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XXI OF 2012

THE DRUG REGULATORY AUTHORITY OF PAKISTAN ACT, 2012

An Act to provide for the establishment of Drug Regulatory 

Authority of Pakistan

[Gazette of Pakistan, Extraordinary, Part I, 13th November, 2012]

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 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;

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 Pakistan.

(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 Islamabad.

(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, Karachi; the National Control Laboratory for Biologicals, Islamabad; and the Federal Drug Surveillance Laboratory, Islamabad shall, upon the commencement of this Act, become part of the Authority.

(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 Punjab

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 Pakistan.

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).

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