THE DRUGS
ACT 1976
OFFICE OF DISTRICT PUBLIC
PROSECUTOR, JHANG.
THE DRUGS ACT, 1976 (XXXI OF 1976)
[11th May, 1976] An Act to
regulate the import, export, manufacture, storage, distribution and sale of
drugs
Preamble: Whereas it is expedient
to regulate the import, export, manufacture,
storage, distribution and sale of drugs:
It is hereby enacted as follows:--
CHAPTER-I
INTRODUCTORY
1. Short title, extent and commencement:
(1) This Act may be called the
Drugs Act, 1976. (2) It extends to the whole of Pakistan. (3) It shall come
into force at once.
2. Application of other laws not
barred:
The provisions of this Act, shall
be in addition to, and not in derogation of, the Dangerous Drugs Act, 1930 (11
of 1930), and any other law for the time being in force.
3. Definitions:
In this Act, unless there is
anything repugnant in the subject or context,--
(a) "Adulterated drugs" 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 [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 or
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 manufacture;
(g) "Drug" includes-
(i) any substance or mixture of substances that
is manufactured, sold, stored, offered for sale or represented for internal or
external use in the treatment, mitigation, prevention or diagnosis of diseases,
an abnormal physical state, or the symptoms thereof in human beings or animals
or the restoration, correction, or modification of organic functions in human
beings or animals, not being a substance exclusively used or prepared for use
in accordance with the ayurvedic, unani, homoeopathic or biochemic system of,
treatment except those substances and in accordance with such conditions as may
be prescribed;
(ii) abortive and contraceptive substances, agents
and devices, surgical ligatures, sutures, bandages, absorbent cotton,
disinfectants, bacteriophages, adhesive plasters, gelatin, capsules and
antiseptic solutions;
(iii) such substances intended to be used for the
destruction or repulsion of such vermin, insects, rodents and other organism as
cause, carry or transmit disease in human beings or animals or for disinfection
in residential areas or in premises in which food is manufactured, prepared or
kept or stored;
(iv) such pesticides as may cause health hazard to
the public;
(v) any substance mentioned as monograph or as a
preparation in the Pakistan Pharmacopoeia or the Pakistan National Formulary or
the International Pharmacopoeia or the British Pharmacopoeia or the British
Pharmaceutical Codex or the United States Pharmacopoeia or the National
Formulary of the United States, whether alone or in combination with any
substance exclusively used in the unani, ayurvedic, homoeopathic or biochemic
system of treatment, and intended to be used for any of the purposes mentioned
in sub-clauses (i), (ii) and (iii), and
(vi) any other substance which the Federal
Government may, by notification in the official Gazette, declare to be a
"drug" for the purposes of this Act;
(h) "Expiry date" means the date stated
on the label of a drug after which the drug is not expected to retain its
claimed efficacy, safety, quality or potency or after which it is not
permissible to sell the drug;
(i) "Expert" means a specialist through
university education and experience in the relevant field;
(j) "Export", with its grammatical variations
and cognate expressions, means to take out of Pakistan by sea, land or air;
(k) "Generic name" means the
non-proprietary, scientific or official name of a drug as approved by the
Federal Government;
(l) "Government analyst" means a
Federal Government Analyst or Provincial Government Analyst appointed under
Section 16;
(m) "Import" with its grammatical
variations and cognate expressions means to bring into Pakistan by sea, land or
air;
(n) "Inspector" means a Federal
Inspector or a Provincial Inspector appointed under Section 17;
(o) "Label" means a display of written,
printed or graphic matter upon the immediate container, or the outside
container or wrapper of a drug package;
(p) "Labelling" means all labels and
other written, printed or graphic matter accompanying any drug;
(q) "Licensing authority" means such
authority as may be prescribed;
(r)
"Manufacture", in relation to a drug, means all operations
involved in the production of the drug, including processing, compounding,
formulating, filling, packing, repacking, altering, ornamenting, finishing and
labelling with a view to its storage, sale and distribution, but does not
include the compounding and dispensing or the packing of any drug in the
ordinary course of retail business or on a prescription of a registered medical
practitioner or dentist or of a veterinarian and "to manufacture"
shall be construed accordingly;
(s) "Misbranded drug" means a drug
(i) which is not labelled in the prescribed
manner; or
(ii) on the label or labelling of which any word,
statement or other matter or information required by the rules to appear on the
label or labelling is not prominently placed with such conspicuousness (as
compared with other words, statements, designs, or devices on the label or
labelling) and in such terms as may render it likely to be read 'and understood
by the ordinary individual under customary conditions of purchase and use; or
(iii) which is not labelled with such directions
for use and such warnings against use in indications where its use may be
dangerous to health, or against unsafe dosage or duration of administration or
application in such manner and form as are necessary for the protection of
users or as may be prescribed; or
(iv) the label or container of which, or anything
accompanying which, bears any statement, design or device which makes any false
claim for the drug or which is false or misleading in any particular; or
(v) which is so coloured, coated,
powdered or polished that damage is concealed, or which is made to appear of
better or greater therapeutic value than it really is; or
(vi) which is manufactured according to the
specifications of a particular pharmacopoeia or any other document as may be
prescribed and the label does not bear the name of that pharmacopoeia or
document;
(t) "Prescribed" means prescribed by
rules;
(u) "Provincial Quality Control Board"
means a Board set up under Section 11;
(v) "Registration Board" means a Board
set up under Section 7;
(w) "Registered drug" means any drug
registered under Section 7;
(x)
"Rules' means rules made under this Act;
(y) "Drug Court" means a Court
established under Section 31;
(z) "Specifications" when applied to a
drug mean
(i) such specifications as may be prescribed; or
(ii) when the specifications are not prescribed,
the specifications as contained in the most recent edition of any of the
following publications, namely:-
(1) the Pakistan Pharmacopoeia;
(2) the International Pharmacopoeia; (3) the European Pharmacopoeia; (4) the
United States Pharmacopoeia; (5) the British Pharmacopoeia; (6) the British
Pharmaceutical Codex; (7) the United States National Formulary; and (8) such
other publication as may be prescribed: Provided that, if the specifications do
not appear in the most recent edition of any such publication, the
specifications appearing in the next preceding edition of such publication in
which the specifications appear shall apply; or
(iii) if no specifications are
either prescribed or contained in any of the publications referred to in
sub-clause (ii), the specification approved for the purpose of registration
under this Act;
(z-a) "Sell" means sell, offer for sale,
expose for. sale, have in possession for sale and distribution and "to
sell", "sold" or "sale" shall be construed
accordingly;
(z-b) "Spurious drug" means a drug
(i) which purports to be a drug but does not
contain the active ingredient of that drug; or
(ii) which purports to be the product of a
manufacturer, place or country of whom or of which it is not truly a product;
or
(iii) which is imported or exported or sold or
offered or exposed for sale under a particular name while actually it is
another drug; or
(iv) the label of which bears the name of an
individual or company purporting to be its manufacturer or producer which
individual or company is fictitious or does not exist;
(z-c)
"Storage" means storage for sale and "to store" or
"stored" shall be construed accordingly; and
(zz) "Sub-standard drug'
means a drug which is not of specifications.
CHAPTER II
Administration and Enforcement
4. Regulation and prohibition of import, etc., of drugs:
(1) The Federal Government shall
regulate the import and export of drugs in the prescribed manner and for that
purpose may make such orders and issue such directions to the importers and
exporters as it may deem fit.
(2) If in the opinion of the
Federal Government the public interest so requires, the Federal Government may,
by notification in the official Gazette,
(a) direct that a drug or a class of drugs
specified in the notification, or drugs
generally, shall not be imported or exported otherwise than under the
authority of 'a license issued under this
Act or except by an importer or exporter or through an indentor registered in accordance with the
rules;
(b) direct that a drug or class of drugs specified in the notification
shall not be imported except by an
agency of Government so specified; or
(c) prohibit the import or export of any drug or class of drugs
specified in the notification.
[(3) Subject to sub-sections (1)
& (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 licenses to
manufacture drugs shall be regulated in accordance with such conditions and
procedure as may be prescribed, by a Central Licensing Board to be set up by
the Federal Government and consisting of such representatives of the Federal
Government and the Provincial Governments as may be prescribed.
(2) The members of the Central
Licensing Board shall exercise such powers, including the powers of an
Inspector, as may be prescribed.
(3) The Central Licensing Board
shall, [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 directions 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 that purpose set up a Registration
Board, consisting of such number of persons, possessing such qualifications, as
may be prescribed.
Explanation: In this section, "drugs" means
drugs which are in the finished form ready for use.
(2) The members of the
Registration Board shall exercise such powers, including the powers of an
Inspector, as may be prescribed.
(3) The Registration Board shall,
[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 sub-section (4),
the members of the Registration Board shall hold office for the prescribed
period.
(6) The Federal Government shall,
by notification in the official Gazette, fix the date after which no drug which
is not registered shall be allowed to be exported, imported, manufactured,
stored, distributed or sold.
(7) A person applying for the
registration of a drug shall furnish such information in respect of the drug as
may be prescribed, including information relating to its efficacy, safety, and
quality, or as may be required by the Registration Board for the purpose of the
evaluation of the drug.
(8) Single-ingredient drugs shall
be registered generally by their generic names while compound drugs shall be
registered generally by their proprietary names.
Explanation: In this sub-section,-- (a)
"single-ingredient drugs" means drugs containing one active
ingredient; (b) "compound drugs" means drugs containing more than one
active ingredient.
[(9) The registration of a drug
shall be subject to such conditions, 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.
8. Pakistan National Formulary:
The Federal Government shall
compile and publish in the official Gazette Pakistan National Formulary
comprising all drugs allowed to be imported, manufactured or sold and such
Formulary may be reviewed and modified from time to time.
9. Appellate Board:
(1) The: Federal Government
shall, in accordance with the rules, constitute an Appellate Board for the
disposal of appeals preferred by persons aggrieved by any decision of the
Central Licensing Board or the Registration Board or the Licensing Authority or
a Board or Authority to which the powers of the Federal Government under
section 12 have been delegated under subsection (3) of that section and for
revision of any such decision on its own motion.
(2) The Appellate Board shall consist of such
representatives of the Federal Governments and the Provincial Governments,
including a Chairman, as the Federal Government may from time to time
appoint.
(3) Subject to sub-section (4),
the Chairman and other members of the Appellate.-Board shall hold office for
the prescribed period.
(4) The Chairman or any other
member of the Appellate Board may, by writing under his hand addressed to the
Federal Government, resign his office or shall vacate his office if the Federal
Government, being of opinion that in the public interest it is necessary so to
do, so directs.
(5) The members of the Appellate
Board shall exercise such powers, including the powers of an 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,
[with the approval of the Federal Government and by notification in the
official gazette,] make regulations to regulate the conduct of its
business.
[(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 cases to be recorded.]
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.]
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 Control Board shall hold office during the
pleasure of the Provincial Government, on such terms and conditions as that
Government may determine.
(3) 'The provincial Government
shall appoint a person to be the Secretary of the Provincial Quality Control
Board and provide the Board with such staff as the Provincial Government may
consider necessary.
(4)The Provincial Quality Board
shall, [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 the Government Analysts in respect of drugs
sent to them by the Provincial
Inspectors for test and analysis and issue instructions to the Inspectors to the action to be taken on
such reports:
Provided that the Provincial Quality Control
Board may specify the class of cases in
which a Provincial Inspector may make a complaint to the Drug Court, or take any other action, without the specific instructions
of the Board;
(c) to exercise all the powers of an Inspector
under this Act and the rules;
(d) to advise the Provincial Government on
ways and means to ensure quality control
of drugs manufactured in the Province;
(e) to ascertain the names of such directors,
partners and employees of the company,
corporation, firms 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; and
(i) to submit a monthly report of decisions
and activities to the Federal
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.
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.
12. Power to fix maximum prices
of drug, etc.:-
(1) The Federal Government may,
by notification in the official Gazette,--
(a) fix the maximum price at which any drug
specified in the notification is to be sold; and
(b) specify a certain percentage of the
profits of manufacturers of drugs which shall be utilised, in accordance with
the rules for purposes of research in drugs.
(2) For the purpose of the
exercise of its powers under sub-section (1), the Federal Government may
require a manufacturer, stockist, importer, exporter, retailer or other dealer
in drugs to furnish such relevant information as may be necessary.
(3) The Federal Government may,
by notification in the official Gazette, delegate any of its powers under this
section .to any Board or other authority.
13. Directions to Provincial
Governments:
The Federal Government may give
such directions to a Provincial Government as may appear to the Federal
Government to be necessary for carrying into execution in the Province of any
of the provisions of this Act or of any rule or order made there under or
for maintaining supplies of drugs of standard
quality at reasonable prices or for the achievement of uniformity in respect of
any matter in different parts of Pakistan.
14. Federal Drugs Laboratory and
institutes etc.:
The Federal Government shall, as
soon as may be, establish a Federal Drug Laboratory and may also set up such
other institutes and drugs testing and research laboratories for the purposes
of this Act as may be prescribed.
15. Provincial Drugs Testing
Laboratory:
Each Provincial Government shall,
as soon as may be, set up a Provincial Drugs Testing Laboratory for such
purposes as may be prescribed.
16. Government Analysts:
The Federal Government or a
Provincial Government may, by notification in the official Gazette, appoint
such persons as it thinks fit, having the prescribed qualifications, to be the
Federal Government Analysts or, as the case may be, Provincial Government
Analysts, for such areas and in respect of such drugs or classes of drugs as
may be specified in the notification:
Provided that no person who has
any financial interest in the manufacture, import, export or sale of drugs
shall be so appointed:
Provided further that a person
serving under the Federal Government or another Provincial Government shall not
be so appointed without the previous consent of that Government
17. Inspectors:
The Federal Government or a
Provincial Government may, by notification in the official Gazette, appoint
such persons as it thinks fit, having the prescribed qualifications, to be
Federal Inspectors, or, as the case may be, Provincial Inspectors for the purposes
of this Act within such local limits as it may assign to them
respectively:
Provided that no person who has
any financial interest in the manufacture, import, export or sale of any drug
shall be 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
18. Powers
of Inspectors:
(1) Subject to the provisions of
section 19 and of any rules made in this behalf, an Inspector may, within the
local limits for which he is appointed, and in any other area within the
permission of the licensing authority,-
(a) inspect any premises-wherein any drug is
manufactured, the plant and process of
manufacture, the means employed for standardising and testing the drugs
and all relevant records and
registers;
(b) inspect any premises wherein any drug is
sold or is stocked or exhibited for sale
or is distributed, the storage arrangements and all relevant records and registers;
(c) take samples of any drug which is being
manufactured, or being sold or is
stocked or exhibited for sale or is being distributed;
(d) enter and search, with such assistance, if
any, as he considers necessary, any
building, vessel or place, in which he has reason to believe that an
offence under this Act or any rules has
been or is being committed or may continue to be committed;
(e) call any person to be present as witness
in the course of search or seizure or in
connection with any other matter where the presence of witnesses is
necessary;
(f) seize such drug and all materials used in
the manufacture thereof and any other
articles, including registers, cash memos, invoices and bills, which he
has reason to believe may furnish
evidence of the commission of an offence punishable under this Act or any rules:
[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 (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 [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 commission of an offence under this Act or the rules; and
(j) exercise such other powers as may be
necessary for carrying out the purposes
of this Act or any rules:
Provided that the powers under causes (f) to
(j) shall be exercisable only by an
Inspector specifically authorised in this behalf, by an order in writing,
by the Government appointing him,
subject to such conditions as may be specified in such order.
(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 therefore
in the prescribed form.
(2) Where an Inspector takes a
sample of a drug for the purpose of test or analysis, he shall intimate such
purpose in writing in the prescribed form to the person from whom he takes it
and, in the presence of such person unless he willfully absents himself, shall
divide the sample into [five] portions and effectively seal and suitably mark
the same and permit such persons to add his own seal, if any, and mark to all
or any of the portions so sealed and marked:
Provided that, where the sample
is taken from premises whereon the drug is being manufactured, it shall be
necessary to divide the sample into three portions only:
Provided further that, where the
drug is made up in containers of small volume, instead of dividing a sample as
aforesaid, the Inspector may, and if the drug be such that it is likely to
deteriorate or be otherwise damaged by exposure shall, take three or four, as
the case may be, of the said containers after suitably marking the same and,
where necessary, sealing them:
Provided further that if the
contents of one container are insufficient for the laboratory test and
analysis, the Inspector may increase the number of the containers in order to
make the sample sufficient for this purpose.
(3) The Inspector shall restore
one portion of a sample so divided or one container, as the case may be, to the
person from whom he takes it, and shall retain the remainder and dispose of the
same within seven days as follows :-
(i) one portion of sample he shall send to the
Government Analyst concerned for test
and analysis;
(ii) the second he shall send to the Chairman,
Provincial Quality Control Board or the
Central Licensing Board or the Registration Board, as the case may be;
(iii) the third, where taken, he shall send to
the warrantor, if any, named under the
proviso to sub-section (3) of Section 32;
[(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 he shall, as soon as possible inform the Board
concerned or its Chairman and take order as to the custody of the stocks of the
drug seized by him.
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.]
(a) he shall as soon as practicable ascertain
whether or not the drug contravenes any
of the provisions of this Act and, it is ascertained that the drug does not
so contravene, he shall forthwith revoke
the order passed under the said section or,
as the case may be, take such action as may be necessary for the return
of the stock seized and payment for the
samples taken, under intimation to the Board
concerned;
(b) if he seizes the stock of the drug he
shall, as soon as may be inform the Board
concerned and take its order as to the custody thereof:
Provided that where a Federal Inspectors not
competent to take action under section
30, he shall as soon as may be, report the matter and hand over the stock, if any, to the Provincial Inspector for
further action under this Act.
(6) The Provincial Inspector on finding any
contravention of this Act shall, unless the Board otherwise directs, always
refer the case to the Provincial Quality Control Board and seek orders as to
the action to be taken in respect of such contravention.
(7) The Federal Inspector on
finding any contravention of this Act for which he is authorised shall, unless
otherwise directed, always refer the case to the Central Licensing Board or the
Registration Board or any other authority as may be specified for the purpose
and seek any further orders as to the action to be taken in respect of such
contravention.
20. Persons bound to disclose place where drugs are manufactured or kept:
Every person for the time being
in charge of any premises whereon any drug is being manufactured or is kept for
sale or distribution shall, on being required by an Inspector so to do,
disclose to the Inspector the place where the drug is being manufactured or is
kept, as the case may be.
21. Disclosure of the name of the manufacturer:
Every person, not being the
manufacturer of a drug or his agent for the distribution thereof, shall if so
required by an Inspector, disclose to him the name, address and other
particulars of the manufacturer or other person from whom he acquired the
drug.
22. Reports of Government Analysts:
(1) The Government Analyst to
whom a sample of any drug has been submitted for test and analysis under
sub-section (3) of section 19 shall deliver to the Inspector submitting it a
signed report in quadruplicate in the prescribed form and forward one copy
thereof to the authority as may be prescribed.
(2) The Government Analyst, as
far as may be, shall submit the report referred to in subsection (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 [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 and shall ensure the receipt of results of such test and analysis
within a further period as may be prescribed and shall make the test report
available to the Inspector for further action.
(3) On receipt of the report, the
Inspector shall—
(a) deliver one copy thereof to the person
from whom the sample was taken;
(b) forward one copy to the
warrantor, if any, named under the proviso to sub section (3) of Section 32;
(c) forward one copy to the [Central Licensing
Board or, as the case may be, the
Registration Board or the Provincial Quality Control Board] concerned
for its directions as to the action to
be taken; and
(d) retain the fourth copy for use in any
prosecution or for any other purpose.
(4) Notwithstanding anything
contained in any other law for the time being in force, any document purporting
to be a report signed by a Government analyst shall be admissible as evidence
of the facts stated therein without formal proof and such evidence shall be
conclusive unless the person from whom the sample was taken or the said
warrantor has, within thirty days of the receipt of a copy of the report
notified in writing to the Inspector or [Provincial Quality 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 Government Analyst's report, [Provincial Quality 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 [as the
case may be, the Central Licensing Board, the Registration Board, the
Provincial Quality Control Board or such other Authority as may be prescribed
for this purpose] under sub-section (3) of section 19 to be sent for test or
analysis to the Federal Drug Laboratory or any other laboratory specified for
the purpose by the Federal Government which shall make the test or analysis and
report in [ within thirty days of the receipt of the sample] 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 there of and such report shall be conclusive evidence of the facts
stated therein.
(6) The cost of a test or
analysis made by the Federal Drug Laboratory or other laboratory under
sub-section (5) shall be paid by the complainant or accused as the Drug Court
or the Board concerned shall direct.
CHAPTER III
PROHIBITIONS
23. Import, manufacture and sale of drug:
(1) No person shall himself or by
any other person on his behalf-- (a)
export, import or manufacture for sale or sell:- (i) any spurious drug; (ii) any imitation product; (iii) any misbranded drug; (iv) any adulterated drug; (v) any substandard drug; (vi) any drug after its expiry date; (vii) any drug which is not registered or is
not in accordance with the conditions
of registration; (viii) any drug which,
by means of any statement, design or device
accompanying it or by any other means, purports or claims to cure or mitigate any such disease or ailment, or to
have any such other effect, as may be
prescribed; (ix) any drug if it is
dangerous to health when used in the dosage or with the frequency, or, for the duration
specified, recommended or suggested in
the labelling thereof; or (x)
any drug in contravention of any of the provisions of this Act or any rule;
(b) manufacture for sale any drug except
under, and in accordance with the
conditions of, a licence issued under this Act;
(c) sell any drug except under, and in
accordance with the conditions of, a licence
issued under this Act;
(d) import or export any drug the import or
export of which is prohibited by or
under this Act;
(e) import or export any drug for the import
or export of which a licence is
required, except under, and in accordance with the conditions of, such
licence;
(f) supply an incorrect, incomplete or
misleading information, when required to
furnish any information under this Act or the rules;
(g) peddle, hawk or offer for sale any drug in
a park or public street or on a highway,
footpath or public transport or conveyance;
(h) import, manufacture for sale, or sell any
substance, or mixture of substances,
which is not a drug but is
presented in a form or a manner which is intended or likely to cause the public to believe it to
be a drug;
(i) sell any drug without having a warranty in
the prescribed form bearing the name
and batch number of the drug issued,--
(i) in the case of a drug manufactured in Pakistan, by the
manufacturer holding a valid licence
to manufacture drugs and permission to
manufacture that drug or by his authorised agent;
(ii) in the case of an imported drug, by the manufacturer or importer
of that drug or, if the drug is
imported through an indentor by such indentor;
(j) apply an incorrect batch number to a drug
and
[(k) sell or import a drug above the maximum
price fixed under this Act on which the
drug shall be sold or imported.]
(2) Nothing in sub-section (1)
shall apply to the manufacture or subject to prescribed conditions, of small
quantities or any drug for the purpose of clinical trial examination, test,
analysis or personal use.
24. Control of advertisement:
No person shall himself or by any
other person on his behalf advertise, except in accordance with such conditions
as may be prescribed,--
(i) any drug;
(ii) any substance used or
prepared for use in accordance with the ayurvedic, unani, homoeopathic or biochemic
system of treatment or any other substance or mixture of substances as may be
prescribed;
(iii) any remedy, treatment or
offer of a treatment for any disease.
Explanation:
In this section,
"advertise" means to make any representation by any means whatsoever
for the purpose of promoting directly or indirectly the sale or disposal of a
drug, a substance or a mixture of substances, a remedy or a 'treatment except
the display of sign boards for a clinic, a dispensary or a hospital or such
other institution offering treatment.
25. Control of samplings:
No person shall distribute or
cause to be distributed any drug as a sample except in accordance with such
conditions as may be prescribed.
26. Control of printing of labelling:
No person shall print any
labelling in respect of any drug which is required to be registered under this
Act but is not so registered after the date fixed by the Federal Government
under sub-section (6) of section 7 or for a person who does not possess a licence
under this Act to manufacture that drug.
CHAPTER IV
OFFENCES, PENALTIES AND PROCEDURE
27. Penalties:
(1) Whoever himself or by any
other person on his behalf:
(a) exports, imports, manufactures for sale or sells any spurious drug
or any drug which is not registered;
(b) manufactures for sale any drug without a
licence; or
(c) imports without licence any drug for the import of which a licence
is required; shall be punishable with
imprisonment for a term which shall not be less than five years or more than ten years and with fine
which may extend to five lakh rupees:
Provided that the Drug Court may,
for any special reasons to be recorded, award a sentence of imprisonment for a
term of less than three years.
(2) Whoever himself or by any
other person on his behalf—
(a)imports, manufactures for sale or sells any
imitation product; or
(b) gives to the purchaser a false warranty in
respect of any drug sold by him that the drug does not in any way contravene
the provisions of Section 23 and is not able to prove that, when he gave the
warranty, he had good and sufficient reason to believe the same to be true; or
(c) applies or permits to be applied to any
drug sold, or stocked or exhibited for sale, by him, whether on the container
or a label or in any other manner, a warranty given in respect of any other
drug, or
(d) imports, manufactures for sales or sells
any drug under a name other than the registered name; or
(e) exports, imports, manufactures for sale or
sells any drug with which any substance, which should not actually be its
component, has been mixed or packed so as to reduce its quality or strength or
for which any such substance has been substituted wholly or in part; shall be
punishable with imprisonment for a term which may extend to seven years, [and
with fine which may extend to one lakh rupees 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 one year, or with fine which may extend to ten thousand rupees, or with
both.
(4) Subject to the provisions of
sub-section (1), sub-section (2) and sub-section (3), whoever himself or by any
other person on his behalf contravenes any of the provisions of this Act or any
rule shall be punishable with imprisonment for a term which may extend to five
years, or with fine which may extend to fifty thousand rupees, or with both.
28. Penalty for subsequent offence:
(1) Whoever having been convicted
of an offence under sub-section (1) of section 27 is again [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 five
years and with fine which may extend to ten lakh rupees.
(2) Whoever having been convicted
of an offence under sub-section (2) of section 27 is [convicted for a
subsequent offence] under that sub-section shall be punishable with
imprisonment for a term which shall not be less than two years or more than ten
years, or with fine which may extend to two lakh rupees, or with both.
(3) Whoever having been convicted
of an offence under sub-section (4) of section 27 is [convicted for a
subsequent offence] under that sub-section shall be punishable with
imprisonment for a term which may extend to seven years, or with fine which may
extend to one lakh rupees, or with both.
29. Forfeiture:
(1) Where any person has been
convicted under this Act, for contravening any such provisions of this Act or
any rule as may be prescribed in this behalf, the Drug Court may order that the
stock of drug or substance by means of or in relation to which the offence was
committed or anything of a similar nature belonging to or in the possession of
the accused or found with such drug or substance, and if such contravention is
punishable under sub-section (1) of section 27, any implements used in
manufacture or sale of such drug and any receptacles, packages or coverings in
which such drug is contained and the animals, vehicles, vessels or other
conveyances, used in carrying such drug, be forfeited to the Federal Government
or, as the case may be, the Provincial Government and, upon such order being
made, such .drug, substance, implements, receptacles, packages or coverings,
animals, vehicles, vessels or conveyance may be disposed of as that Government
may direct.
(2) Without prejudice to the
provisions of sub-section (1), where the Drug Court is satisfied on the
application of an Inspector or otherwise, and after such inquiry as may be
necessary that a drug contravenes the provisions of this Act, the Drug Court
may order that such drug be forfeited to the Federal Government or, as the case
may be, the Provincial Government and, upon such order being made, such drug
may be destroyed or
Otherwise disposed of as that
Government may direct.
(3) An Inspector shall release
any drug or article seized by him under this Act when he is satisfied that all
the provisions of this Act and the rules with respect thereto have been complied
with.
30. Cognizance of offences:
(1) Subject to the provisions of
Section 19, no prosecution shall be instituted under this Chapter except--
(a) by a Federal Inspector, where the
prosecution is in respect of a contravention
of clause (h) of sub-section (1) of section 23 or section 24 or any of
the provisions of this Act or the rules
relating to the import or export of drugs or the manufacture for sale, or sale, of a drug which is not for
the time being registered or for the
manufacture for sale of which a licence is not for the time being in
force; or
(b) by a Provincial Inspector:
Provided that, where the public
interest so requires, the Federal Inspector may, with the prior permission of
the Federal Government, institute a prosecution for a contravention of any
other provision of this Act.
(2) Notwithstanding anything
contained in the Code of Criminal Procedure, 1898 (Act V of 1898),
(a) an offence punishable under this Chapter
other than an offence mentioned in
sub-section (1) of section 27, shall be non-cognizable, and
(b) no Court other than a Drug Court shall try
an offence punishable under this
Chapter.
(3) Nothing contained in this
Chapter shall be deemed to prevent any person from being prosecuted under any
other law for any act or omission which constitutes an offence punishable under
this Chapter or to require the transfer to a Drug Court of any case which may
be pending in any Court immediately before the establishment of the Drug Court.
31. Drug Courts:
(1) The Federal Government may,
by notification in the official Gazette, establish as many Drug Courts as it
considers necessary and, where it establishes more than one Drug Court, shall
specify in the notification the territorial limits within which, of the class
of cases in respect of which, each one of them shall exercise jurisdiction
under this Act.
(2) A Drug Court shall consist of
a person who is, or has been, or is qualified for
appointment as, a Judge of a High
Court, who shall be the Chairman, and two members being persons who, in the
opinion of the Federal Government, are experts in the medical or pharmaceutical
fields.
[Provided that for deciding
applications of bail the chairman any one member shall constitute full quorum
of a Drug Court.] (3) A Drug Court
shall sit at such place or places as the Federal Government [ as the case may
be, the Provincial Government] may direct.
(4) A Drug Court shall have all
the powers conferred by the Code of Criminal Procedure, 1898 (Act V of 1898),
on a Court of Session exercising original jurisdiction.
(5) A Drug Court shall not merely
by reason of a change in its composition, be bound to recall and rehear any
witness who has given evidence, and may act on the evidence already recorded by
or produced before it.
(6) A Drug Court shall, in all
matters with respect to which no procedure has been prescribed by this Act,
follow the procedure prescribed by the Code of Criminal Procedure, 1898 (Act V
of 1898), for the trial of summons cases by Magistrates.
(7) A person sentenced by a Drug
Court may prefer an appeal to a Bench of the High Court consisting of not less
than two Judges within thirty days of the judgment.
(8) The provisions of Sections 5
and 12 of the Limitation Act, 1908 (IX of 1908), shall be applicable to an
appeal referred to in sub-section (7).
32. Pleas:
(1) Save as hereafter provided in
this section, it shall be no defence in a prosecution under this Act to prove
merely that the accused was ignorant of the nature, substance or quality of the
drug in respect of which the offence has been committed or of the circumstances
of its manufacture or import, or that a purchaser, having bought only for the
purpose of test or analysis, has not been prejudiced by the sale.
(2) A drug shall not be deemed to
be misbranded or adulterated or sub-standard only by reason of the fact that
there has been added thereto some innocuous substance or. ingredient because
the same is required for the manufacture or preparation of the drug fit for
carriage or consumption and not to increase the bulk, weight or measure of the
drug or to conceal its inferior quality or other defect or there is a
decomposed substance which is the result of a natural process of
decomposition:
Provided that such decomposition
is not due to any negligence on the part of the manufacturer or the drug or the
dealer thereof and that it does not render the drug injurious to health or does
not make it substandard.
(3) A person, not being the manufacturer of a
drug or his agent for the distribution thereof, shall not be liable for a
contravention of section 23 if he proves--
(a) that he did not know, and could not with
reasonable diligence have ascertained, that
the drug in any way contravened the provision of this Act and that the drug while in his possession
remained in the same state as when he
acquired it; and
(b) that he acquired the drug from a duly
licensed manufacturer or his authorised
agent or an importer or an indentor resident in Pakistan under a written
warrant, in the prescribed form stating,
in particular. the batch number of the drug and signed by such person that the drug does not in any
way contravene the provisions of Section
23 and that the drug while in his possession was properly stored and remained in the same state as when he
acquired it and that the drug has been
manufactured by a manufacturer holding a valid licence to manufacture
drugs and permission to manufacture that
drug:
Provided that a defence under
clause (b) shall be open to a person only--
(i) if he has, within seven days of the service on him of the summons,
sent to the Inspector a copy of the
warranty with a written notice stating that he
intends to rely upon it and giving the name and address of the
warrantor, and
(ii) if he proves that he has, within the same period, sent written
notice of such intention to the said
warrantor.
33. Application of law relating to customs and powers of officers of
customs:
(1) The law for the time being in
force relating to customs and to goods the import of which is prohibited by or
under the Customs Act, 1969 (IV of 1969), shall, subject to the provisions of
section 27 of this Act, apply in respect of drugs the import of which is
prohibited under this Act, and officers of customs and officers to whom any of
the functions of an officer of customs have been entrusted under the said Act
shall have the same powers in respect of such drugs as they have for the time
being in respect of such goods as aforesaid.
(2) Without prejudice to the
provisions of sub-section (1), an officer of customs or a Federal Inspector or
any other person as may be authorized 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
[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 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 (Act XLV of 1860), and shall be officially subordinate to such authority
as the Government appointing him may specify in this behalf.
38. Indemnity:
Except as otherwise expressly provided
in this Act, no suit, prosecution or other legal proceeding shall lie against
Government or any other authority or person for anything which is in good faith
done or intended to be done under this Act or any rule.
39. Finality of order, etc.:
Save as otherwise expressly
provided in this Act, every order passed or decision given by any Board, a Drug
Court or any other authority under this Act shall be final and shall not be
called in question by or before any Court or other authority.
40. Publication of result of test or analysis, etc.:
(1) It shall be lawful for the
Federal Government to publish, in such manner as it may deem fit, the result of
any test or analysis of any drug for public information and to pass such orders
relating to the withdrawal of such drug from sale and its disposal as it may
consider necessary.
(2) The Federal Government may,
if it considers it necessary in the public interest so to do, publish for
public information, in such manner as it may deem fit, any information relating
to a drug or to the use of a drug in specified circumstances.
41. Cancellation or suspension of licences:
Where any person has been found
to have contravened any of the provisions of this Act, or the rules in respect
of any drug and the contravention is of such a nature that the import, export,
manufacture or sale of any drug by such person is, in the opinion of the
licensing authority or the Central Licensing Board, likely to endanger public
health, that authority may, after giving such person an opportunity of being
heard, cancel the licence to import, export, manufacture or sell drugs issued
to such person or suspend such licence for a specified period.
42. Cancellation or suspension of
registration of registered drugs:
Where any person has been found
to have contravened any of the provisions of this Act, or the rules in respect
of any registered drug, the Registration Board may, after giving such person an
opportunity of being heard, cancel the registration of such drug or suspend
such registration for a specified period.
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 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 there from; 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 there for;
(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 there for;
(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 there for and mode of
labelling packed drugs and prescribe the
matters which shall or shall not be included in such labels or on the leaflets accompanying the
drugs;
(k) require that the non-proprietary or
chemical or accepted scientific name or the
proprietary name of any specified drug or any ingredient thereof shall
be displayed in the prescribed
manner;
(l) prescribe the requirements and conditions
in respect of good practices in the
manufacture and quality control of drugs;
(m) prescribe conditions for distribution of
samples for sales promotion of drugs;
(n) prescribe the procedure for introduction
in Pakistan of a new drug;
(o) prescribe terms and conditions of members
of the Central Licensing Board and the
Registration Board;
(p) prescribe types of registration of drugs,
the form of application for such
registration, the conditions subject to which such registration may be
granted, the manner of registration and
post-registration and surveillance and deregistration of registered drugs and the fees payable there
for;
(q) prescribe conditions for registration of
indentors, importers, wholesalers and
distributors within Pakistan and any establishment within any foreign
country engaged in the manufacture for
export of a drug and prescribe conditions providing effective and adequate means, by arrangement with the Government
of such foreign country or otherwise, to
enable the licensing authority or the Registration Board to determine from time to time whether drugs manufactured in
such establishment, if imported or offered for
import into Pakistan, shall be refused admission where the public
interest so requires;
Page 31 of 32
(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 there for, where so required;
(v) prescribe measures for securing and
maintaining supplies of drugs at
reasonable prices, conditions to be met in respect of manufacture,
production, pricing, keeping, movement
and disposal of drugs and to fix prices, commissions, discount of the manufacturer, wholesaler,
distributor, retailer or any other dealer
of drugs, to control giving of bonus in cash or kind or in any other
manner to any of the said parties and for
collecting or calling for any information, statistics, records or books with a view to regulating
the matters aforesaid;
(w) specify drugs which may be advertised and
the conditions subject to which such
drugs may be advertised;
(x) prescribe conditions subject to which
small quantities of drugs may be
imported or manufactured or exported for the purpose of examination,
test or analysis, clinical trial or
personal use; and
(y) prescribe any other matter which is to be,
or may be, prescribed by the Federal
Government.
(3) The power to make rules
conferred by this section shall, except on the first occasion of the exercise
thereof, be subject to the condition of previous publication.
44. Power of the Provincial Government to make rules:
(1) The Provincial Government may
by notification in the official Gazette, make rules in respect of the following
matters, namely :-- (a) the establishment of laboratories for testing and
analysing drugs; (b) the qualifications and the procedure, for exercise of
powers and performance of functions of Provincial Inspectors; (c) the forms of
reports to be given by Government Analysts and the manner of application for
test or analysis and the fees payable there for; (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 there for and the condition subject to which such licences may be
issued; (g) the procedure to be followed by the Provincial Quality Control
Board;
(h) and any other matter which is
to be or may be, prescribed by the Provincial Government.
(2) The power to make rules
conferred by this section shall, except on the first occasion' of the 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 (XlII of 1940), by sub-section (1),-
(a) any licence to manufacture
for sale issued there under 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 there under to any person, shall, unless it
expires earlier under the terms thereof, continue to be valid for such periods
as the Federal Government, or as the case may be, the Provincial Government may
by notification in the official Gazette, specify in this behalf:
Provided that in case of drugs to
be imported or exported licences may continue to be issued under the rules
framed under the Drugs Act, 1940, till the rules under this Act are framed or,
as the case may be, a date is fixed under sub-section (6) of section 7 in
respect of drugs in the finished form ready for use.