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;

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, 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.

CHAPTER –II
Administration

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.

(o) develop working manuals, references, materials and procedures in order to improving the working environment of different departments under the Authority;

(p) coordinate the implementation of foreign-aided technical assistance projects on drug and medicines;

(q) perform and carry out any other act, thing or function assigned to it by the Federal Government.

8. Meetings 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 and under the directions of the Director General at any time on any matter requiring a decision by the Authority.
.

(3) The meeting of the Board shall be held at least twice a year.

(4) A simple majority of the total membership shall constitute the quorum for a meeting of the Board.

9. Drug Regulatory Authority Policy Board.- (1) The Federal Government shall set up Drug Regulatory Authority Policy Board.

(2) The Policy Board shall be responsible for the framing the policy for execution of the working and functions of the Drug Regulatory Authority.

(3) Advise the Federal Government regarding the international negotiations in the area of drugs and medicines;

(4) The Policy Board may, as and when it considers necessary, issue policy directives to the Authority in respect of its activities and the compliance whereof shall be binding on the Authority.

10. Composition of the Drug Regulatory Authority Policy Board.- (1) The Federal Government shall , by notification in the official Gazette, constitute a Policy Board of the Authority consisting of Chairman and such other members from the public and private sectors, as may deem fit.

(2) Notwithstanding the composition of the Board constituted under sub-section (1), Federal Government may increase or decrease the number of members and prescribe the qualifications and mode and manner of their appointment.

(3) The Director General shall act as ex-officio Secretary of the Board.

11. Meeting of the Policy Board.- (1) The Policy Board shall regulate the procedure for its meetings.
(2) The meetings of the Board shall be convened by and under directions of the Board.

(3) A simple majority of the total membership shall constitute the quorum for a meeting of the Board.

12. Delegation of powers.- The Authority may, by general or special order in writing subject to such limitations, restrictions or conditions, delegate all or any of its powers and functions to any officer as it may deem appropriate.

13. Recruitment, Removal and disqualification of Officers and staff, etc., by the Authority.- (1) The Authority may create posts and appoint such officers, employees, experts and consultants, as it may consider necessary for the performance of its functions.
(2) The Authority shall notify the rules and procedures for Recruitment, Removal and disqualification of Officers and staff, etc.

14. Officers, etc., to be public servants.- The Director General, officers, employees, experts and consultants 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).

15. Conflict of Interest.- No person shall be appointed y the Federal Government as Director General if he has any direct or indirect financial interest in, or has any connection which might reasonably be viewed as giving rise to a conflict of interest with any person involved in any regulated activity. No person appointed as Director General or Officer or staff shall during his term in office have or maintain any direct or indirect financial interest in any person involved in any regulated activity. The Director General shall not at any time during their term of office engage themselves in any other services, business, vocation, or employment with any other person.

Chapter III

Budget and Accounts

16. Drug Regulatory Authority of Pakistan Fund.- (1) There shall be created a fund to be known as Drug Regulatory Authority of Pakistan Fund which shall vest in the Authority and shall be utilized by the Authority to meet charges in connection with its functions under this Act including the payment of salaries and other remuneration to the Director General, officers, employees, experts and consultants of the Authority.

(2) The Drug Regulatory Authority of Pakistan Fund shall be financed from the following sources, namely:-

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

(b) loans and grants from the national or international agencies; and

(c) revenue earned from the levy of Cess and Research Fund collected under the Drugs Act, 1976 and the rules made thereunder or any other law , etc. administered by the Authority

17. Budget.- The Authority shall, in respect of each financial year submit for approval of the Federal Government, on such date as may be prescribed, a statement of the estimated receipts and expenditure, including requirements of foreign exchange for the next financial year.

18. Audit and Accounts.- (1) The accounts of the Authority shall be maintained in the manner prescribed by the Controller General of Accounts.

(2) The Auditor General of Pakistan shall conduct audit of the accounts of the Authority.

(3) A copy of the audit report shall be sent to the Federal Government alongwith the comments of the Authority.

(4) The Federal Government may issue directions to the Authority for the rectification of any item objected to by the Auditor – General of Pakistan and the Authority shall comply with such directions.

19. Submission of yearly 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 programmes, projects and further plans formulated in furtherance of its aims and objectives.

(2) The Federal Government may require the Authority to furnish it with.-

(a) any return, statement, estimate, statistics or other information regarding any matter under the control of the Authority;

(b) a report on any subject with which the Authority’s concerned; and

(c) a copy of any document in the custody of the Authority.

20. Recovery of arrears.- (1) All amounts due to the Authority may be recovered as arrears of land revenue.

CHAPTER IV
Rules and Miscellaneous

21. Power to amend the Schedule.- The Authority may amend the Schedule so as to add any entry thereto or modify or omit any entry therefrom.

22. Power to make rules. The Authority may, with the approval of the Federal Government, make rules and notify the same in official Gazette for carrying out the purposes of this Act.

23. Power to make regulations. The Authority may by notification in the official Gazette, make regulations not inconsistent with this Act or the rules made thereunder to carry out the purposes of this Act.

24. Indemnity. Except as otherwise expressly provided in this Act or the rules no suit, prosecution or other legal proceeding shall lie against any employee of the Authority or person for any thing which is in good faith done or intended to be done under this Act or any rule.

25. Power to call for information.- The Authority may call for any pertinent information required by it for carrying out the purposes of this Act from any person involved, directly or indirectly, in the provision of any regulated activity or any matter incidental or consequential thereto. Any person called upon to provide such information shall do so with in the period prescribed by the Authority and his failure so to do shall be punishable by the imposition of such penalty as may be prescribed.

26. Complaints. – (1) Any interested person may file a written complaint with the Authority against contravention of any provision of this Act or any Act or Ordinance provided in the Schedule of this Act.

(2) The Authority shall, on receipt of a complaint cause it to be investigated and provide an opportunity to the complainant as well as any other person against whom such complaints has been made, to state its case before taking any action therein.

27. Winding up of the Authority.- No provision of any law relating to the winding up of bodies corporate shall apply to the Authority. The Authority shall only be wound up by an Ordinance or Act of Parliament.

SCHEDULE
[See Section 7(a)]

1. The Drugs Act, 1976 (XXXI of 1976)
2. The Medical Devices Act,
3.