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ORDINANCE NO. I OF 2012

DRUG REGULATORY AGENCY OF PAKISTAN ORDINANCE, 2012

An Ordinance to provide for the establishment of Drug Regulatory Agency of Pakistan

[Gazette of Pakistan, Extraordinary, Part-I, 16th February, 2012]

No. F. 2(1)/2012-Pub.—The following Ordinance promulgated by the President is hereby published for general information ;—

WHEREAS it is expedient to establish a Drug Regulatory Agency of Pakistan to provide for effective coordination and enforcement of Drugs Act, 1976 (XXXI of 1976) and to bring harmony in inter-provincial trade and commerce of Drugs and therapeutic goods;

AND WHEREAS that is expedient to regulate, manufacture, import, export, storage, distribution and sale of therapeutic good and medical devices;

AND WHEREAS the Provincial Assemblies of Khyber Paktunkhwa, Punjab and Sindh have passed resolution under Article 144 of the Constitution of the Islamic Republic of Pakistan to the effect that Majlis-e-Shoora (Parliament) may by Law regulate the issue;

AND WHEREAS the Senate and the National Assembly are not in session and the President of Islamic Republic of Pakistan is satisfied that circumstances exist which render it necessary to take immediate action;

Now, THEREFORE, in exercise of the powers conferred by clause (1) of Article 89 of the Constitution of the Islamic Republic of Pakistan, the President is pleased to make and promulgate the following Ordinance:—

CHAPTER-I

PRELIMINARY

1.       Short title, extent and commencement.—(1) This Ordinance may be called the Drug Regulatory Agency of Pakistan Ordinance, 2012.

(2)     It extends to the whole of Pakistan.

(3)     It shall come into force at once.

 

2.       Definitions.—In this Ordinance, unless there is anything repugnant in the subject or context,—

(a)     "Act" means the Drugs Act, 1976 (XXXI of 1976);

(b)     "Agency" means the Drug Regulatory Agency of Pakistan established under Section 3;

(c)     "Board" means the Policy Board of the Agency constituted under Section 11;

(d)     "CEO" means the Chief Executive Officer of the Agency appointed under Section 5;

(e)     "Chairperson" means the Chairperson of the Board;

(f)      "Civil servant" means a civil servant as defined in the Civil Servants Act, 1973 (LXXI of 1973);

(g)     "Decision" includes an order, determination or direction of the Agency or the Board made in accordance with laws, rules and regulations;

(h)     "Drug" means drug as defined in Schedule-I;

(i)      "Fee" means fee prescribed by the Board for any service;

(j)      "Fund" means the Drug Regulatory Agency of Pakistan Fund created under Section 19;

(k)     "Inspectors" means the Inspector appointed under the Act;

(l)      "Medical device" includes—

          (i)      instruments, medical equipment, implants, disposables and software, used mainly for the purpose of diagnosis, monitoring and treatment of disease; or

          (ii)     any other item which the Federal Government may, by notification in the official Gazette, declare as medical device;

(m)    "Member" means a Member of the Board;

(n)     "Therapeutic goods" includes drug or medicine or medical device or biologicals or other related thins as may be notified by the Agency;

(o)     "Penalty" means penalty as specified in Schedule II;

(p)     "Person" includes means any individual or any legal entity;

(q)     "Pharmaceutical field" means regulation, manufacturing, quality control and pharmacy services in drugs.

(r)      "Pharmacy Services" means services rendered by 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, 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;

(s)      "Prescribed" means prescribed by rules or regulations under this Ordinance;

(t)      "Prohibitions" means prohibitions as specified in Schedule III;

(u)     "Regulation" means the regulations made under this Ordinance;

(v)     "Rules" means the rules made under this Ordinance;

(w)    "Secretary" means Secretary of the Board; and

(x)     "Schedule" means Schedule to this Ordinance;

CHAPTER-II

AGENCY AND BOARD

3.       Establishment of the Agency.—(1) As soon as may be, after the commencement of this Ordinance, the Federal Government shall establish an Agency to be known as the Drug Regulatory Agency of Pakistan to carry out the purposes of this Ordinance.

(2)  The Agency shall be a body corporate having perpetual succession and a common seal with powers, subject to the provisions of this Ordinance, to acquire, purchase, hold and dispose of property both movable and immovable and shall by its name sue and be sued.

The Agency shall be an autonomous body under the administrative control of the Federal Government.

(4)     The Headquarters of the Agency shall be at Islamabad.

(5)     The Agency 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, Karachi, the National Control Laboratory for Biologicals, Islamabad and the Surveillance Laboratory, Islamabad shall, upon the commencement of this Ordinance, become part of the Agency, subject to sub-section (2) of Section 14.

4.       Composition of the Agency.—The Agency shall consist of a Chief Executive Officer (CEO) and seven full time Members to be appointed by the Federal Government whose qualifications, terms and conditions shall be such as may be prescribed. The members shall be designated as:

(a)     Member Registration;

(b)     Member Alternative Medicines/Traditional Drugs (Ayurvedic, Unani and Homeopathy);

(c)     Member Biologicals and Medical devices;

(d)     Member Licensing and Quality Control;

(e)     Member Pharmacy Services;

(f)      Member Pricing; and

(g)     Member Administration, Human Resources and Legal Affairs:

Provided that the Federal Government, on the recommendations of the Board, may increase the number of Members and prescribe the qualifications, terms, mode and manner of their appointment.

5.       Chief Executive Officer.—(1) The Federal Government may appoint a person as CEO who has a post graduate degree in pharmacy, public health, or medicine with a minimum of twenty years experience, in pharmacy services, public health, management or regulatory affairs from either public or private sector. The term of appointment shall be for a period of three years and extendable for one similar term only.

(2)  The CEO shall be the head of the Agency and shall discharge such duties and perform such functions as are assigned to him by or under this Ordinance or as may be prescribed.

6.       Meetings of the Agency.—(1) Save as hereinafter provided, the Agency shall regulate the procedure for its meetings.

(2)  The meetings of the Agency shall be convened by and under the directions of the CEO any time on any matter requiring decision by the Agency.

7.       Powers and functions of the Agency.—The powers and functions of the Agency 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 for,—

          (i)      licensing of therapeutic goods;

          (ii)     registration of therapeutic goods;

          (iii)    specifications and laboratory practices;

          (iv)    prosecution and appeals under this Ordinance relating to Federal subjects;

          (v)     regulation and allocation of quota of narcotics and psycholropic drugs and precursor substances;

          (vi)    regulation for pricing and mechanism for fixation of prices;

          (vii)   determining standards for biological manufacturing and testing;

          (viii)  current good manufacturing practices;

          (ix)    inspections, investigations and other like functions and; and

          (x)     any other function under this Ordinance which the Agency may deem fit;

(d)     promote Pharmacy Services;

(e)     coordinate, monitor or engage, in conjunction with other organizations, Provincial Governments and international agencies, in training, study or project related to therapeutic goods. The Agency 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;

(f)      facilitate the up gradation of industry to meet international standards and also to promote export of therapeutic goods;

(g)     coordinate at policy level and provide policy guidance to the Provincial Governments in the performance of their functions with a purpose to bring uniformity;

(h)     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;

(i)      take steps for development and promotion of pharmacy services;

(j)      to advise the Federal Government on issues related to obligations and commitments related to therapeutic goods;

(k)     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 to be based on merit and productivity;

(l)      prescribe rules for seniority, promotion, code of conduct and terms and condition of its employees;

(m)    levy such charges or fees as may be prescribed for services and facilities provided by the Agency and its offices;

(n)     carry out such other works or activities as may be deemed necessary by the Agency to carry out the purposes of this Ordinance;

(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 Agency;

(s)      prescribe, regulate or implement measures and standards on matters related or connected with the Agency; and

(t)      perform and carry out any other act, duty or function as may be assigned to it by the Federal Government.

8.       Delegation of powers.—The Agency may, 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) There shall be a Policy Board of the agency consisting of the following, namely:—

(a)     Secretary, of the concerned Divisions,   Chairperson

(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 Punjab.                    Member

(e)     Secretary, of the concerned Department, 

Government of the Sindh.                      Member

(f)      Secretary, of the concerned Department, 

Government of the Khyber Pakhtunkhwa.         Member

(g)     Secretary, of the concerned Department, 

Government of the Balochistan.             Member

(h)     Secretary, of the concerned Department, 

Government of Gilgit Baltistan.              Member

(i)      Representative from Federally 

Administered Tribal Area.                      Member; and

(j)      Six experts from the public and private 

sector with equal representation.            Member

(2)  The CEO shall also be the Secretary of the Boards.

(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 industry, quality control, regulation, public health, pharmacy services, finance and health economics and management:

Provided that the expert member shall be appointed for a period of three years and shall be eligible for one more similar term only:

Provided further that the expert Member shall himself attend, the netting 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 Federal Government constituted under sub-section (1) and (2), the board may increase or decrease the number of its members and prescribe the qualifications and procedure for their appointment.

10.     Meeting of the Board.—(1) Save as hereinafter provided, the Board shall make regulations for the conduct of its business.

(2)     The meetings of the Board shall be convened by the Secretary with the prior approval of the Chairperson. In case of absence of the Chairperson, the members present may elect the Chairperson for that meeting.

(3)     The meetings of the Board shall be held at least twice a year. A special meeting may also be called at any time to deal with any urgent 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, determinations taken by the Board shall be recorded in writing.

11.     Functions of the Board.—(1) The Board shall have the following functions, namely:—

(a)     to frame the policy and provide guidelines to the Agency and monitor the implementation and performance of the guidelines and of the functions of the Agency;

(b)     approval of the Budget of the Agency;

(c)     the Board determines the fees.

(2)     The Federal Government, as and when it considers necessary, may issue policy directives in accordance with law to the Agency in respect of its activities and the compliance whereof shall be binding on the Agency, within a stipulated time.

(3)     Notwithstanding anything contained in sub-section (2) if there is any difficulty in implementation of the directions and guidelines of the Board, the Agency shall refer the case back to the Board for its review specifying reasons for non-implementation, within the stipulated time.

12.     Committees of the Board.—(1) The Board may constitute committees of experts as it considers necessary or expedient to assist it in the performance of its functions under this Ordinance.

(2)  A 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 committees 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 Agency.—(1) The Agency, 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.

(2) Selection, recruitment, appointment of all officers, employees, experts and consultants including the officers and employees of the Federal Drug Control Administration, the sub-offices or laboratories as referred in sub-section (5) of Section 3 shall be based on merit. The criteria for recruitment selection of employees officers to be determined by the Board according to the rules as prescribed.

15.     Integration of Federal Drugs Control Administration its sub-offices and Laboratories.—Upon the commencement of this Ordinance, the Drugs Control Administration, its sub-offices, its Laboratories hereinafter referred to as the said offices shall become part of the Agency, and,—

(a)     All assets, rights, powers, authorities and privileges and all properties, movable and immovable, cash and bank balance, reserve funds, investment and all other interest and rights in, or arising out of such properties and all debts, liabilities and obligations of whatever kind of the said offices subsisting immediately before their integration shall stand transferred to and vest in the Agency;

(b)     all debts and obligations 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 or for the Agency; and

(c)     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 Agency and may be proceeded or otherwise dealt with accordingly.

(d)     Notwithstanding anything contained in any contract or agreement or in the conditions of services, —

          (i)      every employee of the said offices under the Federal Government immediately before the commencement of this Ordinance shall be required to exercise an irrevocable option either to continue in the present pay and service structure or to opt absorption form in the agency within a period of thirty days from the date of promulgation of this Ordinance.

          (ii)     all employees to be included in this Scheme shall be governed by this Ordinance and the terms and conditions prescribed; and

          (iii)    no health personnel who opts to be governed under the Ordinance shall be entitled to any compensation because of such transfer.

16.     Experts, consultants and advisers not to be civil servants.—The experts, consultants, employees or advisers employed by the Agency shall be governed by the terms and conditions of their appointment and shall not be deemed to be Civil Servant.

17.     CEO and officers etc., to be public servants.—The CEO, officers, employees, experts and consultants of the Agency shall, when acting or purporting to act in pursuance of any of the provisions of this Ordinance, 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, Member consultant, advisor, officer or employee of the Agency if he or she has any financial or professional conflict of interest.

(2)  No person shall be member of the Board if he has immediate family members (parent, child, sibling or spouse) as senior officials or owner of pharmaceutical companies.

CHAPTER-III

FUND, BUDGET AND ACCOUNTS

19.     Drug Regulatory Agency Fund.—(1) There shall be a fund to be known as the Drug Regulatory Agency of Pakistan Fund which shall vest in the Agency and shall be utilized by the Agency to meet its expenses and charges properly incurred in connection with the carrying out of its functions and duties assigned or transferred to it under this Ordinance, including but not limited to the payment of salaries and other remuneration to the CEO, Members, employees, experts, consultants and advisers of the Agency.

(2)  The Drug Regulatory Agency Fund shall be financed from the following sources namely:—

(a)     initial Grant to be provided by the Federal Government;

(b)     grants and loans by the Federal Government or a Provincial Government;

(c)     loans and grants from the national or international agencies received by the Federal Government to finance the function of the Agency;

(d)     charges and fees collected by the Agency to recover the costs of regulated activities under this Ordinance;

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