THE DRUGS ACT 1976
Healthcare & Medical Law
Preamble
THE DRUGS ACT 1976
( Act XXXI of 1976)
C O N T E N T S
S ECTION H EADING
CHAPTER I
INTRODUCTORY
Section 1 Short title, extent and commencement
Section 2 Application of other laws not barred
Section 3 Definitions
CHAPTER II
ADMINISTRATION AND ENFORCEMENT
Section 4 Regulation anted prohibition of import, etc., of drugs
Section 5 Regulation of manufacture of drugs
Section 6 Regulation of sale of drugs
Section 7 Registration of drugs
8 . Pakistan National Formulary
Section 9 Appellate Board
Section 9A Appeals to the Provincial Appellate Authority
Section 10 Expert Committees
Section 11 Provincial Quality Control Board
Section 11A Conflict of interest
11 B . Provincial Drugs Monitoring Teams
11 C . Independent inspection
Section 12 Power to fix maximum prices of drugs, etc
Section 13 Directions to Provincial Governments
Section 14 Federal Drug Laboratory and institutes, etc
Section 15 Provincial Drugs Testing Laboratory
Section 16 Government Analysts
Section 17 Inspector
Section 18 Powers' of Inspectors
Section 19 Procedure for Inspectors
Section 20 Persons bound to disclose place where drugs rue manufactured or kept
Section 21 Disclosure of the name of the manufacturer
Section 22 Reports of Government Analysts
Section 22A Reports of the Notified Drugs Laboratories
CHAPTER III
PROHI BI TIONS
Section 23 Import, manufacture and safe of drugs
Section 23A Prohibition on aiding, abetment or association in contravention of the Act
Section 23B Prohibition of acquisition and possession of assets derived from contravention of
the Act.
Section 23C Prohibition on owning, operating premises or machinery for manufacture of drugs,
etc.
Section 24 Control of advertisement
Section 25 Control of sampling
Section 26 Control of printing of labeling
4 The Punjab Laws
CHAPTER IV
OFFENCES, PENALTIES AND PROCEDURE
Section 27 Penalties
27 A . False statement
Section 28 Penalty for subsequent offence
Section 29 Forfeiture
Section 30 Cognizance of offences
Section 31 Drug Courts
Section 31A Appeal
Section 32 Pleas
Section 33 Application of law relating to customs and powers of officers of customs
Section 34 Offences by companies, etc
Section 35 Publication of offender's name
CHAPTER V
MISCELLANEOUS
Section 36 Powers to exempt
Section 37 Inspectors to be public servants
Section 38 Indemnity
Section 39 Finality of orders, etc.
Section 40 Publication of result of test or analysis, etc
Section 41 Cancellation or suspension of licences
Section 41A Suspension of license by Provincial Quality Control Board
Section 42 Cancellation or suspension of registration of registered drugs
Section 43 Power of Federal Government to make rules
Section 43A Power to delegate
Section 44 Power of the Provincial Government to make rules
Section 45 Repeal and Savings
1
THE DRUGS ACT 1976
( Act XXXI of 1976)
[1 1
th
May 1976]
An Act to regulate the import, export, manufacture, storage, distribution and sale of drugs
WHEREAS it is expedient to regulate the import, export, manufacture, storage, distribution
and sale of drugs;
It is hereby enacted as fo llows:
CHAPTER I
INTRODUCTORY
Section 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.
Section 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
2
, and any other law for
the time being in force.
Section 3 Definitions
In this Act, unless there is anything repugnant in the subject or context, --
(a) “ adulterated drug ” means a drug -
(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
3
[ ha s] 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 B oard c onstituted under section 9;
(c) “ batch ” means a quantity of any drug produced during a given cycle of
manufacture;
1
For Statement of Objects and Reasons, see Gaze t te of Pakistan, 1976, Extraordinary, Part III, page 250.
Previously, an offence punishable under the Drugs Act, 1976, was made triable and punishable by a Military Court, vide Notifi cation No.
57/1(1)1943/AJAG/CMLA/82, dated 16 - 11 - 1982, see Gazette of Pakistan, Extraordinary, Part I, p.153.
This Act is originally with in the Federal ambit, however , it w as first amended , to the extent of Province of the Punjab, by the Punjab Assembly
(section 31 of the 1976 Act) , through the Punjab Drugs (Amendment) Act 2016 (XXXIII of 2016) with the following provision contained
in section 3 of the 2016 Act:
“3. Transition . – All the powers exercisable by the Federal Government under the said Act in respect of the existing Drug Courts
in the Punjab shall be the powers of the Provincial Government on and from the commencement of this Act.”
Another set of amendments was made in t he principal law subsequently, through the Punjab Drugs (Amendment) Act 2017 (V of 2017).
2
II of 1930
3
Substituted for the words “may have” by the Drugs (Amendment) Ordinance, 2002 ( Federal Ordinance CXXVIII of 2002).
4 The Punjab Laws
(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 outer - packing 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 manufacturer;
(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 disease, 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 organisms as cause, carry or
transmit disease in human beings or animals o r 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 monopraph or as a preparation in the
Pakistan Pharmacopoeia or the Pakistan National Formulary or the
International Pharmacopeia 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 );
1
[*]
2
[ (va) Therapeutic goods as defined under clause (xxxvi) of section 2 of the
Drug Regulatory Authority of Pakistan Act, 2012 (XXI of 2012); 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
1
The word “and” omitted ” by the Drugs (Second Amendment) Act 2025 ( C III of 202 5 ).
2
Inserted b y the Drugs (Second Amendment) Act 2025 ( C III of 202 5 ).
The Drugs Act 1976 (XXXI OF 1976) 5
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 Analyst ” means a Federal Government Analyst or a Provincial
Government Analyst appointed under section 16;
(m) “ import ” , with its grammatical variations and cognate expressions, means to
bring into Pakistan by sea, land or air;
(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;
(p) “ 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 labeling
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;
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1
[(sa) “Notified Drugs Laboratory” means the drug testing laboratory notified by the
Provincial Government under subsection (2) of section 15 of the Act;]
(t) “ prescribed ” means prescribed by rules;
2
[(ta) “Provincial Drugs Monitoring Team” means one or more Provincial Drugs
Monitoring Team constituted under section 11B of the Act;]
(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 ” mean 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
pr e ceding 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;
(za) “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;
(zb) “spurious drug” means a drug -
(i) which purports to be a drug but does not contain the active ingredient
of that drug;
(ii) which purports to be the product of a manufacturers , place or country
of whom or of which 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;
(zc) “storage” means storage for sale and “to store” or “stored” shall be construed
accordingly;
3
[(zd) “sub - standard drug” means a drug which is not of specifications; and
1
Inserted by the Punjab Drugs (Amendment) Act 201 7 ( V of 201 7 ).
2
Inserted by the Punjab Drugs (Amendment) Act 201 7 ( V of 201 7 ).
3
Substituted by the Punjab Drugs (Amendment) Act 201 7 ( V of 201 7 ) for the following:
The Drugs Act 1976 (XXXI OF 1976) 7
(ze) “professional member” means a person who is qualified for appointment as
Inspector or Government Analyst and appointed by the Provincial
Government in such manner and on such terms and conditions as may be
prescribed.]
CHAPTER II
ADMINISTRATION AND ENFORCEMENT
Section 4 Regulation and prohibition of import, etc., of drugs . – (1) The Federal Government stall
regulate t he 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 licence 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.
1
[(3) Subject to sub - sections (1) and (2), only such drugs shall be imported which
are on sale in the market of any of the western European countries, USA, Japan, Australia or
any other country as may be prescribed.]
Section 5 Regulation of manufacture of drugs
(1) The grant of licences 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
2
[,with the approval of the Federal
Government and by notification in the official Gazette,] 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 subsection (4), a member of the Central Licensing Board shall hold
office for the prescribed period.
Section 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, stockiest , retailers or other dealers of drugs, as
they may deem fit.
Section 7 Registration of drugs
(1) The Federal Government shall cause all drugs to be
“ (zz) “sub - standard drug means a drug which is not of specifications . ”
1
Added by the Drugs (Amendment) Ordinance, 2002 ( Federal Ordinance CXXVIII of 2002).
2
Inserted by the Drugs (Amendment) Ordinance, 2002 ( Federal Ordinance CXXVIII of 2002).
8 The Punjab Laws
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
1
[, with the approval of the Federal Government,
and by notification in the official Gazette,] 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 subsection (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 subsection, -
(a) “ Single - ingredient drugs ” means drugs containing one active
ingredient;
(b) “ compound drugs ” means drugs containing more than one active
ingredient.
2
[(9) The registration of a drug shall be subject to such conditions as may be
prescribed.]
(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 B oard m ay , after affording to the person on whose application the drug wa s
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
1
Inserted by the Drugs (Amendment) Ordinance, 2002 ( Federal Ordinance CXXVIII of 2002).
2
Substituted by the Drugs (Amendment) Ordinance, 2002 ( Federal Ordinance CXXVIII of 2002).
The Drugs Act 1976 (XXXI OF 1976) 9
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 be en registered; or
(b) the registration of which has been cancelled or stands suspended.
Section 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.
Section 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
Government 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 Inspector, as may be prescribed.
(6) The Appellate Board may appoint experts for the purposes of detailed study of
any specific matter before it.
(7) The Appellate Board shall
1
[, with the approval of the Federal Government and
by notification in the official Gazette,] make regulations to regulate the conduct of its
business.
2
[(8) The Appellate Board shall meet at least every month and shall decide any
appeal preferred to it within sixty days of receipt of appeal unless the Board is prevented
from doing so for sufficient cause to be recorded.]
3
[ 9A. Appeals to the Provincial Appellate Authority . – (1) Any person aggrieved by any
decision of the licensing authority may prefer appeal to the Provincial Appellate Authority.
(2) The Provincial Government shall constitute a Provincial Appellate Authority for the
disposal of appeal preferred under sub - section (1) as may be prescribed.]
Section 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
1
Inserted by the Drugs (Amendment) Ordinance, 2002 ( Federal Ordinance CXXVIII of 2002).
2
Added by the Drugs (Amendment) Ordinance, 2002 ( Federal Ordinance CXXVIII of 2002).
3
Inserted by the Drugs (Amendment) Ordinance, 2002 ( Federal Ordinance CXXVIII of 2002).
10 The Punjab Laws
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.
Section 11 Provincial Quality Control Board
(1) Each Provincial Government shall set up a
Provincial Quality Control Board consisting of 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) Provincial Quality Control Board shall
1
[, with the approval of the Provincial
Government and by notification in the official Gazette,] make regulations to regulate the
conduct of its business.
(5) The following shall be the powers and functions of the Provincial Quality
Control Board , n amely:
(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 Government Analysts in
respect of drugs sent to them by Provincial Inspectors for test and
analys i s and issue instructions to the Inspectors as 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 I nspector may m ake 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;
2
[*]
(d) to advise the Provincial Government on ways and means to ensure
quality control of drugs manufactured in the Province
3
[;]
4
[(e) to ascertain the names of such directors, partners and employees of the
company, corporation, firm or institution who are prima facie
responsible for the commission of any offence under this Act or the
rules and allow an Inspector to institute prosecution only against such
persons;
(f) to conduct annual validation of all instruments in the provincial drug
testing laboratories and to recommend measures to upgrade such
laboratories, if required;
(g) identify and accredit on payment of fee other laboratories in the
Province with suitable facilities and expertise;
1
Inserted by the Drugs (Amendment) Ordinance, 2002 ( Federal Ordinance CXXVIII of 2002).
1
The word ‘and’ om itted by the Drugs (Amendment) Ordinance, 2002 ( Federal Ordinance CXXVIII of 2002).
3
Substituted for the “full - stop” by the Drugs (Amendment) Ordinance, 2002 ( Federal Ordinance CXXVIII of 2002).
4
Added by the Drugs (Amendment) Ordinance, 2002 ( Federal Ordinance CXXVIII of 2002).
The Drugs Act 1976 (XXXI OF 1976) 11
(h) to conduct training programs to update Government Analysts and for
improving their knowledge according to latest analytical method and
technology;
1
[*]
2
[(i) to specify, by general or special order, the drugs which may be sent for
test and analysis to the Notified Drugs Laboratory for drug testing and
analysis; and ]]
3
[ (j) to submit a monthly report of the decisions and activities to the Federal
Government and the Provincial Government. ]
(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.
4
[ (7) The Provincial Quality Control Board may constitute a committee or
committees, consisting of the members of the Board and other persons including at least two
professional members and delegate to the committee any of its powers and functions under
subsection (5) for exercise within the specified area. ]
5
[ 11A. Conflict of interest . – No person who is a member of the Appellate Board, Central
Licensing Board, a Provincial Quality Board, the Registration Board or a member of Expert
Committee shall be a member of the any other board or committee of which he is a member
to avoid any conflict of interest.]
6
[ 11B. Provincial Drugs Monitoring Teams . – (1) The Provincial Government may, by
notification, constitute one or more Provincial Drugs Monitoring Team consisting of the
Chairperson and members including at least two professional members on such terms and
conditions as the Provincial Government may determine.
(2) The Ch a i r person a nd m e mb er s of t h e Provincial Drugs Monitoring Team shall
hold o ff i c e du r i n g the pl e asu r e o f the P r ovin c i a l Gov er nm e nt.
(3) The Provincial Drugs Monitoring Team s h a ll, w it h t he a ppro v a l of t he
Provincial G o v e rn me nt a nd by no ti f icati on i n t he o ff icia l G a z ette, frame re g ul a ti o ns to
r e g ul a te t h e c ondu c t of its busin e ss.
(4) T he Provincial Drugs Monitoring Team may –
( a ) subject to subsection (5), exercise the powers of an Inspector under this
Act;
(b) insp ec t a n y p re mis e s wh er e a n y d r u g is b e i n g , or is to b e ,
m a n u fac tu r e d or sold a nd, in addition to any other action under the
Act, rec omm e nd to the a pp r op r i a te a utho r i t y for the ca n ce ll a tion or
susp e nsion of the li c e nce to m a nu f ac tu r e or s e ll d r u g s held by a n y
p e r son who is f ound to be c ont r a v e ni n g , or to h a ve c ont r a v e n e d, a n y of
t h e p r ovi s ions of the A c t or the r ul e s;
(c) a dvise the P r ovin c i a l Gov er nm e nt on w a y s a nd m ea ns to e nsu r e the
provision of qu a li t y d r u g s to the people;
(d) a s c e r t a in the n a m e s of s u c h di r ec to r s, p ar t n er s a nd e mpl o y e e s of the
1
The word ‘and’ omitted by the Punjab Drugs (Amendment) Act 201 7 ( V of 201 7 ).
2
Substituted by the Punjab Drugs (Amendment) Act 201 7 ( V of 201 7) for the following:
“ (i) to submit a monthly report of decisions and activities to the Federal Government. ”
3
New clause inserted by the Punjab Drugs (Amendment) Act 201 7 ( V of 201 7).
4
New subsection (7) inserted by the Punjab Drugs (Amendment) Act 201 7 ( V of 201 7).
5
Inserted by the Drugs (Amendment) Ordinance, 2002 ( Federal Ordinance CXXVIII of 2002).
6
New sections 11B and 11C inserted by the Punjab Drugs (Amendment) Act 201 7 ( V of 201 7).
12 The Punjab Laws
c omp a n y , c o r p o ra tion, f i r m or institution who ar e p r ima f ac ie
r e sponsible f or the c ommission of a n y o ffe n c e und e r the A c t or the
r ul e s a nd rec omm e nd to the a pp r op r i a te a utho r i ty action a g a inst su c h
p er sons;
(e) submit a monthly report of the recommendations and activities to the
Provincial Government; and
(f) perform such other functions under the Act or the rules as the
Provincial Government may, by notification, assign.
(5) The Provincial Drugs Monitoring Team shall exercise the powers of an
Inspector in the presence of at least one professional member.
Section 11C Independent inspection
(1) Subject to subsection (2), the Provincial Government
may, on the recommendations of the Provincial Quality Control Board, engage the services
of a consultant or a firm of consultants for independent inspection and evaluation of units for
manufacture of drugs, distribution networks or sale - points as the Government may specify.
(2) No person shall be engaged as consultant unless he is qualified to be
appointed as an Inspector or Government Analyst and is an expert in the relevant field and no
firm shall be so engaged unless it has inhouse capacity for the task and has in its service
persons who are qualified to be appointed as Inspectors or Government Analysts and are
experts in the relevant field.
(3) The consultant or the firm of consultants shall submit the report to the
Provincial Quality Control Board within the specified time and the Board shall take
necessary action on the report in accordance with law.
(4) For purposes of inspection and evaluation, the consultant or the experts
engaged by the firm of consultants shall have the powers of an Inspector. ]
Section 12 Power to fix maximum prices of drugs, 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 u tilized , in accordance with rules for purposes of
research in drugs.
(2) For the purpose s 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.
Section 13 Directions to Provincial Governments
The Federal Government may g ive 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.
Section 14 Federal Drug Laboratory and institutes, etc
The Federal Government shall, as
soon as may be, establish a Federal Drug L aboratory and may also set up such other institutes
and drugs testing and research laboratories for the purposes of this Act as may be prescribed.
The Drugs Act 1976 (XXXI OF 1976) 13
1
[ 15 . Provincial Drugs Testing Laboratory . – (1) The Provincial Government shall, as
soon as may be, set up one or more Provincial Drugs Testing Laboratory for such purposes as
may be prescribed.
(2) The Provincial Government may, by notification, engage or authorize a
reputed drugs testing laboratory, within the country or abroad, for test and analysis of the
drug samples. ]
Section 16 Government Analysts
The Federal Government or Provincial Government may, by
notification in the official Gazette, appoint such persons as it think s 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.
Section 17 Inspector
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:
Provided that no person who has any financial interest in the manufacture, import,
export or sale of any drug 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 such
Government.
Section 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 with 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 standardizing 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
1
Substituted by the Punjab Drugs (Amendment) Act 201 7 ( V of 201 7) for the following:
“ 15. Provincial Drugs Testing Laboratory. – Each Provincial Government shall, as soon as may be, set up a Provincial Drug
Testing Laboratory for such purposes as may be prescribed. ”
14 The Punjab Laws
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
1
[:]
2
[Provided that where the contravention is such which can be
remedied, the stocks shall not be seized upon undertaking in writing of
the person not to sell drug without remedying the defect, under
intimation to the Board concerned;]
(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
3
, 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
4
[two] weeks or such
further period, which shall not b e 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 communication 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 clauses (f) to (j) shall be
exerciseable 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
5
[ . ]
6
[* * * * * * ]
(2) The provisions of the Code of Criminal Procedure 1898
7
, in so far as they are
not inconsistent with the provisions of this Act, shall apply to searches and seizures made
under this Act.
Section 19 Procedure for Inspectors
(1) 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
1
Substituted for the “semi - colon” by the Drugs (Amendment) Ordinance, 2002 (Federal Ordinance CXXVIII of 2002).
2
Added by the Drugs (Amendment) Ordinance, 2002 (Federal Ordinance CXXVIII of 2002).
3
Act V of 1908
4
Substituted for the word “four” by the Drugs (Amendment) Ordinance, 2002 (Federal Ordinance CXXVIII of 2002).
5
Substituted for the “colon” by the Drugs (Amendment) Ordinance 2002 (Federal Ordinance CXXVIII of 2002).
6
Second Proviso omitted by the Drugs (Amendment) Ordinance 2002 (Federal Ordinance CXXVIII of 2002).
7
Act V of 1898
The Drugs Act 1976 (XXXI OF 1976) 15
takes it and, in the presence of such person unless he wilfully absents himself, shall divide the
sample into
1
[five] portions and effectively seal and suitably mark the game and permit such
person 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 : -
2
[ (i) one portion or sample he shall send to the Government Analyst or, if so
specified by the Provincial Quality Control Board, to the Board for
sending it to the Notified Drugs Laboratory ; ]
(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;
3
[ * * * * *]
(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
[; and]
5
[(iv) the fourth, where taken, he shall send to the person purporting to be its
manufacturer or importer, as the case may be.]
(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 e y e, 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, if 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
1
Substituted for the word “four” by the Drugs (Amendment) Ordinance, 2002 ( Federal Ordinance CXXVIII of 2002).
2
Substituted by the Punjab Drugs (Amendment) Act 201 7 ( V of 201 7) for the following:
“ (i) one portion or sample he shall send to the Government Analyst concerned for test and analysis; ”
3
Omitted the word “and” by the Drugs (Amendment) Ordinance, 2002 ( Federal Ordinance CXXVIII of 2002) .
4
Substituted for the “full - stop” by the Drugs (Amendment) Ordinance, 2002 ( Federal Ordinance CXXVIII of 2002).
5
Added by the Drugs (Amendment) Ordinance, 2002 ( Federal Ordinance CXXVIII of 2002) .
16 The Punjab Laws
the Board concerned and take its order as to the custody thereof :
Provided that where a Federal Inspector is 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 A ct for which he is
authorized 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.
Section 20 Persons bound to disclose place where drugs are manufactured or kept
Every
person for the time being incharge of any pr e mises 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.
Section 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.
Section 22 Reports of Government Analysts
(1) The Government Analys t 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
1
[Central Licensing Board or, as the case
may be, the Registration Board or the Provincial Quality Control Board] who shall have the
sample tested from the same or any other Government Analyst or a Government Drug
Testing Laboratory or any other l aboratory
2
[ or the Notified Drugs 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
subsection (3) of section 32;
(c) forward one copy to the
3
[Central Licensing Board or, as the case may
be, the Registration Board or the Provincial Quality Control Board] 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
1
Substituted for the words “Board concerned” by the Drugs (Amendment) Ordinance, 2002 ( Federal Ordinance CXXVIII of 2002).
2
Inserted by the Punjab Drugs (Amendment) Act 201 7 ( V of 201 7).
3
Substituted for the words “Board concerned” by the Drugs (Amendment) Ordinance, 2002 ( Federal Ordinance CXXVIII of 2002).
The Drugs Act 1976 (XXXI OF 1976) 17
force, any document purporting to be a report signed by a Government Analyst
1
[ or the
Notified Drugs Laboratory] 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
2
[Provincial Quality Control Board or, as the case may
be, the Central Licensing Board or the Registration Board or the Drug Court] 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 subsection (4), notified his intention of adducing
evidence in controversion of a
3
[ report of Government Analyst or of Notified Drugs
Laboratory ] ,
4
[Provincial Quality Control Board or, as the case may be, the Central Licensing
Board or the Registration Board or the Drug Court] may, of its own motion or in its discretion
at the request either of the complainant or the accused, cause the sample of the drug lying
with the Board concerned under subsection (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
5
[ or the Provincial 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 subsection (5) shall be paid by the complainant or accused as the Drug
Court or the Board concerned shall direct.
6
[ 22A. Reports of the Notified Drugs Laboratories . – (1) The Notified Drugs Laboratory
shall submit its report to the Chairperson of the Provincial Quality Control Board.
(2) The provisions of section 22 of the Act shall, as far as may be, apply to the
report of a Notified Drugs Laboratory.
(3) The Board shall take necessary action on the report in accordance with the Act
and the rules. ]
CHAPTER III
PROHI BI TIONS
Section 23 Import, manufacture and sa l e of drugs
(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
1
Inserted by the Punjab Drugs (Amendment) Act 201 7 ( V of 201 7).
4
Substituted for the words and commas “the Drug Court or, as the case may be, the Central Licensing Board or the Registration Board” by
the Drugs (Amendment) Ordinance, 2002 ( Federal Ordinance CXXVIII of 2002).
3
Substituted for the words “ Government Analyst's report ” by the Punjab Drugs (Amendment) Act 201 7 ( V of 201 7).
4
Substituted for the words “the Drug Court or the Board concerned” by the Drugs (Amendment) Ordinance, 2002 ( Federal Ordinance
CXXVIII of 2002).
5
Inserted by the Punjab Drugs (Amendment) Act 201 7 ( V of 201 7).
6
New section inserted by the Punjab Drugs (Amendment) Act 201 7 ( V of 201 7).
18 The Punjab Laws
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 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 of any drug for the purpose of clinical trial,
examination, test, analysis or personal use .
1
[ 23A. Prohibition on aiding, abetment or association in contravention of the Act . – No
one shall participate in, associate or conspire to commit, or attempt to commit, aid, abet,
facilitate, incite, induce or counsel the commission of an offence punishable under this Act.
Section 23B Prohibition of acquisition and possession of assets derived from contravention of
the Act . – No person shall knowingly:
1
New sections inserted by the Punjab Drugs (Amendment) Act 201 7 ( V of 201 7).
The Drugs Act 1976 (XXXI OF 1976) 19
(a) possess, acquire, use, convert, assign or transfer any assets which have been
derived, generated or obtained, directly or indirectly, either in his own name or
in the name of his associates, relative or any other person through an act or
omission which contravenes any of the prohibitions contained in section 23 of
this Act;
(b) hold or possess on behalf of any other person any assets referred to in clause
(a); and
(c) conceal or disguise the true nature, source, location, disposition, movement,
title or ownership of such assets by making false declaration in relation
thereto.
Section 23C Prohibition on owning, operating premises or machinery for manufacture of
drugs, etc . – No one shall own, manage, operate or control any premises, place, equipment or
machinery for purposes of manufacture of any drugs save in accordance with the conditions
of a valid and extant licence issued by the Licensing Authority. ]
Section 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, homoepathie 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.
Section 25 Control of sampling
No person shall distribute or cause to be distributed any drug
as a sample except in accordance with such conditions as may be prescribed.
Section 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 IV
OFFENCES, PENALTIES AND PROCEDURE
27 . Penalties . –
1
[ (1) Whoever himself or by any other person on his behalf:
(a) exports, imports, manufactures or sells any spurious drug or
adulterated drug or any drug which is not registered;
(b) manufactures for sale any drug without a licence;
1
Substituted by the Punjab Drugs (Amendment) Act 201 7 ( V of 201 7) for the following:
“ (1) Whoever himself or by any other person on his behalf -
(a) exports, imports, manufactures for sale or or sells any spurious drug or any drug which is not registered;
(b) manufactures for sale any drug without a license; 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 fin e 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. ”
20 The Punjab Laws
(c) manufactures, transports or sells a temperature sensitive drug in
conditions which are likely to cause the drug to lose its potency; or
(d) imports without licence any drug for the import of which a licence is
required -
shall be punished with imprisonment which may extend to ten years but which shall
not be less than three years and with fine which may extend to fifty million rupees but which
shall not be less than twenty five million rupees. ]
(2) Whoever himself or by any other person on his behalf -
(a) imports, manufactures for sale or sells any counterfeit drug; 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 sale 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 punish able with imprisonment for a term which may extend to seven years ,
1
[ but which shall not be less than two years and with fine which may extend to ten million
rupees but which shall not be less than three million 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
2
[ one year but which shall not
be less than fourteen days and with fine which may extend to one million rupees but which
shall not be less than five hundred thousand rupees ].
3
[ (3a) Whoever himself or by any other person on his behalf, exports, imports,
manufactures for sale or sells any substandard drug shall be punishable with imprisonment
for a term which may extend to five years but which shall not be less than six months and
with fine which may extend to fifty million rupees but which shall not be less than ten million
rupees.”;
(3b) Whoever himself or by any other person contravenes the provisions of section
23B shall be punishable with imprisonment which may extend to ten years but which shall
not be less than three years and with fine which shall not be less than the prevailing value of
the assets and such assets shall also be liable to forfeiture to the Provincial Government.
(3c) Whoever himself or by any other person contravenes the provisions of section
23C shall be punishable with imprisonment which may extend to fourteen years but which
shall not be less than five years and with fine which shall not be less than the prevailing value
of the assets and such assets shall also be liable to forfeiture to the Provincial Government. ]
1
Substituted firstly for the words “ and with fine which may extend to one lakh rupees ” by the Drugs (Amendment) Ordinance, 2002 ( Federal
Ordinance CXXVIII of 2002) and then for the words “ or with fine which may extend to one lakh rupees, or with both ” by the Punjab
Drugs (Amendment) Act 2017 (V of 2017) .
2
Substitu ted for the words “ one year, or with fine which may extend to ten thousand rupees, or with both ” by the Punjab Drugs
(Amendment) Act 2017 (V of 2017) .
3
New subsections inserted by the Punjab Drugs (Amendment) Act 2017 (V of 2017) .
The Drugs Act 1976 (XXXI OF 1976) 21
1
[(4) Subject to the provisions of subsections (1), (2), (3), (3a), (3b) and (3c),
whoever himself or by any other person on his behalf contravenes any of the provisions of
this Act or the rules shall be punishable with imprisonment for a term which may extend to
five years but which shall not be less than thirty days and with fine which may extend to five
million rupees but which shall not be less than five hundred thousand rupees. ]
2
[ (5) If a Provincial Inspector or an official of the Provincial Drugs Testing
Laboratory:
(a) is guilty of any willful breach or neglect of any provisions of the Act or
the rules or any order which he is bound to observe and obey;
(b) is guilty of dereliction of duty;
(c) extends any assistance to any person in contravention of the Act or the
rules; or
(d) abets the contravention of any provisions of the Act or the rules -
shall, without prejudice to any other action in accordance with law, be liable to
imprisonment for a term which may extend to three years but which shall not be less than six
months and with fine which may extend to one million rupees but which shall not be less than
one hundred thousand rupees. ]
3
[ 27A. False statement . – When any person is required under this Act to prepare a report,
make a statement or furnish an information, prepares the report or makes the statement or
furnishes the information which is false in any material particular and which he knows or has
reasonable cause to believe to be false, or does not believe to be true, shall be punishable with
imprisonment for a term which may extend to three years but which shall not be less than six
months and with fine which may extend to one million rupees but which shall not be less than
one hundred thousand rupees. ]
Section 28 Penalty for subsequent offence
(1) Whoever having been convicted of an offence
under sub - section (1) of section 27 is
4
[convicted for a subsequent] offence under that
subsection shall be punishable with imprisonment for life or with imprisonment which shall
not be less than
5
[ ten years and with fine which may extend to one hundred million rupees but
which shall not be less than fifty million rupees] .
(2) Whoever having been convicted of an offence under subsection (2) of section
27 is
6
[convicted for a subsequent] offence under that subsection shall be punishable with
imprisonment for a term
7
[ which may extend to ten years but which shall not be less than five
years and with fine which may extend to seventy million rupees but which shall not be less
than thirty million rupees ] .
8
[ (2a) Whoever having been convicted of an offence under subsection (3a) of section
27 is convicted for a subsequent offence under that subsection shall be punishable with
1
Substitu ted by the Punjab Drugs (Amendment) Act 2017 (V of 2017) for the following:
“ (4) Subject to the provisions of subsection (1), subsection (2) and subsection (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. ”
2
New subsection inserted by the Punjab Drugs (Amendment) Act 2017 (V of 2017) .
3
New subsection inserted by the Punjab Drugs (Amendment) Act 2017 (V of 2017) .
4
Substituted for the words “again convicted of an” by the Drugs (Amendment) Ordinance, 2002 ( Federal Ordinance CXXVIII of 2002).
5
Substitu ted for the words “ five years and with fine which may extend to two lakh rupees ” by the Punjab Drugs (Amendment) Act 2017 (V
of 2017) .
6
Substituted for the words “again convicted of an” by the Drugs (Amendment) Ordinance, 2002 ( Federal Ordinance CXXV II I of 2002).
7
Substitu ted for the expression “ 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 ” by the Punjab Drugs (Amendment) Act 2017 (V of 2017) .
8
New subsection inserted by the Punjab Drugs (Amendment) Act 2017 (V of 2017) .
22 The Punjab Laws
imprisonment for a term which may extend to seven years but which shall not be less than
two years and with fine which may extend to seventy five million rupees but which shall not
be less than twenty five million rupees. ]
(3) Whoever having been convicted of an offence under sub - section (4) of section
27 is
1
[convicted for a subsequent] offence under that subsection shall be punishable with
imprisonment for a term which may extend to
2
[ ten years but which shall not be less than
ninety days and with fine which may extend to ten million rupees but which shall not be less
than one million rupees].
Section 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 conveyances 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 dr u g 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.
Section 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.
3
[ (2) Notwithstanding anything contained in the Code of Criminal Procedure,
1898
4
:
1
Substituted for the words “again convicted of an” by the Drugs (Amendment) Ordinance, 2002 ( Federal Ordinance CXXVIII of 2002).
2
Substitu ted for the expression “ seven years, or with fine which may extend to one lakh rupees, or with both ” by the Punjab Drugs
(Amendment) Act 2017 (V of 2017) .
3
Substitu ted by the Punjab Drugs (Amendment) Act 2017 (V of 2017) for the following:
The Drugs Act 1976 (XXXI OF 1976) 23
(a) an offence punishable under subsection (1) of section 27 shall be
cognizable and non - bailable;
(b) an offence other than the offence mentioned in subsection (1) of
Section 27 , shall be cognizable on the complaint of the Provincial
Quality Control Board or the Provincial Drugs Monitoring Team; and
(c) all offences under the Act shall be non - bailable.
(2a) No court other than a Drug Court established under the Act shall try an
offence punishable under the Act. ]
(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 c ourt immediately before the establishment of the Drug Court.
Section 31 Drug Courts
(1) The
1
[Provincial 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,
or the class of cases in respect of which, each one of them shall exercise jurisdiction under
this Act.
2
[ (2) A Drug Court shall consist of:
(a) a Chairperson who is or has been a District and Sessions Judge or
Additional District and Sessions Judge to be appointed, in consultation
with the Chief Justice, Lahore High Court, for a period of three years,
by the Provincial Government on such terms and conditions as it may
determine; and
(b) two members, each from the field of pharmaceutical and medical with
fifteen years’ experience in such field, to be appointed, for a period of
three years, by the Provincial Government on such terms and
conditions as it may determine.
(2a) The Chairperson and one of the members shall constitute the quorum of a
Drug Court for deciding the matters, other than final hearing and decision of the case, under
the Act. ]
(3) A Drug Court shall sit at such place or places as the
3
[Provincial Government]
may direct.
(4) A Drug Court shall h a ve all the powers conferred by the Code of Criminal
“(2) Notwithstanding anything contained in the Code of Criminal Procedure, 1898 (V of 1898), -
(a) an offence punishable under this Chapter other than an offence mentioned in subsection (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. ”
4
Act V of 1898
1
Substituted for the words “Federal Government” by the Punjab Drugs (Amendment) Act 2016 (XXXIII of 2016).
2
S ubstitu ted first by the Punjab Drugs (Amendment) Act 2017 (V of 2017) for the following:
“ (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 [Provincial Government], are experts in the
medical or pharmaceutical fields [:]
[Provided that for deciding applications of bail the Chairman and any one member shall constitute full quorum of a Drug
Court. ]”
*Substituted for the words “Federal Government” by the Punjab Drugs (Amendment) Act 2016 (XXXIII of 2016)
**Substituted for the “full - stop” by the Drugs (Amendment) Ordinance, 2002 (Federal Ordinance CXXVIII of 2002)
***Added by the Drugs (Amendment) Ordinance, 2002 (Federal Ordinance CXXVIII of 2002) .
Now substituted by the Drugs (Amendment) Act 2025 (XXXIV of 2025) for the following:
“(2) A Drug Court shall consist of the Chairperson who is or has been, or is qualified for appointment as a Judge of High Court,
and one full - time member who is an expert in the medical field and another full - time member who is an expert in pharmaceutical
field.”
3
Substituted for the words “Federal Government” by the Punjab Drugs (Amendment) Act 2016 (XXXIII of 2016).
24 The Punjab Laws
Procedure, 1898
1
, on a Court of Session s 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
2
, for the trial of summons cases by Magistrates.
3
[* * * *]
4
[ 31A. Appeal . – (1) The Provincial Government or the person sentenced by a Drug Court
may, within sixty days, file an appeal against the final order of the Drug Court to Lahore
High Court and the appeal shall be heard by a Bench of that Court consisting of not less than
two Judges.
(2) The Drug Court shall, as soon as possible, supply copies of the final order to
the parties free of cost.
(3) The provisions of sections 5 and 12 of the Limitation Act, 1908
5
shall be
applicable to an appeal under this section. ]
Section 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 substandard
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 f it 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 of 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 pr o vision 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 warranty in the prescribed form stating, in particular,
1
Act V of 1898
2
Act V of 1898
3
The following subsections omitted by the Punjab Drugs (Amendment) Act 2017 (V of 2017):
“ (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 t o in
sub - section (7). ”
4
New section inserted by the Punjab Drugs (Amendment) Act 2017 (V of 2017).
5
Act IX of 1908
The Drugs Act 1976 (XXXI OF 1976) 25
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 be 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.
Section 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
1
, 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 subsection (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
2
[with whose knowledge or consent the offence was
committed shall be guilty of the offence].
Section 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 is the same manner as a
fine is recoverable.
Section 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.
Section 37 Inspectors to be public servants
Every Inspector shall be deemed to be a public
1
Act IV of 1969
2
Substituted for the words and commas “shall, unless he proves that the offence was committed without his knowledge and consen t, be
guilty of the offence” by the Drugs (Amendment) Ordinance, 2002 ( Federal Ordinance CXXVIII of 2002).
26 The Punjab Laws
servant within the meaning of section 21 of the Pakistan Penal Code
1
, and shall be officially
subordinate to such authority as the Government appointing him may specify in this behalf.
Section 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.
Section 39 Finality of orders, 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.
Section 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.
Section 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.
2
[ 41A. Suspension of license by Provincial Quality Control Board . – (1) Notwithstanding
anything in section 41, the Provincial Quality Control Board may, subject to the conditions
mentioned in that section, and after affording an opportunity of hearing to the manufacturer
and recording detailed reasons including the grounds of suspension, suspend the
manufacturing license of a manufacturer within the Punjab for such period not exceeding
thirty days as the Board may determine and shall, as soon as may be, report the matter to the
Central Licensing Board for such action as the Board may deem app ropriate.
(2) A copy of the order under subsection (1) shall immediately be supplied to the
manufacturer, requiring him to take appropriate remedial measures.
(3) The manufacturer shall take remedial measures and shall request the
Provincial Quality Control Board for an immediate inspection of the unit, and the Board shall
promptly arrange an inspection.
(4) If the Board is satisfied that the grounds leading to the suspension of the
licence have been remedied, it shall restore the licence of the manufacturer and report the
matter to the Central Licensing Board but if the Board is not so satisfied, it may require the
manufacturer to take the remaining remedial measures.
(5) Notwithstanding anything in subsection (3) or subsection (4), the Board shall
arrange inspection of the Unit for manufacture of drugs at five days prior to the expiry of the
period of suspension and if it is of the view that sufficient remedial steps have not been taken,
the Board may, from time to time and after recording reasons, extend the period of
suspension up to the maximum period of ninety days in all.
1
Act XLV of 1860
2
New section inserted by the Punjab Drugs (Amendment) Act 2017 (V of 2017).
The Drugs Act 1976 (XXXI OF 1976) 27
(6) If the manufacturer does not take effective remedial steps during the period or
extended period of suspension of the licence, the Board shall refer the matter to the Central
Licensing Board for immediate cancellation of the manufacturing licence.
(7) Any manufacturer aggrieved by the order of suspension may, within seven
days from the receipt of the order, prefer an appeal to the appellate authority as notified by
the Government and the appellate authority shall dispose of the appeal maximum within
seven days. ]
Section 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.
CHAPTER V
MISCELLANEOUS
Section 43 Power of Federal Government to make rules
(1) Subject to section 44, the
Federal Government may, by notification in the official Gazette, make rules
1
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,
1
For the Drugs (Appellate Board) Rules 1976, see SRO No.595(1)/76, dated 20 - 06 - 1976; Gazette of Pakistan, 1976 (Extraordinary),
Islamabad, Pt II, pages 1125 - 1127; and for the Drugs (Federal Inspectors, Federal Drug Laboratory and Federal Government Analysts),
Rules 1976, see SRO No.793(1)/76, dated 06 - 08 - 1976; pages 1627 - 1636.
28 The Punjab Laws
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 bottle s ,
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 lebels 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;
(n) 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
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 an 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;
The Drugs Act 1976 (XXXI OF 1976) 29
(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.
(2) 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.
1
[ 43A. Power to delegate . – (1) The Provincial Government may, subject to such conditions
as it may determine, delegate any of its functions to the Provincial Quality Control Board or
to any other person or authority.
(2) The Provincial Quality Control Board may, subject to such conditions as it
may determine, delegate any of its functions and powers under this Act or the rules to the
Monitoring Committee or any other person or authority. ]
Section 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
2
[ and
Therapeutic goods ] ;
(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
3
[ and
Therapeutic goods ] or any specific drug or class of drugs;
(e) the offences against this Act or any rule in relation to which the stock
1
New section inserted by the Punjab Drugs (Amendment) Act 2017 (V of 2017).
2
Inserted b y the Drugs (Second Amendment) Act 2025 ( C III of 202 5 ).
3
Inserted b y the Drugs (Second Amendment) Act 2025 ( C III of 202 5 ).
30 The Punjab Laws
of drugs
1
[ and Therapeutic goods ] shall be liable to confiscation and
destruction under this Act;
(f) the forms of licences for the sale or distribution of drugs
2
[ and
Therapeutic goods ] 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 conditions subject to
which such licences may be issued;
(g) the procedure to be followed by the Provincial Quality Control Board;
and
(h) 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 exercise thereof, be subject to the condition of previous publication.
Section 45 Repeal and Savings
(1) The Drugs Act, 1940
3
, the Drugs (Generic Names) Act,
1972
4
, and the Drugs Ordinance, 1976
5
, are hereby repealed.
(2) Notwithstanding the repeal of the Drugs Act, 1940 by subsection (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 subsection (6) of section 7 in respect of
drugs in the finished form ready for use.
1
Inserted b y the Drugs (Second Amendment) Act 2025 ( C III of 202 5 ).
2
Inserted b y the Drugs (Second Amendment) Act 2025 ( C III of 202 5 ).
3
Act XXIII of 1940
4
Act XXIV of 1972
5
Act IV of 1976