THE DRUGS ACT 1976

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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;

6 The Punjab Laws

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

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