Updated: Saturday March 01, 2014/AsSabt
Rabi' Thani 29, 1435/Sanivara
Phalguna 10, 1935, at 02:18:11 PM
The Drug Regulatory Authority of
XXI OF 2012
An Act to provide for the establishment of Drug
Regulatory
Authority of Pakistan
[Gazette of
No. F. 9(12)/2012-Legis--The following Act of Majlis-e-Shoora (Parliament)
received the assent of the President on 12th November, 2012, is hereby
published for general information:---
WHEREAS it
is expedient to establish a Drug Regulatory Authority of Pakistan to provide
for effective co-ordination and enforcement of The Drugs Act, 1976 (XXXI of
1976) and to bring harmony in inter-provincial trade and commerce of
therapeutic goods;
AND
WHEREAS it is expedient to regulate, manufacture, import, export, storage,
distribution and sale of therapeutic goods;
AND
WHEREAS the Provincial Assemblies of Khyber Pakhtunkhwa,
It is
hereby enacted as follows:---
CHAPTER-I
PRELIMINARY
1. Short title, extent and commencement.--(1) This Act may be called the Drug Regulatory
Authority of Pakistan Act, 2012.
(2) It extends to the whole of
(3) It shall come into force at once.
2. Definitions.--In this Act, unless there is anything repugnant in the subject or
context,---
(i) “Act” means the Drugs Act, 1976 (XXXI of
1976);
(ii) “Alternative Medicine” means a product used
exclusively in Homeopathic, Unani, Ayurvedic, Biochemic, Chinese or other traditional
system of treatment;
(iii) “Appellate Board” means an Appellate Board
constituted under Section 12 for the disposal of appeals against the decisions
of the Licensing Board or the Registration Board or Pricing Committee;
(iv) “Authority” means the Drugs Regulatory
Authority of Pakistan established under Section 3;
(v) “Biologicals” means biological drugs as
defined in Schedule-I;
(vi) “Board” means the Policy Board of the
Authority constituted under Section 9;
(vii) “CEO” means the Chief Executive Officer of the
Authority appointed under Section 5;
(viii) “Chairperson” means the Chairperson of the
Board;
(ix) “civil servant” means a civil servant as
defined in the Civil Servants Act, 1973 (LXXI of 1973);
(x) “decision” includes an order, determination
or direction of the Authority or the Board made in accordance with laws, rules
and regulations;
(xi) “Director” means director of a department of
the Authority;
(xii) “drug” means drug as defined in Schedule-I;
(xiii) “fee” means fee prescribed by the Board for any
service;
(xiv) “Fund” means the Drug Regulatory Authority of
Pakistan Fund created under Section 19;
(xv) “health and OTC Products (non-drugs)” include
probiotics and disinfectant, nutritional products, food supplements, baby milk
and foods, medicated cosmetics, medicated soaps and medicated shampoos;
(xvi) “Inspector” means the Inspector appointed
under the Act as specified in Schedule-V;
(xvii) “Licensing Board” means a Licensing
Board constituted under Section 7 sub-section (u) of this Act to regulate the
grant of licenses for the manufacture of therapeutic goods;
(xviii) “Medical Device” means medical devices
as specified in Schedule-I;
(xix) “Medicated Cosmetics” means cosmetics
containing drugs as specified in Schedule-1;
(xx) “Member” means a member of the Board;
(xxi) “OTC” mean over-the-counter
non-prescription products;
(xxii) “penalty” means penalty as specified in
Schedule III;
(xxiii) “person” means any individual or any legal
entity;
(xxiv) “Pension Endowment Fund” means an endowment
fund separate from the Fund of the Authority dedicated only for the payment of
pension benefits of Authority’s employees;
(xxv) “pharmaceutical field” means regulation,
manufacturing, quality control, quality assurance, research, academia, import,
export, and pharmacy services in drugs;
(xxvi) “pharmacy services” means services rendered
by a pharmacist in pharmaceutical care, selection, posology, counseling,
dispensing, use, administration, prescription monitoring, pharmacoepidemiology,
therapeutic goods information and poison control, pharmacovigillance,
pharmacoeconomics, storage, sales, procurement, forecasting, supply chain
management, distribution, drug utilization evaluation, drug utilization review,
formulary based drug utilization and managing therapeutic goods at all levels
including pharmacy, clinic, medical store, hospital or medical institution;
(xxvii) “pharmaceutical evaluation” means the
assessment of a detailed pharmaceutical dossier submitted for the registration
of a therapeutic good;
(xxviii) “pharmaceutical dossier” means a set of
documents, as specified in Schedule-I;
(xxix) “prescribed” means prescribed by rules or
regulations under this Act;
(xxx) “Prohibitions” means Prohibitions as
specified in Schedule-II;
(xxxi) “regulation” means the regulations made
under this Act;
(xxxii) “Registration Board” means a Registration
Board constituted under Section 7 sub-section (u) of this Act to regulate the grant
of registration to therapeutic goods;
(xxxiii) “rules” means the rules made under this Act;
(xxxiv) “Secretary” means Secretary of the Board;
(xxxv) “Schedule” means Schedule to this Act; and
(xxxvi) “Therapeutic goods” includes drugs or
alternative medicine or medical devices or biologicals or other related
products as may be notified by the Authority.
CHAPTER-II
AUTHORITY AND BOARD
3. Establishment of the Authority.--(1) As soon as may be, after the commencement of this
Act, the Federal Government shall, by notification in the official Gazette,
establish an Authority to be known as the Drug Regulatory Authority of
Pakistan, to carry out the purposes of this Act.
(2) The Authority shall be a body corporate
having perpetual succession and a common seal, and may sue and be sued in its
own name and, subject to and for the purposes of this Act, may enter into
contracts and may acquire, purchase, take, hold and enjoy moveable and
immovable property of every description and may convey, assign, surrender, yield
up, charge, mortgage, demise, reassign, transfer or otherwise dispose of or
deal with, any moveable or immovable property or any interest vested in it.
(3) The Authority shall be an autonomous body
under the administrative control of the Federal Government with its
headquarters at
(4) The Authority may set up its establishments
including sub-offices and laboratories at provincial capitals and such other
places, as it may deem necessary from time to time. The existing Federal Drugs
Control Administration and the sub-offices set up in all provinces and
laboratories called the Central Drugs Laboratory,
(5) The
common seal of the Authority shall be kept in the custody of the Chief
Executive Officer or such other person as may be prescribed by regulations and
documents required or permitted to be executed under the common seal shall be
specified and authenticated in such manner as may be prescribed by regulations.
4. Composition
of the Authority.--(1) The Authority
shall consist of a full time Chief Executive Officer (CEO) and thirteen
Directors who shall be appointed by the Federal Government on the
recommendation of Board, whose qualifications, terms and conditions shall be
such as may be prescribed. The Directors shall be designated as:---
(a) Director
Pharmaceutical Evaluations and Registration.--He shall be incharge of the
Division of Pharmaceutical Evaluations and Registration which shall be
responsible for the evaluation, assessment and registration of Pharmaceuticals
drugs for human beings, animals and to perform other functions connected
therewith and assigned by the Board;
(b) Director
Drug Licensing.--He shall be the incharge of the Division of Drug Licensing
which shall be responsible for the licensing of the drugs manufacturing
facilities and to perform other functions connected therewith;
(c) Director
Quality Assurance and Laboratory testing.--He shall be incharge of the
Division of Quality Assurance and Laboratory testing which shall be responsible
for enforcement of current Good Manufacturing Practices under the Act, and for
testing or research of drugs and to perform other functions connected
therewith. The Division will also perform the functions related to post
marketing surveillance and shall be responsible for the evaluation,
co-ordination and monitoring of safety, efficacy and quality of registered
drugs and inactive materials including the clinical and toxicological study,
drug recalls and with drawls, and to perform other functions connected
therewith;
(d) Director Medical Devices and Medicated
Cosmetics.--He shall be incharge of the Division of Medical Devices and
Medicated Cosmetics which shall be responsible for the assessment, enlistment
or registration of medical devices and medicated cosmetics, medicated shampoos
and medicated soaps for human beings, animals and to perform other functions
connected therewith;
(e) Director
Biological Drugs.--He shall be incharge of the Division of Biological
Evaluation and Research which shall be responsible for the evaluation,
assessment, registration and licensing of Biologicals for human beings, animals
and to perform other functions connected therewith including all the functions
of national control authority for biologicals as required for the
prequalification by World Health Organizations of locally manufactured human
biological drugs;
(f) Director
Controlled Drugs.--He shall be incharge of the Division of Controlled Drugs
which shall in consultation with the Federal Government be responsible for
regulation and allocation of quota of narcotic drugs, psychotropic substances
and precursor chemicals and to perform other functions connected therewith;
(g) Director
Pharmacy Services.--He shall be incharge of the Division of Pharmacy
Services which shall be responsible for the development and promotion of
pharmacy services and to perform other functions connected therewith;
(h) Director
Health and OTC Products (non-drugs).--He shall be incharge of the Division
of Health and OTC Products (non-drugs) which shall be responsible for the
assessment, licensing and registration of Alternative Medicines such as Ayurvedic,
Chinese, Unani and Homeopathy, enlistment or registration of nutritional
products and food supplements for human beings, animals and to perform other
functions connected therewith;
(i) Director
Costing and Pricing.--He shall be incharge of the Division of Costing and
Pricing which shall be responsible for the costing and pricing of therapeutic
goods and to perform other functions corrected therewith;
(j) Director
Budget and Accounts.--He shall be incharge of the Division for Budget and
Accounts which shall be responsible for budgetary and financial aspects of the
Authority and other daily accounting matters connected therewith or ancillary
thereto;
(k) Director
Administration, Human Resource and Logistics.--He shall be incharge of the
Division for Administration, Human Resource and Logistics which shall be
responsible for administration, recruitment, appointment, capacity building and
development for the Authority and other matters connected therewith and
ancillary there to;
(l) Director
Legal Affairs.--He shall be incharge of the Division for Legal Affairs
which shall be responsible for legal aspects of the Authority and other matters
connected with Drug Court and other Court cases therewith or ancillary thereto;
and
(m) Director
Management Information Services.--He shall be incharge of the Division for
Management Information Services which shall be responsible for development of
automation of functions using information technology for the Authority and
other matters connected therewith and ancillary there to;
(2) The Federal Government, on the
recommendations of the Board may increase or decrease the number of Divisions
or Director and prescribe their functions and the relevant experience,
qualification, terms, mode and manner of appointment of Directors and related
staff in each Division.
5. Chief Executive Officer.--(1) The Federal Government may, on the recommendations
of the Board appoint a person as Chief Executive Officer who,---
(a) has a post graduate degree in Pharmacy or
medicine with an age not less than 45 years or more than 56 years, with a
minimum of twenty years experience in management or pharmaceutical field or
regulatory affairs, in public sector, or if no such person of aforesaid
qualifications is available in the public sector, then a person possessing
above qualifications and experience from the private sector;
(b) the tenure of appointment of CEO shall be
for a period of three years, extendable on the recommendation of the Board for
one year only; and
(c) the CEO shall exercise general Control and
supervision over the affairs of the Authority and shall ensure the provisions
of the Act, the rules, and that the regulations, policies and directions of the
Board are properly executed;
(2) The CEO shall discharge such duties and
perform such functions as are assigned to him by or under this Act or as may be
prescribed by the Board and in particular shall,---
(a) keep in custody the records and seal of the
Authority;
(b) submit plan of work and budget estimates of
the Authority for approval of the Board; and
(c) submit to the Board, in accordance with the
rules and regulations reports on the activities of the Authority.
(3) The CEO shall also have the power to,---
(a) supervise the activities connected with the
execution of programs for training, research, institutional consultancies, and
other services;
(b) authorize expenditure provided for in the
budget in accordance with the rules and regulations;
(c) re-appropriate funds within the approved
budget;
(d) delegate his powers to appropriate levels
of management subject to such conditions as he may deem fit;
(e) issue notices of meetings of the Board and
Appellate Board and to maintain proper record of the minutes and proceedings
thereof;
(f) execute deeds and documents on behalf of
the Board; and
(g) perform any other duty assigned to him by
the Board.
(4) The CEO shall not, except with the prior
approval of the Board in each case or unless already approved in the budget
duly itemized, allow expenditure on items of civil works, or capital expenditure
on office or laboratory equipment or automobiles,
(5) The CEO may tender his resignation under
his own hand.
(6) In case of occurrence of vacancy of CEO the
Federal Government is authorised to appoint any person having prescribed
qualification as CEO for a period of three months or till the appointment of
CEO, whichever is earlier.
6. Meeting
of the Authority.--(1) Save as
hereinafter provided, the Authority shall regulate the procedure for its
meetings.
(2) The
meetings of the Authority shall be convened by the CEO at any time on his own
or as directed by the Policy Board on any matter requiring decision by the
Authority.
7. Powers
and functions of the Authority.--The
powers and functions of the Authority shall be to,---
(a) administer the laws specified in the
Schedule-VI that apply to Federal Government, and advise the Provincial
Governments for the laws that are applicable to the Provinces;
(b) monitor the enforcement of laws specified
in the Schedule-VI and collect relevant data and information;
(c) issue guidelines and monitor the
enforcement of,---
(i) licensing
of the manufacture of therapeutic goods;
(ii) registration
of therapeutic goods;
(iii) regulation
for the advertisement;
(iv) drug
specifications and laboratory practices;
(v) prosecution
and appeals under this Act and the Drugs Act, 1976 (XXXI of 1976) relating to
Federal subject;
(vi) regulation
and allocation of quota of narcotic drugs, psychotropic substances and
precursor substances (chemicals) in consultation with Federal Government;
(vii) regulation
for pricing and mechanism for fixation of prices of various therapeutic goods
under its ambit;
(viii) determining
standards for biological manufacturing and testing;
(ix) implementation
of internationally recognized standards such as good laboratory practices,
current good manufacturing practices, good distribution practices, cold chain
management, bioequivalence studies, stability studies, anti-spurious codes,
clinical trials, biosimilar evaluations, and endorsement and systematic implementation
of World Health Organization, International Confer-ence on Harmonizations and
Food and Drug Administration guidelines etc.;
(x) regulation,
enforcement and monitoring of advertisement rule and ban on false
advertisement;
(xi) manufacturing
of active pharmaceutical ingredients in all its forms; and
(xii) use
of central research fund.
(d) co-ordinate, monitor or engage, in
conjunction with other organizations, Provincial Governments and international
agencies, in training, study or project related to therapeutic goods. The
Authority may engage any individual or counsel to advise or work for managing
national and international opportunities for training, education, seminars,
conferences etc., with a view to improve capacity building;
(e) facilitate advancement and up gradation of
the sector to meet international standards and also to promote manufacture and
export of active pharmaceutical ingredients and therapeutic goods;
(f) co-ordinate at policy level and provide
policy guidance to the Provincial Government in the performance of their
functions with a purpose to bring uniformity;
(g) facilitate the procurement and
implementation of foreign aided technical assistance on therapeutic goods where
such expertise does not exist but its existence would promote public good;
(h) take steps for development and promotion of
pharmacy services;
(i) undertake awareness campaigns regarding
prevention of diseases, patients’ rights, healthcare privileges etc., through
media, seminars, publications, and other available means of information
technology;
(j) issue guidelines and monitor proceedings
and funding and accounts of health seminars, workshops and conferences;
(k) advise the Federal Government on issues
related to obligations and commitments related to therapeutic goods;
(l) appoint such employees, consultants and
experts as deemed necessary on prescribed terms and conditions including their
salaries and remunerations with consultation and approval of the Board. Such
recruitment, continuation and remuneration shall be based on merit and
productivity;
(m) prescribe rules for seniority, promotion,
code of conduct and terms and condition of service of its employees;
(n) levy such charges or fees as may be
prescribed for services and facilities provided by the Authority and its
offices;
(o) enter into contract for the supply of
materials or for the execution of works as may be necessary for the discharge
of any of its duties and functions;
(p) prepare annual budget to be approved by the
Board;
(q) to monitor and regulate the marketing
practices, so as to ensure rational use of drugs, and ethical criteria for
promotion of therapeutic goods in line with international practices;
(r) develop working manuals, guidelines,
references, materials and procedures in order to improve the working
environment of offices etc., set up under the Authority;
(s) prescribe, regulate or implement measures
and standards on matters related or connected with the Authority;
(t) develop, issue, adopt, and enforce the
standards and guidelines to ensure safety, efficacy, and quality of therapeutic
goods with rational use at reasonable price;
(u) perform licensing, registration, pricing
and appellate function thereof;
(v) co-ordinate with Provincial Governments and
International agencies for smooth implementation of laws, capacity building and
training of the regulatory staff;
(w) develop standard operating procedures,
manuals, guidelines for transparent working of offices and conduct quality
audits for conformance of the same;
(x) establish system of cost recovery to ensure
financial autonomy and efficient functioning of the authority without becoming
burden on the Government; and
(y) perform and carry out any other act, duty
or function as may be assigned to it by the Policy Board and the Federal
Government for furthering the provisions of this Act.
8. Delegation of powers.--The Authority may with the approval of the Board, by
general or special order in writing subject to such conditions or limitations,
delegate any of its powers and functions to any of its officers as it may deem
appropriate.
9. Policy Board.--(1) The general direction, administration and monitoring of the
Authority shall vest in the Policy Board which shall consist of fifteen
members, namely:---
|
(a) Secretary of the concerned Division
(Federal Secretary BS-22) |
Chair Person |
|
(b) CEO |
Member |
|
(c) Representative of Ministry of Law and
Justice not below BPS-20 |
Member |
|
(d) Secretary of the concerned Department,
Government of the Balochistan |
Member |
|
(e) Secretary of the concerned Department,
Government of the Sindh |
Member |
|
(f) Secretary of the concerned Department,
Government of the Khybcr Pakhtunkhwa |
Member |
|
(g) Secretary of the concerned Department,
Government of the |
Member |
|
(h) Secretary of the concerned Department, Government
of the Gilgil-Bultistan |
Member |
|
(i) Representative from Federally
Administered Tribal Area |
Member |
|
(j) Six experts from the public and private
sector with equal representation from each Province, these members shall be
from different specialties as defined in sub-section (3) below. |
Member |
(2) The
CEO shall also be the Secretary of the Board. The Board shall look after and be
responsible for the affairs of the Authority.
(3) The
Federal Government shall, by notification in the official Gazette, appoint six
expert members, with representation from the Provinces, under Clause (j) of
sub-section (1) preferably one from each province having specialty in the
fields of drug manufacturing, quality control, drug regulation, public health,
pharmacy services, health finance, health economics, health management,
pharmacology, or biotechnology:---
Provided
that unless earlier removed by the Federal Government the term of the expert
member shall be two years and shall be eligible for one more similar term only.
The expert member may resign his office by writing under his hand addressed to
the Federal Government:---
Provided
further that the expert member shall himself attend the meeting and shall not
send a representative;
(4) No act or proceeding of the Board shall be
invalid by reason only if the existence of a vacancy in the constitution of the
Board.
(5) Notwithstanding the composition of the
Board constituted by the Federal Government under sub-section (1), the Board
may increase or decrease the number of its members and prescribe the
qualifications and procedure for their appointment.
10. Meeting
of the Policy Board.--(1) The
meetings of the Board shall be convened by the Secretary of the Board with the
prior approval of the Chairperson. In case of absence of the Chairperson, the
members present may elect the Chairperson for that meeting.
(2) The meetings of the Board shall be held at
twice a year or more as and when required. A special meeting may also be called
at any time to deal with any urgent business.
(3) Save as hereinafter provided, the Board
shall make regulations for the conduct of its business.
(4) A simple majority of the total membership
shall constitute the quorum for a meeting of the Board and in case of equality
of votes, the Chairperson or the person presiding over the meeting shall have a
casting vote.
(5) All decisions or determinations taken by
the Board shall be recorded in writing.
(6) The Board meeting shall be called by giving
an advance notice of at least seven days.
11. Functions
of the Board.--(1) The Board shall
have the following functions, namely:---
(a) frame the policy and provide guidelines
based on global and regional trends to the Authority and monitor the
implementation and performance of the guidelines and of the functions of the Authority
ensuring good governance and accountability;
(b) monitor and supervise all the functions of
the Authority;
(c) approve the Budget of the Authority; and
(d) determine all fees and levies.
12. Appellate Board and Committees of the Policy
Board.--(1) The Board may constitute
Appellate Board and Committees of experts as it considers necessary or
expedient to assist it in the performance of its functions under this Act.
(2) A
Board and Committee constituted under sub-section (1) shall act in accordance
with the regulations made by the Board.
13. Invitation
by Board.--The Board may invite any
person to attend its meeting or deliberations including any meeting of the
Appellate Board or its Committees constituted under Section 12, for the purpose
of advising it on any matter under discussion but such person shall have no
right to vote at the meeting or deliberation.
14. Appointment
of officers and employees etc., of the Authority.--(1) The Authority, with approval of the Board, may
create posts and appoint such officers, employees, experts and consultants, as
it may consider necessary, for the performance of its functions in the
prescribed manner. The criteria for recruitment and selection of employees and
officers will be determined by the Board according to the rules as prescribed.
(2) The age of superannuation for each employee
shall be sixty years.
(3) No person shall be appointed as the CEO or
Director of the Authority unless he is a citizen of
15. Integration
of Federal Drugs Control Administration its sub-offices and Laboratories.--(1) Upon the commencement of this Act the Drugs
Control Administration, its sub-offices and its Laboratories hereinafter
referred to as the said offices as referred in sub-section (4) of Section 3
shall become part of the Authority.
(2) All assets, rights, powers, authorities and
privileges and all properties, movable and immovable, cash and bank balance,
reserve funds, investment and all other interest rights in, or arising out of
such properties and all debts, liabilities and obligation of whatever kind of
the said offices subsisting immediately before there integration shall stand
transferred to and vest in the Authority.
(3) All debts and obligation incurred or
contracts entered into or rights acquired and all matters and things engaged to
be done by, with or for the said offices before their integration, shall be
deemed to have been incurred, entered into, acquired or engaged to be done by
for the Authority.
(4) All suits and other legal proceedings instituted
by or against the said offices before their integration shall be deemed to be
suits and proceedings by or against the Authority and may be proceeded or
otherwise dealt with accordingly.
(5) Notwithstanding anything contained in any
contract or agreement or in the conditions of services,---
(a) every employee of the said offices under
the Federal Government immediately after the commencement of this Act shall be
required to exercise an irrevocable option either to continue in the present
pay and service structure as a civil servant or to opt for absorption in the
Authority within a period of thirty days from the date of commencement of this
Act;
(b) all employees who opt to be included in the
Authority under its rules shall be governed by this Act and the terms and
conditions so prescribed;
(c) no health personnel who opts to be governed
under this Act shall be entitled to any compensation because of such transfer;
and
(d) the terms and conditions of service of all
officers and staff employed in the Drug Regulatory Agency of Pakistan under
Ordinance (I of 2012) before the commencement of this Act shall not be varied
to their disadvantage under the Authority.
16. Experts,
consultants and advisers not to be civil servants.--The experts, consultants, employees or advisers
employed by the Authority shall be governed by the terms and conditions of
their appointment and shall not be deemed to be civil servant within the
meaning of Civil Servants Act, 1973 (LXXI of 1973).
17. CEO and
officers etc., to be public servants.--The
CEO. officers, employees, experts and consultant of the Authority shall, when
acting or purporting to act in pursuance of any of the provisions of this Act,
be deemed to be public servants within the meaning of Section 21 of the
Pakistan Penal Code (Act, XLV of 1860).
18. Conflict of interest.--(1) No person shall be appointed as CEO, Director,
consultant, advisor, officer or employee of the Authority if he or she has any
financial or professional conflict of interest.
(2) No
person shall be member of the Board or Director if he has immediate family
members (parent, child, sibling or spouse) as senior officials or owners of
concerns dealing in therapeutic goods.
CHAPTER-III
FUND, BUDGET AND ACCOUNTS
19. Drug Regulatory Authority of Pakistan Fund.--(1) There shall be a fund to be known as the Drug
Regulatory Authority of Pakistan Fund which shall vest in the Authority and
shall be utilized by the Authority to meet us expenses and charges properly
incurred in connection with the carrying out of its functions and duties
assigned or transferred to it under this Act, including but not limited to the
payment of salaries and other remuneration to the CEO, Director, members of the
different Boards, employees, experts, consultants and advisers of the Authority.
(2) The Drug Regulatory Authority Funds shall
be financed from the following sources namely:---
(a) grant-in-aid in terms of salaries and
retirement benefits of the existing staff to be provided by the Federal
Government;
(b) donations and endowments;
(c) grants and loans by the Federal Government
or a Provincial Government;
(d) loans and grants from the national and
international agencies received by the Federal Government and Provincial
Governments to finance the function of the Authority;
(e) charges and fees collected by the Authority
to recover the costs of regulated activities under this Act;
(f) proceeds of any investments made by the
Authority which are not required for immediate use. All investments to be made
by the Authority shall be with the approval of the Board;
(g) proceeds from any other service rendered by
the Authority, including Inspection Services, foreign or local, or sale of any
publication; and
(h) Central Research Fund collected from the
pharmaceutical industry.
(3) At the end of each financial year, the
balance sheet shall be prepared and any un-spent remaining amount and all other
collections including Central Research Fund shall be securely invested only in
Government schemes in order to achieve self-sufficiency of the Authority.
(4) A separate pension endowment fund shall be
established for the payment of pensions of employees recruited in the
Authority.
20. Fees and other charges to be levied by the
Authority.--(1) The Authority shall
levy and collect such fees, in respect of any of its functions at such rates as
may be determined, from time to time by the Authority, with the approval of the
Policy Board, in accordance with rules.
(2) The Central Research Fund fee shall be
deposited in the non-lapsable sub-account of the Authority to be utilized as
per existing rules.
(3) The existing Central Research Fund kept
with the Federal Government shall be transferred to the Authority immediately
after the notification of establishment of the Authority.
21. Budget.--(1) The Authority shall, in respect of each financial
year prepare on such date as may be prescribed a statement of the estimated
receipts and expenditure, including the revised and estimated budgets,
requirements of grant-in-aid from Federal Government, and foreign exchange for
the next financial year for consideration and approval of the Board. Any
foreign exchange requirements within the overall annual approved budget by the
Board shall be sent to Federal Government for appropriate provision and
allocation.
(2) It
shall not be necessary for the Authority to take prior approval from the
Government to spend money from its own generated funds, and shall practice
financial freedom as the Board deem fit for furtherance of its functions.
22. Accounting
and Audit.--(1) The Authority may
open its accounts with any scheduled Bank or financial institution within the
framework of the prescribed rules. The Authority may approach the Government,
for the grant of initial funds in this respect.
(2) The accounts of the Authority shall be maintained
as a double entry system and in the manner prescribed by the Controller General
of Accounts.
(3) The Authority shall cause to be carried out
audit of its accounts by one or more auditors registered as chartered
accountants within the meaning of the Chartered Accountants Act, 1961 (X of
1961).
(4) Notwithstanding the audit provided by in
sub-section (3) the Auditor General shall have the power to audit or cause to
be audited the accounts of the Authority.
(5) A copy of the audit report shall be sent to
the Federal Government along with the comments of the Authority.
(6) The Authority shall take the requisite
steps for the rectification of any objection raised by the Auditor-General of
CHAPTER-IV
RULES AND REGULATIONS
23. Power to
make rules.--The Authority may, with
the approval of the Federal Government, by notification in the official
Gazette, make rules for carrying out the purposes of this Act.
24. Power to
make regulations.--The Authority may,
by notification in the official Gazette, with the approval of the Board, make
regulations, for its internal working and terms and condition of employees not
inconsistent with the provisions of the Act or the rules, for the carrying out
of its functions under ityis Act.
CHAPTER-V
MISCELLANEOUS
25. Submission
of annual reports and returns.--(1)
Within three months of the conclusion of each financial year, the Authority
shall submit an annual report to the Federal Government in respect of the
activities of the Authority including the status of its existing programs,
projects and further plans formulated in furtherance of its aims and
objectives.
(2) The Federal Government may require the
Authority to furnish:---
(a) any return, statement, estimate, statistics
or other information regarding any matter under the control of the Authority;
(b) a report on any subject related to the
Authority; and
(c) a copy of any document in the custody of
the Authority;
(3) The Authority shall expeditiously comply
with such directions.
26. Power to
call for information.--The Authority
may call for any person, involved directly or indirectly, and reasonably
believed to having such information in his control or possession which is
required for carrying out the purposes of this Act. The person so called upon
to provide such information shall do so within the period prescribed by the
Authority and in case of failure to do so he shall be punished by imposition of
such penalty which may not exceed one hundred thousand rupees.
27. Offences,
penalties etc.--(1) The offences
shall be such as specified in Schedule-III.
(2) The
prohibition specified in Schedule-II shall be punished in accordance with
Schedule-III.
28. Offences
by companies etc.--Where the person
guilty of an offence under this Act or the Drugs Act, 1976 (XXXI of 1976), 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.
29. Cognizance of offences.--Cognizance of offences shall be taken by the Inspector
in the manner specified in Schedule-IV.
30. Complaints.--(1) Any aggrieved person may file a written complaint
with the Authority against contravention of any provision of this Act or any
law specified in Schedule-VI.
(2) The Authority shall, on receipt of a
complaint cause it to be investigated as may be prescribed and provide an
opportunity to the complainant as well as the person against whom such
complaints has been made. The Authority may, on completion of investigation,
take any action as may be prescribed under this Act or as the case may be
subject to the provisions of any law specified in the Schedule-VI.
(3) Appeals against the decisions of the
Authority shall be referred to the Board, which shall formulate an Appellate
Board from among its members, who shall decide the case on merit.
31. Confidential
information.--(1) Except as provided
under the regulations, no person shall communicate, or allow to be
communicated, any record or information obtained under this Act to a person not
legally entitled to that record or information or allows any person not legally
entitled to that record or information to have access to any record obtained
under this Act.
(2) A
person who knowingly receives records or information obtained under this Act
shall hold the record or information subject to the same restrictions under
sub-section (1) as apply to the person from who the records or information were
received.
32. Act not
to override other laws.--(1) The
provisions of this Act shall be in addition to and not in derogation of the
provisions made in the Drugs Act, 1976 (XXXI of 1976) and any other law for the
time being in force.
(2) In
case of inconsistency between the provisions of this Act and any other law for
the time being in force, the provisions of this Act shall prevail.
33. Recovery
of arrears.--All amounts due to the
Authority may be recovered as arrears of land revenue.
34. Indemnity.--No suit prosecution or other legal proceeding shall
lie against any person for anything which is in good faith done or intended to
be done under this Act or any rules or regulations made there under.
35. Power to
amend Schedule.--The Federal
Government may, by notification in the official Gazette, amend the Schedule so
as to add any entry thereto or modify or omit any entry therefrom on the
recommendation of the Board.
36. Removal
of difficulties.--If any difficulty
arises in giving effect to any of the provisions of this Act, the Federal
Government may make such Order by notification in the Official Gazette, not
inconsistent with the provisions of this Act, for the purpose of removing the
difficulty.
37. Employment
under the Authority to be employment under the Federal Government.--Every employment under the Authority shall, for the
purpose of Pakistan Essential Services (Maintenance) Act, 1952 (LIII of 1952),
be deemed to be employment under Federal Government and the said Act shall have
effect accordingly.
38. Act X of
2012 not to apply to the Authority.--Nothing
contained in the Industrial Relation Act (X of 2012), shall apply to or in
relation to the Authority or any of the officers and employees of the
Institute.
39. Co-operation
with international organizations.--The
Authority may, subject to the prior approval of the Federal Government,
co-operate with any foreign authority or international organization in the
field of health on the terms and conditions of any program or agreement for
co-operation to which such authority or organization is a party, or pursuant to
any other international agreement made or after the commencement of this Act.
40. Repeal
and Savings.--(1) The Drug Regulatory
Agency of Pakistan Ordinance, 2012 (Ordinance I of 2012) is hereby repealed.
(2)
Notwithstanding the repeal of the Drug Regulatory Agency of Pakistan Ordinance,
2012 (Ordinance I of 2012) by sub-section (1),---
(a) any license to manufacture or any
registration or maximum retail price fixed for sale issued thereunder to any
person, or for the revalidation of an license or registration issued earlier
under the Act, for which an application has been made to the Licensing Board,
Registration Board, and Drug Pricing Committee as the case may be within the
specified time, shall continue to be valid;
(b) any license 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, may by notification in the official Gazette, specify in this
behalf.
(3) All such actions of the Federal Government
as mentioned in sub-section (2) since 20th April, 2010 shall be deemed to have
validly made under this Act.
41. Policy
Directive of Federal Government.--(1)
The Federal Government may issue policy directives in accordance with the law
and Constitution to the Board in respect of any of its activities, powers and
functions and whose compliance shall be binding on the Authority, within a
stipulated time.
(2)
Notwithstanding anything contained in sub-section (1) if there is any difficulty
in implementation of the directions and guidelines of the Policy Board or the
Federal Government, the Authority shall refer the case back to the Federal
Government for its review specifying reasons for non-implementation, within the
stipulated time, whose decision in this respect shall be final.
42. Winding
up of Authority.--No provision of any
law relating to winding up of bodies corporate shall apply to the Authority.
The Authority shall only be wound up by the law to be enacted by the Parliament
for winding up of the Authority).
SCHEDULE-I
[See Section 2
(v, xii, xviii, xix, & xxviii)]
1. BIOLOGICALS
includes,---
(1) Biological drugs produced by biological
systems and which require standardization by biological assays according to the
relevant and updated recommendations of the World Health Organization published
in Technical Report Series and Biological Standardization Report and includes,---
(a) blood
products including Plasma, Albumin, Clotting Factors, Factors VIII, IX, Mixed
Clotting Factors Tractions, Fibrinogens, Immunoglobulins;
(b) immunological
products including Antisera, Antitoxins, specific Immunoglobulins;
(c) in
vivo diagnostics including Tuberculins, Lepronin, Histoplasmin, Coccidioidin,
Allergens, Allergens Extracts, Antibodies conjugated with isotopes for imaging
studies;
(d) antigens,
cytokines/antibodies/eells injected to elicit a biological response;
(e) vaccines,
including:---
(i) bacterial vaccines including live, killed whole cell, protein
sub-unit, polysacchrid or glyco-conjugate, toxin derivatives, and rDNA
biotechnology developed.
(ii) viral vaccines including live, inactivated, sub-unit, rDNA,
conjugated;
(iii) polyvalent combinations of vaccines containing combination of
vaccines defined in e (i) and d(ii).
(f) toxins
and venoms including snake venoms, scorpion venoms etc;
(g) immunostimulanls
of biological origin including BCG vaccine for immunothcrapy;
(h) biotechnology
products which are primarily manufactured using recombinant DNA, recombinant
RNA, hybridoma technology or other processes involving site specific genetic
manipulation techniques.
(i) human
interferons, natural hormones, recombinant antibodies, monoclonal antibodies
and derivatives gene therapy products;
(2) “Biological Drugs (Finished form)”, are
Biological Drugs that are defined in sub-section (1) above and are
manufactured, packed by the manufacturer under his responsibility of quality
assurance and is further released by the National Control Authority or the
National Control Laboratory of the country of origin under the World Health
Organization’s Lot Release system of evaluation.
(3) “Biological Drugs (Ready-to-fill form)”,
are Biological Drugs that are defined in sub-section (1) above but are
manufactured at one site in the form of a “Ready-to-fill Bulk” but are
transferred to another site for final filling, labeling, packaging and quality
control of the finished form. No further formulation or dilution of the
Ready-to-fill bulk is allowed in this case of manufacture. The final product is
released by the
(4) “Biological Drugs (Concentrated form)”, are
Biological Drugs that are defined in sub-section (1) above that are
manufactured at one site but are stored in the form of Concentrated-Bulk of the
active ingredient at controlled temperatures. Such Concentrated-Bulk may be
transferred to any other site under temperature controlled conditions for
further dilution, stabilization, filling and packaging. The diluted and
stabilized bulk requires its own set of quality control test and the final
finished form of such Biological Drugs under go another set of complete quality
control tests. The final product is released by the
(5) ‘‘Biological Drugs (Naked vials)”, are
Biologicals Drugs that are defined in sub-section (1) above that are
manufactured and filled at one site but the final containers are neither
labeled nor packed in cartons. These drugs are imported in unlabeled vials and
are labeled and packed in carton locally. In such cases at least an identity
test is required to confirm the positive identification of the required
antigen. The final product is released by the
(6) Originator Biological Drugs means a
biological drug which has been licensed by the national regulatory authorities
on the basis of a full registration dossier; i.e. the approved indication(s)
for use were granted on the basis of full quality, efficacy and safety data:---
(a) reference
biotherapeutic product (RBP) means an originator biological drug product that
was licensed on the basis of a full registration dossier. It does not refer to
measurement standards such as international, pharmacopoeial, or national
standards or reference standards;
(b) biosimilar
biological drugs mean Similar Biotherapeutic Product (SBP) which is similar in
terms of quality, safety and efficacy to an already licensed reference
biotherapeutic product;
(c) similarity
means absence of a relevant difference in the parameter of interest.
(7) No human biological drug is allowed sale
and use until a “Lot Release Certificate” from the Federal Government Analyst
of the National Control Laboratory for Biologicals,
(8) Pharmaceutical dossier includes a set of
documents submitted by a Person for the registration of a therapeutic good,
containing complete information about,---
(a) muster
formula;
(b) all
ingredients both active pharmaceutical ingredients and inactive excipients
added with their safety profile data;
(c) complete
manufacturing procedure of the drug, biological or medical device;
(d) quality
control steps and procedures at each level of raw material selection,
in-process testing, finished drug testing, and stability testing;
(e) clinical
trial data and published reports about the safety and efficacy of the drug;
(f) complete
details of manufacturing plant and equipment, quality control laboratories and
equipment;
(g) ware-houses
capacities and facilities; details of human resources available and the latest
cGMP report shall also be part of this document set;
(h) any
other information required by the registration board for establishing the
safety, efficacy, bioavailability, bioequivalence, or biosimilarity of the
drug.
2. DRUG
includes:---
(a) 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, including substance used or prepared for use in accordance
with the Ayurvedic, Unani, Homoeopathic, Chinese or biochemic system of
treatment except those substances and in accordance with such conditions as may
be prescribed;
(b) abortive and contraceptive substances,
agents and devices, surgical ligatures, sutures, bandages, absorbent cotton,
disinfectants, bacteriophages, adhesive plasters, gelatin capsules and
antiseptic solution;
(c) 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;
(d) such pesticides as may cause health hazard
to the public;
(e) 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, Chinese or
Biochemic system of treatment, and intended to be used for any of the purposes
mentioned in sub-Clauses (a), (b) and (c); and
(f) any other substance which the Federal
Government may by notification in the official Gazette, declare to be a drug
for the purpose of this Act.
3. MEDICAL
DEVICES include,---
(a) instruments, medical equipment, implants,
disposables and software, used mainly for the purpose of diagnosis, monitoring
and treatment of disease, or
(b) any other item which the Federal Government
may, by notification in the official Gazette, declare as medical device;
4. MEDICATED
COSMETICS include,—Cosmetics containing drugs and are defined as articles
containing active drug ingredients intended to be rubbed, poured, sprinkled,
or-sprayed on, or introduced into, or otherwise applied to human body or part
thereof for cleansing, beautifying, promoting attractiveness, or altering the
appearance, and articles intended for use as a component of any such articles;
except that such term shall not include soap.
SCHEDULE-II
[See Section
2(xxx)]
PROHIBITIONS
A. Import,
manufacture and sale of therapeutic goods:
(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 therapeutic good;
(ii) any counterfeit therapeutic good;
(iii) any misbranded therapeutic good;
(iv) any adulterated therapeutic good;
(v) any substandard therapeutic good;
(vi) any therapeutic good after its expiry date;
(vii) any therapeutic good which is not registered or is not in
accordance with conditions of registration as disclosed in the registration
dossier and that has undergone pharmaceutical evaluation;
(viii) any therapeutic good 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 labeling thereof; or
(x) any therapeutic good in contravention of any of the provisions
of this Act or rules made thereunder;
(b) manufacture
for sale any therapeutic good except under, and in accordance with the
condition of a license issued under this Act;
(c) sell
any therapeutic good except under, and in accordance with the conditions of a
license issued under this Act;
(d) import
or export any therapeutic good the import or export of which is prohibited by
or under this Act;
(e) import
or export any therapeutic good drug for the import or export of which a license
is required, except under, and in accordance with the conditions of, such
license;
(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 therapeutic good 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 therapeutic good but is presented in a form or a manner which is intended
or likely to cause the public to believe it to be a therapeutic good;
(i) sell
any therapeutic good without having warranty in the prescribed form bearing the
name and batch number of the therapeutic good issued,---
(i) in the case of a therapeutic good manufactured in Pakistan, by
the manufacturer holding a valid license to manufacture therapeutic good and
permission to manufacture that therapeutic good or by his authorized agent;
(ii) in the case of an imported drug, by the manufacture or importer
of that therapeutic good or if the therapeutic good is imported through an
indenter by such indenter; and
(iii) apply an incorrect batch number to a therapeutic good.
(2) Nothing in Paragraph (1) shall apply to the
manufacture of small quantities of any therapeutic good for the purpose of
clinical trial examination, test, analysis or personal use in small quantities.
B. 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,---
(a) any therapeutic good;
(b) any substance used or prepared for use in
accordance with the Ayurvedic, Unani, Homoeopathic, Chinese or Biochemic system
of treatment or any other substance or mixture of substances as may he
prescribed;
(c) any remedy, treatment or offer of a treatment
for any disease.
Explanation.--For the purpose of this entry “Advertise” means to
make any representation by any means whatsoever for the purpose of promoting
directly or indirectly the sale or disposal of therapeutic good, 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.
C. Control
of samplings:---
No person
shall distribute or cause to be distributed any therapeutic good as a sample
except in accordance with such conditions as may be prescribed.
D. Control of
printing of labeling:---
No person
shall print any label in respect of any therapeutic good 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 of Act, or for a
person who does not possess a license under that Act to manufacture that
therapeutic good.
SCHEDULE-III
[See Section
27]
OFFENCE
(1) Whoever himself or by any other person on
his behalf,---
(a) exports, imports, manufactures for sale or
sells any spurious therapeutic good or any therapeutic good which is not
registered;
(b) manufactures for sale any therapeutic good
without a license;
(c) imports without license any therapeutic
good for the import of which a license 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 ten lakh rupees:---
Provided that the
(2) Whoever himself or by any other person on
his behalf,---
(a) imports, manufactures for sale or sells any
counterfeit therapeutic good; or
(b) gives to the purchaser a false warranty in
respect of any therapeutic good sold by him that the therapeutic good does not
in any way contravene the provisions of Schedule II 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
therapeutic good sold, or stocked or exhibited for sale, by him, whether the
container or a label or in any other manner, a warranty given in respect of any
other therapeutic good; or
(d) imports, manufactures for sales or sells
any therapeutic good under a name other than the registered name; or
(e) exports, imports, manufactures for sale or
sells any therapeutic good with which any substance, which should not actually
be its component, or has been mixed or packed it 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, or with fine which may extend to five lakh rupees or
with both.
(3) Obstruction
of Inspector.--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 one lakh rupees, or with
both.
(4) Contravention
of rules.--Subject to the provisions of Clauses (1), (2) and (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 one lakh rupees, or
with both.
(5) Penalty
for subsequent offence.--Whoever having been convicted of an offence under
Clause (1) of Schedule-Ill is convicted for a subsequent offence under that
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 five
hundred thousand rupees.
(6) Penalty
for violating the prohibitions.--Whoever himself or by any other person on
his behalf violates any prohibitions specified in Schedule-II shall be punished
with imprisonment for a term up to five years and with fine up to five hundred
thousand rupees.
SCHEDULE-IV
[See Section 29]
COGNIZANCE OF
OFFENCES
(1) Subject to the provisions of Schedule-V no
prosecution shall be instituted under this Act except,---
(a) by a Federal Inspector, where the
prosecution is in respect of a contravention of Clause (h) of Paragraph (1) of
heading A of Schedule-II or any of the provisions of this Act or the rules
relating to the import or export of therapeutic goods or the manufacture for
sale, or sale, of a therapeutic good which is not for the time being registered
or for the manufacture for sale of which a license 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 Registration Board or Licensing Board as the case may be,
institute a prosecution for a contravention of any other provision of this Act
and The Drugs Act, 1976 (XXXI of 1976).
(2) Notwithstanding anything contained in the
Code of Criminal Procedure, 1898 (Act V of 1898):---
(a) an offence punishable under Schedule-III
other than an offence mentioned in Clause (1) of that Schedule shall be
non-cognizable, and
(b) no Court other than a Drug Court
established under The Drugs Act, 1976, (XXXI of 1976) shall try an offence
punishable under this Act and Drugs Act, 1976 (XXXI of 1976);
(c) nothing contained in this Schedule 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 Act or The
Drugs Act, 1976 (XXXI of 1976) or to require the transfer to a drug Court of
any case which may be pending in any Court immediately before the establishment
of Drug Court.
SCHEDULE-V
[See Section
2(xvi)]
POWERS OF
INSPECTORS
(1)
Subject to the provisions of this Schedule 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 or Licensing
Board as the case may be,---
(a) inspect any premises where in any
therapeutic good is manufactured, the plant and process of manufacture, the
means employed, for standardizing and testing the therapeutic goods and all
relevant records and registers;
(b) inspect any premises wherein any
therapeutic good 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 therapeutic good 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 therapeutic good 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;
(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 any offence under this
Act and the Drugs Act, 1976 (XXXI of 1976) or the rules:---
Provided that the exemption
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 Schedule;
(h) lock and seal any factory, laboratory,
shop, building, store-hose or godown, or a part thereof, where any therapeutic
good is or is being manufactured, stored, sold or exhibited for sale in
contravention of any of the provisions of this Act, the Drugs Act, 1976 or the
rules;
(i) forbid for a reasonable period, not
exceeding four 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 Licensing Board, the Registration Board, as the case may be,
specify, any person in charge of any premises from removing or dispensing of
any therapeutic good, 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 Paragraph (f) to (j) shall be exercisable only by an Inspector
specifically authorized in this behalf, by an order in writing, by the
Government appointing him, subject to such conditions as may be specified in
such order:---
Provided further that the
power under Paragraph (h) may be exercised by an Inspector not authorized as
aforesaid where the contravention is of a provision which requires a license to
be obtained for the manufacture, storage or sale of drug.
(2) The
provisions of the Code of Criminal Procedure, 1898 (Act V of 1898), insofar as
they are not inconsistent with the provisions of this Act and The Drugs Act,
(XXXI of 1976), shall apply to searches and seizures made under this Act.
PROCEDURE FOR
INSPECTORS
(1) Where an Inspector seizes any therapeutic
good or any other article under this Schedule he shall tender a receipt
therefore in the prescribed form.
(2) Where an Inspector takes a sample of a
therapeutic good 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
divided the sample into four portions and effectively seal and suitable 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 therapeutic good is made up in containers of small
volume, instead of dividing a sample as aforesaid, the Inspector may, and if
the therapeutic good 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
also 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 return 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, namely,---
(a) one portion of sample he shall send to the
Government Analyst concerned for test and analysis;
(b) the second he shall send to the Chairman,
Provincial Quality Control Board or the Licensing Board or the Registration
Board, as the case may be; and
(c) the third, where taken, he shall send to
the warrantor, if any, named under proviso to sub-section (3) of Section 32 of
The Drugs Act, 1976 (XXXI of 1976).
(4) Where an Inspector seizes any therapeutic
good 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 therapeutic good to
add his own seal, if any, and mark to it and shall produce the same before the
Drug Court, or the Provincial Quality Control Board, or the 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 this Schedule,---
(a) he shall as soon as practicable ascertain
whether or not the therapeutic good 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 therapeutic
good 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 Schedule-IV, 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 or The Drugs Act, 1976.
(6) The Provincial Inspector on finding any
contravention of this Act or the Drugs Act, 1976 (XXXI of 1976) 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
contraventions.
(7) The Federal Inspector on finding any
contravention of this Act or the Drugs Act, 1976 (XXXI of 1976) for which he is
authorized shall unless otherwise directed, always refer the case to the
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.
SCHEDULE-VI
[See Section
2(i)]
(1) The
Drugs Act, 1976 (XXXI of 1976).
(2) Rules made under the Drugs Act, 1976 (XXXI
of 1976).
Go to Index
| LL. B. – I | LL. B. – II
| LL. B. – III | LL. B.
Directory | Home