DRUGS ACT, 1976

Exact source transcription retained, including print layout and extraction artifacts. Text SHA-256: 85d00a2899de0131da146aa4e464dc3cdb83e75e469246039c2610b3d8c4c405.

THE DRUGS ACT, 1976 
(XXXI of 1976) 
CONTENTS 
CHAPTER I 
INTRODUCTORY 
1. Short title, extent and commencement 
2. Application of other laws not barred 
3. Definitions 
CHAPTER II 
ADMINISTRATION AND ENFORCEMENT 
4. Regulation and prohibition of import, etc., of drugs 
5. Regulation of manufacture of drugs 
6. Regulation of sale of drugs 
7. Registration of drugs 
8. Pakistan National Formulary 
9. Appellate Board 
9A. Appeals to the Provincial Appellate Authority 
10. Expert Committees 
11. Provincial Quality Control Board 
11A. Conflict of interest 
11B.  Provincial Drugs Monitoring Teams 
11C. Independent inspection 
12. Power to fix maximum prices of drugs, etc 
13. Directions to Provincial Governments 
14. Federal Drug Laboratory and institutes, etc 
15. Provincial Drugs Testing Laboratory 
16. Government Analysts 
17. Inspector 
18. Powers of Inspectors 
19. Procedure for Inspectors 
20. Persons bound to disclose place where drugs a r e manufactured or 
kept 
21. Disclosure of the name of the manufacturer 
22. Reports of Government Analysts 
22A. Reports of the Notified Drugs Laboratories 
CHAPTER III 
PROHITIONS 
23. Import, manufacture and sale of drugs 
23A. Omitted 
23B. Omitted 
23C. Omitted 
24. Control of advertisement 
25. Control of samplings 
26. Control of printing of labeling 
CHAPTER IV 
OFFENCES, PENALTIES AND PROCEDURE 
27. Penalties 
27A.  Omitted 
28. Penalty for subsequent offence 
28A. Recall of drugs 
29. Forfeiture 
30. Cognizance of offences  
31. Drug Courts 
31A. Appeal 
32. Pleas 
33. Application of law relating to customs and powers of officers of customs 
34. Offences by companies, etc 
35. Publication of offender's name 
36. Powers to exempt 
37. Inspectors to be public servants 
38. Indemnity 
39. Finality of orders, etc. 
40. Publication of result of test or analysis, etc 
41. Cancellation or suspension of licences 
41A. Suspension of license by Provincial Quality Control Board 
42. Cancellation or suspension of registration of registered drugs 
CHAPTER V 
MISCELLANEOUS 
43. Power of Federal Government to make rules 
43A.  Power to delegate 
44. Power of the Provincial Government to make rules 
45. Repeal and Savings 
TEXT 
1
THE DRUGS ACT, 1976 
(XXXI of 1976) 
[18 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, m anufacture, 
storage, distribution and sale of drugs; 
It is hereby enacted as follows:– 
CHAPTER I 
INTRODUCTORY 
1. Short title, extent and commencement.– (1) This Act may be called the 
Drugs Act, 1976. 
(2) It extends to the whole of Pakistan. 
(3) It shall come in to force at once. 
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 (II of 1930), and 
any other law for the time being in force. 
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 subst ance 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 
2
[has] 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 
                                                           
1This Act was assented to by the President on 11  May 1976 and published in the Gazette of Pakistan (Extraordinary), on 18 May 
1976, pp.299-320. For Statement of Objects and Reasons, see Gaz., of P., 1976, Ext., Pt. III, p. 250. 
An offence punishable under the Drugs Act, 1976, will be tried and punished by a Military Court, see Notification No. 
57/1(1)1943/AJAG/CMLA/82, dated, see Gaz. of P., Ext., Pt. I, p. 153. 
2Substituted for the words “may have” by the Drugs (Amendment) Ordinance, 2002 (CXXVIII of 2002), published in the Gazette 
of Pakistan (Extraordinary), dated:15 November 2002, pp. 1984-1989, s.2.  
(v) with which any subst ance has been mixed or packed so as to 
reduce its quality
 
or
 
strength
 
or
 
for
 
which
 
any
 
substance
 
has
 
been
 
substituted wholly or in part; 
(b) "Appellate Board" means the Board constituted under section 9; 
(c) "batch" means a quantity of any drug produced during a given cycle of 
manufacture; 
(d) "batch
 
number"
 
means
 
a
 
designation
 
printed
 
on
 
the
 
label
 
of
 
a
 
drug
 
that 
identifies the batch and permits the production history of  the batch, 
including all stages of m anufacture 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 subst ance or
 
mixture of subst ances that is m anufactured, 
sold, sto red, offered for sale or represented for internal or 
external use in the t reatment, 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 t reatment except those substances and in 
accordance with such conditions as may be prescribed; 
(ii) abortive and contraceptive subst ances, agents and d evices, 
surgical li gatures, sutu res, bandages, absorbent cotton, 
disinfectants, b acteriophages, adhesive pl asters, gelatine 
capsules and antiseptic solutions; 
(iii) such substances intended to be us ed for the d estruction or 
repulsion of su ch vermin, insects, rodents and other organisms 
as cause, carry or t ransmit disease in human beings or animals 
or for disinfection in residential areas or in premises in which food 
is manufactured, prepared or kept or stored; 
(iv) such pesticides as may cause health hazard to the public; 
(v) any substance
 
mentioned
 
as
 
monograph or
 
as
 
a
 
preparation
 
in
 
the 
Pakistan Pharmacopoeia or the Pakistan National Formulary or 
the International Pharmacopoeia or the British Pharmacopoeia or 
the British Pharmaceutical
 
Codex
 
or
 
the
 
United
 
States
 
Pharmacopoeia or
 
the National
 
 Formulary
 
 of
 
 the
 
 United
 
 States,
 
 
whether
 
 alone
 
 or
 
 in combination
 
 with
 
 any
 
 substance
 
 exclusively 
used
 
 in
 
 the
 
 unani, ayurvedic,
 
 homoeopathic
 
 or
 
 biochemic 
system
 
 of
 
 treatment,
 
 and int ended to be used for any of the 
purposes mentioned in sub-clauses (i), (ii) and (iii); 3[*] 
                                                           
3Omitted for the word “and” by the Drugs ( Second Amendment) Act 2025 (CIII of 2025), published in the Punjab Gazette 
4[(va) Therapeutic goods as defined under clause (xxxvi) of sec tion 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 o fficial Gazette, declare to be  a "drug" for the 
purposes of this Act; 
(h) "expiry date" means the date stated on the label of a drug after which 
the drug is not expected to retain its claimed efficacy, safety, quality or 
potency or after which it is not permissible to sell the drug; 
(i) "expert" means a specialist through university education and experience 
in the relevant field; 
(j) "export", with its grammatical variations and cognate expressions, 
means to take out of Pakistan by sea, land or air; 
(k) "generic name" means the non-proprietary, scientific or official name 
of a drug as approved by the Federal Government; 
(l) "Government 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" m eans a displ ay of w ritten, p rinted or graphic m atter 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 p roduction of the drug, including p rocessing, compounding, 
formulating, filling, packing, repacking, altering, ornamenting, finishing 
and labelling with a vi ew 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 p rescription of a  
registered medical practitioner or d entist
 
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 
                                                                                                                                                                                       
(Extraordinary), dated:18 December 2025, pp. 3279-3280, s.2(a).   
4Inserted by the Drugs (Second Amendment) Act 2025 (CIII of 2025), published in the Punjab Gazette (Extraordinary), dated:18 
December 2025, pp. 3279-3280, s.2(b).   
on the label or labelling) and in such terms as may render it likely 
to be read and understood by the o rdinary 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 su ch 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 wh ich m akes 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 l abel does not  bear the n ame of  that 
pharmacopoeia or document; 
5
[(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; 
6
[(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 s pecifications 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;  
                                                           
5Inserted by the Punjab Drugs (Amendment) Act, 2017 (V of 2017), published in the Punjab Gazette (Extraordinary), dated: 13 
February 2017, pp.4519-4525, s.2. 
6Inserted by the Punjab Drugs (Amendment) Act, 2017 (V of 2017), published in the Pu njab Gazette (Extraordinary), dated: 13 
February 2017, pp.4519-4525, s.2. 
(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 th at, if t he sp ecifications do not  appear in the  
most recent edition of any such publication, the 
specifications appearing in the next proceeding edition of 
such publication in which the sp ecifications appear shall 
apply; or 
(iii) if no specifications are either prescribed or contained in any of  
the publi cations referred to in sub-clause (ii), the sp ecification 
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; or 
(ii) which purports to be the product of a manufacturer, place or 
country of whom or of which it is not truly a product; or 
(iii) which is imported or exported or sold or offered or exposed 
for sale under a particular name while actually it is another drug; 
or 
(iv) the
 
label
 
of
 
which
 
bears
 
the
 
name
 
of
 
an
 
individual
 
or
 
company 
purporting to be its manufacturer or producer which individual or 
company is fictitious or does not exist; 
(zc) "storage" means storage for sale and "to store" or "stored" shall 
be construed accordingly; and 
7
[(zd) “sub-standard drug” means a drug which is not of specifications; 
(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 
4. Regulation
 
and
 
prohibition
 
of
 
import,
 
etc.,
 
of
 
drugs.– (1) The
 
Federal 
Government stall regulate tile import and export of drugs in the prescribed manner 
                                                           
7Substituted by the Punjab Drugs (Amendment) Act, 2017 (V of 2017), published in the Punjab Gazette (Extraordinary), dated: 13 
February 2017, pp.4519-4525, s.2. 
and for th at 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 o r 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 th rough an ind entor 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. 
8
[(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.] 
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 Gov ernment and consisting of such representatives o f the Federal 
Government and the Provincial Governments as may be prescribed. 
(2) The members of the C entral Licensing Board shall exercise such 
powers, including the powers of an Inspector, as may be prescribed. 
(3) The Central Licensing Board shall 
9
[,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 sub-section (4), a member of the Central Licensing Board 
shall hold office for the prescribed period. 
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 di rections to the importers, manufacturers, stockists, retailers or 
other dealers of drugs, as they may deem fit. 
7.  Registration of drugs.– (1) The Federal Government shall cause all drugs to 
be registered in accordance with such conditions and procedure as may be 
prescribed and for th at purpose set up a Registration Board, consisting of  such 
                                                           
8Added by the Drugs ( Amendment) Ordinance, 2002 (CXXVIII of 2002), published in the Gazette of Pakistan (Extraordinary), 
dated:15 November 2002, pp 1984-1989, s.3. 
9Inserted by the Drugs (Amendment) Ordinance, 2002 (CXXVIII of 2002), published in the Gazette of Pakistan (Extra ordinary), 
dated:15 November 2002, pp 1984-1989, s.4. 
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 R egistration Board shall 
10
[, with the approval of the  Federal 
Government, and by notification in the o fficial 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 h and addressed to the Federal Government, resign his office or sh all 
vacate his office if the Federal Government, being of opinion that in the public interest 
it is necessary so to do, so directs. 
(5) Subject to sub-section (4), the members of the Registration Board shall 
hold office for the prescribed period. 
(6) The Federal Government shall, by notification in the official Gazette, fix 
the date after which no drug which is not registered shall be allowed to be exported, 
imported, manufactured, stored, distributed or sold. 
(7) A person applying for the registration of a drug sh all furnish such 
information in respect of the drug as may be prescribed, including information relating 
to its efficacy, safety and quality, or as may be required by the Registration Board for 
the purpose of the evaluation of the drug. 
(8) Single-ingredient drugs shall be registered generally by their generic 
names while compound drugs shall be registered generally by their proprietary names. 
Explanation.– In this sub-section,– 
(a) "Single-ingredient drugs" means drugs containing one active ingredient; 
(b) "compound drugs" means drugs  containing more than  one active 
ingredient. 
11
[(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 
                                                           
10Inserted by the Drugs (Amendment) Ordinance, 2002 (CXXVIII of 2002), published in the Gazette of Pakistan (Extraordinary), 
dated:15 November 2002, pp 1984-1989, s.5. 
11Substituted by the Drugs (Amendmen t) Ordinance, 2002 (CXXVIII of 2002), published in the Gazette of Pakistan 
(Extraordinary), dated:15 November 2002, pp 1984-1989, s.5. 
(d) it is necessary in the public interest so to do; 
the Registration Board may, after affording to the person on whose application 
the drug was registered an opportunity of showing cause against the action proposed 
to be taken,  cancel or suspend the registration or specify any further condition s to 
which the registration shall be subject and inform such person and the  Provincial 
Governments accordingly. 
(12) The Provincial Governments shall take all such steps as may be 
necessary to  ensure compliance with the conditions s ubject to which a drug is 
registered and to prevent the manufacture or sale of a drug– 
(a) which has not been registered; or 
(b) the registration of which has been cancelled or stands suspended. 
8. Pakistan Na tional Formulary.– The Federal Government sh all compile and 
publish in the official Gazette Pakistan National Formulary comprising all drugs 
allowed to be imported, manufactured or sold and such Formulary may be reviewed 
and modified from time to time. 
9. Appellate Board.– (1) The Federal Government shall, in accordance with 
the rules, constitute an App ellate Board for the dispos al 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 o ther 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 
12
[,with the approval of the Federal 
Government and by notification in the official Gazette,] make regulations to regulate 
the conduct of its business. 
13
[(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 
                                                           
12Inserted by the Drugs (Amendment) Ordinance, 2002 (CXXVIII of 2002), published in the Gazette of Pakistan (Extraordinary ), 
dated:15 November 2002, pp 1984-1989, s.6. 
13Added by the Drugs (Amendment) Ordinance, 2002 (CXXVIII of 2002), published in the Gazette of Pakistan (Extraordinary), 
dated:15 November 2002, pp 1984-1989, s.6. 
prevented from doing so for sufficient cause to be recorded.] 
14
[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 dispos al of appeal preferred under sub-section (1) as m ay be 
prescribed.] 
10. Expert Committees.– (1) The Federal Government may constitute 
committees of experts on Drugs Evaluation, on Pakistan Pharmacopoeia, on 
Advertising and on such other matters as may be necessary for the purposes of this 
Act. 
(2) Each committee constituted under sub-section (1) shall consist of such 
members as the Federal Government may appoint from time to time and each such 
member shall hold office during the pleasure of the Federal Government. 
11. Provincial Quality Control Board.– (1) Each Provincial Government shall set 
up a Provincial Quality Control Board  consisting 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 Con trol 
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 Cont rol Board and provide the Board with such staff as the 
Provincial Government may consider necessary. 
(4) The Provincial Quality Control Board shall 
15
[, 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, namely:– 
(a) to inspect any p remises where any d rug 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 p erson 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 th em by Provincial Inspectors for test and 
analysis 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 
                                                           
14Inserted by the Drugs (Amendment) Ordinance, 2002 (CXXVIII of 2002), published in the Gazette of Pakistan (Extraordinary), 
dated:15 November 2002, pp 1984-1989, s.7. 
15Inserted by the Drugs (Amendment) Ordinance, 2002 (CXXVIII of 2002), published in the Gazette of Pakistan (Extraordinary), 
dated:15 November 2002, pp 1984-1989, s.8. 
of cases in which a Provincial Inspector may make a complaint to the 
Drug Court, or take any other action, without the specific instructions of 
the Board; 
(c) to exercise all the pow ers of an Inspector und er this  Act and the 
rules;
16
[*] 
(d) to advise the Provincial Government on ways and means to ensure 
quality control of drugs manufactured in the Province 
17
[;] 
18
[(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 l aboratories and to recommend measures to upgrade su ch 
laboratories, if required; 
(g) identify and accredit on payment of fee other laboratories in the 
Province with suitable facilities and expertise; 
(h) to
 
conduct
 
training
 
programs
 
to
 
update
 
Government
 
Analysts
 
and
 
for 
improving th eir knowledge according to  latest analytical method and 
technology; 
19
[*] 
20
[(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] 
21
[(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. 
22
[(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.] 
                                                           
16The word “and” was omitted by the Drugs (Amendment) Ordinance, 2002 (CXXVIII of 2002), published in the Gazette of 
Pakistan (Extraordinary), dated:15 November 2002, pp 1984-1989, s.8. 
17Substituted for the “full -stop” by the  Drugs (Amendment) Ordinance, 2002 (CXXVIII of 2002), published in the Gazette of 
Pakistan (Extraordinary), dated:15 November 2002, pp 1984-1989, s.8. 
18Added by the Drugs (Amendment) Ordinance, 2002 (CXXVIII of 2002), published in the Gazette of Pakistan ( Extraordinary), 
dated:15 November 2002, pp 1984-1989, s.8. 
19Deleted the word “and” by the Punjab Drugs (Amendment) Act, 2017 (V of 2017), published in the Punjab Gazette 
(Extraordinary), dated: 13 February 2017, pp.4519-4525, s.3. 
20Substituted by the Punja b Drugs (Amendment) Act, 2017 (V of 2017), published in the Punjab Gazette (Extraordinary), dated: 
13 February 2017, pp.4519-4525, s.3. 
21Inserted by the Punjab Drugs (Amendment) Act, 2017 (V of 2017), published in the Punjab Gazette (Extraordinary), dated:  13 
February 2017, pp.4519-4525, s.3. 
22Inserted by the Punjab Drugs (Amendment) Act, 2017 (V of 2017), published in the Punjab Gazette (Extraordinary), dated: 13 
February 2017, pp.4519-4525, s.3. 
23
[11A. Conflict of interest.– No person who is a m ember 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.] 
24
[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 mem bers on such 
terms and conditions as the Provincial Government may determine. 
(2) The Chairperson and members of the Provincial Drugs Monitoring 
Team shall hold office during the pleasure of the Provincial Government. 
(3) The Provincial Drugs Monitoring Te am s hall, with the approval of the 
Provincial Government and by notification in the official Gazette, frame regulations to 
regulate the conduct of its business. 
(4) The Provincial Drugs Monitoring Team may– 
(a) subject to subsection (5), exercise the powers of an Inspector under this 
Act; 
(b) inspect any p remises where any d rug is being, or is to be, 
manufactured or sold and, in addition to any other action under the Act,  
recommend to the appropriate authority for the  cancellation or 
suspension of the licence to manufacture or sell drugs held by  any 
person who is found to be contravening, or to have contravened, any of 
the provisions of the Act or the rules; 
(c) advise the Provincial Government on ways and means to ensure the 
provision of quality drugs to the people; 
(d) 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
 
the A ct
 
or the
 
rules and 
recommend to the appropriate authority action against such persons; 
(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. 
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. 
                                                           
23Inserted by the Drugs (Amendment) Ordinance, 2002 (CXXVIII of 2002), published in the Gazette of Pakistan (Extraordinary), 
dated:15 November 2002, pp 1984-1989, s.9. 
24Inserted by the Punjab Drugs (Amendment) Act, 2017 (V of 2017), published in the Punjab Gazette (Extraordinary), dated: 13 
February 2017, pp.4519-4525, s.4. 
(2) No person sh all 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 in  house 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.] 
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 utilised, in accordance with the rules for purposes of 
research in drugs. 
(2) For the purpose of the exercise of its powers under sub-section (1), the 
Federal Government may require a manufacturer, stockist, importer, exporter, retailer 
or other dealer in drugs to furnish such relevant information as may be necessary. 
(3) The Federal Government may, by noti fication in the official Gazette, 
delegate any of its powers under this section to any Board or other authority. 
13. Directions to Provincial Governments.– The Federal Government may give 
such di rections to a Provincial Government as may appear to the
 
Federal
 
Government to be necessary for carrying into execution in the Province of any of the 
provisions of this Act or of any rule or order made thereunder or for maintaining 
supplies of drugs of standard quality at reasonable prices or for the achievement of 
uniformity in respect of any matter in different parts of Pakistan. 
14. Federal Drug Laboratory and institutes, etc.– The Federal Government 
shall, as soon as may be, establish a Federal Drug Laboratory and may also set up 
such other institutes and drugs testing and research laboratories for the purposes of 
this Act as may be prescribed. 
25
[15. Provincial Drugs Testing Laboratory .– (1) The Prov incial 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 th e country or abroad, for test and analysis of 
the drug samples.] 
16. Government Analysts.– The Federal Government or a Provincial Government 
may, by notification
 
in
 
the
 
official
 
Gazette,
 
appoint
 
such
 
persons it
 
thinks
 
fit,
 
having the 
                                                           
25Substituted by the Punjab Drugs (Amendment) Act, 2017 (V of 2017), published in the Punjab Gazette (Extraordinary), dated: 
13 February 2017, pp.4519-4525, s.5. 
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 p revious 
consent of that Government. 
17. Inspectors.– The Federal Government or a Provincial Government may, by 
notification in the official Gazette, appoint such persons as it thinks fit, h aving 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 p revious 
consent of such Government. 
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 s ale or is  distributed, the sto rage 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 buildin g, vessel or pl ace, in which he h as reason to 
believe that an offence under this Act or any rules has been or is being 
committed or may continue to be committed; 
(e) call any person to be present as witness in the course of search or 
seizure or in connection
 
with
 
any
 
other
 
matter
 
where
 
the
 
presence
 
of
 
witnesses
 
is necessary; 
(f) seize such drug and all materials used in the manufacture thereof 
and any other articles, including registers, cash-memos, invoices and 
bills, which he h as reason to believe may furnish evidence of the 
commission of an offence punishable under this Act or any rules 
26
[:] 
                                                           
26Substituted for the “semi -colon” by the Drugs (Amendment) Ordinance, 2002 (CXXVIII of  2002), published in the Gazette of 
Pakistan (Extraordinary), dated:15 November 2002, pp 1984-1989, s.10. 
27
[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 p erson to appear before him at any reasonable time and 
place to give s tatement, assistance or in formation relating to or in  
connection with the inv estigation of an offence und er this Act or the 
rules: 
Provided that the exemptions under sections 132 and 133 of the Code of  
Civil Procedure, 1908 (Act V of 1908), shall be applicable to requisitions for 
attendance under this clause; 
(h) lock and seal any factory, laboratory, shop, building, store-house or 
godown, or a part thereof, where any drug is or is being manufactured, 
stored, sold or exhibited for sale in contravention of any of the 
provisions of this Act or the rules; 
(i) forbid for a reasonable period, not exceeding 
28
[two] weeks or such 
further p eriod, which shall not be more th an three mont hs, 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 b e, sp ecify, any person in charge of any 
premises from removing or dispensing of any drug, article or other thing 
likely to be used in evidence of the commission of an offence under this 
Act or the rules; and 
(j) exercise such other powers as may be necessary for carrying out the 
purposes of this Act or any rules: 
Provided that the powers under clauses (f) to (j) shall be exercisable only by an 
Inspector specifically authorised in this behalf, by an order in w riting, by the 
Government appointing him, subject to such conditions as may be specified in such 
order 
29
[.]  
30
[* * * * * * * * * * * *   ] 
(2) The provisions of the Code of Criminal Procedure, 1898 (Act V of 1898), 
in so far as they are not inconsistent with the provisions of this Act, shall apply 
to searches and seizures made under this Act. 
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 s hall intimate such purpose in writing in the prescribed form to the 
person from whom he takes it and, in the presence of such person unless he wilfully 
                                                           
27Added by the Drugs (Amendment) Ordinance, 2002 (CXXVIII of 2002), published in the Gazette of Pakistan (Extraordinary), 
dated:15 November 2002, pp 1984-1989, s.10. 
28Substituted for the word “four”  by the Drugs (Amendment) Ordinance, 2002 (CXXVIII of 2002), published in the Gazette of 
Pakistan (Extraordinary), dated:15 November 2002, pp 1984-1989, s.10. 
29Substituted for the “colon” by the Drugs (Amendment) Ordinance, 2002 (CXXVIII of 2002), published in the Gazette of Pakistan 
(Extraordinary), dated:15 November 2002, pp 1984-1989, s.10. 
30The second proviso was o mitted by the Drugs (Amendment) Ordinance, 2002 (CXXVIII of 2002), published in the Gazette of  
Pakistan (Extraordinary), dated:15 November 2002, pp 1984-1989, s.10. 
absents himself, shall divide the sample into 
31
[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 m anufactured, it shall be necessary to divide the s ample into th ree po rtions 
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 th at if the contents of one container are insu fficient for t he 
laboratory t est 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 po rtion of a s ample 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– 
32
[(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 Cont rol 
Board or the C entral Licensing Board or the Registration Board, as the 
case may be; 
33
[*] 
(iii) the third, where taken, he shall send to the  warrantor, if any, named 
under the proviso to sub-section (3) of section 32 
34
[; and] 
35
[(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 d rug containing any filthy or putrid 
substance, vermin, worm, rodent, insect or any foreign matter which is visible to the 
naked eye, and the sample is such that it cannot or need not be divided, he shall 
effectively seal and suitably mark the same and permit the person from whom he 
seizes the drug to add his own seal if any, and mark to it and shall produce the
 
same 
before the Drug Court or the C entral Licensing Board or the Registration Board, as 
the case may be , before which proceedings are institut ed or action is ini tiated in 
respect of the drug. 
(5) Where an Inspector takes any action under section 18,– 
                                                           
31Substituted for the word “four” by the Drugs (Amendment) Ordinance, 2002 (CXXVIII of 2002), published in the Gazette of 
Pakistan (Extraordinary), dated:15 November 2002, pp 1984-1989, s.11. 
32Substituted by the Punjab Drugs (Amendment) Act, 2017 (V of 2017), published in the Punjab Gazette (Extraordinary), dated: 
13 February 2017, pp.4519-4525, s.6. 
33The word “and” was omitted by the Drugs (Amendment) Ordinance, 2002 (CXXVIII of 2002), p ublished in the Gazette of 
Pakistan (Extraordinary), dated:15 November 2002, pp 1984-1989, s.11. 
34Substituted for the “full -stop” by the Drugs (Amendment) Ordinance, 2002 (CXXVIII of 2002), published in the Gazette of 
Pakistan (Extraordinary), dated:15 November 2002, pp 1984-1989, s.11. 
35Added by the Drugs (Amendment) Ordinance, 2002 (CXXVIII of 2002), published in the Gazette of Pakistan (Extraordinary), 
dated:15 November 2002, pp 1984-1989, s.11. 
(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 s hall forthwith revoke the order 
passed under the said section or, as the case may be, take such action 
as may be necessary for the return of the stock seized and payment for 
the samples taken, under intimation to the Board concerned; 
(b) if he seizes the stock of the drug, he shall, as soon as may be, inform 
the Board concerned and take its order as to the custody thereof: 
Provided that where a Federal 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 Act 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. 
20. Persons bound to disclose place where drugs a re manufactured or 
kept.– Every person for the time being in charge of any premises whereon any 
drug is
 
being manufactured or is kept for sale or distribution shall, on being required 
by an Inspector so to do, disclose to the Inspector the place where the drug is being 
manufactured or is kept, as the case may be. 
21.  Disclosure of the name of the manufacturer.– Every person, not being the 
manufacturer of a drug or his agent for the distribution thereof, shall, if so required by 
an Inspector, disclose to him the name, address and other particulars of the 
manufacturer or other person from whom he acquired the drug. 
22.  Reports of Government Analysts.– (1) The Government Analyst to whom a 
sample of any drug has been submitted for test and analysis under sub-section (3) 
of section 19
 
shall
 
deliver
 
to
 
the
 
Inspector
 
submitting
 
it
 
a
 
signed
 
report
 
in
 
quadruplicate
 
in
 
the p rescribed form and forward one  copy thereof to the authority as m ay 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 
36
[Central Licensing Board o r, as the  case m ay 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 
                                                           
36Substituted for the words “Board concerned” by the Drugs ( Amendment) Ordinance, 2002 (CXXVIII of 2002), published in the 
Gazette of Pakistan (Extraordinary), dated:15 November 2002, pp 1984-1989, s.12. 
Laboratory 
37
[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 p erson from whom the s ample w as 
taken; 
(b) forward one copy to the warrantor, if any, named under the proviso to 
sub-section (3) of section 32; 
(c) forward one copy to the 
38
[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 force, any document purporting to be a report signed by a Government Analyst 
39
[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 
40
[ten days] of the 
receipt of a copy of the report notified in writing to the Inspector or 
41
[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 sub-section (4), notified his intention of 
adducing evidence in controversion of a 
42
[report of Government Analyst or of Notified 
Drugs Laboratory]  
43
[Provincial Quality Cont rol Board or, as the case may b e, 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 sub-section (3) of 
section 19 to be sent for test or analysis to the Federal Drug Laboratory or any other 
laboratory specified for the purpose by the Federal Government 
44
[or the Provincial 
Government] which shall make the test or analysis and report
 
in writing signed by, or 
                                                           
37Inserted by the Punjab Drugs (Amendment) Act, 2017 (V of 2017), published in the Punjab Gazette (Extraordinary) , dated: 13 
February 2017, pp.4519-4525, s.7. 
38Substituted for the words “Board concerned” by the Drugs (Amendment) Ordinance, 2002 (CXXVIII of 2002), published in the 
Gazette of Pakistan (Extraordinary), dated:15 November 2002, pp 1984-1989, s.12. 
39Inserted by the Punjab Drugs (Amendment) Act, 2017 (V of 2017), published in the Punjab Gazette (Extraordinary), dated: 13 
February 2017, pp.4519-4525, s.7. 
40Substituted for the words “thirty days” by the Punjab Drugs (Amendment) Act, 2017 (V of 2017), published  in the Punjab 
Gazette (Extraordinary), dated: 13 February 2017, pp.4519-4525, s.7. 
41Substituted 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, 200 2 (CXXVIII of 2002), published in the Gazette of Pakistan (Extraordinary), 
dated:15 November 2002, pp 1984-1989, s.12. 
42Substituted for the words “Government Analyst’s report” by the Punjab Drugs (Amendment) Act, 2017 (V of 2017), published in 
the Punjab Gazette (Extraordinary), dated: 13 February 2017, pp.4519-4525, s.7. 
43Substituted for the words “the Drug Court or the Board concerned” by the Drugs (Amendment) Ordinance, 2002 (CXXVIII of 
2002), published in the Gazette of Pakistan (Extraordinary), dated:15 November 2002, pp 1984-1989, s.12. 
44Inserted by the Punjab Drugs (Amendment) Act, 2017 (V of 2017), published in the Punjab Gazette (Extraordinary), dated: 13 
February 2017, pp.4519-4525, s.7. 
under the authority of, the person for the time being in charge of the Federal Drug 
Laboratory, or, as the case may b e, 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 l aboratory under sub-section (5) shall be paid by the complainant or 
accused as the Drug Court or the Board concerned shall direct. 
45
[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 
PROHIBITIONS 
23.  Import, manufacture and sale 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 the 
conditions of registration; 
(viii)  any d rug which, by m eans of any statement, design or device 
accompanying it or by any oth er 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 
                                                           
45Inserted by the Punjab Drugs (Amendment) Act, 2017 (V of 201 7), published in the Punjab Gazette (Extraordinary), dated: 13 
February 2017, pp.4519-4525, s.8. 
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 subst ance, 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 import 
subject to prescribed conditions, of small quantities of any d rug for the purpose of 
clinical trial, examination, test, analysis or personal use; 
46
[23A. Prohibition on aiding, abetment or association in contravention of the Act .– * 
 * * * * * * * * * * * *      * 
23B. Prohibition of acquisition and possession of assets der ived from contravention of 
the Act.– * * * * * * * * * * * *      * 
23C. Prohibition on owning, operating premises or machinery for manufacture of drugs, 
etc.– * * * * * * * * * * * *      ] 
24. Control of advertisement.– No person shall himself or by any other person 
on his b ehalf advertise, except in accordance with su ch conditions as m ay be 
prescribed,– 
(i) any drug; 
(ii) any substance used or prepared for use in accordance with the 
ayurvedic, un ani, homoeopathic or biochemic system of treatment or 
any other substance or mixture of substances as may be prescribed; 
                                                           
46Omitted by the Drugs (Punjab Amendment) Act 2018 (XVIII of 2018), published in the Punjab Gazette (Extraor dinary), dated: 
24 May 2018, pp. 8121-8123, s. 2. They were earlier inserted by the Punjab Drugs (Amendment) Act 2017 (V of 2017), published 
in the Punjab Gazette (Extraordinary), dated: 13 February 2017, pp. 4519-4525, s. 9. 
(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. 
25. Control of samplings.– No person shall distribute or cause to be distributed 
any d rug as a  sample except in accordance with su ch conditions as m ay be 
prescribed. 
26. Control of printing of labelling.– No person shall print any l abelling 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 do es not  possess a licence und er this Act to 
manufacture that drug. 
CHAPTER IV 
OFFENCES, PENALTIES AND PROCEDURE 
27. Penalties.– 
47
[(1) Whoever himself or by any other person on his behalf: 
48[(a) exports, imports, manufactures or sells any spurious drug or adulterated 
drug which causes death or physical disability or any drug which is not  
registered;] 
(b) manufactures for sale any drug without a licence; 
49[(c) * * * * * * * * * * *    ] 
(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 
                                                           
47Substituted by the Punjab Drugs (Amendment) Act, 2017 (V of 2017), published in t he Punjab Gazette (Extraordinary), dated: 
13 February 2017, pp.4519-4525, s.10. 
48Substituted by the Drugs (Punjab Amendment) Act 2018  (XVIII of 2018), published in the Punjab Gazette (Extraor dinary), 
dated: 24 May 2018, pp. 8121-8123, s. 3. 
49Omitted ibid. 
(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 punishable with imprisonment for a term which may extend to seven years,
 
50
[or with fine which may extend to one million rupees or with both]. 
(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 
51
[one year 52[or with 
fine which may extend to fifty thousand rupees or with both] ]. 
 
53
[(3a) Whoever is responsible for variation in the specification which is physical 
or chemically ten per cent different from the specification labeled on a drug , shall be  
punishable with imprisonment for a term which may  extend to five years or with fine 
which may extend to one hundred thousand rupees or with both. 
 (3b) Whoever is responsible for variation in the specification which is 
physically or chemically more than  ten per cent  but is not more than twenty per cent 
different from the specification labeled on a drug , shall be  punishable with 
imprisonment for a term which may  extend to five years or with fine which may extend  
to four hundred thousand rupees or with both. 
 (3c) Whoever is responsible for variation in the specification w hich is 
physically or chemically more than twenty per cent  but is not more than  fifty per cent 
different from the specification labeled on a drug, shall be  punishable with 
imprisonment for a term which may ex tend to five years  or with fine which may  extend 
to seven hundred thousand rupees or with both. 
 (3d) Whoever is responsible  for variation in the specification which is 
physically or chemically more than fifty per cent different from the specification  labeled 
on a drug,  shall be punishable with imprisonment for a term  which may extend  to five 
years or with fine which may extend to one million rupees  or which is three times  the 
value of the drug  taken into  custody, whichever  is higher, or with both and the 
manufacturing of the product  shall remain suspended till such  time that the 
responsibility for the lapse is fixed and remedial measures, taken.] 
 
54
[(4) Subject to the provisions of subsection (1),  subsection (2), subsection 
                                                           
50Substituted for the expression “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” by the Drugs (Punjab Amendment) Act 2018  (XVIII of 2018), published in 
the Punjab Gazette (Extraor dinary), dated: 24 May 2018, pp. 8121 -8123, s. 3. It was earlier substituted for the expression “or 
with fine which may extend to one lakh rupees, or with both” by the Punjab Drugs (Amendment) Act, 2017 (V of 2017), published 
in the Punjab Gazette (Extraordinary), dated: 13 February 2017, pp. 4519-4525, s. 10. 
51Substituted for the expression “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), publishe d in the Punjab Gazette (Extraordinary), dated: 13 February 2017, pp.4519 -
4525, s.10. 
52Substituted for the expression “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”  by the Drugs (Punjab Amendment) Act 2018  (XVIII of 
2018), published in the Punjab Gazette (Extraordinary), dated: 24 May 2018, pp. 8121-8123, s. 3. 
53Substituted ibid. They were earlier inserted by the Punjab Drugs (Amendment) Act,  2017 (V of 2017), published in the Punjab 
Gazette (Extraordinary), dated: 13 February 2017, pp. 4519-4525, s. 10. 
54Substituted ibid. It was earlier substituted by the Punjab Drugs (Amendment) Act, 2017 (V of 2017), published in the Punjab 
Gazette (Extraordinary), dated: 13 February 2017, pp. 4519-4525, s. 10. 
(3), subsection (3a), subsection (3b), subsection  (3c) and subsection (3d) , whoever 
himself or by any other person on his behalf contravenes any of the provisions of th e 
Act or the rules , shall be punishable with imprisonment for a term which may extend 
to five years and with fine which m ay extend to five hundred thousand rupees or with 
both.] 
55
[(5)  *  * * * * * * * * * *     ] 
56
[27A. False statement.– *  * * * * * * * *     ] 
28. Penalty for subsequent offence.– (1) Whoever having been convicted of 
an offence under sub-section (1) of section 27 is 
57
[convicted for a subsequent] 
offence under that sub-section shall be punishable with imprisonment for life or with 
imprisonment which shall not be less than 
58
[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 sub-section (2) of 
section 27 is  
59
[convicted for a sub sequent] offence und er that sub-section shall be 
punishable with imprisonment for a term 
60
[which may extend to ten years but 61[which 
shall not to be less than two years and with  fine which may extend to one and a half 
million rupees but which shall not be less than three hundred thousand rupees] ]. 
62
[(2a) Whoever having been convicted of an offence under subse ction (3a) , 
subsection (3b), subsection (3c)  and subsection (3d)  of section 27 , is convicted for a 
subsequent offence under any of those subsections shall, if the drug is not recalled as 
prescribed by the Provincial Government, be punishable with imprisonment for a term 
which shall extend to seven years but which shall not be less than two years and with 
fine which may extend to one and a half million rupees  but which shall not be less 
than five times the value of the drug taken into custody.] 
(3) Whoever having been convicted of an offence under sub-section (4) of 
section 27 is  
63
[convicted for a sub sequent] offence und er t hat sub-section shall be 
                                                           
55Omitted ibid. It was earlier inserted by the Punjab Drugs (Amendment) Act, 2017 (V of 2017), published in the Punjab Gazette 
(Extraordinary), dated: 13 February 2017, pp. 4519-4525, s. 10. 
56Omitted by the Drugs (Punjab Amendment) Act 2018  (XVIII of 2018), published in the Punjab Gazette (Extraor dinary), dated: 
24 May 2018, pp. 8121-8123, s. 4. It was earlier inserted by the Punjab Drugs (Amendment) Act, 2017 (V of 2017), published in 
the Punjab Gazette (Extraordinary), dated: 13 February 2017, pp. 4519-4525, s. 11. 
57Substituted for the words “again convicted of an” by the Drugs (Amendment) Ordinance, 2002 (CXXVIII of 2002), published in 
the Gazette of Pakistan (Extraordinary), dated:15 November 2002, pp 1984-1989, s.14. 
58Substituted for the expression “five years and with fine which may extend to two lakh rupees” by the Punjab Drugs 
(Amendment) Act, 2017 (V of 2017), published in the Punjab Gazette (Extraordinary), dated: 13 February 2017, pp.4519 -4525, 
s.12. 
59Substituted for the words “again convicted of an” by the Drugs (Amendment) Ordinance, 2002 (CXXVIII of 2002), published in 
the Gazette of Pakistan (Extraordinary), dated:15 November 2002, pp 1984-1989, s.14. 
60Substituted for the expression “which shall not to 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), published in the Punjab Gazette 
(Extraordinary), dated: 13 February 2017, pp.4519-4525, s.12. 
61Substituted for the expression “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” by the Drugs (Punjab Amendment) Act 2018  (XVIII of 2018), published in 
the Punjab Gazette (Extraordinary), dated: 24 May 2018, pp. 8121-8123, s. 5. 
62Substituted ibid. It was earlier inserted by the Punjab Drugs (Amendment) Act, 2017 (V of 2017), published in the Punjab 
Gazette (Extraordinary), dated: 13 February 2017, pp. 4519-4525, s. 12. 
63Substituted for the words “again convicted of an” by the Drugs (Amendment) Ordinance, 2002 (CXXVIII of 2002), published in 
the Gazette of Pakistan (Extraordinary), dated:15 November 2002, pp 1984-1989, s.14. 
punishable with imprisonment for a term which may extend to 
64
[ seven years but 
which shall not be less than thirt y days and with fine which may extend to one million 
rupees but which shall not be less than three hundred thousand rupees]. 
65[28A. Recall of drugs.– A person charged with the commission of an offence under 
subsection (3) of section 28, shall be deemed to have committed no offence when the 
drug which is subject of that offence, has not caused any death or physical disability 
and is recalled as prescribed by the Provincial Government.] 
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 whi ch the offence was committed or anything of a similar nature 
belonging to  or in the poss ession 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, v ehicles, v essels or conveyances m ay be disposed of  as th at 
Government may direct. 
(2) Without prejudice to the provisions of sub-section (1), where the Drug 
Court is s atisfied, on the application of an Inspector or otherwise, and after such 
inquiry as may be n ecessary, that a drug contravenes the provisions of this Act, the 
Drug Court may order that such drug be forfeited to the Federal Government or, as 
the case may be, the Provincial Government and, upon such order being made, such 
drug may be destroyed or otherwise disposed of as that Government may direct. 
(3) An Inspector shall release any drug or article seized by him under this 
Act when he is  satisfied that all the provisions of this Act and the rules with respect 
thereto have been complied with. 
30. Cognizance of o ffences.– (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 int erest so requires, the Federal Inspector 
                                                           
64Substituted for the expression “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” by the Drugs (Punjab Amendment) Act 2018  (XVIII of 2018), 
published in the Pu njab Gazette (Extraor dinary), dated: 24 May 2018, pp. 8121-8123, s. 5. It was earlier substituted 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), published in the Punjab Gazette (Extraordinary), dated: 13 February 2017, pp. 4519-4525, s. 12. 
65Inserted by the Drugs (Punjab Amendment) Act 2018  (XVIII of 2018), published in the Punjab Gazette (Extraor dinary), dated: 
24 May 2018, pp. 8121-8123, s. 6. 
may, with the prior permission of the Federal Government institute a prosecution for 
a contravention of any other provision of this Act. 
66
[(2) Notwithstanding anything contained in the Code of Criminal Procedure, 
1898 (V of 1898): 
(a) an offence punishable under subsection (1) of section 27 shall be 
cognizable and non-bailable; 
67[(b) * * * * * * * * * * *    ] 
(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 Ch apter s hall be deemed to  prevent any 
person from b eing prosecuted under any oth er law for any act or omission which 
constitutes an offence punishable under this Chapter or to require the transfer to a 
Drug Court of any case which may be pending in any Court immediately before the 
establishment of the Drug Court. 
31. Drug Courts.– (1) The 
68
[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. 
69[
70
[(2) A Drug Court shall consist of: 
 (a) a Chairperson who is or has be en 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.] 
                                                           
66Substituted by the Punjab Drugs (Amendment) Act, 2017 (V of 2017), published in the Punjab Gazette (Extraordinary), dated: 
13 February 2017, pp.4519-4525, s.13. 
67Omitted by the Drugs (Punjab Amendment) Act 2018 (XVIII of 2018), published in the Punjab Gazette (Ext raordinary), dated: 
24 May 2018, pp. 8121-8123, s. 7. 
68Substituted for the words “Federal Government” by the Punjab Drugs (Amendment) Act 2016 (XXXIII of 2016), published in the 
Punjab Gazette (Extraordinary), dated: 31 May 2015, p. 5559, s. 2. 
69 Substituted by the Punjab Drugs (Amendment) Act, 2017 (V of 2017), published in the Punjab Gazette (Extraordinary), dated: 
13 February 2017, pp.4519-4525, s.14. 
70Substituted by The Drugs (Amendment) Act, 2025 (XXXIV of 2025), published in the Punjab Gazette (Extraordinary), dated: 30 
May 2025, p.4763, s.2. 
 
71
[Provided that for deciding applications of bail the Chairman and any o ne 
member shall constitute full quorum of a Drug Court.] 
72[Provided that the Chairman and one of the members shall constitute quorum 
of a Drug Court for purposes of deciding all the matters under the Act other than the 
final hearing and decision of a case .] 
(3) A Drug Court shall sit at such place or places as the 
73
[ Provincial 
Government] may direct. 
(4) A D rug Cou rt shall h ave all the  powers conferred by the Code of 
Criminal Procedure, 1898 (Act V of 1898), on a Court of Session exercising original 
jurisdiction. 
(5) A Drug Court shall not, merely by reason of a change in its composition, 
be bound to recall and rehear any witness who has given evidence, and may act on 
the evidence already recorded by or produced before it. 
(6) A Drug Court shall, in all matters with respect to which no procedure has 
been p rescribed by this Act, follow the procedure prescribed by the Code of 
Criminal Procedure, 1898 (A ct V of  1898), for the trial of  summons cases by 
Magistrates. 
74
[(7) * * * * * * * * * * *
  
   ] 
 
75
[(8) * * * * * * * * * * *
  
   ] 
76
[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 cons isting 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 (IX of 
1908) shall be applicable to an appeal under this 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 t hat the accused was ignorant of the 
nature, subst ance 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 brought only for the purpose of test or analysis, has not been prejudiced by the 
                                                           
71 Added by the Drugs (Amendment) Ordinance, 2002 (CXXVIII of 2002), published in the Gazette of Pakistan (Extraordinary), 
dated: 15 November 2002, pp 1984-1989, s.15. 
 
72Added by the Drugs (Punjab Amendment) Act 2018 (XVIII of 2018), published in the Punjab Gazette (Extraordinary), dated: 24 
May 2018, pp. 8121-8123, s. 8. 
73Substituted for the words “Federal Government” by the Punjab Drugs (Amendment) Act 2016 (XXXIII of 2016), published in the 
Punjab Gazette (Extraordinary), dated: 31 May 2015, p. 5559, s. 2. 
74Omitted by the Punjab Drugs (Amendment) Act, 2017 (V of 2017), published in the Punjab Gazette (Extraordinary), dated: 13 
February 2017, pp.4519-4525, s.14. 
75Omitted by the Punjab Drugs (Amendment) Act, 2017 (V of 2017), published in the Punjab Gazette (Extraordinary), dated: 13 
February 2017, pp.4519-4525, s.14. 
76Inserted by the Punjab Drugs (Amendment) Act, 2017 (V of 2017), published in the Punjab Gazette (Extraordinary), dated: 13 
February 2017, pp.4519-4525, s.15. 
sale. 
(2) A drug shall not be deemed to be misbranded or adulterated or 
substandard only by reason of the  fact that th ere h as been added thereto some 
innocuous substance or ingredient because the same is required for the manufacture 
or preparation of the drug fit for carriage or consumption and not to increase the bulk, 
weight or measure of the drug or to conceal its inferior quality or other defect or there 
is a decomposed substance which is the result of a natural process of decomposition: 
Provided that such decomposition is not due to any negligence on the part of 
the manufacturer 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 kno w, and could not with reasonable diligence have 
ascertained, that the drug in any way contravened the prevision of this 
Act and th at the d rug while in  his possession remained in the s ame 
state as when, he acquired it; and 
(b) that he acquired the drug from a duly li censed 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, the 
batch number of the drug and signed by such person that the drug does 
not in any way contravene the provisions of section 23 and that the drug 
while in his possession was properly stored and remained in the same 
state as when he acquired it and that the drug has been manufactured 
by a  manufacturer holding a valid licence to m anufacture d rugs and 
permission to manufacture that drug: 
Provided that a defence under clause (b) shall be open to a person only– 
(i) if he has, within seven days of the service on him of the summons, 
sent to  the Inspector a copy of the warranty with a written notice 
stating that he intends to rely upon it and giving the name and address 
of the warrantor, and 
(ii) if he proves that he has, within the same period, sent written notice of 
such intention to the said warrantor. 
33. Application of law relating to customs and powers of officers of 
customs.– (1) The law for the time being in force relating to customs and to goods the 
import of which is prohibited by or under the Customs Act, 1969 (IV of 1969), shall, 
subject to the provisions of section 27 of this Act, apply in respect of drugs the import 
of which is prohibited under this Act, and officers of customs and officers to whom 
any of the functions of an officer of customs have been entrusted under the said Act 
shall have the same powers in respect of such drugs as they have for the time being 
in respect of such goods as aforesaid. 
(2) Without prejudice to the provisions of sub-section (1), an officer of 
customs or a Federal Inspector or any other p erson as may be authorised by the 
Federal Government in this b ehalf may detain any imported package which he 
suspects to contain any drug the import of whi ch 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 
77
[with whose knowledge 
or consent the offence was committed shall be guilty of the offence]. 
35. Publication of offender's name.– (1) If any person is convicted of an offence 
under this Act, it shall be lawful for the Drug Court to cause the offender's name, 
place of residence, the offence of which he has been convicted and the penalty 
which has been inflicted upon him, to be  published at the expense of such person in 
such newspapers or in such other manner as the Court may direct. 
(2) The expenses of such publication shall be recoverable in the same 
manner as a fine is recoverable. 
36. Powers to exempt.– Notwithstanding anything contained in this A ct, 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 d rug 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. 
37. Inspectors to be public servants.– Every Inspector shall be deemed to be a 
public servant within the meaning of section 21 of the Pakistan Penal Code (Act XLV 
of 1860), and sh all be officially subo rdinate to such authority as the Government 
appointing him may specify in this behalf. 
38. Indemnity.– Except as otherwise expressly p rovided in this A ct, no sui t, 
prosecution or other legal proceeding shall lie against Government or any other 
authority or p erson for anything which is in good faith done or intended to be done 
under this Act or any rule. 
39. Finality of orders, etc.– Save as otherwise expressly p rovided in this Act, 
every o rder 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. 
40. Publication of result of test or analysis, etc.– (1) It shall be lawful for the 
Federal Government to publish, in such manner as it may deem fit, the result of any 
test or analysis of any drug for public information and to pass such orders relating to 
the withdrawal of such drug from sale and its disposal as it may consider necessary. 
(2) The Federal Government may, if it considers it necessary in the public 
interest so to do, publish for public information, in such manner as it may deem fit, 
any information relating to a drug or to the use of a drug in specified circumstances. 
41. Cancellation or suspension of licences.– Where any person has been 
                                                           
77Substituted for the words and commas “shall, unless he proves that the offence was committed without his knowledge and 
consent, be guilty of the offence” by the Drugs (Amendment) Ordinance, 2002 (CXXVIII of 2002), published in the Gazette of 
Pakistan (Extraordinary), dated:15 November 2002, pp 1984-1989, s.16. 
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 su ch 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 o f being h eard, cancel the 
licence to import, export, manufacture or sell drugs issued to such person or suspend 
such licence for a specified period. 
78
[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 pe riod not exceeding 79[fifteen] 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 appropriate. 
(2) A copy of the order under subsection (1) shall immediately b e 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 th e 
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. 
(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.] 
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 oppo rtunity of  being heard, cancel the registration of such drug or 
suspend such registration for a specified period. 
                                                           
78Inserted by the Punjab Drugs (Amendment) Act, 2017 (V of 2017), published in the Punjab Gazette (Extraordinary), dated: 13 
February 2017, pp.4519-4525, s.16. 
79Substituted for the word “thi rty” by the Drugs (Punjab Amendment) Act 2018 (XVIII of 2018), published in the Punjab Gazette 
(Extraordinary), dated: 24 May 2018, pp. 8121-8123, s. 9. 
CHAPTER V 
MISCELLANEOUS 
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 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 oth er 
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 d rugs 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 n ecessary for any such l aboratory 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; p rohibit the import, manufacture, sale or stocking or  
exhibition for sale or distribution of any drug in which that proportion is 
exceeded and specify subst ances whi ch sh all be deemed to be 
poisonous; 
(d) specify the drugs or classes of drugs for the import or export of 
which a licence is required, the testing of such drugs, and prescribe the 
form and conditions of such licences, the authority empowered to 
issue the same, and the fees payable therefor; 
(e) prescribe the places at which any specific drug or drugs may be 
imported prohibit their import at any other place, and control their import 
through any specified agency; 
(f) prescribe the evidence to be supplied, whether by accompanying 
documents or otherwise, of the quality of drugs sought to be imported, 
the procedure of officers, of customs in dealing with such evidence and 
the manner of storage at places of  import of drugs detained pending 
admission; 
(g) prescribe the forms of licences for the manufacture for sale of drugs or 
any specified drugs or class of drugs, the form of application for such 
licences, the conditions subject to which such licence may be 
issued, the person under whose signature the same be issued and the 
fees payable therefor; 
(h) require the date of manufacture and the date of expiry of potency to be 
clearly and truly stated on the label and container of any specified drug 
or class of drugs and prohibit the sale, stocking or exhibition for sale or 
distribution of  the s aid 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 obs erved in the packing in bottle, 
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 therefore 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 m anner of  registration and pos t-registration surveillance 
and deregistration of registered drugs and the fees payable therefor; 
(q) prescribe conditions for registration of indentors, importers, wholesalers 
and dist ributors within Pakistan and any establishment within any 
foreign country engaged in the manufacture for export of a drug and 
prescribe conditions providing effective and adequate means, by 
arrangement with the Government of such foreign country or otherwise, 
to enable the licensing authority or the Registration Board to determine 
from time to time wh ether drugs manufactured in such establishment, if 
imported or offered for import into Pakistan, shall be refused admission 
where the public interest so requires; 
(r) prescribe the form of warranty for manufactured drugs; 
(s) specify offences in relation to which the stock of drugs, articles or things 
shall be liable to forfeiture under this Act; 
(t) prescribe the qualifications, and regulate the procedure for exercise of 
powers and performance of functions, of Federal Inspectors; 
(u) prescribe the laboratories to which the Federal Inspectors shall submit 
samples of drugs taken for the purpose of test and analysis and the form 
and procedure for submitting t he 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 m anufacture, 
production, pricing, keeping, movement and disposal of drugs and to fix 
prices, commissions, discount of the manufacturer, wholesaler, 
distributor, retailer or any oth er 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 whi ch small quantities of drugs may be 
imported or manufactured or exported for the p urpose of examination, 
test or analysis, clinical trial or personal use; and 
(y) prescribe any other matter which is to be, or may be, prescribed by the 
Federal Government. 
(3) The power to make rules conferred by this section shall, except on 
the first o ccasion of  the exercise thereof, be subj ect to the  condition of previous 
publication. 
80
[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 t o 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.] 
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 analyzing drugs 81[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 Gov ernment 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 82[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 of 
drugs 83[and Therapeutic goods]  shall be liable to confiscation and 
destruction under this Act; 
                                                           
80Inserted by the Punjab Drugs (Amendment) Act, 2017 (V of 2017), published in the Punjab Gazette (Extra ordinary), dated: 13 
February 2017, pp.4519-4525, s.17. 
81Inserted by the Drugs (Second Amendment) Act 2025 (CIII of 2025), published in the Punjab Gazette (Extraordinary), dated:18 
December 2025, pp. 3279-3280, s.3(a).   
82Inserted by the Drugs (Second Amendment) Act 2025 (CIII of 2025), published in the Punjab Gazette (Extraordinary), dated:18 
December 2025, pp. 3279-3280, s.3(b).    
83Inserted by the Drugs (Second Amendment) Act 2025 (CIII of 2025), published in the Punjab Gazette (Extraordinary), dated:18 
December 2025, pp. 3279-3280, s.3(c).    
(f) the forms of licences for the sale or distribution of drugs 84[and 
Therapeutic goods] or any specified drug or class of drugs, the authority 
empowered to issue the same, the form of applications for su ch 
licences, the fees payable therefor and the conditions subject to which 
such licences may be issued; 
(g) the p rocedure to be  followed by the Provincial Quality Control Board; 
and 
(h) any other m atter wh ich 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 o ccasion of the exercise thereof, be subject to the condition of previous 
publication. 
45. Repeal and Savings.– (1) The Drugs Act, 1940 (XXIII of 1940), the Drugs 
(Generic Names) Act, 1972 (XXIV of 1972), and the Drugs Ordinance, 1976 (IV of 
1976), are hereby repealed. 
(2) Notwithstanding the repeal of the Drugs Act, 1940 (XXIII of 1940), by 
sub-section (1),– 
(a) Any licence to manufacture for sale issued thereunder to any person, for 
the revalidation of which an application has already been made to the 
Central Licensing Board within the date specified by the  Federal 
Government shall continue to be  valid until  orders are p assed by the 
said Board in this behalf. 
(b) Any licence for import or export or sale of drugs issued thereunder to 
any p erson, shall, unless it expires earlier un der 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 impo rted or exported licences may 
continue to be issued under the rules framed under the Drugs Act, 1940, till the  
rules under this Act are framed or as the case may be, a date is fixed under sub-
section (6) of section 7 in respect of drugs in the finished form ready for use. 
                                                           
84Inserted by the Drugs (Second Amendment) Act 2025 (CIII of 2025), published in the Punjab Gazette (Extraordinary), dated:18 
December 2025, pp. 3279-3280, s.3(d).