Updated: Wednesday March 01, 2017/AlArbia'a
Jamada El Thaniah 03, 1438/Budhavara
Phalguna 10, 1938, at 06:09:08 AM
[1][1]The Drugs Act 1976
(Act XXXI of
1976)
[11th May 1976]
An Act
to regulate the import, export, manufacture, storage, distribution and sale of
drugs
WHEREAS it is expedient to regulate the
import, export, manufacture, storage, distribution and sale of drugs;
It is hereby enacted as follows:---
INTRODUCTORY
1.
Short title, extent and commencement.– (1)
This Act may be called the Drugs Act, 1976.
(2) It extends to the whole of
(3) It shall come into 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[2][2],
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 substance or which contains any foreign matter,
vermin, worm, rodent or insect; or
(ii) which has been manufactured, packed, or
held under unsanitary conditions whereby it [3][3][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
(v) with which any substance has been mixed or
packed so as to reduce its quality or strength or for which any substance has
been substituted wholly or in part;
(b) “Appellate Board” means the Board
constituted under section 9;
(c) “batch” means a quantity of any drug
produced during a given cycle of manufacture;
(d) “batch number” means a designation printed
on the label of a drug that identifies the batch and permits the production
history of the batch, including all stages of manufacture and control, to be
traced and reviewed;
(e) “Central Licensing Board” means a Board
set up under section 5;
(f ) “counterfeit drug” means a drug the label
or outer-packing of which is an imitation of, or resembles or so nearly
resembles as to be calculated to deceive, the label or outer-packing of a drug
of another manufacturer;
(g) “drug” includes,---
(i) any substance or mixture of substances
that is manufactured, sold, stored, offered for sale or represented for
internal or external use in the treatment, mitigation, prevention or diagnosis
of disease, an abnormal physical state, or the symptoms thereof in human beings
or animals, or the restoration, correction, or modification of organic
functions in human beings or animals, not being a substance exclusively used or
prepared for use in accordance with the ayurvedic, unani, homoeopathic or
biochemic system of treatment except those substances and in accordance with
such conditions as may be prescribed;
(ii) abortive and contraceptive substances,
agents and devices, surgical ligatures, sutures, bandages, absorbent cotton,
disinfectants, bacteriophages, adhesive plasters, gelatine capsules and
antiseptic solutions;
(iii) such substances intended to be used for the
destruction or repulsion of such vermin, insects, rodents and other organisms
as cause, carry or transmit disease in human beings or animals 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 monopraph or as
a preparation in the Pakistan Pharmacopoeia or the Pakistan National Formulary
or the International Pharmacopeia or the British Pharmacopoeia or the British
Pharmaceutical Codex or the United States Pharmacopoeia or the National
Formulary of the United States, whether alone or in combination with any
substance exclusively used in the unani, ayurvedic, homoeopathic or biochemic
system of treatment, and intended to be used for any of the purposes mentioned
in sub-clauses (i), (ii) and (iii); and
(vi) any other substance which the Federal
Government may, by notification in the official Gazette, declare to be a “drug”
for the purposes of this Act;
(h) “expiry date” means the date stated on the
label of a drug after which the drug is not expected to retain its claimed efficacy,
safety, quality or potency or after which it is not permissible to sell the
drug;
(i) “expert” means a specialist through
university education and experience in the relevant field;
(j) “export”, with its grammatical variations
and cognate expressions, means to take out of
(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
(n) “Inspector” means a Federal Inspector or a
Provincial Inspector appointed under section 17;
(o) “label” means a display of written, printed
or graphic matter upon the immediate container, or the outside container or
wrapper of a drug package;
(p) “labelling” means all labels and other
written, printed or graphic matter accompanying any drug;
(q) “licensing authority” means such authority
as may be prescribed;
(r) “manufacture”, in relation to a drug,
means all operations involved in the production of the drug, including
processing, compounding, formulating, filling, packing, repacking, altering,
ornamenting, finishing and labelling with a view to its storage, sale and
distribution, but does not include the compounding and dispensing or the
packing of any drug in the ordinary course of retail business or on a
prescription of a registered medical practitioner or dentist or of a
veterinarian and “to manufacture” shall be construed accordingly;
(s) “misbranded drug” means a drug,---
(i) which is not labelled in the prescribed
manner; or
(ii) on the label or labelling of which any
word, statement, or other matter or information required by the rules to appear
on the label or labeling is not prominently placed with such conspicuousness
(as compared with other words, statements, designs, or devices on the label or
labelling) and in such terms as may render it likely to be read and understood
by the ordinary individual under customary conditions of purchase and use; or
(iii) which is not labelled with such directions
for use and such warnings against use in indications where its use may be
dangerous to health, or against unsafe dosage or duration of administration or
application, in such manner and form as are necessary for the protection of
users or as may be prescribed ; or
(iv) the label or container of which, or anything
accompanying which, bears any statement, design or device which makes any false
claim for the drug or which is false or misleading in any particular; or
(v) which is so coloured, coated, powdered or
polished that damage is concealed, or which is made to appear of better or
greater therapeutic value than it really is; or
(vi) which is manufactured according to the
specifications of a particular pharmacopoeia or any other document as may be
prescribed and the label does not bear the name of that pharmacopoeia or
document;
[4][4][(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;
[5][5][(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) “
(z) “specifications” when applied to a drug
mean-
(i) such specifications as may be prescribed; or
(ii) when the specifications are not prescribed,
the specifications as contained in the most recent edition of any of the
following publications, namely:---
(1) the
(2) the International Pharmacopoeia;
(3) the European Pharmacopoeia;
(4) the
(5) the British Pharmacopoeia;
(6) the British Pharmaceutical Codex;
(7) the
(8) such other publication as may be prescribed:---
Provided that, if the
specifications do not appear in the most recent edition of any such
publication, the specifications appearing in the next preceding edition of such
publication in which the specifications appear shall apply; or
(iii) if no specifications are either prescribed or
contained, in any of the publications referred to in sub-clause (ii), the
specification approved for the purpose of registration under this Act;
(za) “sell” means sell, offer for sale, expose for sale, have in
possession for sale and distribution and “to sell”, “sold” or “sale” shall be
construed accordingly;
(zb) “spurious drug” means a drug,---
(i) which purports to be a drug but does not
contain the active ingredient of that drug;
(ii) which purports to be the product of a
manufacturers, place or country of whom or of which is not truly a product; or
(iii) which is imported or exported or sold or
offered or exposed for sale under a particular name while actually it is
another drug; or
(iv) the label of which bears the name of an individual or
company purporting to be its manufacturer or producer which individual or
company is fictitious or does not exist;
(zc) “storage” means storage for sale and “to store” or “stored”
shall be construed accordingly;
[6][6][(zd) “sub-standard
drug” means a drug which is not of specifications; and
(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
(2) If in the opinion of the Federal
Government the public interest so requires, the Federal Government may, by
notification in the official Gazette,---
(a) direct that a drug or a class of drugs
specified in the notification, or drugs generally, shall not be imported or
exported otherwise than under the authority of a licence issued under this Act
or except by an importer or exporter or through an indentor registered in
accordance with the rules;
(b) direct that a drug or class of drugs
specified in the notification shall not be imported except by an agency of
Government so specified; or
(c) prohibit the import or export of any drug or
class of drugs specified in the notification.
[7][7][(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.]
(2) The members of the Central Licensing
Board shall exercise such powers, including the powers of an Inspector, as may
be prescribed.
(3) The Central Licensing Board shall [8][8][,with
the approval of the Federal Government and by notification in the official Gazette,]
make regulations to regulate the conduct of its business.
(4) Any member of the Central Licensing
Board may, at any time, by writing under his hand addressed to the Federal
Government, resign his office or shall vacate his office if the Federal Government,
being of opinion that in the public interest it is necessary so to do, so
directs.
(5) Subject to subsection (4), a member of
the Central Licensing Board shall hold office for the prescribed period.
Explanation: In this section, “drugs”
means drugs which are in the finished form ready for use.
(2) The members of the Registration Board
shall exercise such powers, including the powers of an Inspector, as may be
prescribed.
(3) The Registration Board shall [9][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 Registration Board
may, at any time, by writing under his hand addressed to the Federal
Government, resign his office or shall vacate his office if the Federal
Government, being of opinion that in the public interest it is necessary so to
do, so directs.
(5) Subject to subsection (4), the members
of the Registration Board shall hold office for the prescribed period.
(6) The Federal Government shall, by
notification in the official Gazette, fix the date after which no drug which is
not registered shall be allowed to be exported, imported, manufactured, stored,
distributed or sold.
(7) A person applying for the registration
of a drug shall furnish such information in respect of the drug as may be
prescribed, including information relating to its efficacy, safety and quality,
or as may be required by the Registration Board for the purpose of the
evaluation of the drug.
(8) Single-ingredient drugs shall be
registered generally by their generic names while compound drugs shall be
registered generally by their proprietary names.
Explanation.- In this subsection,-
(a) “Single-ingredient drugs” means drugs containing one active
ingredient;
(b) “compound drugs” means drugs containing more than one active
ingredient.
[10][10][(9)
The registration of a drug shall be subject to such conditions as may be
prescribed.]
(10) Where the Registration Board
registers a drug, it shall inform the person applying for its registration and
the Provincial Governments of its having done so and of the conditions subject
to which it has been registered.
(11) If the Registration Board, on the
basis of information received or an inquiry conducted by it, is of opinion that,---
(a) the
registration of a drug was procured by fraud or misrepresentation; or
(b) the
circumstances in which a drug was registered no longer exist; or
(c) there
has been a violation of the conditions subject to which a drug was registered;
or
(d) it
is necessary in the public interest so to do;
the Registration Board may, after
affording to the person on whose application the drug was registered an
opportunity of showing cause against the action proposed to be taken, cancel or
suspend the registration or specify any further conditions to which the
registration shall be subject and inform such person and the Provincial
Governments accordingly.
(12) The Provincial Governments shall take
all such steps as may be necessary to ensure compliance with the conditions
subject to which a drug is registered and to prevent the manufacture or sale of
a drug,---
(a) which
has not been registered; or
(b) the
registration of which has been cancelled or stands suspended.
9. Appellate Board.–
(1) The Federal Government shall, in accordance with the rules, constitute an
Appellate Board for the disposal of appeals preferred by persons aggrieved by
any decision of the Central Licensing Board or the Registration Board or the
licensing authority or a Board or Authority to which the powers of the Federal Government under section 12 have been
delegated under sub-section (3) of that section and for revision of any such
decision on its own motion.
(2) The Appellate Board shall consist of
such representatives of the Federal Government and the Provincial Governments,
including a Chairman, as the Federal Government may from time to time appoint.
(3) Subject to sub-section (4), the Chairman
and other members of the Appellate Board shall hold office for the prescribed
period.
(4) The Chairman or any other member of
the Appellate Board may, by writing under his hand addressed to the Federal
Government, resign his office or shall vacate his office if the Federal
Government, being of opinion that in the public interest it is necessary so to
do, so directs.
(5) The members of the Appellate Board
shall exercise such powers, including the powers of an Inspector, as may be
prescribed.
(6) The Appellate Board may appoint
experts for the purposes of detailed study of any specific matter before it.
(7) The Appellate Board shall [11][11][,
with the approval of the Federal Government and by notification in the official
Gazette,] make regulations to regulate the conduct of its business.
[12][12][(8)
The Appellate Board shall meet at least every month and shall decide any appeal
preferred to it within sixty days of receipt of appeal unless the Board is
prevented from doing so for sufficient cause to be recorded.]
[13][13][9A.
Appeals to the Provincial Appellate Authority.– (1) Any person
aggrieved by any decision of the licensing authority may prefer appeal to the
Provincial Appellate Authority.
(2) The Provincial Government shall
constitute a Provincial Appellate Authority for the disposal of appeal
preferred under sub-section (1) as may be prescribed.]
(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.
(2) The Chairman and other members of the
Provincial Quality Control Board shall hold office during the pleasure of the
Provincial Government, on such terms and conditions as that Government may
determine.
(3) The Provincial Government shall
appoint a person to be the Secretary of the Provincial Quality Control Board
and provide the Board with such staff as the Provincial Government may consider
necessary.
(4) Provincial Quality Control Board shall
[14][14][,
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 premises where any drug is being, or is to be, manufactured or sold
and to recommend to the appropriate authority the cancellation or suspension of
the licence to manufacture or sell drugs granted to any person who is found to
be contravening, or to have contravened, any of the provisions of this Act, or
the rules;
(b) to
scrutinize the reports of Provincial Inspectors in respect of contraventions of
this Act and reports of Government Analysts in respect of drugs sent to them by
Provincial Inspectors for test and 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 of cases in which a Provincial Inspector
may make a complaint to the
(c) to
exercise all the powers of an Inspector under this Act and the rules; [15][15][*]
(d) to
advise the Provincial Government on ways and means to ensure quality control of
drugs manufactured in the Province [16][16][;]
[17][17][(e)
to ascertain the names of such directors, partners and employees of the
company, corporation, firm or institution who are prima facie responsible for
the commission of any offence under this Act or the rules and allow an
Inspector to institute prosecution only against such persons;
(f) to
conduct annual validation of all instruments in the provincial drug testing
laboratories and to recommend measures to upgrade such laboratories, if
required;
(g) identify
and accredit on payment of fee other laboratories in the Province with suitable
facilities and expertise;
(h) to
conduct training programs to update Government Analysts and for improving their
knowledge according to latest analytical method and technology; [18][18][*]
[19][19][(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]]
[20][20][(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.
[21][21][(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.]
[22][22][11A.
Conflict of interest.– No person who is a member of the
Appellate Board,
Central Licensing Board, a Provincial Quality Board, the Registration Board or
a member of Expert Committee shall be a member of the any other board or
committee of which he is a member to avoid any conflict of interest.]
[23][23][11B. Provincial
Drugs Monitoring Teams.– (1) The Provincial Government may, by notification, constitute
one or more Provincial Drugs Monitoring Team consisting of the Chairperson and
members including at least two professional members on such terms and
conditions as the Provincial Government may determine.
(2) The Chairperson
and members of the Provincial Drugs Monitoring Team shall hold office during the pleasure of the Provincial Government.
(3) The Provincial Drugs
Monitoring Team shall, 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 premises where any
drug 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 Act
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.
(2) No person shall be engaged as consultant
unless he is qualified to be appointed as an Inspector or Government Analyst
and is an expert in the relevant field and no firm shall be so engaged unless
it has inhouse capacity for the task and has in its service persons who are
qualified to be appointed as Inspectors or Government Analysts and are experts
in the relevant field.
(3) The
consultant or the firm of consultants shall submit the report to the Provincial
Quality Control Board within the specified time and the Board shall take
necessary action on the report in accordance with law.
(4) For purposes of inspection and
evaluation, the consultant or the experts engaged by the firm of consultants
shall have the powers of an Inspector.]
(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
utilized, in accordance with rules for purposes of research in drugs.
(2) For the purposes of the exercise of
its powers under sub-section (1), the Federal Government may require a
manufacturer, stockist, importer, exporter, retailer or other dealer in drugs
to furnish such relevant information as may be necessary.
(3) The Federal Government may, by
notification in the official Gazette, delegate any of its powers under this
section to any Board or other authority.
[24][24][15. Provincial
Drugs Testing Laboratory.–
(1) The Provincial Government shall, as soon as may be, set up one or more
Provincial Drugs Testing Laboratory for such purposes as may be prescribed.
(2) The Provincial Government may, by notification, engage or
authorize a reputed drugs testing laboratory, within the country or abroad, for
test and analysis of the drug samples.]
16. Government Analysts.–
The Federal Government or Provincial Government may, by notification in the
official Gazette, appoint such persons as it thinks fit, having the prescribed
qualifications, to be the Federal Government Analysts or, as the case may be,
Provincial Government Analysts, for such areas and in respect of such drugs or
classes of drugs as may be specified in the notification:---
Provided that no person who
has any financial interest in the manufacture, import, export or sale of drugs
shall be so appointed:---
Provided further that a
person serving under the Federal Government or another Provincial Government
shall not be so appointed without the previous consent of that Government.
Provided that no person who
has any financial interest in the manufacture, import, export or sale of any
drug shall be so appointed:---
Provided further that a
person serving under the Federal Government or another Provincial Government
shall not be so appointed without the previous consent of such Government.
(a) inspect
any premises wherein any drug is manufactured, the plant and process of
manufacture, the means employed for standardizing and testing the drugs and all
relevant records and registers;
(b) inspect
any premises wherein any drug is sold or is stocked or exhibited for sale or is
distributed; the storage arrangements and all relevant records and registers;
(c) take
samples of any drug which is being manufactured, or being sold or is stocked or
exhibited for sale or is being distributed;
(d) enter
and search, with such assistance, if any, as he considers necessary, any
building, vessel or place, in which he has reason to believe that an offence
under this Act or any rules has been or is being committed or may continue to
be committed;
(e) call
any person to be present as witness in the course of search or seizure or in
connection with any other matter where the presence of witnesses is necessary;
(f) seize
such drug and all materials used in the manufacture thereof and any other
articles, including registers, cash-memos, invoices and bills, which he has
reason to believe may furnish evidence of the commission of an offence
punishable under this Act or any rules [25][25][:]
[26][26][Provided that where the contravention is
such which can be remedied, the stocks shall not be seized upon undertaking in
writing of the person not to sell drug without remedying the defect, under
intimation to the Board concerned;]
(g) require
any person to appear before him at any reasonable time and place to give
statement, assistance or information relating to or in connection with the
investigation of an offence under this Act or the rules:
Provided that the exemptions under
sections 132 and 133 of the Code of Civil Procedure, 1908[27][27], 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][28][two] weeks or such further period, which
shall not be more than three months, as the Inspector may, with the approval of
the Provincial Quality Control Board, the Central Licensing Board, the
Registration Board or the licensing authority, as the case may be, specify, any
person in charge of any premises from removing or dispensing of any drug,
article or other thing likely to be used in evidence of the communication of an
offence under this Act or the rules; and
(j) exercise
such other powers as may be necessary for carrying out the purposes of this Act
or any rules:---
Provided that the powers under clauses (f)
to (j) shall be exerciseable only by an Inspector specifically authorised in
this behalf, by an order in writing, by the Government appointing him, subject
to such conditions as may be specified in such order [29][29][.]
[30][30][* * * * * * ]
(2) The provisions of the Code of Criminal
Procedure 1898[31][31], in so far as they are not inconsistent
with the provisions of this Act, shall apply to searches and seizures made
under this Act.
(2) Where an Inspector takes a sample of a
drug for the purpose of test or analysis, he shall intimate such purpose in
writing in the prescribed form to the person from whom he takes it and, in the
presence of such person unless he wilfully absents himself, shall divide the
sample into [32][32][five]
portions and effectively seal and suitably mark the game and permit such person
to add his own seal, if any, and mark to all or any of the portions so sealed
and marked:---
Provided that, where the
sample is taken from premises whereon the drug is being manufactured, it shall
be necessary to divide the sample into three portions only:---
Provided further that, where
the drug is made up in containers of small volume, instead of dividing a sample
as aforesaid, the Inspector may, and if the drug be such that it is likely to
deteriorate or be otherwise damaged by exposure shall, take three or four, as
the case may be, of the said containers after suitably marking the same and,
where necessary, sealing them:---
Provided further that if the
contents of one container are insufficient for the laboratory test and
analysis, the Inspector may increase the number of the containers in order to
make the sample sufficient for this purpose.
(3) The Inspector shall restore one
portion of a sample so divided or one container, as the case may be, to the
person from whom he takes it, and shall retain the remainder and dispose of the
same within seven days as follows:---
[33][33][(i) one portion or sample he shall send to
the Government Analyst or, if so specified by the Provincial Quality Control
Board, to the Board for sending it to the Notified Drugs Laboratory;]
(ii) the second he shall send to the Chairman, Provincial Quality
Control Board or the Central Licensing Board or the Registration Board, as the
case may be;[34][34][
* * * * *]
(iii) the third, where taken, he shall send to the
warrantor, if any, named under the proviso to sub-section (3) of section 32 [35][35][;
and]
[36][36][(iv) the fourth, where taken, he
shall send to the person purporting to be its manufacturer or importer, as the
case may be.]
(4) Where an Inspector seizes any drug
containing any filthy or putrid substance, vermin, worm, rodent, insect or any
foreign matter which is visible to the naked eye, and the sample is such that
it cannot or need not be divided, he shall effectively seal and suitably mark the
same and permit the person from whom he seizes the drug to add his own seal if
any, and mark to it and shall produce the same before the Drug Court or the
Central Licensing Board or the Registration Board, as the case may be, before
which proceedings are instituted or action is initiated in respect of the drug.
(5) Where an Inspector takes any action
under section 18,---
(a) he
shall as soon as practicable ascertain whether or not the drug contravenes any
of the provisions of this Act and, if it is ascertained that the drug does not
so contravene, he shall forthwith revoke the order passed under the said
section or, as the case may be, take such action as may be necessary for the
return of the stock seized and payment for the samples taken, under intimation
to the Board concerned;
(b) if
he seizes the stock of the drug, he shall, as soon as may be, inform 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.
(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 [37][37][Central
Licensing Board or, as the case may be, the Registration Board or the
Provincial Quality Control Board] who shall have the sample tested from the
same or any other Government Analyst or a Government Drug Testing Laboratory or
any other laboratory [38][38][or
the Notified Drugs Laboratory] and shall ensure the
receipt of results of such test and analysis within a further period as may be
prescribed and shall make the test report available to the Inspector for
further action.
(3) On receipt of the report, the
Inspector shall,---
(a) deliver one copy thereof to the person from whom the sample was
taken;
(a) forward
one copy to the warrantor, if any, named under the proviso to subsection (3) of
section 32;
(c) forward
one copy to the [39][39][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 [40][40][or
the Notified Drugs Laboratory] shall be admissible as
evidence of the facts stated therein without formal proof and such evidence
shall be conclusive unless the person from whom the sample was taken or the
said warrantor has, within thirty days of the receipt of a copy of the report
notified in writing to the Inspector or [41][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 subsection
(4), notified his intention of adducing evidence in controversion of a [42][42][report
of Government Analyst or of Notified Drugs Laboratory],
[43][43][Provincial
Quality Control Board or, as the case may be, the Central Licensing Board or
the Registration Board or the Drug Court] may, of its own motion or in its
discretion at the request either of the complainant or the accused, cause the
sample of the drug lying with the Board concerned under subsection (3) of
section 19 to be sent for test or analysis to the Federal Drug Laboratory or
any other laboratory specified for the purpose by the Federal Government [44][44][or the Provincial Government] which shall
make the test or analysis and report in writing signed by, or under the
authority of, the person for the time being incharge of the Federal Drug
Laboratory, or, as the case may be, such other laboratory, the result thereof
and such report shall be conclusive evidence of the facts stated therein.
(6) The cost of a test or analysis made by
the Federal Drug Laboratory or other laboratory under subsection (5) shall be
paid by the complainant or accused as the
[45][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 drug which, by means of any statement,
design or device accompanying it or by any other means, purports or claims to
cure or mitigate any such disease or ailment, or to have any such other effect,
as may be prescribed;
(ix) any drug if it is dangerous to health when
used in the dosage or with the frequency, or for the duration specified,
recommended or suggested in the labelling thereof; or
(x) any drug in contravention of any of the
provisions of this Act or any rule;
(b) manufacture for sale any drug except under,
and in accordance with the conditions of, a licence issued under this Act;
(c) sell any drug except under, and in
accordance with the conditions of, a licence issued under this Act;
(d) import or export any drug the import or
export of which is prohibited by or under this Act;
(e) import or export any drug for the import or
export of which a licence is required, except under, and in accordance with the
conditions of, such licence;
(f) supply an incorrect, incomplete or
misleading information, when required to furnish any information under this Act
or the rules;
(g) peddle, hawk or offer for sale any drug in a
park or public street or on a highway, footpath or public transport or
conveyance;
(h) import, manufacture for sale, or sell any
substance, or mixture of substances, which is not a drug but is presented in a
form or manner which is intended or likely to cause the public to believe it to
be a drug;
(i) sell any drug without having a warranty in
the prescribed form bearing the name and batch number of the drug issued,---
(i) in the case of a drug manufactured in
(ii) in the case of an imported drug, by the manufacturer or importer
of that drug or, if the drug is imported through an indentor by such indentor;
and
(j) apply
an incorrect batch number to a drug.
(2) Nothing in sub-section (1) shall apply
to the manufacture or subject to prescribed conditions, of small quantities of
any drug for the purpose of clinical trial, examination, test, analysis or
personal use.
[46][46][23A. Prohibition on aiding, abetment or
association in contravention of the Act.– No one shall participate in, associate
or conspire to commit, or attempt to commit, aid, abet, facilitate, incite,
induce or counsel the commission of an offence punishable under this Act.
23B.
Prohibition of acquisition and possession of assets derived from contravention
of the Act.– No person shall
knowingly:---
(a) possess, acquire, use, convert, assign or
transfer any assets which have been derived, generated or obtained, directly or
indirectly, either in his own name or in the name of his associates, relative or
any other person through an act or omission which contravenes any of the
prohibitions contained in section 23 of this Act;
(b) hold or possess on behalf of any other person
any assets referred to in clause (a); and
(c) conceal or disguise the true nature, source,
location, disposition, movement, title or ownership of such assets by making
false declaration in relation thereto.
23C.
Prohibition on owning, operating premises or machinery for manufacture of
drugs, etc.– No one shall own,
manage, operate or control any premises, place, equipment or machinery for
purposes of manufacture of any drugs save in accordance with the conditions of
a valid and extant licence issued by the Licensing Authority.]
(i) any drug;
(ii) any substance used or prepared for use in accordance with the
ayurvedic, unani, homoepathie or biochemic system of treatment or any other
substance or mixture of substances as may be prescribed;
(iii) any remedy, treatment or offer of a treatment
for any disease.
Explanation.– In this section,
“advertise” means to make any representation by any means whatsoever for the
purpose of promoting directly or indirectly the sale or disposal of a drug, a
substance or a mixture of substances, a remedy or a treatment except the
display of sign boards for a clinic, a dispensary or a hospital or such other
institution offering treatment.
26. Control of
printing of labelling.– No
person shall print any labelling in respect of any drug which is required to be
registered under this Act but is not so registered after the date fixed by the
Federal Government under sub-section (6) of section 7 or for a person who does
not possess a licence under this Act to manufacture that drug.
CHAPTER IV
OFFENCES, PENALTIES AND PROCEDURE
27. Penalties.– [47][47][(1) Whoever
himself or by any other person on his behalf:---
(a) exports,
imports, manufactures or sells any spurious drug or adulterated drug or any
drug which is not registered;
(b) manufactures
for sale any drug without a licence;
(c) manufactures,
transports or sells a temperature sensitive drug in conditions which are likely
to cause the drug to lose its potency; or
(d) imports
without licence any drug for the import of which a licence is required,---
shall be
punished with imprisonment which may extend to ten years but which shall not be
less than three years and with fine which may extend to fifty million rupees
but which shall not be less than twenty five million rupees.]
(2) Whoever himself or by any other person
on his behalf,---
(a) imports, manufactures for sale or sells any
counterfeit drug; or
(b) gives to the purchaser a false warranty in
respect of any drug sold by him that the drug does not in any way contravene
the provisions of section 23 and is not able to prove that, when he gave the
warranty, he had good and sufficient reason to believe the same to be true; or
(c) applies or permits to be applied to any drug
sold, or stocked or exhibited for sale, by him, whether on the container or a
label or in any other manner, a warranty given in respect of any other drug; or
(d) imports, manufactures for sale or sells any
drug under a name other than the registered name; or
(e) exports, imports, manufactures for sale or
sells any drug with which any substance, which should not actually be its
component, has been mixed or packed so as to reduce its quality or strength or
for which any such substance has been substituted wholly or in part;
shall be punishable with imprisonment for
a term which may extend to seven years, [48][48][but which shall not be less than two years and with
fine which may extend to ten million rupees but which shall not be less than
three million rupees].
(3) Whoever obstructs an Inspector in the
exercise of any power conferred upon him by or under this Act, or disobeys the
lawful authority of any Inspector, shall be punishable with imprisonment for a
term which may extend to [49][49][one year but which shall not be less than fourteen
days and with fine which may extend to one million rupees but which shall not
be less than five hundred thousand rupees].
[50][50][(3a) Whoever
himself or by any other person on his behalf, exports, imports, manufactures
for sale or sells any substandard drug shall be punishable with imprisonment for
a term which may extend to five years but which shall not be less than six
months and with fine which may extend to fifty million rupees but which shall
not be less than ten million rupees.”;
(3b) Whoever
himself or by any other person contravenes the provisions of section 23B shall
be punishable with imprisonment which may extend to ten years but which shall
not be less than three years and with fine which shall not be less than the
prevailing value of the assets and such assets shall also be liable to forfeiture
to the Provincial Government.
(3c) Whoever
himself or by any other person contravenes the provisions of section 23C shall
be punishable with imprisonment which may extend to fourteen years but which
shall not be less than five years and with fine which shall not be less than
the prevailing value of the assets and such assets shall also be liable to
forfeiture to the Provincial Government.]
[51][51][(4)
Subject to the provisions of
subsections (1), (2), (3), (3a), (3b) and (3c), whoever himself or by any other
person on his behalf contravenes any of the provisions of this Act or the rules
shall be punishable with imprisonment for a term which may extend to five years
but which shall not be less than thirty days and with fine which may extend to
five million rupees but which shall not be less than five hundred thousand
rupees.]
[52][52][(5) If a Provincial Inspector or an official of the
Provincial Drugs Testing Laboratory:---
(a) is guilty of any willful breach or
neglect of any provisions of the Act or the rules or any order which he is
bound to observe and obey;
(b) is guilty of dereliction of duty;
(c) extends any assistance to any person in
contravention of the Act or the rules; or
(d) abets the contravention of any provisions of the
Act or the rules,---
shall, without prejudice to any other action in
accordance with law, be liable to imprisonment for a term which may extend to
three years but which shall not be less than six months and with fine which may
extend to one million rupees but which shall not be less than one hundred
thousand rupees.]
[53][53][27A. False
statement.– When any
person is required under this Act to prepare a report, make a statement or
furnish an information, prepares the report or makes the statement or furnishes
the information which is false in any material particular and which he knows or
has reasonable cause to believe to be false, or does not believe to be true,
shall be punishable with imprisonment for a term which may extend to three
years but which shall not be less than six months and with fine which may
extend to one million rupees but which shall not be less than one hundred
thousand rupees.]
28. Penalty for
subsequent offence.– (1) Whoever having been convicted of an offence under
sub-section (1) of section 27 is [54][54][convicted
for a subsequent] offence under that subsection shall be punishable with
imprisonment for life or with imprisonment which shall not be less than [55][55][ten years and
with fine which may extend to one hundred million rupees but which shall not be
less than fifty million rupees].
(2)
Whoever having been convicted of an offence under subsection (2) of section 27
is [56][56][convicted for a subsequent] offence under
that subsection shall be punishable with imprisonment for a term [57][57][which may extend
to ten years but which shall not be less than five years and with fine which
may extend to seventy million rupees but which shall not be less than thirty
million rupees].
[58][58][(2a) Whoever having been convicted of an
offence under subsection (3a) of section 27 is convicted for a subsequent
offence under that subsection shall be punishable with imprisonment for a term
which may extend to seven years but which shall not be less than two years and
with fine which may extend to seventy five million rupees but which shall not
be less than twenty five million rupees.]
(3)
Whoever having been convicted of an offence under sub-section (4) of section 27
is [59][59][convicted for a subsequent] offence under
that subsection shall be punishable with imprisonment for a term which may
extend to [60][60][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].
(2)
Without prejudice to the provisions of sub-section (1), where the Drug Court is
satisfied, on the application of an Inspector or otherwise, and after such
inquiry as may be necessary, that a drug contravenes the provisions of this Act, the Drug Court may order that such
drug be forfeited to the Federal Government or, as the case may be, the
Provincial Government and, upon such order being made, such drug may be
destroyed or otherwise disposed of as that Government may direct.
(3)
An Inspector shall release any drug or article seized by him under this Act
when he is satisfied that all the provisions of this Act and the rules with
respect thereto have been complied with.
(a) by a Federal
Inspector, where the prosecution is in respect of a contravention of clause (h)
of sub-section (1) of section 23 or section 24 or any of the provisions of this
Act or the rules relating to the import or export of drugs or the manufacture
for sale, or sale, of a drug which is not for the time being registered or for
the manufacture for sale of which a licence is not for the time being in force;
or
(b) by a Provincial
Inspector:---
Provided that, where the public interest so requires, the Federal
Inspector may, with the prior permission of the Federal Government, institute a
prosecution for a contravention of any other provision of this Act.
[61][61][(2) Notwithstanding anything contained in the Code of
Criminal Procedure, 1898[62][62]:---
(a) an offence punishable under subsection (1)
of section 27 shall be cognizable and non-bailable;
(b) an offence other than the offence mentioned
in subsection (1) of section 27, shall be cognizable on the complaint of the
Provincial Quality Control Board or the Provincial Drugs Monitoring Team; and
(c) all offences under the Act shall be
non-bailable.
(2a) No court other than a
(3) Nothing contained in this Chapter
shall be deemed to prevent any person from being prosecuted under any other law
for any act or omission which constitutes an offence punishable under this
Chapter or to require the transfer to a Drug Court of any case which may be
pending in any court immediately before the establishment of the
31. Drug Courts.–
(1) The [63][63][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.
[64][64][(2) A Drug Court shall consist of the Chairperson who
is or has been, or is qualified for appointment as a Judge of High Court, and
one full-time member who is an expert in the medical field and another
full-time member who is an expert in pharmaceutical field.]
(6) A Drug Court shall, in all matters
with respect to which no procedure has been prescribed by this Act, follow the
procedure prescribed by the Code of Criminal Procedure, 1898[67][67], for the trial of summons cases by
Magistrates.
[68][68][* * * *]
[69][69][31A. Appeal.– (1) The Provincial Government
or the person sentenced by a Drug Court may, within sixty days, file an appeal
against the final order of the Drug Court to Lahore High Court and the appeal
shall be heard by a Bench of that Court consisting of not less than two Judges.
(2) The
(3) The
provisions of sections 5 and 12 of the Limitation Act, 1908[70][70]
shall be applicable to an appeal under this section.]
(2) A drug shall not be deemed to be
misbranded or adulterated or substandard only by reason of the fact that there
has been added thereto some innocuous substance or ingredient because the same
is required for the manufacture or preparation of the drug 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 know, and could not with
reasonable diligence have ascertained, that the drug in any way contravened the
provision of this Act and that the drug while in his possession remained in the
same state as when he acquired it; and
(b) that he acquired the drug from a duly
licensed manufacturer or his authorised agent or an importer or an indentor
resident in Pakistan under a written 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 be acquired it and that the drug has been manufactured by a
manufacturer holding a valid licence to manufacture drugs and permission to
manufacture that drug:---
Provided that a defence under
clause (b) shall be open to a person only,---
(i) if
he has, within seven days of the service on him of the summons, sent to the
Inspector a copy of the warranty with a written notice stating that he intends
to rely upon it and giving the name and address of the warrantor, and
(ii) if
he proves that he has, within the same period, sent written notice of such
intention to the said warrantor.
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[71][71], shall, subject to the provisions of
section 27 of this Act, apply in respect of drugs the import of which is
prohibited under this Act, and officers .of customs and officers to whom any of
the functions of an officer of customs have been entrusted under the said Act
shall have the same powers in respect of such drugs as they have for the time
being in respect of such goods as aforesaid.
(2) Without prejudice to the provisions of
subsection (1), an officer of customs or a Federal Inspector or any other
person as may be authorised by the Federal Government in this behalf may detain
any imported package which he suspects to contain any drug the import of which
is prohibited under this Act, and shall forthwith report such detention to the
licensing authority and, if required by it, forward the package or samples of
any suspected drug found therein to a laboratory specified by it.
34. Offences by
companies, etc.– Where the person guilty of an offence under this Act, is a
company, corporation, firm or institution, every director, partner and employee
of the company, corporation, firm or institution [72][72][with
whose knowledge or consent the offence was committed shall be guilty of the
offence].
(2) The expenses of such publication shall
be recoverable is the same manner as a fine is recoverable.
36. Powers to exempt.– Notwithstanding anything contained in
this Act, the Federal Government may, if it is of opinion that the public
interest so requires, at any time, of its own motion or on a representation
made to it, by notification in the official Gazette, exempt any drug or class
of drugs from the operation of any of the provisions of this Act, subject to
such conditions, if any, and for such period, as may be specified in the
notification.
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[73][73],
and shall be officially subordinate to such authority as the Government
appointing him may specify in this behalf.
39. Finality of
orders, etc.– Save as otherwise expressly provided in this Act, every order
passed or decision given by any Board, a
(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.
[74][74][41A. Suspension of license by
Provincial Quality Control Board.– (1) Notwithstanding anything in section 41, the
Provincial Quality Control Board may, subject to the conditions mentioned in
that section, and after affording an opportunity of hearing to the manufacturer
and recording detailed reasons including the grounds of suspension, suspend the
manufacturing license of a manufacturer within the Punjab for such period not
exceeding thirty days as the Board may determine and shall, as soon as may be,
report the matter to the Central Licensing Board for such action as the Board
may deem appropriate.
(2) A copy
of the order under subsection (1) shall immediately be supplied to the
manufacturer, requiring him to take appropriate remedial measures.
(3) The
manufacturer shall take remedial measures and shall request the Provincial
Quality Control Board for an immediate inspection of the unit, and the Board
shall promptly arrange an inspection.
(4) If the
Board is satisfied that the grounds leading to the suspension of the licence
have been remedied, it shall restore the licence of the manufacturer and report
the matter to the Central Licensing Board but if the Board is not so satisfied,
it may require the manufacturer to take the remaining remedial measures.
(5) Notwithstanding
anything in subsection (3) or subsection (4), the Board shall arrange
inspection of the Unit for manufacture of drugs at five days prior to the
expiry of the period of suspension and if it is of the view that sufficient
remedial steps have not been taken, the Board may, from time to time and after
recording reasons, extend the period of suspension up to the maximum period of
ninety days in all.
(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.]
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[75][75]
for carrying out the purposes of this Act.
(2) In particular and without prejudice to
the generality of the foregoing provision, such rules may,---
(a) prescribe the functions of the Federal Drug Laboratory and any
other laboratory set up under section 14 or specified under section 22 or
section 33 and the procedure for the submission to any such laboratory of
samples of drugs for analysis or test, the forms of the laboratory's reports
thereon and the fees payable in respect of such reports; and such other matters
as may be necessary for any such laboratory to perform its functions;
(b) prescribe specifications, including the strength, potency, purity,
quality or other property, of any drug, and the methods of test or analysis to
be employed in determining whether a drug is of required specifications;
(c) prescribe the maximum proportion of any poisonous or other
substance which may be added to or contained in any drug, or extracted or
omitted therefrom; prohibit the import, manufacture, sale or stocking or
exhibition for sale or distribution of any drug in which that proportion is
exceeded and specify substances which shall be deemed to be poisonous;
(d) specify the drugs or classes of drugs for the import or export of
which a licence is required, the testing of such drugs, and prescribe the form
and conditions of such licences, the authority empowered to issue the same, and
the fees payable therefor;
(e) prescribe the places at which any specific drug or drugs may be
imported, prohibit their import at any other place, and control their import
through any specified agency;
(f) prescribe the evidence to be supplied, whether by accompanying
documents or otherwise, of the quality of drugs sought to be imported, the
procedure of officers, of customs in dealing with such evidence and the manner
of storage at places of import of drugs detained pending admission;
(g) prescribe the forms of licences for the manufacture for sale of
drugs or any specified drugs or class of drugs, the form of application for
such licences, the conditions subject to which such licence may be issued, the
person under whose signature the same be issued and the fees payable therefor;
(h) require the date of manufacture and the date of expiry of potency to
be clearly and truly stated on the label and container of any specified drug or
class of drugs and prohibit the sale, stocking or exhibition for sale or
distribution of the said drug or class of drugs after the expiry of a specified
period from the date of manufacture or after the expiry date and prescribe the
manner of disposal of such drug or class of drugs;
(i) prescribe the conditions to be observed in the packing in bottles,
packages and other containers of drugs and prohibit the sale, stocking or
exhibition for sale or distribution of drugs packed in contravention of such
conditions;
(j) regulate the mode of packing and packaging, including its size,
dimensions, fill and other specifications, the material used therefor and mode
of labelling packed drugs and prescribe the matters which shall or shall not be
included in such 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
(o) prescribe terms and conditions of members of the Central Licensing
Board and the Registration Board;
(p) prescribe types of registration of drugs, the form of application
for such registration, the conditions subject to which such registration may be
granted, the manner of registration and post-registration surveillance and
deregistration of registered drugs and the fees payable therefor;
(q) prescribe conditions for registration of indentors, importers,
wholesalers and distributors within Pakistan and any establishment within any
foreign country engaged in the manufacture for export of a drug and prescribe
conditions providing effective an adequate means, by arrangement with the
Government of such foreign country or otherwise, to enable the licensing
authority or the Registration Board to determine from time to time whether
drugs manufactured in such establishment, if imported or offered for import
into Pakistan, shall be refused admission where the public interest so
requires;
(r) prescribe
the form of warranty for manufactured drugs;
(s) specify offences in relation to which the stock of drugs, articles
or things shall be liable to forfeiture under this Act;
(t) prescribe the qualifications, and regulate the procedure for
exercise of powers and performance of functions, of Federal Inspectors;
(u) prescribe the laboratories to which the Federal Inspectors shall
submit samples of drugs taken for the purpose of test and analysis and the form
and procedure for submitting the report of such test and analysis and the fee
payable therefor, where so required;
(v) prescribe measures for securing and maintaining supplies of drugs at
reasonable prices, conditions to be met in respect of manufacture, production,
pricing, keeping, movement and disposal of drugs and to fix prices,
commissions, discount of the manufacturer, wholesaler, distributor, retailer or
any other dealer of drugs, to control giving of bonus in cash or kind or in any
other manner to any of the said parties and for collecting or calling for any
information, statistics, records or books with a view to regulating the matters
aforesaid;
(w) specify drugs which may be advertised and the conditions
subject to which such drugs may be advertised;
(x) prescribe conditions subject to which small quantities of drugs may
be imported or manufactured or exported for the purpose of examination, test or
analysis, clinical trial or personal use; and
(y) prescribe any other matter which is to be, or may be, prescribed by
the Federal Government.
(2) The power to make rules conferred by
this section shall, except on the first occasion of the exercise thereof, be
subject to the condition of previous publication.
[76][76][43A. Power to delegate.– (1) The Provincial Government may, subject to such
conditions as it may determine, delegate any of its functions to the Provincial
Quality Control Board or to any
other person or authority.
(2) The
Provincial Quality Control Board may, subject to such conditions as it may
determine, delegate any of its functions and powers under this Act or the rules
to the Monitoring Committee or any other person or authority.]
(a) the establishment of laboratories for testing and analysing
drugs;
(b) the qualifications and the procedure, for exercise of powers and
performance of functions of Provincial Inspectors;
(c) the forms of reports to be given by Government Analysts and the
manner of application for test or analysis and the fees payable therefor;
(d) the conditions to regulate sale or storage or distribution of
drugs or any specific drug or class of drugs;
(e) the offences against this Act or any rule in relation to which
the stock of drugs shall be liable to confiscation and destruction under this
Act;
(f) the forms of licences for the sale or distribution of drugs or
any specified drug or class of drugs, the authority empowered to issue the
same, the form of applications for such licences, the fees payable therefor and
the conditions subject to which such licences may be issued;
(g) the procedure to be followed by the Provincial Quality Control
Board; and
(h) any other matter which is to be or may be, prescribed by the
Provincial Government.
(2) The power to make rules conferred by
this section shall, except on the first occasion of the exercise thereof, be
subject to the condition of previous publication.
45. Repeal and
Savings.– (1) The Drugs Act, 1940[77][77],
the Drugs (Generic Names) Act, 1972[78][78],
and the Drugs Ordinance, 1976[79][79],
are hereby repealed.
(2) Notwithstanding the repeal of the
Drugs Act, 1940 by subsection (1),---
(a) Any licence to manufacture for sale issued
thereunder to any person, for the revalidation of which an application has
already been made to the Central Licensing Board within the date specified by
the Federal Government shall continue to be valid until orders are passed by
the said Board in this behalf.
(b) Any licence for import or export or sale of
drugs issued thereunder to any person, shall, unless it expires earlier under
the terms thereof, continue to be valid for such periods as the Federal
Government or, as the case may be, the Provincial Government may, by
notification in the official Gazette, specify in this behalf:---
Provided that in case of
drugs to be imported or exported licences may continue to be issued under the
rules framed under the Drugs Act, 1940, till the rules under this Act are
framed or as the case may be, a date is fixed under subsection (6) of section 7
in respect of drugs in the finished form ready for use.
[1][1] For Statement of Objects
and Reasons, see Gazzete of Pakistan, 1976,
Extraordinary, Part III, page 250.
Previously, an offence
punishable under the Drugs Act, 1976, was made triable and punishable by a
This Act
was originally in the Federal ambit, however, the subject on which this law was
enacted, devolved to the provinces by virtue of 18th Amendment in the
Constitution, hence it was first amended by the Punjab Assembly (section 31 of
the 1976 Act), through the Punjab Drugs
(Amendment) Act 2016 (XXXIII of 2016) with the following provision contained in
section 3 of the 2016 Act:
“3. Transition.– All the powers
exercisable by the Federal Government under the said Act in respect of the
existing Drug Courts in the
The principal law was
subsequently adapted, with comprehensive amendments, by the Punjab Drugs
(Amendment) Act 2017 (V of 2017).
[2][2] II of 1930
[3][3] Substituted for the
words “may have” by the Drugs (Amendment) Ordinance, 2002 (Federal Ordinance
CXXVIII of 2002).
[4][4] Inserted
by the
[5][5] Inserted
by the
[6][6] Substituted by the
Punjab Drugs (Amendment) Act 2017 (V of 2017) for the following:
“(zz) “sub-standard drug means a drug which is not of specifications.”
[7][7] Added by the Drugs
(Amendment) Ordinance, 2002 (Federal Ordinance CXXVIII of 2002).
[8][8] Inserted by the Drugs (Amendment) Ordinance, 2002 (Federal Ordinance CXXVIII
of 2002).
[9][9] Inserted by the Drugs
(Amendment) Ordinance, 2002 (Federal
Ordinance CXXVIII of 2002).
[10][10] Substituted by the Drugs
(Amendment) Ordinance, 2002 (Federal
Ordinance CXXVIII of 2002).
[11][11] Inserted by the Drugs
(Amendment) Ordinance, 2002 (Federal
Ordinance CXXVIII of 2002).
[12][12] Added by the Drugs
(Amendment) Ordinance, 2002 (Federal
Ordinance CXXVIII of 2002).
[13][13] Inserted by the Drugs
(Amendment) Ordinance, 2002 (Federal
Ordinance CXXVIII of 2002).
[14][14] Inserted by the Drugs
(Amendment) Ordinance, 2002 (Federal
Ordinance CXXVIII of 2002).
1 The word ‘and’ omitted
by the Drugs (Amendment) Ordinance, 2002 (Federal Ordinance CXXVIII of 2002).
[16][16] Substituted for the “full-stop” by the Drugs (Amendment)
Ordinance, 2002 (Federal Ordinance CXXVIII of 2002).
[17][17] Added by the Drugs
(Amendment) Ordinance, 2002 (Federal
Ordinance CXXVIII of 2002).
[18][18] The word ‘and’ omitted
by the Punjab Drugs (Amendment) Act 2017 (V of 2017).
[19][19] Substituted by the
Punjab Drugs (Amendment) Act 2017 (V of 2017) for the following:
“(i) to submit a monthly report of
decisions and activities to the Federal Government.”
[20][20] New clause inserted by
the Punjab Drugs (Amendment) Act 2017 (V of 2017).
[21][21] New subsection (7)
inserted by the Punjab Drugs (Amendment) Act 2017 (V of 2017).
[22][22] Inserted by the Drugs
(Amendment) Ordinance, 2002 (Federal
Ordinance CXXVIII of 2002).
[23][23] New
sections 11B and 11C inserted by the Punjab Drugs (Amendment) Act 2017 (V of
2017).
[24][24] Substituted by the
Punjab Drugs (Amendment) Act 2017 (V of 2017) for the following:
“15. Provincial Drugs Testing
Laboratory.– Each Provincial Government shall, as
soon as may be, set up a Provincial Drug Testing Laboratory for such purposes
as may be prescribed.”
[25][25] Substituted for the “semi-colon” by the Drugs (Amendment)
Ordinance, 2002 (Federal Ordinance CXXVIII of 2002).
[26][26] Added by the Drugs (Amendment) Ordinance,
2002 (Federal Ordinance CXXVIII of 2002).
[27][27] Act V of 1908
[28][28] Substituted for the
word “four” by the Drugs (Amendment) Ordinance, 2002 (Federal Ordinance CXXVIII
of 2002).
[29][29] Substituted for the
“colon” by the Drugs (Amendment) Ordinance 2002 (Federal Ordinance CXXVIII of
2002).
[30][30] Second Proviso omitted by the Drugs
(Amendment) Ordinance 2002 (Federal Ordinance CXXVIII of 2002).
[31][31] Act V of 1898
[32][32] Substituted for the word “four” by the Drugs (Amendment)
Ordinance, 2002 (Federal Ordinance CXXVIII of 2002).
[33][33] Substituted by the
Punjab Drugs (Amendment) Act 2017 (V of 2017) for the following:
“(i) one portion or sample he
shall send to the Government Analyst concerned for test and analysis;”
[34][34] Omitted the word “and” by the Drugs (Amendment) Ordinance, 2002 (Federal Ordinance
CXXVIII of 2002).
[35][35] Substituted for the “full-stop” by the Drugs (Amendment)
Ordinance, 2002 (Federal Ordinance CXXVIII of 2002).
[36][36] Added by the Drugs
(Amendment) Ordinance, 2002 (Federal Ordinance CXXVIII of 2002).
[37][37] Substituted for the
words “Board concerned” by the Drugs (Amendment) Ordinance, 2002 (Federal
Ordinance CXXVIII of 2002).
[38][38] Inserted
by the
[39][39] Substituted for the words “Board concerned” by the Drugs
(Amendment) Ordinance, 2002 (Federal Ordinance CXXVIII of 2002).
[40][40] Inserted
by the
4 Substituted for the words and commas “the
[42][42] Substituted
for the words “Government
Analyst's report” by the Punjab Drugs
(Amendment) Act 2017 (V of 2017).
[43][43] Substituted for the words “the
[44][44] Inserted
by the
[45][45] New section inserted by
the Punjab Drugs (Amendment) Act 2017 (V of 2017).
[46][46] New sections inserted by
the Punjab Drugs (Amendment) Act 2017 (V of 2017).
[47][47] Substituted by the
Punjab Drugs (Amendment) Act 2017 (V of 2017) for the following:
“(1) Whoever himself
or by any other person on his behalf-
(a) exports, imports,
manufactures for sale or or sells any spurious drug or any drug which
is not registered;
(b) manufactures for
sale any drug without a license; or
(c) imports without licence any drug for the
import of which a licence is required;
shall be punishable
with imprisonment for a term which shall not be less than three years or more
than ten years and with fine which may extend to one lakh rupees:
Provided that the
[48][48] Substituted firstly
for the words “and with fine which
may extend to one lakh rupees”
by the Drugs (Amendment) Ordinance, 2002 (Federal Ordinance CXXVIII of 2002)
and then for the words “or with fine which may extend to one lakh rupees, or with
both” by the Punjab Drugs (Amendment) Act 2017 (V of 2017).
[49][49] Substituted for the
words “one year, or with fine which may extend to ten thousand rupees, or
with both” by the Punjab Drugs (Amendment) Act 2017 (V of 2017).
[50][50] New subsections
inserted by the Punjab Drugs (Amendment) Act 2017 (V of 2017).
[51][51] Substituted by the Punjab Drugs
(Amendment) Act 2017 (V of 2017) for the following:
“(4) Subject to the provisions of
subsection (1), subsection (2) and subsection (3), whoever himself or by any
other person on his behalf contravenes any of the provisions of this Act or any
rule, shall be punishable with imprisonment for a term which may extend to five
years, or with fine which may extend to fifty thousand rupees, or with both.”
[52][52] New subsection
inserted by the Punjab Drugs (Amendment) Act 2017 (V of 2017).
[53][53] New subsection
inserted by the Punjab Drugs (Amendment) Act 2017 (V of 2017).
[54][54] Substituted for the
words “again convicted of an” by the Drugs (Amendment)
Ordinance, 2002 (Federal Ordinance CXXVIII of 2002).
[55][55] Substituted for the
words “five years and with fine which may extend to two lakh rupees” by
the Punjab Drugs (Amendment) Act 2017 (V of 2017).
[56][56] Substituted for the
words “again convicted of an” by the Drugs (Amendment) Ordinance, 2002
(Federal Ordinance CXXVIII of 2002).
[57][57] Substituted for the
expression “which shall not be less than two years or more than ten years, or
with fine which may extend to two lakh rupees, or with both” by the Punjab
Drugs (Amendment) Act 2017 (V of 2017).
[58][58] New subsection
inserted by the Punjab Drugs (Amendment) Act 2017 (V of 2017).
[59][59] Substituted for the words “again convicted of an” by the Drugs (Amendment)
Ordinance, 2002 (Federal Ordinance CXXVIII of 2002).
[60][60] 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).
[61][61] Substituted by the Punjab Drugs
(Amendment) Act 2017 (V of 2017) for the following:
“(2) Notwithstanding
anything contained in the Code of Criminal Procedure, 1898 (V of 1898),-
(a) an
offence punishable under this Chapter other than an offence mentioned in
subsection (1) of section 27, shall be non-cognizable, and
(b) no court other than a
[62][62] Act V of 1898
[63][63] Substituted
for the words “Federal Government” by the Punjab Drugs (Amendment) Act 2016
(XXXIII of 2016).
[64][64] Substituted by the Punjab Drugs
(Amendment) Act 2017 (V of 2017) for the following:
“(2) A Drug Court
shall consist of a person who is, or has been, or is qualified for appointment
as, a Judge of a High Court, who shall be the Chairman, and two members being
persons who, in the opinion of the *[Provincial Government], are experts in the
medical or pharmaceutical fields **[:]
***[Provided that for
deciding applications of bail the Chairman and any one member shall constitute
full quorum of a Drug Court.]”
*Substituted for the words “Federal Government” by the
Punjab Drugs (Amendment) Act 2016 (XXXIII of 2016)
**Substituted for the
“full-stop” by the Drugs (Amendment) Ordinance, 2002 (Federal Ordinance CXXVIII
of 2002)
***Added by the Drugs (Amendment) Ordinance, 2002
(Federal Ordinance CXXVIII of 2002)
[65][65] Substituted
for the words “Federal Government” by the Punjab Drugs (Amendment) Act 2016
(XXXIII of 2016).
[66][66] Act V of 1898
[67][67] Act V of 1898
[68][68] The following
subsections omitted by the Punjab Drugs (Amendment) Act 2017 (V of 2017):
“(7) A person sentenced
by a
(8) The provisions of sections 5 and 12 of the
Limitation Act, 1908 (IX of 1908), shall be applicable to an appeal referred to
in sub-section (7).”
[69][69] New section inserted by the Punjab Drugs
(Amendment) Act 2017 (V of 2017).
[70][70] Act IX of 1908
[71][71] Act IV of 1969
[72][72] Substituted 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 (Federal Ordinance CXXVIII of 2002).
[73][73] Act XLV of 1860
[74][74] New section inserted by the Punjab Drugs
(Amendment) Act 2017 (V of 2017).
[75][75] For the Drugs (Appellate Board) Rules
1976, see SRO No.595(1)/76, dated 20-06-1976; Gazette of Pakistan, 1976
(Extraordinary), Islamabad, Pt II, pages 1125-1127; and for the Drugs (Federal
Inspectors, Federal Drug Laboratory and Federal Government Analysts), Rules
1976, see SRO No.793(1)/76, dated 06-08-1976; pages 1627-1636.
[76][76] New section inserted by the Punjab Drugs
(Amendment) Act 2017 (V of 2017).
[77][77] Act XXIII of 1940
[78][78] Act XXIV of 1972
[79][79] Act IV of 1976
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