same. Mere fact that advertisement might have benefited the accused, held, would not justify raising
of presumption against the accused under section 114 (f) of the Evidence Act (I of 1872), the appeal
Appeal was, therefore, allowed, conviction and sentence were set aside. 1986 P Cr. L J 486.
Handbill displaying picture of healthy seminude male and female with writing "it is well-known about
Knight Pills that husband who takes Knight Pills never gets old and knight Pills keeps the potency of a
male ready for action". Ingredients of Knight Pills was totally missing from handbill. Language used in
the handbill was calculated to induce persons interested in combating sexual weakness to buy pills
mentioned in the handbill, thereby promoted sale of pills and as such handbill would fall within the
definition of "advertisement". 1984 P Cr. L J 2895.
Burden of proof: Prosecution not producing any witness to prove the fact that the accused caused
publication of advertisement in newspaper and pamphlet. Accused disputing publication of such
advertisement to have been caused by him. Burden of proof, would lie squarely on prosecution. 1986
P Cr. L J 486.
25. Control of samplings: No person shall distribute or cause to be distributed any drug as a sample
except in accordance with such conditions as may be prescribed.
26. Control of printing of labelling: No person shall print any labelling in respect of any drug which
is required to be registered under this Act but is not so registered after the date fixed by the Federal
Government under sub-section (6) of section 7 or for a person who does not possess a licence under
this Act to manufacture that drug.
CHAPTER III
Prohibitions
23. Import, manufacture and sale of drug: (1) No person shall himself or by any other person on his
behalf--
(a) export, import or manufacture for sale or sell
(i) any spurious drug;
(ii) any counterfeit drug;
(iii) any misbranded drug;
(iv) any adulterated drug;
(v) any substandard drug;
(vi) any drug after its expiry date;
(vii) any drug which is not registered or is not in
accordance with the conditions of registration;
(viii) 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;
(ix) any drug if it is dangerous to health when used in the dosage or with the frequency, or, for the
duration specified, recommended or suggested in the labelling thereof; or
(x) any drug in contravention of any of the provisions of this Act or any rule;
(b) manufacture for sale any drug except under, and in accordance with the conditions of, a licence
issued under this Act;
(c) sell any drug except under, and in accordance with the conditions of, a licence issued under this
Act;
(d) import or export any drug the import or export of which is prohibited by or under this Act;
(e) import or export any drug for the import or export of which a licence is required, except under, and
in accordance with the conditions of, such licence;
(f) supply an incorrect, incomplete or misleading information, when required to furnish any information
under this Act or the rules;
(g) peddle, hawk or offer for sale any drug in a park or public street or on a highway, footpath or public
transport or conveyance;
(h) import, manufacture for sale, or sell any substance, or mixture of substances, which is not a drug
but is presented in a form or a manner which is intended or likely to cause the public to believe it to be
a drug;
(i) sell any drug without having a warranty in the prescribed form bearing the name and batch number
of the drug issued,--
(i) in the case of a drug manufactured in Pakistan, by the manufacturer holding a valid licence to
manufacture drugs and permission to manufacture that drug or by his authorised agent;
(ii) in the case of an imported drug, by the manufacturer or importer of that drug or, if the drug is
imported through an indentor by such indentor; and
(j) apply an incorrect batch number to a drug.
(2) Nothing in sub-section (1) shall apply to the manufacture or subject to prescribed conditions, of
small quantities or any drug for the purpose of clinical trial examination, test, analysis or personal use.
COMMENTS
Scope: Where drugs are stocked in a shop the presumption is that they have been stocked for sale.
Distributing includes dispensing and the Mens rea is not necessary for conviction of the accused. It is
not necessary that the accused should have known that it was an offence to stock drugs for sale
without licence. P L D 1957 Kar. 671.
ingredient of the evidence was that the drugs sold by the accused were drugs which has been
offence that the Inspector of P.W. had produced the letter of the Health Department, that the alleged
manufacturers did not have any licence to manufacture drugs. But the burden was on the prosecution
to prove that the manufacturers did not have any licence under the Drugs Act and as the accused had
taken objection to the production of this letter the prosecution should have prove it in the manner
prescribed under Section 67 of the Evidence Act. This it did not care to do. It was contended that the
letter had not been proved : Held : This submission was supported by the unanimous view of the
Supreme Court in the case of Muhammad Khattak v. S.M. Ayub, 1974 P Or, L J Note 81. Additionally
there was also no provision in the Drugs Act which could relieve the prosecution of its obligation to
prove this letter under section 67 of the Evidence Act, held the letter had not been proved.
The substandard drug for the manufacture of which the respondent herein was sought to be
prosecuted was actually manufactured by Laboratories which being a private Limited Company,
incorporated under the Companies Act, 1913, would be a 'person' in its own right within the meaning
of that expression as appearing in section 18, section 19(3) and section 27, Drug Act, 1940. By the
plain language of the said three sections, therefore, prima facie Messrs. Laboratories seemed to have
brought itself within the mischief of the law. Therefore if the prosecution had proceeded against the
said Company, in view of the bar contained in section 19, it would not be open to it to plead in defence
that it was ignorant of the nature, substance or quality of the said substandard drug or of the
circumstances in which it was manufactured. In point of fact under section 19(3), its liability would
seem to be total. And consequently upon its conviction it could under section 27 be awarded the
punishment of fine. The difficulty in the way of the appellants, however, is that no proceedings were
drawn up against the said Company. Nor indeed the Company was made a co-accused in the challan
submitted against the respondent, herein in the criminal Court. In so far as the liability of the
respondent is concerned, it would not only arise if he can be shown to have manufactured the said
substandard drugs for and on behalf of Messrs. Nawabsons Laboratories Limited, as in the nature of
things the said Company had to act through a living person. It was true that at the relevant time
respondent was the Managing Director of the said Company. But then in the challan submitted
against him in the trial Court no allegation was made that it was he who had manufactured the said
drug on behalf of the said company. Furthermore, it is common knowledge that in the hierarchy of a
Limited Company, the Managing Director was assisted by other directors as well as executives,
officers and workers. There was no reason to believe that in the case of Laboratories the system was
any different. Therefore, it would be difficult .to presume that the respondent was guilty of the
manufacture of the said substandard drug for and on behalf of the Company, just because he
happened to be its Managing Director. P L D 1978 S C 193; N L R 1978 S C 768; P L J 1978 S C
283.
Omission by the prosecution to bring on record expert's opinion in proof of the allegation that drug
allegedly recovered from accused's premises was spurious and such omission entitles the accused to
a clean acquittal even at the preliminary stage. Drug Court accepted accused's application under
section 249-A, Cr.P.C. on additional grounds that complaint was incompetently lodged and recovery
was in contravention of section 103, Cr.P.C. N L R 1985 Or. L J 266.
Prosecution on the basis of complaint of 'the Drug Inspector who is not duly notified under Section 17,
cannot be sustained in a case where recovery was not witnessed according to section 103, Cr.P.C.
The Drug Court accepted accused's application and ordered their acquittal. N L R 1985 U C 386 (2),
Where a dealer in medicines purchased drugs from a manufacturer and obtained a warranty that
there had been no contravention of this section from the manufacturer and sent a copy of warranty
with written notice to Inspector of Drugs and warrantor within 7 days of the service of .summons upon
him, it was held that in such circumstances the dealer could not be held guilty. 1973 P Cr. L J 218.
The word "building" in Schedule B, para. 2 of the Drugs (Licensing, Registering and Advertising)
Rules is synonymous with the word "premises". The word "premises" as used in various rules and the
Schedule does not mean a detached or separate building or structure. Mere use of a portion of
premises or building for residential purposes does not render it unsuitable for a licensed premises and
manufacturing place is only required to be separate from the residential place. P L D 1978 Lah. 445.
Where the applicant committed a breach of the provisions of this section and also of rule, a charge
can be framed even if the complaint does not expressly state the provision of law which has been
contravened. 1955 All. W.R. (HC) 328.
For committing an offence under this section, intention to do the guilty act which is made penal by the
statute is not required. The Act creates an absolute liability and rules out mens rea as a constituent
part of the crime. It would only affect the question of punishment. 1958-2 Mad. L Jour. 308.
The complaint against the accused for manufacturing for sale substandard Ampicillin Dry Syrup
containing 89% Ampicillin against U.S.P. limits of 90% to 120% and thus violating provisions of the
Drugs Act. The accused, however, explaining carton of drug containing instructions for its keeping in a
cool and dark place and as per WHO pamphlet loss of activity of international standard if drug stored
at temperature less than 20oC and such requirements having not been fulfilled, there appeared a
slight discrepancy in quantum of active agent. Ampicillin according to B.P. to be in a well closed
container at a temperature not exceeding 25oC but climatic conditions in Pakistan ranging from 30oC
to 40oC. Drug after the purchase remaining in normal temperature and possibility of deficiency in
contents as required by B.P. existing. The accused was given the benefit of doubt and acquitted, in
circumstances. 1979 P Cr. L J 872.
Offences falling under section 23 of the Drugs Act, being punishable up to 10 years, the prohibition
under section 497, Cr.P.C., was attracted, the offences related to clandestine sale of stolen
Government medicines as well as their genuineness, hence bail is declined. 1981 P Cr. L J 243.
Instructions against provisions of Section 23 could not be relied upon. Petitioner has referred to
Section 23 of the Drugs Act, 1976 which provide that any drug of which the expiry period had not
expired could be imported. In view of the provision of Section 23 of the Drugs Act, respondent No. 1,
could not decline permission to the petitioner company to clear any drug of which the period of expiry
had not been completed as was the present case, therefore, the reliance on the instructions as
against the express provisions of Section 23 of the Act, could not have been made. 1994 C L C 2270.
Self-contradictory order: Acquittal of the accused under section 265-K, Cr.P.C. with observation
tantamounting to punish him while the order is impugned. Petitioner was acquitted and convicted by
one and the same order being self-contradictory, petition was converted into appeal and impugned
observations were expunged. 1987 S C M R 2100.
Quashment of F.I.R. : Registration of the F.I.R. in respect of the offence was not a case classified by
the Provincial Quality Control Board. nor the Provincial Inspector had submitted a report to the said
Board Provincial Inspector had also not obtained instructions from the Provincial Quality Control
Quashment of proceedings : Only allegation against the manufacturer being that sample pack of
drug contained 15 mi. of drug and that under R. 32 contents should have been less than 15 mi. No
allegation made to the effect that manufacturer sold physician's sample to any one in contravention of
the provisions of the Act or Rules. Nowhere in the complaint it was urged that quantity impact was
unreasonable or that unreasonably large quantity of sample was supplied to any physician or
institution. No fresh case could be permitted to be argued against the manufacturer in that behalf.
Complaint being based on erroneous view of law no case, held, was made out against the
manufacturer for violation of R. 32 which could entail any punishment under section 27(4) or 23(1)(x),
Drug Act, 1976, therefore, the proceedings were quashed. P L D 1985 Lah. 503.
The accused was proceeded against for manufacturing spurious drugs. Drug Inspector could not
identify accused who was admittedly not present at the premises in question when raid was
conducted. Two persons, apprehended on the spot exonerated accused and denied having any
acquaintance with him or having ever seen him in the premises. Disputed premises was neither
owned by the accused nor occupied by him. Lease agreement showed that premises was rented out
to someone else by the owner and the proceedings were quashed in such circumstances. 1991 P Cr.
L J 2329.
Constitutional petition concerned only with import of drugs and their clearance. Applicant
shareholder, desirous to become a party to Constitutional petition in view of disputes inter se between
shareholders of the company. Applicant's locus standi to be impleaded as a party in Constitutional
petition. Clearance of drugs being for the benefit of the company of which applicants were
shareholders, they were, therefore, neither necessary nor proper party in such proceedings. As for
applicant's dispute with other shareholders of the company regarding the affairs of the company, they
could seek remedy in accordance with law. 1994 C L C 2270(b).
Substandard drugs: Record not showing that after purchasing drugs from manufacturer whether
same were stored under the conditions laid down or stated on carton. Reasonable possibility of
having been deteriorated due to its improper storage after the purchase from manufacturers not ruled
out. Accused entitled to the benefit of doubt and the conviction and sentence were set aside. 1985 P
Or. L J 281; 1985 P Cr. L J 281.
According to the case of Fazal Elahi v. The State, 1985 P Cr. L J 268, no prosecution launched
against the company which manufactured drugs in question. Accused not shown to be acting as agent
of the company for distribution of substandard drugs. In absence of the company, accused held, could
not be prosecuted. The liability of manufacturer of the drugs and his agent for distribution thereof
would be co-extensive.
Appreciation of Evidence. Evidence on record did not show that the accused was found selling the
drugs recovered from his possession while keeping them in his shop without a licence. Drugs
recovered could be available almost in every house for daily consumption. Defence version was
believable and the possibility of false implication of accused could not be ruled out. Accused was
Appeal against acquittal: Explanation given by the accused for not complying with a direction of the
Secretary, Registration Board, to mention "Oleoresin of Ginger" as an ingredient on the label was
convincing. Nothing manifestly wrong or perverse was, therefore, found in the conclusion arrived at by
the trial Court, the appeal against the acquittal of the accused was consequently dismissed. P L D
1992 Kar. 347 (d).
24. Control of advertisement: No person shall himself or by any other person on his behalf
advertise, except in accordance with such conditions as may be prescribed,--
(i) any drug;
(ii) any substance used or prepared for use in accordance with the ayurvedic, unani, homoeopathic or
biochemic system of treatment or any other substance or mixture of substances as may be
prescribed;
(iii) any remedy, treatment or offer of a treatment for any disease.
Explanation: In this section, "advertise" means to make any representation by any means whatsoever
for the purpose of promoting directly or indirectly the sale or disposal of a drug, a substance or a
mixture of substances, a remedy or a 'treatment except the display of sign boards for a clinic, a
dispensary or a hospital or such other institution offering treatment.
COMMENTS
Presumption of fact : No evidence having been produced by prosecution to prove factum of

publication of advertisement in newspaper and souvenir by the accused. Accused having disputed the
same. Mere fact that advertisement might have benefited the accused, held, would not justify raising
of presumption against the accused under section 114 (f) of the Evidence Act (I of 1872), the appeal
Appeal was, therefore, allowed, conviction and sentence were set aside. 1986 P Cr. L J 486.
Handbill displaying picture of healthy seminude male and female with writing "it is well-known about
Knight Pills that husband who takes Knight Pills never gets old and knight Pills keeps the potency of a
male ready for action". Ingredients of Knight Pills was totally missing from handbill. Language used in
the handbill was calculated to induce persons interested in combating sexual weakness to buy pills
mentioned in the handbill, thereby promoted sale of pills and as such handbill would fall within the
definition of "advertisement". 1984 P Cr. L J 2895.
Burden of proof: Prosecution not producing any witness to prove the fact that the accused caused
publication of advertisement in newspaper and pamphlet. Accused disputing publication of such
advertisement to have been caused by him. Burden of proof, would lie squarely on prosecution. 1986
P Cr. L J 486.
25. Control of samplings: No person shall distribute or cause to be distributed any drug as a sample
except in accordance with such conditions as may be prescribed.
26. Control of printing of labelling: No person shall print any labelling in respect of any drug which
is required to be registered under this Act but is not so registered after the date fixed by the Federal
Government under sub-section (6) of section 7 or for a person who does not possess a licence under
this Act to manufacture that drug.
25. Control of samplings: No person shall distribute or cause to be distributed any drug as a sample except in
accordance with such conditions as may be prescribed.
26. Control of printing of labelling: No person shall print any labelling in respect of any drug which is required to
be registered under this Act but is not so registered after the date fixed by the Federal Government under sub-
section (6) of section 7 or for a person who does not possess a licence under this Act to manufacture that drug.
26. Control of printing of labelling: No person shall print any labelling in respect of any drug which is required to
be registered under this Act but is not so registered after the date fixed by the Federal Government under sub-
section (6) of section 7 or for a person who does not possess a licence under this Act to manufacture that drug.
CHAPTER 4 - Offences, Penalties and Procedure

27. Penalties.
28. Penalty for subsequent offence.
29. Forfeiture.
30. Cognizance of offences.
31. Drug Courts.
32. Pleas.
33. Application of law relating to customs and powers of officers of customs.
34. Offences by companies, etc.
35. Publication of offender's name.
36. Powers to exempt.
37. Inspectors to be public servants.
38. Indemnity.
39. Finality of order, etc.
40. Publication of result of test or analysis.
41. Cancellation or suspension of licenses.
42. Cancellation or suspension of registration of registered drugs.
CHAPTER IV
Offences, Penalties and Procedure
27. Penalties : (1) Whoever himself or by any other person on his behalf:
(a) exports, imports, manufactures for sale or sells any spurious drug or any drug which is not
registered;
(b) manufactures for sale any drug without a licence; or
(c) imports without licence any drug for the import of which a licence is required;
shall be punishable with imprisonment for a term which shall not be less than three years or more
than ten years and with fine which may extend to one lakh rupees:
Provided that the Drug Court may, for any special reasons to be recorded, award a sentence of
imprisonment for a term of less than three years.
(2) Whoever himself or by any other person on his behalf--

(a) imports, manufactures for sale or sells any counterfeit drugs; or
(b) gives to the purchaser a false warranty in respect of any drug sold by him that the drug does not in
any way contravene the provisions of Section 23 and is not able to prove that, when he gave the
warranty, he had good and sufficient reason to believe the same to be true; or
(c) applies or permits to be applied to any drug sold, or stocked or exhibited for sale, by him, whether
on the container or a label or in any other manner, a warranty given in respect of any other drug, or
(d) imports, manufactures for sales or sells any drug under a name other than the registered name; or
(e) exports, imports, manufactures for sale or sells any drug with which any substance, which should
not actually be its component, has been mixed or packed so as to reduce its quality or strength or for
which any such substance has been substituted wholly or in part;
shall be punishable with imprisonment for a term which may extend to seven years, and with fine
which may extend to one lakh rupees.
(3) Whoever obstructs an Inspector in the exercise of any power conferred upon him by or under this
Act, or disobeys the lawful authority of any Inspector, shall be punishable with imprisonment for a term
which may extend to one year, or with fine which may extend to ten thousand rupees, or with both.
(4) Subject to the provisions of sub-section (1), sub-section (2) and sub-section (3), whoever himself
or by any other person on his behalf contravenes any of the provisions of this Act or any rule shall be
punishable with imprisonment for a term which may extend to five years, or with fine which may
extend to fifty thousand rupees, or with both.
COMMENTS
Substandard or misbranded drugs manufactured by a company: The burden of proof, cast on

Director or employee of a company to prove that substandard or misbranded drug was manufactured
without their knowledge and or consent after prosecution discharged its initial burden. The
presumption, held, would be that all such acts of manufacture of misbranded or substandard drugs
were committed with knowledge and or with consent of every such director or employee. 1986 P Cr. L
J 1265.
Offence being cognizable could be investigated into by the Provincial Police and therefore by the
Federal Investigation Agency also. Prosecution in respect of offence could not, however, be instituted
except by the Drugs Inspector. P L D 1976 Lah. 813.
Manufacturing of substandard drug wherein the petitioner is being the manager of the drug
manufacturing firm, proprietor produced the warranty, both are liable for the offence. 1976 P Cr. J L
649.
Where the warranty was signed not by the petitioner but by another partner of the firm and the drugs
were not found of standard quality, the petitioner was also held liable in respect of offence relating to
drugs. 1973 P Cr. L J 809.
It is a well established proposition of law that whenever the legislature empowers a subordinate
authority to attach any conditions to the grant of a licence the conditions to be valid must fairly and
reasonably relate to the object and purposes of law. P L D 1978 Lah. 445.
The prosecution and conviction of a person for merely stocking certain medicines is misconceived
where the rules have only prohibited the supply or sales of those medicines otherwise than under the
personal supervision of a qualified person. A I R 1956 All. 703.
Powers of search and seizure given to the Drugs Inspectors under section 18(1) is not restricted to
by the Police Officers. Police Officers in such cases were not required to follow procedure laid down in
section 19 but to follow procedure prescribed under the Code of Criminal Procedure, 1898, section
103. 1979 P Cr. L J Note 6.
Government Analyst's report proved the drug kept in store for sale and sold by the petitioner not
containing relevant ingredients but some other powders. The petitioner though given a sample but not
proving drug to have contained necessary components and being genuine and not spurious. The
contention as to drug in question having not been proved to be spurious, was not maintainable. P L D
1981 S C 352.
Facts on record showing that there were conflicting reports of the Government Analyst in respect of
certain drug. Circumstances not ruling out possibility that deterioration may be due to storage and
climatic condition. Proceedings against the accused Nos. 2 to 4 instituted on application of the Special
Prosecutor. The accused were entitled to the benefit of doubt and acquitted. N L R 1982 Or. L J 280.
Drug found deficient of ingredients under warranty. Borax Glycerine manufactured under written
warranty of containing, 12% of borax (main active ingredient) but found substandard and deficient.
containing only 6.73% w/w and absorption of water to extent of 100% of total quantity of glycerine.
Contention that glycerine being highly hygroscopic. absorption moisture could be caused due to
loosely fitted stoppers. No evidence, however, to indicate that bottles containing Borax Glycerine were
not properly stoppered or not dried before use. Accused, held, guilty of offences, in circumstances.
Borax Glycerine a drug where in even major variation of active ingredient can result in no serious
consequences and accused manufacturers also withdrawing entire batch from retailer. Heavy
sentence held further,-not called for in circumstances. Accused sentenced to fine of Rs.5,000/- or I
years RI. in default. 1978 P Cr. L J 287.
Search and Seizure: Powers of search and seizure given to Drugs Inspector under Section 18 (1) not
restricted to such officers. Searches and Seizures in respect of offence under Section 27(1), held, can
also be made by Police Officers. Police Officers in such cases, held further, not required to follow
procedure laid down in Section 19, but to follow procedure prescribed under Code of Criminal
Procedure, 1898, Section 103. 1979. PCr. L J 4.
Criminal liability--Limited company : A limited company or a Corporation is legal 'person' in the eye
of law and by legal fiction capable of taking and defending civil actions in its own name; though even
acting through its Directors/employees or agents, yet in the criminal law position was different.
Despite generality of section 11, Penal Code, it was not indictable for offences which could be
committed by human being only or offences which must be punished with imprisonment. The Trial
Court, held, could not punish company and if any one of its acts amounted to an offence some one or
more of its Directors or employees who did that the act would have to be held responsible for it. 1986
P Cr. L J 1265.
Substandard and misbranded drugs: The person guilty of offence a limited company while accused
its director and employees. Vicarious liability, held, was imposed on every such Director and the
employees of the company unless they proved that offence was committed without their knowledge or
consent. 1986 P Or. L J 1265.
The Drug Analyst submitting his report beyond the period prescribed by law without obtaining
extension from the Quality Control Board. The Drug Analyst, held, committed violation of the
provisions of law and report sent him not in the prescribed form. 1985 P Cr. L J 281.
No offence u/s 23(1)(x) to entail punishment under Section 27(4) Proceeding Quashed: Since
the case of the Inspector of Drugs is based on and erroneous view of the law, no case stands made
out against the petitioner Company for violation of rule 32 of the Drugs Rules. 1976, which may entail
any punishment under Section 27(4) of the Act. Since there is no allegation that the Physician's
Sample was sold by the petitioner. Company to any one in contravention of any of the provisions of
the Act or the rules, no offence stands made out for violation of Section 23(1) (x) of the Act as to entail
any punishment under Section 24 (4) either. Proceedings pending before the Drugs Court under
Section 23/27 of the Drugs Act, 1976, read with Section 32 of the Drugs Rules quashed. P L. D 1985
Lab. 503.
Interpretation of statutes: Where statutory powers are Conferred and specific provisions made in
statute as to manner in which powers are to be exercised they should be exercised by authority
strictly in the manner specified in the statute. 1985 P Cr. L J 281.
ingredient of the evidence was that the drugs sold by the accused were drugs which had been
offence that the Inspector a P.W. had produced the letter of the Health Department, that the alleged
manufacturers did not have. any licence to manufacture drugs, But the burden was on the prosecution
to prove that the manufacturers did not have any licence under the Drugs Act, and as the accused
had taken objection to the production of this letter the prosecution should have proved it in the manner
prescribed under section 67 of the Evidence Act, and the prosecution did' not care to do. It was
contended that the letter had not been proved. This. submission was supported by the unanimous
view of the Supreme Court in the case of Muhammad Khattak v. SM. Ayub. 1974 P Cr. L J Note 81.
Additionally there was also no provision in the Drugs Act which could relieve the prosecution of its
obligation to prove this letter under Section 67 of the Evidence Act: Held, the letter had not been
proved.
The contention that the process of "packing" or "re-packing" of drug was not an offence, within the
purview of Section 27 of the Drugs Act repelled. 1983 P Cr. L J 2491.
Laboratory report showing drug substandard and no indication on record that accused notified to any
of the prescribed authorities of their intention to challenge such report. Contentions that whole
process of manufacturing was not completed nor drug was ready for marketing when drug secured
nor laboratory report disclosed requisite protocols. Contentions were of no consequence therefore,
the conviction was maintained. 1984 P Cr. L J 2007.
The contention that pills sought to be advertised by handbill being harmless and use thereof to any
extent not being dangerous to life therefore manufacturer was not liable for any offence under the
Drugs Act.
The contention was fallacious. Pills, held further, not having been manufactured as a drug in
accordance with conditions of any licence obtained for the manufacture of any drug, manufacturer
committed offence under Section 27 of the Drugs Act. Conviction and sentence were maintained, in
circumstances. 1984 P Cr. L. J 2895.
Conviction of accused by the Drug Court for having substandard drugs. Reasonable possibility
existing that samples which was obtained by the Drug Inspector and subsequently sent to the
National Health Laboratories deteriorated after the acquisition of same due to adverse climatic
conditions. Accused, held, entitled to the benefit of doubt and acquitted. 1984 P Cr. L J 1580.
Non-prosecution of Company--Directors or Employees could not be held vicariously liable: If

the Company was found guilty of the offence then the burden was on the Directors or the employees
of the Company to prove the non-existence of knowledge or consent on the part of the Directors or
employees of the Company. Finding that Company was guilty of the offence was sine qua non to
convict the Directors or employees of the Company that they were guilty of the offence. When the
Company was not before the Court then no adverse finding could be given against the Company and
in such a 'situation the Directors or Employers could not be held vicariously liable. Non-prosecution of
Company itself was, therefore, fatal-for the prosecution. P L D 1991 893.
Appraisal of evidence: It was not proved through qualitative and quantitative analysis of the
ingredients in the offending preparation that the active ingredient/constituent Methyl Salicylate had
been used which formed part of the protected pharmacopocieas. Analyst's report did not determine
the ingredients in the offending preparation quantitatively or even fully. It could not, therefore, be
found that the accused did not use merely a herbal extract in its natural form for the purposes of his
preparation. Offence alleged against the accused, held, had not be proved beyond reasonable doubt,
the accused was acquitted in circumstances. 1990 M L D 1524.
If the company was found guilty of the offence the burden was on the Directors or the employees of
the company to prove the non-existence of knowledge or consent on the part of the Directors or
employees of the company. Finding that the company was guilty of the offence was sine qua non to
convict the Directors or employees of the company that they were guilty of the offence. When the
company was not before the Court then no adverse finding could. be given against the company and
in such a situation the Directors or employees could not be held vicariously liable. Non-prosecution of
company itself, was therefore, fatal for the Prosecution. P L D 1991 S C 893.
Appreciation of evidence: Evidence on record did not show that the accused was found selling the
drugs recouered from his. Possession while keeping them in his shop without a licence. Drugs
recovered could be available almost in every house for daily comsumption. Defence version was
believable and the possibility of false implication if accused could not be ruled out. Accused was
Charge against accused was two-fold; one that the drug recovered by the Drug Inspector from him
was not registered and the other that it was spurious. Prosecution had not produced the concerned
Authority of the Federal Government alongwith the record to prove non-registration of the drug.
Sample taken into possession from the shop of the accused was also not sent to Public Analyst for
analysis nor any public analyst was examined in Court. Sample having been sent to Quality Control
Board for analysis four years after the recovery, no credence at all could be attached to its report
which was not even proved. Spuriousness of the drug, therefore, was also not proved on record.
Accused was acquitted accordingly. P L D 1997 Pesh. 49.
No sample of the drug seized by the complainant Drug Inspector having been taken and sent to the
concerned Laboratory for analysis, it could not be said to be a spurious drug. Drug Inspector although
alleged that the drug seized by him resembled a medicine manufactured by a local pharmaceutical
company, yet he admittedly did not contact the said pharmaceutical company in this respect and
failed to obtain the view of that company regarding the drug in question. Accused was acquitted in
circumstances. 1996 P.Cr.L.J. 540.
Particles and fibres found in the drug could not make it adulterated or for that matter substandard--
Government Analyst's report being silent about the protocols of the test or analysis as required under
the Rules was fatally defective and even otherwise the same was unauthentic and inadmissible in
evidence due to non-appointment of the Government Analyst within the meaning of the Drugs Act,
1976. No Notification was also available to show the appointment of the Drug Inspector prescribing
the limits within which he could have acted as Provincial Inspector for the purpose of the Drugs Act as
envisaged by S. 17. Accused being the Director and Manager of the Company manufacturing the
seized drug could not be convicted of the offence unless proved to be having the knowledge or to
have consented to such offence or when the company had been impleaded as an accused. Accused
were acquitted in circumstances. 1996 P.Cr.L.J. 1183.
Non-Compliance of S. 30 of Drugs Act, 1976. Effect: Failure to raise objection to proceedings by

the defence would not validate the proceedings otherwise invalid. Requirement of law enjoined by S.
30 of the Drugs Act, 1976 is meant to be complied with by the prosecution and if no objection had
been raised by the defence at the trial, it would not validate the proceedings which otherwise stood
vitiated for non-compliance of S. 30, Drugs Act, 1976. 1996 S C M R 767.
Appeal: The Trial Court before convicting the accused discussing evidence of witnesses as well as
documents produced by them and facts deposed in evidence as well as given in documents not
disputed by the accused. Conviction and sentence were maintained. 1986 P Cr. L J 1265.
Jurisdiction of the Drugs Tribunal : Sub-standard drugs manufactured at 'L', sold at 'L' and
thereafter sold within the territorial jurisdiction of the Drugs Court at 'K'. Consequences of
manufacturing substandard drugs at place other than the place of sale of such drugs. Drugs Tribunal
at 'K', would have jurisdiction to try offences under the Drugs Act and no exception could be taken to
impugned order passed by the Tribunal at 'K'. 1987 M L D 1819.
Petitioner's conviction based on his own plea of guilt: Having admitted that the drugs recovered
from him was sub-standard, declined to produce any evidence in defence. There is no interference
called for in the case. Leave to appeal was refused. 1985 S C M R 1405.
Offence by company: The company had to be found guilty of the offence before its Directors and/or
employees could be convicted. P L D 1991 SC 893.
Marking 'DHS' on the packings and coverings of the drugs apparently indicated that they were
property of the 'Director Health Services', Punjab, or for that matter of the Health Department of the
Provincial Government and if the story of prosecution regarding the transportation of some quantity of
the drugs and medicines by the accused in his car was correct, then the possibility of such drugs and
medicines being taken to the Medical Stores of Director Health Services (MSD) or the same being
secretly brought from the MSD for sale to certain wholesale or retail dealers of drugs in a clandestine
manner could not be excluded. Neither the Drugs Inspector nor the SHO constituting the raid party
had explained as to the destination of the drugs being transported by the accused in his car. To probe
into such aspect of the matter to bring to book the real culprits and also in the larger interest of justice
the case was remanded to the trial Court with necessary directions for deciding the same afresh in
accordance with law. 1992 P Cr. L J 1781.
Prosecution witnesses were responsible Government Officers who in the performance of their
statutory duty without any mala fides on their part had conducted the raid taking all precautions and
observing legal formalities. Defence evidence on the other hand did not inspire confidence. Conviction
and sentence of the accused were upheld in circumstances. 1992 S C M R 2072 (b).
No prosecution launched against the company which manufactured drugs in question. Accused not
shown to be acting as Agent of the Company for distribution of substandard drugs. In the absence of
company, accused, held, could not be prosecuted. The liability of manufacturer of drugs and his agent
for distribution thereof would be co-extensive. 1985 P Cr. L J 268.
According to the case of Fazal Ellahi v. State, 1985 P Cr. L J 268, substandard drugs manufactured
by a private limited company and not impleaded as a principal accused alongwith other accused who
were directors of the Company. The accused was acquitted.
According to the case of Muhammad Saeed v. The State, 1985 P Cr. L J 1440. the trial Court
convicting the accused on his statement treating the same as confession, without framing of charge
under Section 242, Cr.P.C. Question of conviction of the accused on his statement in circumstances
held, could not arise. Conviction and the sentence set aside and the case remanded for trial according
to law.
Conviction on charge of keeping substandard drugs on plea of guilty by accused: Accused not
only pleaded guilty but admitted that the drugs recovered from him were substandard and declined to
produce any evidence. Leave to appeal refused on ground that there was no reason why after
complaint and appearance in the Drug Court accused should remain unaware that he was making
statement in Court in proceedings which might result in his conviction and the sentence on his own
plea of guilty. 1985 S C M R 1827.
and Section 22 (5) of the Drugs Act, 1976, makes it compulsory for prosecution to send the samples
for retesting to .the Federal Drugs Laboratory or any other laboratory specified for the purpose by the
provisions of law have to be strictly followed Letters were addressed to the Provincial Quality Control
accused in view of clear violation of section 22(5) of the Drugs Act, 1976. Appeal against the acquittal
was dismissed in circumstances 1990 P Cr. L J 865.
Prosecution could be instituted under the law either by a Federal Drug Inspector or Provincial Drug
Inspector and complainant in the case did not hold any of these positions. Complainant being not
competent to institute the case/prosecution before the Drug Court, the entire proceedings stood
vitiated. View taken by High Court resulting in acquittal of accused was correct and in consonance
with law. Leave to appeal was refused accordingly. 1996 S C M R (b) SC (Pak.) 767.
Prosecution and Proceedings Quashed : Prosecution of drug manufactures for offences under
Section 28/27, was challenged contending that (i) FIR was registered on complaint by Magistrate who
was alien to Drugs Act; (ii) prosecution was initiated by granting approval without personal hearing to
accused as required by R. 4(3). Drugs Rules (1988) (iii) Report of Government Analyst was
inadmissible in evidence. Held, Prosecution and proceedings merited quashing under Section 249-A,
Cr.P.C. as there was no probability of conviction of accused in view of force in contentions raised in
support of application under Section 249, Cr.P.C. N L R1993 Cr. L J 31.
Petitioner stored and was selling spurious drug: It was contended that the report of the
Government Analyst on the basis of which it was 'held by the Courts below that the Petitioner had
stored for sale and was selling a spurious drug viz., Tetracycline Pediatric Powder was not
comprehensive in proving that the drug recovered from the petitioner was in fact spurious. Held, that a
Drug which purported to be a particular Drug but does not contain its active ingredients is a spurious
drug. Further held, that the report of the Government Analyst proved that the Drug Tetracycline
Pediatric powder which was kept in store for sale and was sold by the Petitioner did not contain the
relevant ingredients but rather contained Kaolin and Coco powder. The petitioner at the time the
sample was taken was given a set of that sample but did not prove by leading any evidence that the
Drug contained the necessary components and was genuine and not spurious. Thus the contention
raised by the petitioner was repelled. P L D 1981 S C. 352.
Quashing of F.I.R : Registration of the F.I.R. in respect of the offence was not a case classified by
the Provincial Quality Control Board, nor the Provincial Inspector had submitted a report to the said
Board. Provincial Inspector had also not obtained instructions from the Provincial Quality Control
Leave to appeal: The leave to appeal was granted to consider that the trial of the accused persons
was illegal, in that, sanction from the Quality Control Board was obtained against the Company
(Manufacturer) and not against the accused persons (General Manager and Director, Plant Manager,
Production Manager, Quality Control Manager and Controller) and that the company as such was not
impleaded as an accused and that the High Court erred in invoking section 34 of the Act in this behalf.
P L D 1991 SO 893.
Drug Inspector in the interest of secretary and protection had sought the assistance of the C.I.A. Staff
excluding the participation and association of the police stations having jurisdiction or even the
respectables of the locality. Such a caution on the part of the Drug Inspector would not make the
proceedings suspect for non-inclusion of a respectables of the locality. 1992 S C M R 2072.
The trial Court had omitted to extend benefit of section 382-B, Cr.P.C. to the accused without noticing
any feature justifying such a denial. Benefit of section 382-B, Cr.P.C. was allowed to the accused
accordingly. 1992 S C M R 2072 (c).
28. Penalty for subsequent offence : (1) Whoever having been convicted of an offence under sub-
section (1) of section 27 is again convicted of an offence under that sub-section shall be punishable
with imprisonment for life or with imprisonment which shall not be less than five years and with fine
which may extend to two lakh rupees.
(2) Whoever having been convicted of an offence under sub-section (4) of section 27 is again
convicted of an offence under that sub-section shall be punishable with imprisonment for a term which
shall not be less than two years or more than ten years, or with fine which may extend to two lakh
rupees, or with both.
may extend to seven years, or with fine which may extend to one lakh rupees, or with both.
29. Forfeiture : (1) Where any person has been convicted under this Act, for contravening any such
provisions of this Act or any rule as may be prescribed in this behalf, the Drug Court may order that
the stock of drug or substance by means of or in relation to which the offence was committed or
anything of a similar nature belonging to or in the possession of the accused or found with such drug
or substance, and if such contravention is punishable under sub-section (1) of section 27, any
implements used in manufacture or sale of such drug and any receptacles, packages or coverings in
which such drug is contained and the animals, vehicles, vessels or other conveyances, used in
carrying such drug, be forfeited to the Federal Government or, as the case may be, the Provincial
Government and, upon such order being made, such .drug, substance, implements, receptacles,
packages or coverings, animals, vehicles, vessels or conveyance may be disposed of as that
Government may direct.
(2) Without prejudice to the provisions of sub-section (1), where the Drug Court is satisfied on the
application of an Inspector or otherwise, and after such inquiry as may be necessary that a drug
contravenes the provisions of this Act, the Drug Court may order that such drug be forfeited to the
Federal Government or, as the case may be, the Provincial Government and, upon such order being
made, such drug may be destroyed or otherwise disposed of as that Government may direct.
(3) An Inspector shall release any drug or article seized by him under this Act when he is satisfied that
all the provisions of this Act and the rules with respect thereto have been complied with.
COMMENTS
Power of confiscation can be exercised provided the prosecution ends in conviction of the accused.
When the Appellate Court acquitted the accused but maintained the order of confiscation of medical
packets the order was set aside. 1971 P Cr. L J 641.
30. Cognizance of offences: (1) Subject to the provisions of Section 19, no prosecution shall be
instituted under this Chapter except--
(a) by a Federal Inspector, where the prosecution is in respect of a contravention of clause (h) of sub-
section (1) of section 23 or section 24 or any of the provisions of this Act or the rules relating to the
import or export of drugs or the manufacture for sale, or sale, of a drug which is not for the time being
registered or for the manufacture for sale of which a licence is not for the time being in force; or
(b) by a Provincial Inspector:
Provided that, where the public interest so requires, the Federal Inspector may, with the prior
permission of the Federal Government, institute a prosecution for a contravention of any other
provision of this Act.
(2) Notwithstanding anything contained in the Code of Criminal Procedure, 1898 (Act V of 1898),--
(a) an offence punishable under this Chapter other than an offence mentioned in sub-section (1) of
section 27, shall be non-cognizable, and
(b) no Court other than a Drug Court shall try an offence punishable under this Chapter.
(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 punishable under this
Chapter or to require the transfer to a Drug Court of any case which may be pending in any Court
immediately before the establishment of the Drug Court.
COMMENTS
Question of lodging report with police and arrest of accused are not dealt with by the Drugs Act.
Provisions of the Criminal Procedure Code, 1898 will, therefore, govern such matters. P L D 1976
Lab. 813,
Where the witness was not cross-examined on the point the Magistrate was held to have erred in
holding that the witness was not an Inspector of Drugs merely because he did not produce
documentary evidence about his appointment. 1974 P Cr. L J Note 81, p. 50.
In a prosecution under the Act the complainant has to prove by bringing evidence on record that he is
an Inspector, whether that fact is challenged by the accused or not. His mere allegation in the
complaint that he is an Inspector and the failure of the accused to cross-examine him on that point are
not proof of his status. 1955 B L J R 40.
The prosecution instituted by a person whose appointment as Drugs Inspector was not notified within
the meaning of section 17, violates provisions of the section 30 where under no prosecution could be
instituted except by a properly appointed Drugs Inspector. It was held that since there was a legal
defect in institution of instant case it was not possible to maintain conviction of the appellant or
sentence awarded to him under section 27(4). Appeal was allowed, conviction was set aside and the
appellant was acquitted. N L R 1981 Criminal 369; 1982 P Cr. L J 48.
Report to Police: Question of lodging of report with police and arrest of accused not dealt with by
Drugs Act. Provisions of Criminal Procedure Code, 1898, hence, govern such matters. P L D 1976.
Lah. 813.
In the Court of Sindh Quality Control Board of Drug M/s. Pioneer Laboratories Karachi: Having heard
the appeal, the Supreme Court take up a more important question involved in principle namely,
whether in a Criminal prosecution it is proper to exercise jurisdiction under Art, 199 of the constitution,
particularly when remedies have been provided under the statute to the accused. In a prosecution
under the Drugs Act, the provisions of the Code of Criminal Procedure are applicable, and the trial by
the Drugs Court is conducted as provided by the Drugs Act as well as the Code of Criminal
Procedure. Under Section 31(4) of the Drugs Act a Drugs Court has all the powers conferred by the
Code of Criminal Procedure on a Court of a Session exercising original jurisdiction. Therefore whether
the cognizance of offence could be taken under Section 30 in view of the objection raised by the
respondent in the constitution Petition before the High Courts, could be pressed before the Drugs
Court under Section 265-K, Cr. P.C. for challenging the proceedings if they were defective and not as
provided by Section 30 of the Drugs Act. In such circumstances the High Court should have refused
to exercise discretion under Article 199 of the Constitution. 1993 S C M R 1177.
31. Drug Courts : (1) The Federal Government may, by notification in the official Gazette, establish
as many Drug Courts as it considers necessary and, where it establishes more than one Drug Court,
shall specify in the notification the territorial limits within which, of the class of cases in respect of
which, each one of them shall exercise jurisdiction under this Act.
(2) A Drug Court shall consist of a person who is, or has been, or is qualified for appointment as, a
Judge of a High Court, who shall be the Chairman, and two members being persons who, in the
opinion of the Federal Government, are experts in the medical or pharmaceutical fields.
(3) A Drug Court shall sit at such place or places as the Federal Government may direct.
(4) A Drug Court shall have all the powers conferred by the Code of Criminal Procedure, 1898 (Act V
of 1898), on a Court of Session exercising original jurisdiction.
(5) A Drug Court shall not merely by reason of a change in its composition, be bound to recall and
rehear any witness who has given evidence, and may act on the evidence already recorded by or
produced before it.
(6) A Drug Court shall, in all matters with respect to which no procedure has been prescribed by this
Act, follow the procedure prescribed by the Code of Criminal Procedure, 1898 (Act V of 1898), for the
trial of summons cases by Magistrates.
(7) A person sentenced by a Drug Court may prefer an appeal to a Bench of the High Court consisting
of not less than two Judges within thirty days of the judgment.
(8) The provisions of Sections 5 and 12 of the Limitation Act, 1908 (IX of 1908), shall be applicable to
an appeal referred to in sub-section (7).
COMMENTS
Revisional jurisdiction of High Court, is available in cases tried under the Drugs Act, 1976:
Even if the Drugs Act, 1976: did not confer High Court revisional jurisdiction, same could be invoked
under Sections 435 and 439, Criminal Procedure Code. High Court, under section 31, Drugs Act,
could exercise appellate jurisdiction against decision of the Drugs Court thus Drugs Court is an
'inferior' Court. Use of the word 'inferior' in section 435, Criminal Procedure Code, enables the High
Court to exercise revisional jurisdiction in respect of those Courts also which were not subordinate to
it in technical sense. High Court is competent to exercise revisional jurisdiction and could interfere to
the extent of examining the correctness, legality or propriety of any finding, sentence or order
recorded or passed and as to regularity of proceeding pending before the Trial Court. All powers
allowed under sections 435 and 439, Criminal Procedure Code, could be exercised by the High Court.
P L D 1986 Kar. 390.
Under repealed Act of 1940, in the event of conviction by a Magisterial Court, accused had aright to
file an appeal against the order of conviction, in Sessions Court and yet a further remedy of revision in
High Court, against dismissal of appeal, while under the repealing Drugs Act of 1976, accused having
only one remedy by way of appeal to High Court. Rule of retrospectivity would not be applicable as
change in procedural law affects a "vested right, of accused under old law unless an express
provision to take such right made in new law. The trial of the accused by the Drugs Court, constituted
under section 31 of the Drugs Act, 1976, for an offence committed by him under section 18 (a) of the
Drugs Act, 1940 and his eventual conviction for such offence, was illegal and without jurisdiction. The
conviction and sentence was set aside in circumstances. 1980 P Cr. L J 1212.
Complaint in the Drug Court for taking action against the accused for manufacturing substandard
quality of vitamins. The accused challenged such action in the High Court through constitutional
petition, which was validly allowed. Exercise of the Constitutional jurisdiction by the High Court in a
criminal prosecution was not proper particularly when remedies had been provided under the Statute
(Drugs Act, 1976) 1o the accused. Case was directed to proceed before the Drug Court where the
respondents would be at liberty to raise such objections as would be possible under law. P L D 1993
SC (Pak.) 1177.
The word "inferior" substituted in section 435 for the word "subordinate" appearing in Section 295 in
order to keep hands of High Court quite free in dealing with a case in its ultimate stage of revision,
etc. Drugs Court having been made subject to appellate jurisdiction of High Court, and, in such sense,
inferior to High Court, High Court, could exercise revisional jurisdiction against the orders of the Drugs
Court. Having made Drugs Court judicially inferior to High Court no necessity existed for duplicating
matter over again by expressly providing for a revisional jurisdiction of High Court. P L D 1981 S C
352.
Sanction for lodging complaint: Drug Inspector obtaining sanction for lodging complaint from the
Provincial Quality Control Board against the accused who were actively connected with accused
company and lodged complaint against them. But omitting to get such sanction and consequently to
lodge complaint, regarding accused company. Second complaint lodged against the accused
company afterwards without getting such sanction. The High Court finding that Provincial Quality
Control Board after considering matter and reports from the laboratories had concluded that
prosecution be launched against the manufacturer. Intention of Board very clear that manufacturer of
drugs to be prosecuted which included company also. The defect of not getting sanction against the
accused company, was merely procedural in nature and not vitiating proceedings. No bar was present
against consolidation of both complaints by the trial Court. 1985 P Cr. L J 2064.
"Dihydrallazine" or "Dihydralline Sulphate" : Protocols of tests (details of process of tests) was not
provided with report by Analyst. Sample was sent to Federal Laboratory did not' appear to be the
same sample as sealed and marked by the Inspector. Federal Laboratory tested and analysed
"Dihydrallazine tablets" instead of testing and analysing "Dihydrallazine Sulphate" tablets. Provisions
of Act and Rules with regard to despatch of samples and submission of report not observed with
complete strictness. Accused, held, could not be prosecuted and convicted in circumstances.
Direction contained in Section 19(2) of Act and rules 14 and 15 in regard to making of sample, could
not directory but mandatory. In absence of "nil mark", Drug Court could not convict the accused on
ground of report of analyst that sample was substandard. Importance of strict observance in regard to
sample emphasised in Form No. 6.
Adulterated drug--Test report : Action of the Provincial Quality Control Board for sending sample for
second report when first test report was already adverse to accused was uncalled for. The report in
second test also adverse but findings in both reports conflicting with each other. Test report not made
on the prescribed form. Details of result of test or analysis not given in report. Report not to be relied.
upon test report of sample showing that sodium bicarbonate was found to be 1.24% whereas limit was
0.98.1% Sodium bicarbonate in sample was found to. be in excess of by 0.24% as against 1%. Such
excess found to be neither dangerous nor detrimental as still the ingredient was within the range of
normal dose. Prosecution, therefore, failed to prove case in circumstances. 1985 P Cr. L J. 2064.
Revisional jurisdiction of High Court: Drugs Court having been made subject to appellate
jurisdiction of High Court, and in such sense, inferior to High Court. High Court held, could exercise
revisional jurisdiction against orders of Drugs Court, Having made drugs Court judicially inferior to
High Court, no necessity held further, existed for duplicating matter over again by expressly providing
for a revisional jurisdiction of High Court. P L D 1981. Supreme Court: 352.
disputed by the accused. Coviction and sentence were maintained. 1986 P Cr. L J 1265.
32. Pleas: (1) Save as hereafter provided in this section, it shall be no defence in a prosecution under
this Act 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) A drug shall not be deemed to be misbranded or adulterated or sub-standard only by reason of the
fact that there has been added thereto some innocuous substance or. ingredient because the same is
required for the manufacture or preparation of the drug 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 defect or
there is a decomposed substance which is the result of a natural process of decomposition:
Provided that such decomposition is not due to any negligence on the part of the manufacturer or the
drug or the dealer thereof and that it does not render the drug injurious to health or does not make it
substandard.
(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 23 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 provision of this Act and that the drug while in his possession remained in
the same state as when he acquired it; and
(b) that he acquired the drug from a duly licensed manufacturer or his authorised agent or an importer
or an indentor resident in Pakistan under a written warrant, in the prescribed form stating, in particular.
the batch number of the drug and signed by such person that the drug does not in any way
contravene the provisions of Section 23 and that the drug while in his possession was properly stored
and remained in the same state as when he acquired it and that the drug has been manufactured by a
manufacturer holding a valid licence to manufacture drugs and permission to manufacture that drug:
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.
33. Application of law relating to customs and powers of officers of customs : (1) The law for
the time being in force relating to customs and to goods the import of which is prohibited by or under
the Customs Act, 1969 (IV of 1969), shall, subject to the provisions of section 27 of this Act, apply in
respect of drugs the import of which is prohibited under this Act, and officers of customs and officers
to whom any of the functions of an officer of customs have been entrusted under the said Act shall
have the same powers in respect of such drugs as they have for the time being in respect of such
goods as aforesaid.
(2) Without prejudice to the provisions of sub-section

(1), an officer of customs or a Federal Inspector or any other person as may be authorised by the
Federal Government in this behalf may detain any imported package which he suspects to contain
any drug the import of which is prohibited under this Act, and shall forthwith report such detention to
the licensing authority and, if required by it, forward the package or samples of any suspected drug
found therein to a laboratory specified by it.
34. Offences by companies, etc.: Where the person guilty of an offence under this Act, is a
company, corporation, firm or institution, every director, partner and employee of the company,
corporation, firm or institution shall, unless he proves that the offence was committed without his
knowledge or consent, be guilty of the offence.
COMMENTS
Vicarious liability : No evidence produced by Director of the accused firm that substandard drug
manufactured without his knowledge or consent. The accused was equally responsible for offence by
virtue of being a Director of accused firm. The conviction was maintained, in circumstances. 1984 P
Cr. L J 2007.
According to the case of Fazal Ellahi v. The State, 1985 P Cr. L J 268, where the person guilty of
offence was a company, vicarious liability was imposed on a Director, a partner or employer unless
they prove that offence was committed without their knowledge.
Offence by company: The company itself was not impleaded as an accused but the General
Manager and Director, Plant Manager, Production Manager, Quality Control Manager and Controller
of the Company were convicted and sentenced under Section 27 (2)(b) and (4). Held, company
having not been impleaded as an accused in the proceedings constituted against the accused
persons, conviction and sentence of the accused persons as such was not legal. The accused
persons being the employees and Director of the company, could be held to be guilty of the offence,
provided the company, was found guilty of the offence. P L D 1991 SC 893,
Substandard and misbranded drugs: The person quilty of offence a limited company while the
accused its director and employees. The vicarious liability, was imposed on every such Director and
the employees of the company unless they proved that offence was committed without their
knowledge or consent. 1986 P Or. L J 1265.
Substandard drugs--Manufactured by a Company-Responsibility: The Drug Inspector to find out,

as to which of directors, partners or employees, etc., were prima facie concerned and responsible for
manufacturing substandard drug, and would launch prosecution against such persons alongwith
principal accused, i.e., Corporation, firm or institution. 1985 P Cr. L J 268.
Conviction of employees of the company: If the company which is a juristic person is not
impleaded as an accused, its employees cannot be guilty of the offence. 1996 P.Cr.L.J. (b) 1183.
disputed by the accused. The conviction and sentence were maintained. 1986 P Cr. L J 1265.
P L D 1991 SC 893.
35. Publication of offender's name: (1) If any person is convicted of an offence under this Act, it
shall be lawful for the Drug Court to cause the offender's name, place of residence, the offence of
which he has been convicted and the penalty which has been inflicted upon him, to be published at
the expense of such person in such newspapers or in such other manner as the Court may direct.
(2) The expenses of such publication shall be recoverable in the same manner as a fine is
recoverable.
36. Powers to exempt : Notwithstanding anything contained in this Act, the Federal Government
may, if it is of opinion that the public interest so requires, at any time, of its own motion or on a
representation made to it, by notification in the official Gazette, exempt any drug or class of drugs
from the operation of any of the provisions of this Act, subject to such conditions, if any, and for such
period, as may be specified in the notification.
COMMENTS
S.R.O. 1090(1)/92, dated 5-11-1992: In exercise of the powers conferred by section 36 of the Drugs
Act, 1976 (XXXI of 1976), the Federal Government being of the opinion that the public interest so
requires, is pleased to exempt the drugs specified below from operation of the provisions of the said
Act, except sections 24 and 25, till further orders, namely:--
(i) Infant formula; and
(ii) Infant food.
37. Inspectors to be public servants : Every Inspector shall be deemed to be a public servant within
the meaning of section 21 of the Pakistan Penal Code (Act XLV of 1860), and shall be officially
subordinate to such authority as the Government appointing him may specify in this behalf.
COMMENTS
Public servant: According to the Pakistan Penal Code the Public servant is as follows :-
The words "public servant" denote a person falling under any of the description hereinafter following,
namely: -
First: [Omitted].
Second: Every commissioned Officer in the Military, Naval Or Air Forces of Pakistan while serving
under the Federal Government or any Provincial Government;
Third: Every Judge;
Fourth: Every officer of a Court of Justice whose duty it is, as such officer, to investigate or report on
any matter of law or fact, or to make, authenticate, or keep any document, or to take charge or
dispose of any property, or to execute any judicial process, or to administer any oath or to interpret, or
to preserve order in the Court; and every person specially authorised by a Court of Justice to perform
any of such duties;
Fifth: Every juryman, assessor, or member of a punchayat assisting a Court of Justice or public
servant;
Sixth: Every arbitrator or other person to whom any cause or matter has been referred for decision or
report by any Court of Justice, or by any other competent public authority;
Seventh: Every person who holds any office by virtue of which he is empowered to place or keep any
person in confinement;
Eighth: Every officer of the Government whose duty it is, as such officer, to prevent offences, to give
information of offences, to bring offenders to justice, or to protect the public health, safety or
convenience;
Ninth: Every officer whose duty it is, as such officer, to take, receive, keep or expend any property on
behalf of the Government, or to make any survey, assessment or contract on behalf of the
Government or to execute any revenue process, or to investigate, or to report on any matter affecting
the pecuniary interests of the Government, or to make, authenticate or keep any document relating to
the pecuniary interests of the Government, or to prevent the infraction of any law for the protection of
the pecuniary interests of the Government and every officer in the service or pay of the Government
or remunerated by fees or commission for the performance of any public duty;
Tenth: Every officer whose duty it is, as such officer, to take, receive, .keep or expend any property, to
make any survey or assessment or to levy any rate or tax for any secular common purpose of any
village, town or district, or to make, authenticate or keep any document for the ascertaining of the
rights of the people of any village, town or district;
Eleventh: Every person who holds any office in virtue of which he is empowered to prepare, publish,
maintain or revise an electoral roll or to conduct an election or part of an election.
Illustrations
Municipal Commissioner is a public servant.
Explanation 1: Persons falling under any of the above descriptions are public servants, whether
appointed by the Government or not.
Explanation 2: Wherever the words "public servant" occur, they shall be understood of every persons
who is in actual possession of the situation of a public servant, whatever legal defect there may be in
his right to hold that situation.
Explanation 3 : The word "election" denotes an election for the purpose of selecting members of any
legislative, municipal or other public authority, of whatever character, the method of selection to which
is by, or under, any law prescribed as by election.
38. Indemnity : Except as otherwise expressly provided in this Act, no suit, prosecution or other legal
proceeding shall lie against Government or any other authority or person for anything which is in good
faith done or intended to be done under this Act or any rule.
39. Finality of order, etc.: Save as otherwise expressly provided in this Act, every order passed or
decision given by any Board, a Drug Court or any other authority under this Act shall be final and shall
not be called in question by or before any Court or other authority.
COMMENTS
Finality was attached to orders of Drugs Court, subject to any other provision provided otherwise.
Such provision in case in hand; incident of Drugs Court being inferior to the High Court by virtue of its
orders had been made appealable to High Court. Section 2 of Act not barring application of other laws
and provisions of Act having been made subject to "any other law for the time being in force".
Sections 435 and 439, Criminal Procedure Code, 1898 were fully attracted to the Drugs Court. P L D
1981 S C 352.
40. Publication of result of test or analysis, etc.: (1) It shall be lawful for the Federal Government
to publish, in such manner as it may deem fit, the result of any test or analysis of any drug for public
information and to pass such orders relating to the withdrawal of such drug from sale and its disposal
as it may consider necessary.
(2) The Federal Government may, if it considers it necessary in the public interest so to do, publish for
public information, in such manner as it may deem fit, any information relating to a drug or to the use
of a drug in specified circumstances.
41. Cancellation or suspension of licences: Where any person has been found to have
contravened any of the provisions of this Act, or the rules in respect of any drug and the contravention
is of such a nature that the import, export, manufacture or sale of any drug by such person is, in the
opinion of the licensing authority or the Central Licensing Board, likely to endanger public health, that
authority may, after giving such person an opportunity of being heard, cancel the licence to import,
export, manufacture or sell drugs issued to such person or suspend such licence for a specified
period.
42. Cancellation or suspension of registration of registered drugs: Where any person has been
found to have contravened any of the provisions of this Act, or the rules in respect of any registered
drug, the Registration Board may, after giving such person an opportunity of being heard, cancel the
registration of such drug or suspend such registration for a specified period.
COMMENTS
Registration cancelled without hearing: Cancellation of registration of drug without hearing
petitioner. Authority expressed its willingness to take up petitioner's case and to rehear him on
condition that contesting respondent would also be heard alongwith petitioner. Petition disposed of in
terms of statements of respondents. 1989 M L D 2227.
CHAPTER IV
registered;

COMMENTS

J 1265.
649.
drugs. 1973 P Cr. L J 809.
103. 1979 P Cr. L J Note 6.
1981 S C 352.
P Cr. L J 1265.
Lab. 503.
proved.
Drugs Act.


to law.
P L D 1991 SO 893.
COMMENTS
COMMENTS
Lab. 813,
Lah. 813.
produced before it.
COMMENTS
P L D 1986 Kar. 390.
SC (Pak.) 1177.
352.
substandard.
warrantor.
goods as aforesaid.

COMMENTS
Cr. L J 2007.

P L D 1991 SC 893.
recoverable.
COMMENTS
(ii) Infant food.
COMMENTS
namely: -
First: [Omitted].
Third: Every Judge;
any of such duties;
servant;
convenience;
Illustrations
COMMENTS
1981 S C 352.
period.
COMMENTS
CHAPTER IV
registered;

COMMENTS

J 1265.
649.
drugs. 1973 P Cr. L J 809.
103. 1979 P Cr. L J Note 6.
1981 S C 352.
P Cr. L J 1265.
Lab. 503.
proved.
Drugs Act.


to law.
P L D 1991 SO 893.
COMMENTS
COMMENTS
Lab. 813,
Lah. 813.
produced before it.
COMMENTS
P L D 1986 Kar. 390.
SC (Pak.) 1177.
352.
substandard.
warrantor.
goods as aforesaid.

COMMENTS
Cr. L J 2007.

P L D 1991 SC 893.
recoverable.
COMMENTS
(ii) Infant food.
COMMENTS
namely: -
First: [Omitted].
Third: Every Judge;
any of such duties;
servant;
convenience;
Illustrations
COMMENTS
1981 S C 352.
period.
COMMENTS
CHAPTER IV
registered;

COMMENTS

J 1265.
649.
drugs. 1973 P Cr. L J 809.
103. 1979 P Cr. L J Note 6.
1981 S C 352.
P Cr. L J 1265.
Lab. 503.
proved.
Drugs Act.


to law.
P L D 1991 SO 893.
COMMENTS
COMMENTS
Lab. 813,
Lah. 813.
produced before it.
COMMENTS
P L D 1986 Kar. 390.
SC (Pak.) 1177.
352.
substandard.
warrantor.
goods as aforesaid.

COMMENTS
Cr. L J 2007.

P L D 1991 SC 893.
recoverable.
COMMENTS
(ii) Infant food.
COMMENTS
namely: -
First: [Omitted].
Third: Every Judge;
any of such duties;
servant;
convenience;
Illustrations
COMMENTS
1981 S C 352.
period.
COMMENTS
CHAPTER IV
registered;

COMMENTS

J 1265.
649.
drugs. 1973 P Cr. L J 809.
103. 1979 P Cr. L J Note 6.
1981 S C 352.
P Cr. L J 1265.
Lab. 503.
proved.
Drugs Act.


to law.
P L D 1991 SO 893.
COMMENTS
COMMENTS
Lab. 813,
Lah. 813.
produced before it.
COMMENTS
P L D 1986 Kar. 390.
SC (Pak.) 1177.
352.
substandard.
warrantor.
goods as aforesaid.

COMMENTS
Cr. L J 2007.

P L D 1991 SC 893.
recoverable.
COMMENTS
(ii) Infant food.
COMMENTS
namely: -
First: [Omitted].
Third: Every Judge;
any of such duties;
servant;
convenience;
Illustrations
COMMENTS
1981 S C 352.
period.
COMMENTS
CHAPTER IV
registered;

COMMENTS

J 1265.
649.
drugs. 1973 P Cr. L J 809.
103. 1979 P Cr. L J Note 6.
1981 S C 352.
P Cr. L J 1265.
Lab. 503.
proved.
Drugs Act.


to law.
P L D 1991 SO 893.
COMMENTS
COMMENTS
Lab. 813,
Lah. 813.
produced before it.
COMMENTS
P L D 1986 Kar. 390.
SC (Pak.) 1177.
352.
substandard.
warrantor.
goods as aforesaid.

COMMENTS
Cr. L J 2007.

P L D 1991 SC 893.
recoverable.
COMMENTS
(ii) Infant food.
COMMENTS
namely: -
First: [Omitted].
Third: Every Judge;
any of such duties;
servant;
convenience;
Illustrations
COMMENTS
1981 S C 352.
period.
COMMENTS
CHAPTER IV
registered;

COMMENTS

J 1265.
649.
drugs. 1973 P Cr. L J 809.
103. 1979 P Cr. L J Note 6.
1981 S C 352.
P Cr. L J 1265.
Lab. 503.
proved.
Drugs Act.


to law.
P L D 1991 SO 893.
COMMENTS
COMMENTS
Lab. 813,
Lah. 813.
produced before it.
COMMENTS
P L D 1986 Kar. 390.
SC (Pak.) 1177.
352.
substandard.
warrantor.
goods as aforesaid.

COMMENTS
Cr. L J 2007.

P L D 1991 SC 893.
recoverable.
COMMENTS
(ii) Infant food.
COMMENTS
namely: -
First: [Omitted].
Third: Every Judge;
any of such duties;
servant;
convenience;
Illustrations
COMMENTS
1981 S C 352.
period.
COMMENTS
CHAPTER IV
registered;

COMMENTS

J 1265.
649.
drugs. 1973 P Cr. L J 809.
103. 1979 P Cr. L J Note 6.
1981 S C 352.
P Cr. L J 1265.
Lab. 503.
proved.
Drugs Act.


to law.
P L D 1991 SO 893.
COMMENTS
COMMENTS
Lab. 813,
Lah. 813.
produced before it.
COMMENTS
P L D 1986 Kar. 390.
SC (Pak.) 1177.
352.
substandard.
warrantor.
goods as aforesaid.

COMMENTS
Cr. L J 2007.

P L D 1991 SC 893.
recoverable.
COMMENTS
(ii) Infant food.
COMMENTS
namely: -
First: [Omitted].
Third: Every Judge;
any of such duties;
servant;
convenience;
Illustrations
COMMENTS
1981 S C 352.
period.
COMMENTS
CHAPTER IV
registered;

COMMENTS

J 1265.
649.
drugs. 1973 P Cr. L J 809.
103. 1979 P Cr. L J Note 6.
1981 S C 352.
P Cr. L J 1265.
Lab. 503.
proved.
Drugs Act.


to law.
P L D 1991 SO 893.
COMMENTS
COMMENTS
Lab. 813,
Lah. 813.
produced before it.
COMMENTS
P L D 1986 Kar. 390.
SC (Pak.) 1177.
352.
substandard.
warrantor.
goods as aforesaid.

COMMENTS
Cr. L J 2007.

P L D 1991 SC 893.
recoverable.
COMMENTS
(ii) Infant food.
COMMENTS
namely: -
First: [Omitted].
Third: Every Judge;
any of such duties;
servant;
convenience;
Illustrations
COMMENTS
1981 S C 352.
period.
COMMENTS
CHAPTER IV
registered;

COMMENTS

J 1265.
649.
drugs. 1973 P Cr. L J 809.
103. 1979 P Cr. L J Note 6.
1981 S C 352.
P Cr. L J 1265.
Lab. 503.
proved.
Drugs Act.


to law.
P L D 1991 SO 893.
COMMENTS
COMMENTS
Lab. 813,
Lah. 813.
produced before it.
COMMENTS
P L D 1986 Kar. 390.
SC (Pak.) 1177.
352.
substandard.
warrantor.
goods as aforesaid.

COMMENTS
Cr. L J 2007.

P L D 1991 SC 893.
recoverable.
COMMENTS
(ii) Infant food.
COMMENTS
namely: -
First: [Omitted].
Third: Every Judge;
any of such duties;
servant;
convenience;
Illustrations
COMMENTS
1981 S C 352.
period.
COMMENTS
CHAPTER IV
registered;

COMMENTS

J 1265.
649.
drugs. 1973 P Cr. L J 809.
103. 1979 P Cr. L J Note 6.
1981 S C 352.
P Cr. L J 1265.
Lab. 503.
proved.
Drugs Act.


to law.
P L D 1991 SO 893.
COMMENTS
COMMENTS
Lab. 813,
Lah. 813.
produced before it.
COMMENTS
P L D 1986 Kar. 390.
SC (Pak.) 1177.
352.
substandard.
warrantor.
goods as aforesaid.

COMMENTS
Cr. L J 2007.

P L D 1991 SC 893.
recoverable.
COMMENTS
(ii) Infant food.
COMMENTS
namely: -
First: [Omitted].
Third: Every Judge;
any of such duties;
servant;
convenience;
Illustrations
COMMENTS
1981 S C 352.
period.
COMMENTS
CHAPTER IV
registered;
COMMENTS

J 1265.
649.
drugs. 1973 P Cr. L J 809.
103. 1979 P Cr. L J Note 6.
1981 S C 352.
P Cr. L J 1265.
Lab. 503.
proved.
Drugs Act.


to law.
P L D 1991 SO 893.
COMMENTS
COMMENTS
Lab. 813,
Lah. 813.
produced before it.
COMMENTS
P L D 1986 Kar. 390.
SC (Pak.) 1177.
352.
substandard.
warrantor.
goods as aforesaid.

COMMENTS
Cr. L J 2007.

P L D 1991 SC 893.
recoverable.
COMMENTS
(ii) Infant food.
COMMENTS
namely: -
First: [Omitted].
Third: Every Judge;
any of such duties;
servant;
convenience;
Illustrations
COMMENTS
1981 S C 352.
period.
COMMENTS
CHAPTER IV
registered;

COMMENTS

J 1265.
649.
drugs. 1973 P Cr. L J 809.
103. 1979 P Cr. L J Note 6.
1981 S C 352.
P Cr. L J 1265.
Lab. 503.
proved.
Drugs Act.


to law.
P L D 1991 SO 893.
COMMENTS
COMMENTS
Lab. 813,
Lah. 813.
produced before it.
COMMENTS
P L D 1986 Kar. 390.
SC (Pak.) 1177.
352.
substandard.
warrantor.
goods as aforesaid.

COMMENTS
Cr. L J 2007.

P L D 1991 SC 893.
recoverable.
COMMENTS
(ii) Infant food.
COMMENTS
namely: -
First: [Omitted].
Third: Every Judge;
any of such duties;
servant;
convenience;
Illustrations
COMMENTS
1981 S C 352.
period.
COMMENTS
CHAPTER IV
registered;

COMMENTS

J 1265.
649.
drugs. 1973 P Cr. L J 809.
103. 1979 P Cr. L J Note 6.
1981 S C 352.
P Cr. L J 1265.
Lab. 503.
proved.
Drugs Act.


to law.
P L D 1991 SO 893.
COMMENTS
COMMENTS
Lab. 813,
Lah. 813.
produced before it.
COMMENTS
P L D 1986 Kar. 390.
SC (Pak.) 1177.
352.
substandard.
warrantor.
goods as aforesaid.

COMMENTS
Cr. L J 2007.

P L D 1991 SC 893.
recoverable.
COMMENTS
(ii) Infant food.
COMMENTS
namely: -
First: [Omitted].
Third: Every Judge;
any of such duties;
servant;
convenience;
Illustrations
COMMENTS
1981 S C 352.
period.
COMMENTS
CHAPTER IV
registered;

COMMENTS

J 1265.
649.
drugs. 1973 P Cr. L J 809.
103. 1979 P Cr. L J Note 6.
1981 S C 352.
P Cr. L J 1265.
Lab. 503.
proved.
Drugs Act.

to law.
P L D 1991 SO 893.
COMMENTS
COMMENTS
Lab. 813,
Lah. 813.
produced before it.
COMMENTS
P L D 1986 Kar. 390.
SC (Pak.) 1177.
352.
substandard.
warrantor.
goods as aforesaid.

COMMENTS
Cr. L J 2007.

P L D 1991 SC 893.
recoverable.
COMMENTS
(ii) Infant food.
COMMENTS
namely: -
First: [Omitted].
Third: Every Judge;
any of such duties;
servant;
convenience;
Illustrations
COMMENTS
1981 S C 352.
period.
COMMENTS
CHAPTER IV
registered;

COMMENTS
J 1265.
649.
drugs. 1973 P Cr. L J 809.
103. 1979 P Cr. L J Note 6.
1981 S C 352.
P Cr. L J 1265.
Lab. 503.
proved.
Drugs Act.


to law.
P L D 1991 SO 893.
COMMENTS
COMMENTS
Lab. 813,
Lah. 813.
produced before it.
COMMENTS
P L D 1986 Kar. 390.
SC (Pak.) 1177.
352.
substandard.
warrantor.
goods as aforesaid.

COMMENTS
Cr. L J 2007.

P L D 1991 SC 893.
recoverable.
COMMENTS
(ii) Infant food.
COMMENTS
namely: -
First: [Omitted].
Third: Every Judge;
any of such duties;
servant;
convenience;
Illustrations
COMMENTS
1981 S C 352.
period.
COMMENTS
CHAPTER 5 - Miscellaneous
43. Power of Federal Government to make rules.
44. Power of the Provincial Government to make rules.
45. Repeal and Savings.
CHAPTER V
Miscellaneous
43. Power of Federal Government to make rules: (1) Subiect to section 44, the Federal
Government may, by notification in the official Gazette, make rules for carrying out the purposes of
this Act.
(2) In particular and without prejudice to the generality of the foregoing provision, such rules may--
(a) prescribe the functions of the Federal Drug Laboratory and any other laboratory set up under
section 14 or specified under section 22 or section 33 and the procedure for the submission to any
such laboratory 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 and such other matters as may be necessary for any
such laboratory to perform its functions;
(b) prescribe specifications, including the strength, potency, purity, quality or other property, of any
drug, and the methods of test or analysis to be employed in determining whether a drug is of required
specifications:
(c) prescribe the maximum proportion of any poisonous or other substance which may be added to or
contained in any drug, or extracted or omitted therefrom; prohibit the import, 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;
(d) specify the drugs or classes of drugs for the import or export of which a licence is required, the
testing of such drugs, and prescribe the form and conditions of such licences, the authority
empowered to issue the .same, and the fees payable therefor;
(e) prescribe the places at which any specific drug or drugs may be imported, prohibit their import at
any other place, and control their import through any specified agency;
(f) 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;
(g) prescribe the forms of licences for the manufacture for sale of drugs or any specified drugs or
class of drugs, the form of application for such licences, the conditions subject to which such licence
may be issued, the person under whose signature the same be issued and the fees payable therefor;
(h) require the date of manufacture and the date of expiry of potency to be clearly and truly stated on
the label' and 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 date and prescribe the manner of disposal of such
drug or class of drugs;
(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 packing and packaging, including its size, dimensions, fill and other
specifications, the material used therefor and mode of labelling packed drugs and prescribe the
matters which shall or shall not be included in such labels or on the leaflets accompanying the drugs;
(k) require that the non-proprietary or chemical or accepted scientific name or the proprietary name of
any specified drug or any ingredient thereof shall be displayed in the prescribed manner;
(l) prescribe the requirements and conditions in respect of good practices in the manufacture and
quality control of drugs;
(m) prescribe conditions for distribution of samples for sales promotion of drugs; prescribe the
procedure for introduction in Pakistan of a new drug;
(o) prescribe terms and conditions of members of the Central Licensing Board and the Registration
Board;
(p) prescribe types of registration of drugs, the form of application for such registration, the conditions
subject to which such registration may be granted, the manner of registration and post-registration
and surveillance and deregistration of registered drugs and the fees payable therefor;
(q) prescribe conditions for registration of indentors, importers, wholesalers and distributors within
Pakistan and any establishment within any foreign country engaged in the manufacture for export of a
drug and prescribe conditions providing effective and adequate means, by arrangement with the
Government of such foreign country or otherwise, to enable the licensing authority or the Registration
Board to determine from time to time whether drugs manufactured in such establishment, if imported
or offered for import into Pakistan, shall be refused admission where the public interest so requires;
(r) prescribe the form of warranty for manufactured drugs;
(s) specify offences in relation to which the stock of drugs, articles or things shall be liable to forfeiture
under this Act;
(t) prescribe the qualifications, and regulate the procedure for exercise of powers and performance of
functions, of Federal Inspectors;
(u) prescribe the laboratories to which the Federal Inspectors shall submit samples of drugs taken for
the purpose of test and analysis and the form and procedure for submitting the report of such test and
analysis and the fee payable therefor, where so required;
(v) prescribe measures for securing and maintaining supplies of drugs at reasonable prices,
conditions to be met in respect of manufacture, production, pricing, keeping, movement and disposal
of drugs and to fix prices, commissions, discount of the manufacturer, wholesaler, distributor, retailer
or any other dealer of drugs, to control giving of bonus in cash or kind or in any other manner to any of
the said parties and for collecting or calling for any information, statistics, records or books with a view
to regulating the matters aforesaid;
(w) specify drugs which may be advertised and the conditions subject to which such drugs may be
advertised;
(x) prescribe conditions subject to which small quantities of drugs may be imported or manufactured
or exported for the purpose of examination, test or analysis, clinical trial or personal use; and
(y) prescribe any other matter which is to be, or may be, prescribed by the Federal Government.
(3) The power to make rules conferred by this section shall, except on the first occasion of the
exercise thereof, be subject to the condition of previous publication.
44. Power of the Provincial Government to make rules: (1) The Provincial Government may by
notification in the official Gazette, make rules in respect of the following matters, namely :--
(a) the establishment of laboratories for testing and analysing drugs;

(b) the qualifications and the procedure, for exercise of powers and performance of functions of
Provincial Inspectors;
(c) the forms of reports to be given by Government Analysts and the manner of application for test or
analysis and the fees payable therefor;
(d) the conditions to regulate sale or storage or distribution of drugs or any specific drug or class of
drugs;
(e) the offences against this Act or any rule in relation to which the stock of drugs shall be liable to
confiscation and destruction under this Act;
(f) the forms of licences for the sale or distribution of drugs or any specified drug or class of drugs, the
authority empowered to issue the same, the form of applications for such licences, the fees payable
therefor and the condition subject to which such licerices may be issued;
(g) the procedure to be followed by the Provincial Quality Control Board; and any other matter which
is to be or may be, prescribed by the Provincial Government.
(2) The power to make rules conferred by this section shall, except on the first occasion'of the
45, Repeal and savings : [(1) The Drugs Act, 1940 (XXIII of 1940), the Drugs (Generic Names) Act,
1972 (XXIV of 1972), and the Drugs Ordinance, 1976 (IV of 1976), are hereby repealed.
(2) Notwithstanding the repeal of the Drugs Act, 1940 (XlII of 1940), by sub-section (1),--
(a) any licence to manufacture for sale issued thereunder to any person, for the revalidation of which
an application has already been made to the Central Licensing Board within the date specified by the
Federal Government shall continue to be valid until orders are passed by the said Board in this behalf;
(b) any licence for import or export or sale of drugs issued thereunder to any person, shall, unless it
expires earlier under the terms thereof, continue to be valid for such periods as the Federal
Government, or as the case may be, the Provincial
Government may by notification in the official Gazette, specify in this behalf:
Provided that in case of drugs to be imported or exported licences may continue to be issued under
the rules framed under the Drugs Act, 1940, till the rules under this Act are framed or, as the case
may be, a date is fixed under sub-section (6) of section 7 in respect of drugs in the finished form ready
for use.
CHAPTER V
Miscellaneous
this Act.
specifications:
Board;
under this Act;
advertised;

drugs;
for use.
CHAPTER V
Miscellaneous
this Act.
specifications:
Board;
under this Act;
advertised;

drugs;
for use.

Drug Act 1976

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1. Short title, extent and commencement: (1) This Act may be called the Drugs Act, 1976.

(2) It extends to the whole of Pakistan.

Admissibility of admitting expenses : Claim of assessee of sale promotion expenses in excess

"Hexa-Chlorophene liquid soap"-Nature of product : Nature of product, could he gauged from

(b) "Appellate Board" means the Board constituted under Section 9;

(iv) such pesticides as may cause health hazard to the public;

(v) any substance mentioned as monograph or as a preparation in the Pakistan Pharmacopoeia

(i) which is not labelled in the prescribed manner; or

(1) the Pakistan Pharmacopoeia;

Any substance mentioned as a preparation in the Pakistan National Formulary, or Pakistan

Any isolated or synthesised substance mentioned as monograph or as a preparation appearing in

THE DRUGS ACT

[llth May, 1976]

Preamble : Whereas it is expedient to regulate the import, export, manufacture, storage,

Admissibility of admitting expenses : Claim of assessee of sale promotion expenses in excess

"Hexa-Chlorophene liquid soap"-Nature of product : Nature of product, could he gauged from

(b) "Appellate Board" means the Board constituted under Section 9;

(iv) such pesticides as may cause health hazard to the public;

(v) any substance mentioned as monograph or as a preparation in the Pakistan Pharmacopoeia

(i) which is not labelled in the prescribed manner; or

(1) the Pakistan Pharmacopoeia;

Any substance mentioned as a preparation in the Pakistan National Formulary, or Pakistan

Any isolated or synthesised substance mentioned as monograph or as a preparation appearing in

(b) "Appellate Board" means the Board constituted under Section 9;

(iv) such pesticides as may cause health hazard to the public;

(v) any substance mentioned as monograph or as a preparation in the Pakistan Pharmacopoeia

(i) which is not labelled in the prescribed manner; or

(1) the Pakistan Pharmacopoeia;

Any substance mentioned as a preparation in the Pakistan National Formulary, or Pakistan

Any isolated or synthesised substance mentioned as monograph or as a preparation appearing in

CHAPTER 2 - Administration and Enforcement

Interpretation of section--Presumption: A manufacturer of drugs was prosecuted for offence under

Explanation: In this sub-section,--

LIST OF DE-REGISTERED DRUGS

SI. Regn No. Name of the Drug(s) Name of Manufacturer Date

63. 005165 Heomex Tablets25 m.g. M/s. Opel Laboratories, 25-8-1985

67. 004259 Rutin Compound Tablets. M/s. Regent Laboratories, Do.

70. 003385 Clotin Tablets. M/s. Hakimsons Chemical Do.

75 004182 Rutin Compound Tablets. M/s. Cyrus Pharma, Lahore. Do.

12. Power to fix maximum prices of drug, etc.: (1)

Requirement of Drug/Inspector: Requirement about appointment of a person as Drug Inspector is

Drug Inspectors appointment Improper--Sentence set aside :. Record showing no order of

Sanction of competent authority--Violation of licensing conditions--Sealing of premises: Shop

Sanction of competent authority--Violation of licensing conditions--Sealing of premises: Shop

(5) Where an Inspector takes any action under section 18,--

(3) On receipt of the report, the Inspector shall--

Interpretation of section--Presumption: A manufacturer of drugs was prosecuted for offence under

Administration and Enforcement

Interpretation of section--Presumption: A manufacturer of drugs was prosecuted for offence under

Explanation: In this sub-section,--

LIST OF DE-REGISTERED DRUGS

SI. Regn No. Name of the Drug(s) Name of Manufacturer Date

63. 005165 Heomex Tablets25 m.g. M/s. Opel Laboratories, 25-8-1985

67. 004259 Rutin Compound Tablets. M/s. Regent Laboratories, Do.

70. 003385 Clotin Tablets. M/s. Hakimsons Chemical Do.

75 004182 Rutin Compound Tablets. M/s. Cyrus Pharma, Lahore. Do.

76. 004749 Rutin Compound Tablets. M/s. Harman Pharmaceutical, Do.

12. Power to fix maximum prices of drug, etc.: (1)

Requirement of Drug/Inspector: Requirement about appointment of a person as Drug Inspector is