DRUG REGULATORY AUTHORITY ACT, 2006
An Act to provide for the establishment of Drug Regulatory Authority of Pakistan
WHEREAS it is expedient to establish the Drug Regulation System in Pakistan to:
(i) Ensure production, availability and accessibility of quality, safe, efficacious drugs and medicines to those in need,
(ii) Promote relevant research and development, pharmacovigilance and drug information,
(iii) Regulate import and export of drugs and medicines.
(iv) Rationalize pricing of drugs and medicines coupled with effective marketing thereof resulting thereby in rational use of the same through implementation of relevant legislations for achieving the goal of Health for all and matters connected therewith and incidental thereto;
2. It is hereby enacted as follows:-
1. Short title, extent and commencement.- (1) This Act may be called the Drug Regulatory Authority of Pakistan Act, 2006.
(2) It extends to the whole of Pakistan.
(3) It shall come into force at once.
2. Definitions.- In this Act, unless there is any thing repugnant in the subject or context,-
(a) “Authority” means the Drug Regulatory Authority established under Section 3 of this Act.
(b) “ Board” means the Policy Board of the Drug regulatory Authority established under Section 9 of this Act;
(c) “Chairman” means the Chairman of the Drug Regulatory Authority Policy Board;
(d) “Civil Servant” means a Civil Servants defined in Section 2 of the Civil Servants Act, 1973 (LXXI of 1973);
(e) “Decision” means an order, determination , direction or decision of the Authority made in accordance with this Act, rules and regulations, and “decide” shall mean the action taken by the Authority to arrive at such decision;
(f) “Director General” means the Director General appointed under section 6 of this Act;
(g) “DRA” means the Drug Regulatory Authority established under Section 3 of this Act.
(h) “Drugs” means drugs as defined under the Drugs Act, 1976;
(i) “Financial Year” means the period beginning on the first day of July in a calendar year and ending on the thirtieth day of June in the next falling calendar year;
(j) “Medicines” means medicines including homoeopathic and traditional medicines e.g. Unani, Ayurvedic and Biochemic medicines;
(k) “Member” means a member of the DRA and DRA Policy Board including Chairman of the DRA Policy Board and the Director General of the Authority;
(l) “Prescribed” means prescribed by rules made by the Authority;
(m) “Regulation” means regulations made under this Act;
(n) “Rules” means the rules made under this Act;
(o) “Schedule” means a schedule to this Act.
3. Establishment of the Authority.- (1) There shall be established an Authority to be known as 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 with powers, subject to the provisions of this Act, to hold and dispose of the property both movable and immovable and shall by the said name sue and be sued.
(3) The Authority shall be an autonomous Organization under the administrative control of the Ministry of Health.
(4) The Authority may set-up offices of the Organization at such places, as it may deem necessary, as and when required.
4. Composition of the Authority.- (1) The Federal Government shall, by notification in the official Gazette, constitute Authority, consisting of the Director General and five members, as head of units, as it may deem fit.
(2) Notwithstanding the composition of the Board constituted under sub-section (1), the Authority may increase or decrease the number of members and prescribe the qualifications and mode and manner of their appointment.
(3) The members shall be full time employee of the Authority and shall be appointed by the Authority with the concurrence of Federal Government on the merit of seniority cum fitness.
(4) In case of a vacancy occurring due to the death, resignation, retirement or removal of any Director General, the Federal Government shall appoint another qualified person within a period not exceeding three months from the date the vacancy occurred.
Provided that during such vacancy, the senior most member of the Authority shall be appointed by Federal Government as Acting Chairman.
(5) The Federal Government shall designate one of the members to act as Director General and Chief executive Officer of the Authority at any time during which the Director General, for any reason is in capable of exercising the Director General and Chief Executive’s powers or performing the Director General’s duties and when so acting, the Member shall exercise the powers and perform the duties entrusted on the Director General by this Act.
5 Director General.- (1) There shall be a Director General of the Authority who shall be appointed by the Federal Government on terms and conditions as may be prescribed.
(2) The Director General shall be the Chief Executive Officer of the Authority and shall discharge such duties and perform such functions as are assigned to him by or under this Act
(3) The Director General shall comply with such directives that the Federal Government may give from time to time.
6. Tenure of Director General.- (i) The Director General, unless earlier removed for misconduct or physical or mental incapacity, shall hold office for an initial term of four years and shall be eligible for re-appointment for one more similar term prior to age 60.
(2) The Director General or any Member may, by writing under his hand , resign his office.
7. The powers and functions of the Authority.- The powers and functions of the Authority shall be to:-
(a) Administer and coordinate relevant government systems for the regulation of the laws specified in the Schedule and the rules and regulations made thereunder;
(b) Prescribe, regulate or implement measures and standards on any matter related to or connected with Authority.
(c) Appoint such employees, consultants and experts as deemed necessary on terms and conditions prescribed by the Federal Government;
(d) Levy such charges or fees as may be reasonable for services and facilities provided by the Authority and its constituent offices;
(e) Carry out such other works or activities as may be deemed by the Authority to be necessary, with a view to making the best use of the assets of the Authority;
(f) Coordinate, monitor or engage, in conjunction with other authorities, international agencies or Authorities, in any study or cooperation project related to Drug Regulation;
(g) Enter into contracts for the supply of goods or materials or for the execution of works as may be necessary for the discharge of any of its duties and functions;
(h) Advise the Government of Pakistan on policy relating to Drug Regulation;
(i) Plan for development and up-gradation of the DRA infrastructure and capacity in Pakistan;
(j) Promote education and research in the field of drugs and medicines;
(k) Engage in human resource development of its officers and staff;
(l) Promote awareness about drug and medicines related issues in the public and private sector;
(m) Liaise and interact with counterpart Drug and medicines related authorities, institutions and organizations in other countries for capacity building and exchange of information;
(n) Initiate and monitor the enforcement of relevant laws through designated law enforcement agencies of the government and collect related data and information.