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  "title": "Drug Regulatory Authority Act, 2012",
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  "text": "Page 1 of 32 \r\n \r\n \r\n \r\n \r\nTHE DRUG REGULATORY AUTHORITY OF PAKISTAN ACT, \r\n2012 \r\n \r\n \r\n           \r\nCONTENTS \r\nCHAPTER I \r\nPRELIMINARY \r\n \r\n1. Short title, extent, and commencement. \r\n2.  Definitions. \r\nCHAPTER II \r\nAUTHORITY AND BOARD \r\n \r\n3.  Establishment of the Authority. \r\n4.  Composition of the Authority. \r\n5.  Chief Executive Officer. \r\n6.  Meeting of the Authority. \r\n7.  Powers and functions of the Authority. \r\n8.  Delegation of powers. \r\n9.  Policy Board. \r\n10.  Meeting of the Policy Board. \r\n11.  Functions of the Board. \r\n12.  Appellate Board and Committees of the Policy Board. \r\n13.  Invitation by Board. \r\n14.  Appointment of officers and employees etc., of the Authority. \r\n \r\n\r\n \r\nPage 2 of 32 \r\n \r\n15.  Integration of Federal Drugs Control Administration its sub-offices and Laboratories. \r\n16.  Experts, consultants and advisers not to be civil servants. \r\n17.  CEO and officers etc., to be public servants. \r\n18.  Conflict of interest. \r\nCHAPTER III \r\nFUND, BUDGET AND ACCOUNTS \r\n \r\n19.  Drug Regulatory Authority of Pakistan Fund. \r\n20.  Fees and other charges to be levied by the Authority. \r\n21.  Budget. \r\n22. Accounting and Audit. \r\nCHAPTER IV \r\nRULES AND REGULATIONS \r\n \r\n23. Power to make rules. \r\n24. Power to make regulations. \r\nCHAPTER V \r\nMISCELLANEOUS \r\n \r\n25. Submission of annual reports and returns. \r\n26. Power to call for information. \r\n27. Offences, penalties etc. \r\n28. Offences by companies etc. \r\n29. Cognizance of offences.  \r\n30. Complaints. \r\n31. Confidential information. \r\n32. Act not to override other laws. \r\n 33. Recovery of arrears. \r\n 34. Indemnity. \r\n 35. Power to amend Schedule. \r\n 36. Removal of difficulties. \r\n37. Employment under the Authority to be employment under the Federal Government. \r\n \r\nPage 3 of 32 \r\n \r\n 38. Act X of 2012 not to apply to the Authority. \r\n 39. Co-operation with international organizations. \r\n 40. Repeal and Savings. \r\n 41. Policy Directive of Federal Government. \r\n 42. Winding up of Authority. \r\n \r\nSCHEDULE-I \r\nSCHEDULE-II \r\nSCHEDULE-III \r\nSCHEDULE-IV \r\nSCHEDULE-V \r\nSCHEDULE-VI \r\n \r\n \r\n \r\n \r\n \r\n \r\n \r\n \r\n \r\n \r\n \r\n \r\n   \r\n \r\nPage 4 of 32 \r\n \r\nTHE DRUG REGULATORY AUTHORITY OF PAKISTAN ACT, 2012 \r\nACT NO.XXI OF 2012 \r\n[12th November, 2018] \r\nAn Act to provide for the establishment of Drug Regulatory Authority of Pakistan \r\nWHEREAS it is expedient to establish a Drug Regulatory Authority of Pakistan to provide \r\nfor effective co-ordination and enforcement of The Drugs Act, 1976 (XXXI of 1976) and to bring \r\nharmony in inter-provincial trade and commerce of therapeutic goods; \r\n AND WHEREAS it is expedient to regulate, manufacture, import, export, storage, \r\ndistribution and sale of therapeutic goods; \r\n AND WHEREAS the Provincial Assemblies of Khyber Paktunkhwa, Punjab and Sindh have \r\npassed resolution under Article 144 of the Constitution of the Islamic Republic of Pakistan to the \r\neffect that Majlis-e-Shoora (Parliament) may by law regulate the issue; \r\n It is hereby enacted as follows: \r\nCHAPTER-I \r\nPRELIMINARY \r\n 1. Short title, extent and commencement. ___ (1) This Act may be called the Drug \r\nRegulatory Authority of Pakistan Act, 2012. \r\n(2) It extends to the whole of Pakistan. \r\n(3) It shall come into force at once. \r\n2.  Definitions. ⸻In this Act, unless there is anything repugnant in the subject or context,___ \r\n(i)  “Act” means the Drugs Act, 1976 (XXXI of 1976); \r\n(ii)  “Alternative Medicine” means a product used exclusively in \r\nHomeopathic, Unani, Ayurvedic, Biochemic, Chinese or other \r\ntraditional system of treatment; \r\n(iii) “Appellate Board” means an Appellate Board constituted under \r\nSection 12 for the disposal of appeals against the decisions of the \r\nLicensing Board or the Registration Board or Pricing Committee; \r\n(iv) “Authority” means the Drugs Regulatory Authority of Pakistan \r\nestablished under Section 3; \r\n(v)  “Biologicals” means biological drugs as defined in Schedule-I; \r\n \r\nPage 5 of 32 \r\n \r\n(vi)  “Board” means the Policy Board of the Authority constituted under \r\nSection 9; \r\n(vii) “CEO” means the Chief Executive Officer of the Authority appointed \r\nunder Section 5; \r\n(viii)  “Chairperson” means the Chairperson of the Board; \r\n(ix) “civil servant” means a civil servant as defined in the Civil Servants \r\nAct, 1973 (LXXI of 1973); \r\n(x) “decision” includes an order, determination or direction of the \r\nAuthority or the Board made in accordance with laws, rules and \r\nregulations; \r\n(xi)  “Director” means director of a department of the Authority; \r\n(xii)  “drug” means drug as defined in Schedule-I; \r\n(xiii)  “fee” means fee prescribed by the Board for any service; \r\n(xiv)  “Fund” means the Drug Regulatory Authority of Pakistan Fund created \r\nunder Section 19; \r\n(xv)  “health and OTC Products (non-drugs)” include probiotics and \r\ndisinfectant, nutritional products, food supplements, baby milk and \r\nfoods, medicated cosmetics, medicated soaps and medicated \r\nshampoos; \r\n(xvi)  “Inspector” means the Inspector appointed under the Act as specified \r\nin Schedule-V; \r\n(xvii) “Licensing Board” means a Licensing Board constituted under Section \r\n7 sub-section (u) of this Act to regulate the grant of licenses for the \r\nmanufacture of therapeutic goods; \r\n(xviii)  “Medical Device” means medical devices as specified in Schedule-I; \r\n(xix)  “Medicated Cosmetics” means cosmetics containing drugs as specified \r\nin Schedule-1; \r\n(xx)  “Member” means a member of the Board; \r\n(xxi)  “OTC” mean over-the-counter non-prescription products; \r\n(xxii)  “penalty” means penalty as specified in Schedule III; \r\n(xxiii)  “person” means any individual or any legal entity; \r\n \r\nPage 6 of 32 \r\n \r\n(xxiv)  “Pension Endowment Fund” means an endowment fund separate from \r\nthe Fund of the Authority dedicated only for the payment of pension \r\nbenefits of Authority's employees; \r\n(xxv)  “pharmaceutical field” means regulation, manufacturing, quality \r\ncontrol, quality assurance, research, academia, import, export, and \r\npharmacy services in drugs; \r\n(xxvi)  “pharmacy services” means services rendered by a pharmacist in \r\npharmaceutical care, selection, posology, counseling, dispensing, use, \r\nadministration, prescription monitoring, pharmacoepidemiology, \r\ntherapeutic goods information and poison control, pharmacovigillance, \r\npharmacoeconomics, storage, sales, procurement, forecasting, supply \r\nchain management, distribution, drug utilization evaluation, drug \r\nutilization review, formulary based drug utilization and managing \r\ntherapeutic goods at all levels including pharmacy, clinic, medical \r\nstore, hospital or medical institution; \r\n(xxvii)  “pharmaceutical evaluation” means the assessment of a detailed \r\npharmaceutical dossier submitted for the registration of a therapeutic \r\ngood; \r\n(xxviii) “pharmaceutical dossier” means a set of documents, as specified in \r\nSchedule-I; \r\n(xxix)  “prescribed” means prescribed by rules or regulations under this Act; \r\n(xxx)  “Prohibitions” means Prohibitions as specified in Schedule-II; \r\n(xxxi)  “regulation” means the regulations made under this Act; \r\n(xxxii)  “Registration Board” means a Registration Board constituted under \r\nSection 7 sub-section (u) of this Act to regulate the grant of registration \r\nto therapeutic goods; \r\n(xxxiii) “rules” means the rules made under this Act; \r\n(xxxiv) “Secretary” means Secretary of the Board; \r\n(xxxv)  “Schedule” means Schedule to this Act; and \r\n(xxxvi) “Therapeutic goods” includes drugs or alternative medicine or medical \r\ndevices or biologicals or other related products as may be notified by \r\nthe Authority. \r\n \r\n \r\n \r\n \r\n \r\nPage 7 of 32 \r\n \r\nCHAPTER-II \r\nAUTHORITY AND BOARD \r\n3. Establishment of the Authority. ___ (1) As soon as may be, after the commencement of \r\nthis Act, the Federal Government shall, by notification in the official Gazette, establish an Authority \r\nto be known as the Drug Regulatory Authority of Pakistan, to carry out the purposes of this Act. \r\n(2) The Authority shall be a body corporate having perpetual succession and a common seal, \r\nand may sue and be sued in its own name and, subject to and for the purposes of this Act, may enter \r\ninto contracts and may acquire, purchase, take, hold and enjoy moveable and immovable property of \r\nevery description and may convey, assign, surrender, yield up, charge, mortgage, demise, reassign, \r\ntransfer or otherwise dispose of or deal with, any moveable or immovable property or any interest \r\nvested in it. \r\n(3) The Authority shall be an autonomous body under the administrative control of the \r\nFederal Government with its headquarters at Islamabad. \r\n(4) The Authority may set up its establishments including sub-offices and laboratories at \r\nprovincial capitals and such other places, as it may deem necessary from time to time. The existing \r\nFederal Drugs Control Administration and the sub-offices set up in all provinces and laboratories \r\ncalled the Central Drugs Laboratory, Karachi; the National Control Laboratory for Biologicals, \r\nIslamabad; and the Federal Drug Surveillance Laboratory, Islamabad shall, upon the commencement \r\nof this Act, become part of the Authority. \r\n(5) The common seal of the Authority shall be kept in the custody of the Chief Executive \r\nOfficer or such other person as may be prescribed by regulations and documents required or \r\npermitted to be executed under the common seal shall be specified and authenticated in such manner \r\nas may be prescribed by regulations. \r\n4. Composition of the Authority. ___ (1) The Authority shall consist of a full time Chief \r\nExecutive Officer (CEO) and thirteen Directors who shall be appointed by the Federal Government \r\non the recommendation of Board, whose qualifications, terms and conditions shall be such as may be \r\nprescribed. The Directors shall be designated as: ⸻ \r\n(a)  Director Pharmaceutical Evaluations and Registration.⸻He shall be incharge \r\nof the Division of Pharmaceutical Evaluations and Registration which shall be \r\nresponsible for the evaluation, assessment and registration of Pharmaceuticals \r\ndrugs for human beings, animals and to perform other functions connected \r\ntherewith and assigned by the Board; \r\n(b)  Director Drug Licensing.⸻He shall be the incharge of the Division of Drug \r\nLicensing which shall be responsible for the licensing of the drugs \r\nmanufacturing facilities and to perform other functions connected therewith; \r\n(c)  Director Quality Assurance and Laboratory testing.⸻He shall be incharge of \r\nthe Division of Quality Assurance and Laboratory testing which shall be \r\nresponsible for enforcement of current Good Manufacturing Practices under \r\nthe Act, and for testing or research of drugs and to perform other functions \r\n \r\nPage 8 of 32 \r\n \r\nconnected therewith. The Division will also perform the functions related to \r\npost marketing surveillance and shall be responsible for the evaluation, co-\r\nordination and monitoring of safety, efficacy and quality of registered drugs \r\nand inactive materials including the clinical and toxicological study, drug \r\nrecalls and with drawls, and to perform other functions connected therewith; \r\n(d)  Director Medical Devices and Medicated Cosmetics.⸻He shall be incharge of \r\nthe Division of Medical Devices and Medicated Cosmetics which shall be \r\nresponsible for the assessment, enlistment or registration of medical devices \r\nand medicated cosmetics, medicated shampoos and medicated soaps for \r\nhuman beings, animals and to perform other functions connected therewith; \r\n(e)  Director Biological Drugs.⸻He shall be incharge of the Division of \r\nBiological Evaluation and Research which shall be responsible for the \r\nevaluation, assessment, registration and licensing of Biologicals for human \r\nbeings, animals and to perform other functions connected therewith including \r\nall the functions of national control authority for biologicals as required for the \r\nprequalification by World Health Organizations of locally manufactured \r\nhuman biological drugs; \r\n(f)  Director Controlled Drugs.⸻ He shall be incharge of the Division of \r\nControlled Drugs which shall in consultation with the Federal Government be \r\nresponsible for regulation and allocation of quota of narcotic drugs, \r\npsychotropic substances and precursor chemicals and to perform other \r\nfunctions connected therewith; \r\n(g)  Director Pharmacy Services.⸻ He shall be incharge of the Division of \r\nPharmacy Services which shall be responsible for the development and \r\npromotion of pharmacy services and to perform other functions connected \r\ntherewith; \r\n(h)  Director Health and OTC Products (non-drugs).⸻ He shall be incharge of the \r\nDivision of Health and OTC Products (non-drugs) which shall be responsible \r\nfor the assessment, licensing and registration of Alternative Medicines such as \r\nAyurvedic, Chinese, Unani and Homeopathy, enlistment or registration of \r\nnutritional products and food supplements for human beings, animals and to \r\nperform other functions connected therewith; \r\n(i)  Director Costing and Pricing.⸻He shall be incharge of the Division of \r\nCosting and Pricing which shall be responsible for the costing and pricing of \r\ntherapeutic goods and to perform other functions connected therewith; \r\n(j)  Director Budget and Accounts.⸻He shall be incharge of the Division for \r\nBudget and Accounts which shall be responsible for budgetary and financial \r\naspects of the Authority and other daily accounting matters connected \r\ntherewith or ancillary thereto; \r\n(k)  Director Administration, Human Resource and Logistics.⸻He shall be \r\nincharge of the Division for Administration, Human Resource and Logistics \r\n \r\nPage 9 of 32 \r\n \r\nwhich shall be responsible for administration, recruitment, appointment, \r\ncapacity building and development for the Authority and other matters \r\nconnected therewith and ancillary there to; \r\n(l)  Director Legal Affairs.⸻He shall be incharge of the Division for Legal \r\nAffairs which shall be responsible for legal aspects of the Authority and other \r\nmatters connected with Drug Court and other Court cases therewith or \r\nancillary thereto; and \r\n(m)  Director Management Information Services.⸻He shall be in charge  of the \r\nDivision for Management Information Services which shall be responsible for \r\ndevelopment of automation of functions using information technology for the \r\nAuthority and other matters connected therewith and ancillary there to; \r\n(2) The Federal Government, on the recommendations of the Board may increase or decrease \r\nthe number of Divisions or Director and prescribe their functions and the relevant experience, \r\nqualification, terms, mode and manner of appointment of Directors and related staff in each Division. \r\n5. Chief Executive Officer.___ (1) The Federal Government may, on the recommendations of \r\nthe Board appoint a person as Chief Executive Officer who, ⸻ \r\n(a)  has a post graduate degree in Pharmacy or medicine with an age not less than \r\n45 years or more than 56 years, with a minimum of twenty years experience in \r\nmanagement or pharmaceutical field or regulatory affairs, in public sector, or \r\nif no such person of aforesaid qualifications is available in the public sector, \r\nthen a person possessing above qualifications and experience from the private \r\nsector; \r\n(b)  the tenure of appointment of CEO shall be for a period of three years, \r\nextendable on the recommendation of the Board for one year only; and \r\n(c)  the CEO shall exercise general Control and supervision over the affairs of the \r\nAuthority and shall ensure the provisions of the Act, the rules, and that the \r\nregulations, policies and directions of the Board are properly executed; \r\n (2) The CEO shall discharge such duties and perform such functions as are assigned to him \r\nby or under this Act or as may be prescribed by the Board and in particular shall,— \r\n(a)  keep in custody the records and seal of the Authority; \r\n(b)  submit plan of work and budget estimates of the Authority for approval of the \r\nBoard; and \r\n(c)  submit to the Board, in accordance with the rules and regulations reports on \r\nthe activities of the Authority. \r\n (3) The CEO shall also have the power to, — \r\n \r\nPage 10 of 32 \r\n \r\n(a)  supervise the activities connected with the execution of programs for training, \r\nresearch, institutional consultancies, and other services; \r\n(b)  authorize expenditure provided for in the budget in accordance with the rules \r\nand regulations; \r\n(c)  re-appropriate funds within the approved budget; \r\n(d)  delegate his powers to appropriate levels of management subject to such \r\nconditions as he may deem fit; \r\n(e)  issue notices of meetings of the Board and Appellate Board and to maintain \r\nproper record of the minutes and proceedings thereof; \r\n(f)  execute deeds and documents on behalf of the Board; and \r\n(g)  perform any other duty assigned to him by the Board. \r\n (4) The CEO shall not, except with the prior approval of the Board in each case or unless \r\nalready approved in the budget duly itemized, allow expenditure on items of civil works, or capital \r\nexpenditure on office or laboratory equipment or automobiles, \r\n  (5) The CEO may tender his resignation under his own hand. \r\n (6) In case of occurrence of vacancy of CEO the Federal Government is authorised to \r\nappoint any person having prescribed qualification as CEO for a period of three months or till the \r\nappointment of CEO, whichever is earlier. \r\n6. Meeting of the Authority. ___ (1) Save as hereinafter provided, the Authority shall regulate \r\nthe procedure for its meetings. \r\n (2) The meetings of the Authority shall be convened by the CEO at any time on his own or \r\nas directed by the Policy Board on any matter requiring decision by the Authority. \r\n7. Powers and functions of the Authority. ___The powers and functions of the Authority \r\nshall be to, — \r\n(a)  administer the laws specified in the Schedule-VI that apply to Federal \r\nGovernment, and advise the Provincial Governments for the laws that are \r\napplicable to the Provinces; \r\n(b)  monitor the enforcement of laws specified in the Schedule-VI and collect \r\nrelevant data and information; \r\n(c)  issue guidelines and monitor the enforcement of, — \r\n (i)  licensing of the manufacture of therapeutic goods; \r\n (ii)  registration of therapeutic goods; \r\n \r\nPage 11 of 32 \r\n \r\n (iii)  regulation for the advertisement; \r\n (iv)  drug specifications and laboratory practices; \r\n (v)  prosecution and appeals under this Act and the Drugs Act, 1976 \r\n(XXXI of 1976) relating to Federal subject; \r\n (vi)  regulation and allocation of quota of narcotic drugs, psychotropic \r\nsubstances and precursor substances (chemicals) in consultation with \r\nFederal Government; \r\n (vii)  regulation for pricing and mechanism for fixation of prices of various \r\ntherapeutic goods under its ambit; \r\n (viii)  determining standards for biological manufacturing and testing; \r\n (ix) implementation of internationally recognized standards such as good \r\nlaboratory practices, current good manufacturing practices, good \r\ndistribution practices, cold chain management, bioequivalence studies, \r\nstability studies, anti-spurious codes, clinical trials, biosimilar \r\nevaluations, and endorsement and systematic implementation of World \r\nHealth Organization, International Conference on Harmonizations and \r\nFood and Drug Administration guidelines etc.; \r\n (x)  regulation, enforcement and monitoring of advertisement rule and ban \r\non false advertisement; \r\n (xi)  manufacturing of active pharmaceutical ingredients in all its forms; \r\nand \r\n (xii)  use of central research fund. \r\n(d)  co-ordinate, monitor or engage, in conjunction with other organizations, \r\nProvincial Governments and international agencies, in training, study or \r\nproject related to therapeutic goods. The Authority may engage any individual \r\nor counsel to advise or work for managing national and international \r\nopportunities for training, education, seminars, conferences etc., with a view \r\nto improve capacity building; \r\n(e)  facilitate advancement and up gradation of the sector to meet international \r\nstandards and also to promote manufacture and export of active \r\npharmaceutical ingredients and therapeutic goods; \r\n(f)  coordinate at policy level and provide policy guidance to the Provincial \r\nGovernment in the performance of their functions with a purpose to bring \r\nuniformity; \r\n \r\nPage 12 of 32 \r\n \r\n(g)  facilitate the procurement and implementation of foreign aided technical \r\nassistance on therapeutic goods where such expertise does not exist but its \r\nexistence would promote public good; \r\n(h)  take steps for development and promotion of pharmacy services; \r\n(i)  undertake awareness campaigns regarding prevention of diseases, patients' \r\nrights, healthcare privileges etc., through media, seminars, publications, and \r\nother available means of information technology; \r\n(j)  issue guidelines and monitor proceedings and funding and accounts of health \r\nseminars, workshops and conferences; \r\n(k)  advise the Federal Government on issues related to obligations and \r\ncommitments related to therapeutic goods; \r\n(l)  appoint such employees, consultants and experts as deemed necessary on \r\nprescribed terms and conditions including their salaries and remunerations \r\nwith consultation and approval of the Board. Such recruitment, continuation \r\nand remuneration shall be based on merit and productivity; \r\n(m)  prescribe rules for seniority, promotion, code of conduct and terms and \r\ncondition of service of its employees; \r\n(n)  levy such charges or fees as may be prescribed for services and facilities \r\nprovided by the Authority and its offices; \r\n(o)  enter into contract for the supply of materials or for the execution of works as \r\nmay be necessary for the discharge of any of its duties and functions; \r\n(p)  prepare annual budget to be approved by the Board; \r\n(q)  to monitor and regulate the marketing practices, so as to ensure rational use of \r\ndrugs, and ethical criteria for promotion of therapeutic goods in line with \r\ninternational practices; \r\n(r)  develop working manuals, guidelines, references, materials and procedures in \r\norder to improve the working environment of offices etc., set up under the \r\nAuthority; \r\n(s)  prescribe, regulate or implement measures and standards on matters related or \r\nconnected with the Authority; \r\n(t)  develop, issue, adopt, and enforce the standards and guidelines to ensure \r\nsafety, efficacy, and quality of therapeutic goods with rational use at \r\nreasonable price; \r\n(u)  perform licensing, registration, pricing and appellate function thereof; \r\n \r\nPage 13 of 32 \r\n \r\n(v)  coordinate with Provincial Governments and International agencies for \r\nsmooth implementation of laws, capacity building and training of the \r\nregulatory staff; \r\n(w)  develop standard operating procedures, manuals, guidelines for transparent \r\nworking of offices and conduct quality audits for conformance of the same; \r\n(x)  establish system of cost recovery to ensure financial autonomy and efficient \r\nfunctioning of the authority without becoming burden on the Government; and \r\n(y)  perform and carry out any other act, duty or function as may be assigned to it \r\nby the Policy Board and the Federal Government for furthering the provisions \r\nof this Act. \r\n8. Delegation of powers. ___ The Authority may with the approval of the Board, by general or \r\nspecial order in writing subject to such conditions or limitations, delegate any of its powers and \r\nfunctions to any of its officers as it may deem appropriate. \r\n9. Policy Board.____ (1) The general direction, administration and monitoring of the Authority \r\nshall vest in the Policy Board which shall consist of fifteen members, namely:⸻ \r\n(a)    Secretary of the concerned Division (Federal Secretary BS-\r\n22) \r\nChair \r\nperson \r\n(b)    CEO Member \r\n(c)    Representative of Ministry of Law and Justice not below \r\nBPS-20 \r\nMember \r\n(d)  Secretary of the concerned Department, Government of the \r\nBalochistan \r\nMember \r\n(e)   Secretary of the concerned Department, Government of the \r\nSindh \r\nMember \r\n(f)  Secretary of the concerned Department, Government of the \r\nKhybcr Pakhtunkhwa \r\nMember \r\n(g)  Secretary of the concerned Department, Government of the \r\nPunjab \r\nMember \r\n(h)  Secretary of the concerned Department, Government of the \r\nGilgil-Bultistan \r\nMember \r\n(i)     Representative from Federally Administered Tribal Area Member \r\n(j)  Six experts from the public and private sector with equal \r\nrepresentation from each Province, these members shall be \r\nfrom different specialties as defined in sub-section (3) \r\nbelow. \r\nMember \r\n (2) The CEO shall also be the Secretary of the Board. The Board shall look after and be \r\nresponsible for the affairs of the Authority. \r\n(3) The Federal Government shall, by notification in the official Gazette, appoint six expert \r\nmembers, with representation from the Provinces, under Clause (j) of sub-section (1) preferably one \r\nfrom each province having specialty in the fields of drug manufacturing, quality control, drug \r\n \r\nPage 14 of 32 \r\n \r\nregulation, public health, pharmacy services, health finance, health economics, health management, \r\npharmacology, or biotechnology: \r\nProvided that unless earlier removed by the Federal Government the term of the expert \r\nmember shall be two years and shall be eligible for one more similar term only. The expert member \r\nmay resign his office by writing under his hand addressed to the Federal Government: \r\n Provided further that the expert member shall himself attend the meeting and shall not send a \r\nrepresentative; \r\n (4) No act or proceeding of the Board shall be invalid by reason only if the existence of a \r\nvacancy in the constitution of the Board. \r\n (5) Notwithstanding the composition of the Board constituted by the Federal Government \r\nunder sub-section (1), the Board may increase or decrease the number of its members and prescribe \r\nthe qualifications and procedure for their appointment. \r\n10. Meeting of the Policy Board. ____ (1) The meetings of the Board shall be convened by the \r\nSecretary of the Board with the prior approval of the Chairperson. In case of absence of the \r\nChairperson, the members present may elect the Chairperson for that meeting. \r\n (2) The meetings of the Board shall be held at twice a year or more as and when required. A \r\nspecial meeting may also be called at any time to deal with any urgent business. \r\n (3) Save as hereinafter provided, the Board shall make regulations for the conduct of its \r\nbusiness. \r\n (4) A simple majority of the total membership shall constitute the quorum for a meeting of \r\nthe Board and in case of equality of votes, the Chairperson or the person presiding over the meeting \r\nshall have a casting vote. \r\n (5) All decisions or determinations taken by the Board shall be recorded in writing. \r\n (6) The Board meeting shall be called by giving an advance notice of at least seven days. \r\n11. Functions of the Board. ___ (1) The Board shall have the following functions, namely: ___ \r\n(a)  frame the policy and provide guidelines based on global and regional trends to \r\nthe Authority and monitor the implementation and performance of the \r\nguidelines and of the functions of the Authority ensuring good governance and \r\naccountability; \r\n(b)  monitor and supervise all the functions of the Authority; \r\n(c)  approve the Budget of the Authority; and \r\n(d)  determine all fees and levies. \r\n \r\nPage 15 of 32 \r\n \r\n12. Appellate Board and Committees of the Policy Board. ___ (1) The Board may constitute \r\nAppellate Board and Committees of experts as it considers necessary or expedient to assist it in the \r\nperformance of its functions under this Act. \r\n(2) A Board and Committee constituted under sub-section (1) shall act in accordance with the \r\nregulations made by the Board. \r\n13. Invitation by Board. ___ The Board may invite any person to attend its meeting or \r\ndeliberations including any meeting of the Appellate Board or its Committees constituted under \r\nSection 12, for the purpose of advising it on any matter under discussion but such person shall have \r\nno right to vote at the meeting or deliberation. \r\n14. Appointment of officers and employees etc., of the Authority. ___(1) The Authority, \r\nwith approval of the Board, may create posts and appoint such officers, employees, experts and \r\nconsultants, as it may consider necessary, for the performance of its functions in the prescribed \r\nmanner. The criteria for recruitment and selection of employees and officers will be determined by \r\nthe Board according to the rules as prescribed. \r\n(2) The age of superannuation for each employee shall be sixty years. \r\n(3) No person shall be appointed as the CEO or Director of the Authority unless he is a \r\ncitizen of Pakistan. \r\n15. Integration of Federal Drugs Control Administration its sub-offices and \r\nLaboratories. ___ (1) Upon the commencement of this Act the Drugs Control Administration, its sub-\r\noffices and its Laboratories hereinafter referred to as the said offices as referred in sub-section (4) of \r\nSection 3 shall become part of the Authority. \r\n(2) All assets, rights, powers, authorities and privileges and all properties, movable and \r\nimmovable, cash and bank balance, reserve funds, investment and all other interest rights in, or \r\narising out of such properties and all debts, liabilities and obligation of whatever kind of the said \r\noffices subsisting immediately before there integration shall stand transferred to and vest in the \r\nAuthority. \r\n(3) All debts and obligation incurred or contracts entered into or rights acquired and all \r\nmatters and things engaged to be done by, with or for the said offices before their integration, shall \r\nbe deemed to have been incurred, entered into, acquired or engaged to be done by for the Authority. \r\n(4) All suits and other legal proceedings instituted by or against the said offices before their \r\nintegration shall be deemed to be suits and proceedings by or against the Authority and may be \r\nproceeded or otherwise dealt with accordingly. \r\n(5) Notwithstanding anything contained in any contract or agreement or in the conditions of \r\nservices, __ \r\n(a)  every employee of the said offices under the Federal Government \r\nimmediately after the commencement of this Act shall be required to exercise \r\nan irrevocable option either to continue in the present pay and service structure \r\n \r\nPage 16 of 32 \r\n \r\nas a civil servant or to opt for absorption in the Authority within a period of \r\nthirty days from the date of commencement of this Act; \r\n(b)  all employees who opt to be included in the Authority under its rules shall be \r\ngoverned by this Act and the terms and conditions so prescribed; \r\n(c)  no health personnel who opts to be governed under this Act shall be entitled to \r\nany compensation because of such transfer; and \r\n(d)  the terms and conditions of service of all officers and staff employed in the \r\nDrug Regulatory Agency of Pakistan under Ordinance I of (2012) before the \r\ncommencement of this Act shall not be varied to their disadvantage under the \r\nAuthority. \r\n16. Experts, consultants and advisers not to be civil servants. ___ The experts, consultants, \r\nemployees or advisers employed by the Authority shall be governed by the terms and conditions of \r\ntheir appointment and shall not be deemed to be civil servant within the meaning of Civil Servants \r\nAct, 1973 (LXXI of 1973). \r\n17. CEO and officers etc., to be public servants. ___The CEO. officers, employees, experts \r\nand consultant of the Authority shall, when acting or purporting to act in pursuance of any of the \r\nprovisions of this Act, be deemed to be public servants within the meaning of Section 21 of the \r\nPakistan Penal Code (Act, XLV of 1860). \r\n18. Conflict of interest. ___ (1) No person shall be appointed as CEO, Director, consultant, \r\nadvisor, officer or employee of the Authority if he or she has any financial or professional conflict of \r\ninterest. \r\n(2) No person shall be member of the Board or Director if he has immediate family members \r\n(parent, child, sibling or spouse) as senior officials or owners of concerns dealing in therapeutic \r\ngoods. \r\nCHAPTER-III \r\nFUND, BUDGET AND ACCOUNTS \r\n 19.  Drug Regulatory Authority of Pakistan Fund.___(1) There shall be a fund to be known \r\nas the Drug Regulatory Authority of Pakistan Fund which shall vest in the Authority and shall be \r\nutilized by the Authority to meet us expenses and charges properly incurred in connection with the \r\ncarrying out of its functions and duties assigned or transferred to it under this Act, including but not \r\nlimited to the payment of salaries and other remuneration to the CEO, Director, members of the \r\ndifferent Boards, employees, experts, consultants and advisers of the Authority. \r\n (2) The Drug Regulatory Authority Funds shall be financed from the following sources \r\nnamely:⸻ \r\n(a)  grant-in-aid in terms of salaries and retirement benefits of the existing staff to \r\nbe provided by the Federal Government; \r\n \r\nPage 17 of 32 \r\n \r\n(b)  donations and endowments; \r\n(c)  grants and loans by the Federal Government or a Provincial Government; \r\n(d)  loans and grants from the national and international agencies received by the \r\nFederal Government and Provincial Governments to finance the function of \r\nthe Authority; \r\n(e)  charges and fees collected by the Authority to recover the costs of regulated \r\nactivities under this Act; \r\n(f)  proceeds of any investments made by the Authority which are not required for \r\nimmediate use. All investments to be made by the Authority shall be with the \r\napproval of the Board; \r\n(g)  proceeds from any other service rendered by the Authority, including \r\nInspection Services, foreign or local, or sale of any publication; and \r\n(h)  Central Research Fund collected from the pharmaceutical industry. \r\n (3) At the end of each financial year, the balance sheet shall be prepared and any un-spent \r\nremaining amount and all other collections including Central Research Fund shall be securely \r\ninvested only in Government schemes in order to achieve self-sufficiency of the Authority. \r\n (4) A separate pension endowment fund shall be established for the payment of pensions of \r\nemployees recruited in the Authority. \r\n20. Fees and other charges to be levied by the Authority. ____ (1) The Authority shall levy \r\nand collect such fees, in respect of any of its functions at such rates as may be determined, from time \r\nto time by the Authority, with the approval of the Policy Board, in accordance with rules. \r\n(2) The Central Research Fund fee shall be deposited in the non-lapsable sub-account of the \r\nAuthority to be utilized as per existing rules. \r\n(3) The existing Central Research Fund kept with the Federal Government shall be \r\ntransferred to the Authority immediately after the notification of establishment of the Authority. \r\n21. Budget. ___ (1) The Authority shall, in respect of each financial year prepare on such date \r\nas may be prescribed a statement of the estimated receipts and expenditure, including the revised and \r\nestimated budgets, requirements of grant-in-aid from Federal Government, and foreign exchange for \r\nthe next financial year for consideration and approval of the Board. Any foreign exchange \r\nrequirements within the overall annual approved budget by the Board shall be sent to Federal \r\nGovernment for appropriate provision and allocation. \r\n(2) It shall not be necessary for the Authority to take prior approval from the Government to \r\nspend money from its own generated funds, and shall practice financial freedom as the Board deem \r\nfit for furtherance of its functions. \r\n \r\nPage 18 of 32 \r\n \r\n22. Accounting and Audit. ___ (1) The Authority may open its accounts with any scheduled \r\nBank or financial institution within the framework of the prescribed rules. The Authority may \r\napproach the Government, for the grant of initial funds in this respect. \r\n(2) The accounts of the Authority shall be maintained as a double entry system and in the \r\nmanner prescribed by the Controller General of Accounts. \r\n(3) The Authority shall cause to be carried out audit of its accounts by one or more auditors \r\nregistered as chartered accountants within the meaning of the Chartered Accountants Act, 1961 (X of \r\n1961). \r\n(4) Notwithstanding the audit provided by in sub-section (3) the Auditor General shall have \r\nthe power to audit or cause to be audited the accounts of the Authority. \r\n(5) A copy of the audit report shall be sent to the Federal Government along with the \r\ncomments of the Authority. \r\n(6) The Authority shall take the requisite steps for the rectification of any objection raised by \r\nthe Auditor-General of Pakistan. \r\nCHAPTER-IV \r\nRULES AND REGULATIONS \r\n23. Power to make rules. ___ The Authority may, with the approval of the Federal \r\nGovernment, by notification in the official Gazette, make rules for carrying out the purposes of this \r\nAct. \r\n24. Power to make regulations. ___ The Authority may, by notification in the official \r\nGazette, with the approval of the Board, make regulations, for its internal working and terms and \r\ncondition of employees not inconsistent with the provisions of the Act or the rules, for the carrying \r\nout of its functions under this Act. \r\nCHAPTER-V \r\nMISCELLANEOUS \r\n25. Submission of annual reports and returns. ____ (1) Within three months of the \r\nconclusion of each financial year, the Authority shall submit an annual report to the Federal \r\nGovernment in respect of the activities of the Authority including the status of its existing programs, \r\nprojects and further plans formulated in furtherance of its aims and objectives. \r\n(2) The Federal Government may require the Authority to furnish: ⸻ \r\n(a)  any return, statement, estimate, statistics or other information regarding any \r\nmatter under the control of the Authority; \r\n(b)  a report on any subject related to the Authority; and \r\n \r\nPage 19 of 32 \r\n \r\n(c)  a copy of any document in the custody of the Authority; \r\n(3) The Authority shall expeditiously comply with such directions. \r\n26. Power to call for information.___The Authority may call for any person, involved \r\ndirectly or indirectly, and reasonably believed to having such information in his control or possession \r\nwhich is required for carrying out the purposes of this Act. The person so called upon to provide \r\nsuch information shall do so within the period prescribed by the Authority and in case of failure to do \r\nso he shall be punished by imposition of such penalty which may not exceed one hundred thousand \r\nrupees. \r\n27. Offences, penalties etc.____ (1) The offences shall be such as specified in Schedule-III. \r\n (2) The prohibition specified in Schedule-II shall be punished in accordance with Schedule-\r\nIII. \r\n28. Offences by companies etc.___Where the person guilty of an offence under this Act or \r\nthe Drugs Act, 1976 (XXXI of 1976), is a company, corporation, firm or institution, every director, \r\npartner and employee of the company, corporation, firm or institution with whose knowledge or \r\nconsent the offence was committed shall be guilty of the offence. \r\n29. Cognizance of offences. ___ Cognizance of offences shall be taken by the Inspector in the \r\nmanner specified in Schedule-IV. \r\n30. Complaints. ___ (1) Any aggrieved person may file a written complaint with the Authority \r\nagainst contravention of any provision of this Act or any law specified in Schedule-VI. \r\n(2) The Authority shall, on receipt of a complaint cause it to be investigated as may be \r\nprescribed and provide an opportunity to the complainant as well as the person against whom such \r\ncomplaints has been made. The Authority may, on completion of investigation, take any action as \r\nmay be prescribed under this Act or as the case may be subject to the provisions of any law specified \r\nin the Schedule-VI. \r\n(3) Appeals against the decisions of the Authority shall be referred to the Board, which shall \r\nformulate an Appellate Board from among its members, who shall decide the case on merit. \r\n31. Confidential information. ____ (1) Except as provided under the regulations, no person \r\nshall communicate, or allow to be communicated, any record or information obtained under this Act \r\nto a person not legally entitled to that record or information or allows any person not legally entitled \r\nto that record or information to have access to any record obtained under this Act. \r\n(2) A person who knowingly receives records or information obtained under this Act shall \r\nhold the record or information subject to the same restrictions under sub-section (1) as apply to the \r\nperson from who the records or information were received. \r\n32. Act not to override other laws. ____ (1) The provisions of this Act shall be in addition to \r\nand not in derogation of the provisions made in the Drugs Act, 1976 (XXXI of 1976) and any other \r\nlaw for the time being in force. \r\n \r\nPage 20 of 32 \r\n \r\n(2) In case of inconsistency between the provisions of this Act and any other law for the time \r\nbeing in force, the provisions of this Act shall prevail. \r\n33. Recovery of arrears. ___ All amounts due to the Authority may be recovered as arrears of \r\nland revenue. \r\n34. Indemnity. ____ No suit prosecution or other legal proceeding shall lie against any person \r\nfor anything which is in good faith done or intended to be done under this Act or any rules or \r\nregulations made there under. \r\n35. Power to amend Schedule. ____ The Federal Government may, by notification in the \r\nofficial Gazette, amend the Schedule so as to add any entry thereto or modify or omit any entry \r\ntherefrom on the recommendation of the Board. \r\n36. Removal of difficulties. _____If any difficulty arises in giving effect to any of the \r\nprovisions of this Act, the Federal Government may make such Order by notification in the Official \r\nGazette, not inconsistent with the provisions of this Act, for the purpose of removing the difficulty. \r\n37. Employment under the Authority to be employment under the Federal \r\nGovernment.___ Every employment under the Authority shall, for the purpose of Pakistan Essential \r\nServices (Maintenance) Act, 1952 (LIII of 1952), be deemed to be employment under Federal \r\nGovernment and the said Act shall have effect accordingly. \r\n38. Act X of 2012 not to apply to the Authority. ____ Nothing contained in the Industrial \r\nRelation Act (X of 2012), shall apply to or in relation to the Authority or any of the officers and \r\nemployees of the Institute. \r\n39. Co-operation with international organizations. ____ The Authority may, subject to the \r\nprior approval of the Federal Government, co-operate with any foreign authority or international \r\norganization in the field of health on the terms and conditions of any program or agreement for co-\r\noperation to which such authority or organization is a party, or pursuant to any other international \r\nagreement made or after the commencement of this Act. \r\n40. Repeal and Savings. ____ (1) The Drug Regulatory Agency of Pakistan Ordinance, 2012 \r\n(Ordinance I of 2012) is hereby repealed. \r\n (2) Notwithstanding the repeal of the Drug Regulatory Agency of Pakistan Ordinance, 2012 \r\n(Ordinance I of 2012) by sub-section (1),⸻ \r\n(a) any license to manufacture or any registration or maximum retail price fixed \r\nfor sale issued thereunder to any person, or for the revalidation of an license or \r\nregistration issued earlier under the Act, for which an application has been \r\nmade to the Licensing Board, Registration Board, and Drug Pricing \r\nCommittee as the case may be within the specified time, shall continue to be \r\nvalid; \r\n(b)  any license for import or export or sale of drugs issued thereunder to any \r\nperson, shall, unless it expires earlier under the terms thereof, continue to be \r\n \r\nPage 21 of 32 \r\n \r\nvalid for such periods as the Federal Government, may by notification in the \r\nofficial Gazette, specify in this behalf. \r\n(3) All such actions of the Federal Government as mentioned in sub-section (2) since 20th \r\nApril, 2010 shall be deemed to have validly made under this Act. \r\n41. Policy Directive of Federal Government. ____ (1) The Federal Government may issue \r\npolicy directives in accordance with the law and Constitution to the Board in respect of any of its \r\nactivities, powers and functions and whose compliance shall be binding on the Authority, within a \r\nstipulated time. \r\n(2) Notwithstanding anything contained in sub-section (1) if there is any difficulty in \r\nimplementation of the directions and guidelines of the Policy Board or the Federal Government, the \r\nAuthority shall refer the case back to the Federal Government for its review specifying reasons for \r\nnon-implementation, within the stipulated time, whose decision in this respect shall be final. \r\n42. Winding up of Authority. ____ No provision of any law relating to winding up of bodies \r\ncorporate shall apply to the Authority. The Authority shall only be wound up by the law to be \r\nenacted by the Parliament for winding up of the Authority. \r\n \r\nSCHEDULE-I \r\n \r\n[See Section 2 (v, xii, xviii, xix, & xxviii)] \r\n1. BIOLOGICALS includes, ___ \r\n(1) Biological drugs produced by biological systems and which require standardization by \r\nbiological assays according to the relevant and updated recommendations of the World Health \r\nOrganization published in Technical Report Series and Biological Standardization Report and \r\nincludes___ \r\n (a)  blood products including Plasma, Albumin, Clotting Factors, Factors VIII, IX, \r\nMixed Clotting Factors Tractions, Fibrinogens, Immunoglobulins: \r\n (b)  immunological products including Antisera, Antitoxins, specific \r\nImmunoglobulins; \r\n (c)  in vivo diagnostics including Tuberculins, Lepronin, Histoplasmin, \r\nCoccidioidin, Allergens, Allergens Extracts, Antibodies conjugated with \r\nisotopes for imaging studies; \r\n (d)  antigens, cytokines/antibodies/cells injected to elicit a biological response; \r\n (e)  vaccines, including:⸻ \r\n \r\nPage 22 of 32 \r\n \r\n(i)  bacterial vaccines including live, killed whole cell, protein sub-unit, \r\npolysacchrid or glyco-conjugate, toxin derivatives, and rDNA \r\nbiotechnology developed. \r\n(ii)  viral vaccines including live, inactivated, sub-unit, rDNA, conjugated; \r\n(iii)  polyvalent combinations of vaccines containing combination of \r\nvaccines defined in e (i) and d(ii). \r\n (f)  toxins and venoms including snake venoms, scorpion venoms etc; \r\n(g)  immunostimulants of biological origin including BCG vaccine for \r\nimmunothcrapy; \r\n(h)  biotechnology products which are primarily manufactured using recombinant \r\nDNA, recombinant RNA, hybridoma technology or other processes involving \r\nsite specific genetic manipulation techniques. \r\n (i)  human interferons, natural hormones, recombinant antibodies, monoclonal \r\nantibodies and derivatives gene therapy products; \r\n(2) “Biological Drugs (Finished form)”, are Biological Drugs that are defined in sub-section \r\n(1) above and are manufactured, packed by the manufacturer under his responsibility of quality \r\nassurance and is further released by the National Control Authority or the National Control \r\nLaboratory of the country of origin under the World Health Organization's Lot Release system of \r\nevaluation. \r\n(3) “Biological Drugs (Ready-to-fill form)”, are Biological Drugs that are defined in sub-\r\nsection (1) above but are manufactured at one site in the form of a “Ready-to-fill Bulk” but are \r\ntransferred to another site for final filling, labeling, packaging and quality control of the finished \r\nform. No further formulation or dilution of the Ready-to-fill bulk is allowed in this case of \r\nmanufacture. The final product is released by the Pakistan's National Control Laboratory for \r\nBiologicals under the World Health Organization's Lot Release system of evaluation. \r\n(4) “Biological Drugs (Concentrated form)”, are Biological Drugs that are defined in sub-\r\nsection (1) above that are manufactured at one site but are stored in the form of Concentrated-Bulk of \r\nthe active ingredient at controlled temperatures. Such Concentrated-Bulk may be transferred to any \r\nother site under temperature controlled conditions for further dilution, stabilization, filling and \r\npackaging. The diluted and stabilized bulk requires its own set of quality control test and the final \r\nfinished form of such Biological Drugs under go another set of complete quality control tests. The \r\nfinal product is released by the Pakistan's National Control Laboratory for Biologicals under the \r\nWorld Health Organization's Lot Release system of evaluation. \r\n(5) ''Biological Drugs (Naked vials)”, are Biologicals Drugs that are defined in sub-section \r\n(1) above that are manufactured and filled at one site but the final containers are neither labeled nor \r\npacked in cartons. These drugs are imported in unlabeled vials and are labeled and packed in carton \r\nlocally. In such cases at least an identity test is required to confirm the positive identification of the \r\nrequired antigen. The final product is released by the Pakistan's National Control Laboratory for \r\nBiologicals under the World Health Organization's Lot Release system of evaluation. \r\n \r\nPage 23 of 32 \r\n \r\n(6) Originator Biological Drugs means a biological drug which has been licensed by the \r\nnational regulatory authorities on the basis of a full registration dossier; i.e. the approved \r\nindication(s) for use were granted on the basis of full quality, efficacy and safety data: \r\n(a)  reference biotherapeutic product (RBP) means an originator biological drug \r\nproduct that was licensed on the basis of a full registration dossier. It does not \r\nrefer to measurement standards such as international, pharmacopoeial, or \r\nnational standards or reference standards; \r\n(b)  biosimilar biological drugs mean Similar Biotherapeutic Product (SBP) which \r\nis similar in terms of quality, safety and efficacy to an already licensed \r\nreference biotherapeutic product; \r\n(c)  similarity means absence of a relevant difference in the parameter of interest. \r\n(7) No human biological drug is allowed sale and use until a “Lot Release Certificate” from \r\nthe Federal Government Analyst of the National Control Laboratory for Biologicals, Islamabad has \r\nbeen obtained. \r\n(8) Pharmaceutical dossier includes a set of documents submitted by a Person for the \r\nregistration of a therapeutic good, containing complete information about: \r\n(a)  master formula; \r\n(b)  all ingredients both active pharmaceutical ingredients and inactive excipients \r\nadded with their safety profile data; \r\n(c)  complete manufacturing procedure of the drug, biological or medical device; \r\n(d)  quality control steps and procedures at each level of raw material selection, in-\r\nprocess testing, finished drug testing, and stability testing; \r\n(e)  clinical trial data and published reports about the safety and efficacy of the \r\ndrug; \r\n(f) complete details of manufacturing plant and equipment, quality control \r\nlaboratories and equipment; \r\n(g)  ware-houses capacities and facilities; details of human resources available and \r\nthe latest cGMP report shall also be part of this document set; \r\n(h)  any other information required by the registration board for establishing the \r\nsafety, efficacy, bioavailability, bioequivalence, or biosimilarity of the drug. \r\n2. DRUG includes: — \r\n(a)  any substance or mixture of substances that is manufactured, sold, stored, \r\noffered for sale or represented for internal or external use in the treatment, \r\nmitigation, prevention or diagnosis of diseases, an abnormal physical state, or \r\n \r\nPage 24 of 32 \r\n \r\nthe symptoms thereof in human beings or animals or the restoration, \r\ncorrection, or modification of organic functions in human beings or animals, \r\nincluding substance used or prepared for use in accordance with the \r\nAyurvedic, Unani, Homoeopathic, Chinese or biochemic system of treatment \r\nexcept those substances and in accordance with such conditions as may be \r\nprescribed; \r\n(b)  abortive and contraceptive substances, agents and devices, surgical ligatures, \r\nsutures, bandages, absorbent cotton, disinfectants, bacteriophages, adhesive \r\nplasters, gelatin capsules and antiseptic solution; \r\n(c)  such substances intended to be used for the destruction or repulsion of such \r\nvermin, insects, rodents and other organism as cause, carry or transmit disease \r\nin human beings or animals or for disinfection in residential areas or in \r\npremises in which food is manufactured, prepared or kept or stored; \r\n(d)  such pesticides as may cause health hazard to the public; \r\n(e)  any substance mentioned as monograph or as a preparation in the Pakistan \r\nPharmacopoeia or the Pakistan National Formulary or the International \r\nPharmacopoeia or the British Pharmacopoeia or the British Pharmaceutical \r\nCodex or the United States Pharmacopoeia or the National Formulary of the \r\nUnited States, whether alone or in combination with any substance exclusively \r\nused in the Unani, Ayurvedic, Homoeopathic, Chinese or Biochemic system \r\nof treatment, and intended to be used for any of the purposes mentioned in \r\nsub-Clauses (a), (b) and (c); and \r\n(f)  any other substance which the Federal Government may by notification in the \r\nofficial Gazette, declare to be a drug for the purpose of this Act. \r\n3. MEDICAL DEVICES include, — \r\n(a)  instruments, medical equipment, implants, disposables and software, used \r\nmainly for the purpose of diagnosis, monitoring and treatment of disease, or \r\n(b)  any other item which the Federal Government may, by notification in the \r\nofficial Gazette, declare as medical device; \r\n4. MEDICATED COSMETICS include, —Cosmetics containing drugs and are defined as \r\narticles containing active drug ingredients intended to be rubbed, poured, sprinkled, or sprayed on, or \r\nintroduced into, or otherwise applied to human body or part thereof for cleansing, beautifying, \r\npromoting attractiveness, or altering the appearance, and articles intended for use as a component of \r\nany such articles; except that such term shall not include soap. \r\nSCHEDULE-II \r\n[See Section 2(xxx)] \r\nPROHIBITIONS \r\n \r\nPage 25 of 32 \r\n \r\nA. Import, manufacture and sale of therapeutic goods: \r\n(1)  No person shall himself or by any other person on his behalf, — \r\n (a)  Export, import or manufacture for sale or sell, — \r\n (i)  any spurious therapeutic good; \r\n (ii)  any counterfeit therapeutic good; \r\n (iii)  any misbranded therapeutic good; \r\n (iv)  any adulterated therapeutic good; \r\n (v)  any substandard therapeutic good; \r\n (vi) any therapeutic good after its expiry date; \r\n(vii)  any therapeutic good which is not registered or is not in accordance \r\nwith conditions of registration as disclosed in the registration dossier \r\nand that has undergone pharmaceutical evaluation; \r\n(viii)  any therapeutic good which, by means of any statement, design or \r\ndevice accompanying it or by any other means, purports or claims to \r\ncure or mitigate any such disease or ailment, or to have any such other \r\neffect, as may be prescribed; \r\n(ix)  any drug if it is dangerous to health when used in the dosage or with \r\nthe frequency, or for the duration specified, recommended or suggested \r\nin the labeling thereof; or \r\n(x)  any therapeutic good in contravention of any of the provisions of this \r\nAct or rules made thereunder; \r\n(b)  manufacture for sale any therapeutic good except under, and in accordance \r\nwith the condition of a license issued under this Act; \r\n(c)  sell any therapeutic good except under, and in accordance with the conditions \r\nof a license issued under this Act; \r\n(d)  import or export any therapeutic good the import or export of which is \r\nprohibited by or under this Act; \r\n(e)  import or export any therapeutic good drug for the import or export of which \r\na license is required, except under, and in accordance with the conditions of, \r\nsuch license; \r\n(f)  supply an incorrect, incomplete or misleading information, when required to \r\nfurnish any information under this Act or the rules; \r\n \r\nPage 26 of 32 \r\n \r\n(g)  peddle, hawk or offer for sale any therapeutic good in a park, or public street \r\nor on a highway footpath or public transport or conveyance; \r\n(h)  import, manufacture for sale, or sell any substance, or mixture of substances, \r\nwhich is not a therapeutic good but is presented in a form or a manner which is \r\nintended or likely to cause the public to believe it to be a therapeutic good; \r\n(i)  sell any therapeutic good without having warranty in the prescribed form \r\nbearing the name and batch number of the therapeutic good issued; \r\n(i)  in the case of a therapeutic good manufactured in Pakistan, by the \r\nmanufacturer holding a valid license to manufacture therapeutic good \r\nand permission to manufacture that therapeutic good or by his \r\nauthorized agent; \r\n(ii)  in the case of an imported drug, by the manufacture or importer of that \r\ntherapeutic good or if the therapeutic good is imported through an \r\nindenter by such indenter; and \r\n(iii)  apply an incorrect batch number to a therapeutic good. \r\n (2) Nothing in Paragraph (1) shall apply to the manufacture of small quantities of any \r\ntherapeutic good for the purpose of clinical trial examination, test, analysis or personal use in small \r\nquantities. \r\nB. Control of advertisement:—  \r\nNo person shall himself or by any other person on his behalf advertise, except in accordance \r\nwith such conditions as may be prescribed,— \r\n(a)  any therapeutic good; \r\n(b)  any substance used or prepared for use in accordance with the Ayurvedic, \r\nUnani, Homoeopathic, Chinese or Biochemic system of treatment or any other \r\nsubstance or mixture of substances as may he prescribed; \r\n(c)  any remedy, treatment or offer of a treatment for any disease. \r\n Explanation.--For the purpose of this entry “Advertise” means to \r\nmake any representation by any means whatsoever for the purpose of \r\npromoting directly or indirectly the sale or disposal of therapeutic good, a \r\nsubstance or a mixture of substances, a remedy or a treatment except the \r\ndisplay of sign boards for a clinic, a dispensary or a hospital or such other \r\ninstitution offering treatment. \r\nC. Control of samplings:—  \r\nNo person shall distribute or cause to be distributed any therapeutic good as a sample except \r\nin accordance with such conditions as may be prescribed. \r\n \r\nPage 27 of 32 \r\n \r\nD. Control of printing of labeling: — \r\nNo person shall print any label in respect of any therapeutic good which is required to be \r\nregistered under this Act but is not so registered after the date fixed by the Federal Government \r\nunder sub-section (6) of Section 7 of Act, or for a person who does not possess a license under that \r\nAct to manufacture that therapeutic good. \r\nSCHEDULE-III \r\n[See Section 27] \r\nOFFENCE \r\n(1) Whoever himself or by any other person on his behalf, — \r\n(a)  exports, imports, manufactures for sale or sells any spurious therapeutic good \r\nor any therapeutic good which is not registered; \r\n(b)  manufactures for sale any therapeutic good without a license; \r\n(c) imports without license any therapeutic good for the import of which a license \r\nis required; \r\n Shall be punishable with imprisonment for a term which shall not be less than three years or \r\nmore than ten years and with fine which may extend to ten lakh rupees: \r\n Provided that the Drug Court may, for any special reasons to be recorded, award a sentence \r\nof imprisonment for a term of less than three years. \r\n(2) Whoever himself or by any other person on his behalf, — \r\n(a)  imports, manufactures for sale or sells any counterfeit therapeutic good; or \r\n(b)  gives to the purchaser a false warranty in respect of any therapeutic good sold \r\nby him that the therapeutic good does not in any way contravene the \r\nprovisions of Schedule II and is not able to prove that, when he gave the \r\nwarranty, he had good and sufficient reason to believe the same to be true; or \r\n(c)  applies or permits to be applied to any therapeutic good sold, or stocked or \r\nexhibited for sale, by him, whether the container or a label or in any other \r\nmanner, a warranty given in respect of any other therapeutic good; or \r\n(d)  imports, manufactures for sales or sells any therapeutic good under a name \r\nother than the registered name; or \r\n(e)  exports, imports, manufactures for sale or sells any therapeutic good with \r\nwhich any substance, which should not actually be its component, or has been \r\nmixed or packed it so as to reduce its quality or strength or for which any such \r\nsubstance has been substituted wholly or in part, \r\n \r\nPage 28 of 32 \r\n \r\nshall be punishable with imprisonment for a term which may extend to \r\nseven years, or with fine which may extend to five lakh rupees or with both. \r\n(3) Obstruction of Inspector.⸻ Whoever obstructs an Inspector in the exercise of any power \r\nconferred upon him by or under this Act, or disobeys the lawful authority of any Inspector, shall be \r\npunishable with imprisonment for a term which may extend to one year, or with fine which may \r\nextend to one lakh rupees, or with both. \r\n(4) Contravention of rules.⸻ Subject to the provisions of Clauses (1), (2) and (3), whoever \r\nhimself or by any other person on his behalf contravenes any of the provisions of this Act or any rule \r\nshall be punishable with imprisonment for a term which may extend to five years, or with fine which \r\nmay extend to one lakh rupees, or with both. \r\n(5) Penalty for subsequent offence.⸻ Whoever having been convicted of an offence under \r\nClause (1) of Schedule-Ill is convicted for a subsequent offence under that section shall be \r\npunishable with imprisonment for life or with imprisonment which shall not be less than five years \r\nand with fine which may extend to five hundred thousand rupees. \r\n(6) Penalty for violating the prohibitions. ⸻Whoever himself or by any other person on his \r\nbehalf violates any prohibitions specified in Schedule-II shall be punished with imprisonment for a \r\nterm up to five years and with fine up to five hundred thousand rupees. \r\nSCHEDULE-IV \r\n[See Section 29] \r\nCOGNIZANCE OF OFFENCES \r\n(1) Subject to the provisions of Schedule-V no prosecution shall be instituted under this Act \r\nexcept, — \r\n(a)  by a Federal Inspector, where the prosecution is in respect of a contravention \r\nof Clause (h) of Paragraph (1) of heading A of Schedule-II or any of the \r\nprovisions of this Act or the rules relating to the import or export of \r\ntherapeutic goods or the manufacture for sale, or sale, of a therapeutic good \r\nwhich is not for the time being registered or for the manufacture for sale of \r\nwhich a license is not for the time being in force; or \r\n(b)  by a Provincial Inspector: \r\n Provided that, where the public interest so requires, the Federal Inspector may, with the prior \r\npermission of the Registration Board or Licensing Board as the case may be, institute a prosecution \r\nfor a contravention of any other provision of this Act and The Drugs Act, 1976 (XXXI of 1976). \r\n(2) Notwithstanding anything contained in the Code of Criminal Procedure, 1898 (Act V of \r\n1898): \r\n(a)  an offence punishable under Schedule-III other than an offence mentioned in \r\nClause (1) of that Schedule shall be non-cognizable, and \r\n \r\nPage 29 of 32 \r\n \r\n(b)  no Court other than a Drug Court established under The Drugs Act, 1976, \r\n(XXXI of 1976) shall try an offence punishable under this Act and Drugs Act, \r\n1976 (XXXI of 1976); \r\n(c) nothing contained in this Schedule shall be deemed to prevent any person from \r\nbeing prosecuted under any other law for any act or omission which \r\nconstitutes an offence punishable under this Act or The Drugs Act, 1976 \r\n(XXXI of 1976) or to require the transfer to a drug Court of any case which \r\nmay be pending in any Court immediately before the establishment of Drug \r\nCourt. \r\nSCHEDULE-V \r\n[See Section 2(xvi)] \r\nPOWERS OF INSPECTORS \r\n (1) Subject to the provisions of this Schedule and of any rules made in this behalf, an \r\nInspector may, within the local limits for which he is appointed, and in any other area within the \r\npermission of the licensing Authority or Licensing Board as the case may be,— \r\n(a)  inspect any premises where in any therapeutic good is manufactured, the plant \r\nand process of manufacture, the means employed, for standardizing and \r\ntesting the therapeutic goods and all relevant records and registers; \r\n(b)  inspect any premises wherein any therapeutic good is sold or is stocked or \r\nexhibited for sale or is distributed, the storage arrangements and all relevant \r\nrecords and registers; \r\n(c)  take samples of any therapeutic good which is being manufactured, or being \r\nsold or is stocked or exhibited for sale or is being distributed; \r\n(d)  enter and search, with such assistance, if any, as he considers necessary, any \r\nbuilding, vessel or place, in which he has reason to believe that an offence \r\nunder this Act or any rules has been or is being committed or may continue to \r\nbe committed; \r\n(e)  call any person to be present as witness in the course of search or seizure or in \r\nconnection with any other matter where the presence of witnesses is \r\nnecessary; \r\n(f)  seize such therapeutic good and all materials used in the manufacture thereof \r\nand any other articles, including registers cash memos, invoices and bills, \r\nwhich he has reason to believe may furnish evidence of the commission of an \r\noffence punishable under this Act or any rules; \r\n(g)  require any person to appear before him at any reasonable time and place to \r\ngive statement, assistance or information relating to or in connection with the \r\n \r\nPage 30 of 32 \r\n \r\ninvestigation of any offence under this Act and the Drugs Act, 1976 (XXXI of \r\n1976) or the rules: \r\nProvided that the exemption under Sections 132 and 133 of the Code \r\nof Civil Procedure, 1908 (Act V of 1908), shall be applicable to requisitions \r\nfor attendance under this Schedule; \r\n(h)  lock and seal any factory, laboratory, shop, building, store-hose or godown, or \r\na part thereof, where any therapeutic good is or is being manufactured, stored, \r\nsold or exhibited for sale in contravention of any of the provisions of this Act, \r\nthe Drugs Act, 1976 or the rules; \r\n(i)  forbid for a reasonable period, not exceeding four weeks or such further \r\nperiod, which shall not be more than three months, as the Inspector may, with \r\nthe approval of the Provincial Quality Control Board, the Licensing Board, the \r\nRegistration Board, as the case may be, specify, any person in charge of any \r\npremises from removing or dispensing of any therapeutic good, article or other \r\nthing likely to be used in evidence of the commission of an offence under this \r\nAct or the rules; and \r\n(j)  exercise such other powers as may be necessary for carrying out the purposes \r\nof this Act or any rules: \r\nProvided that the powers under Paragraph (f) to (j) shall be exercisable \r\nonly by an Inspector specifically authorized in this behalf, by an order in \r\nwriting, by the Government appointing him, subject to such conditions as may \r\nbe specified in such order: \r\nProvided further that the power under Paragraph (h) may be exercised \r\nby an Inspector not authorized as aforesaid where the contravention is of a \r\nprovision which requires a license to be obtained for the manufacture, storage \r\nor sale of drug. \r\n(2) The provisions of the Code of Criminal Procedure, 1898 (Act V of 1898), insofar as they \r\nare not inconsistent with the provisions of this Act and The Drugs Act, (XXXI of 1976), shall apply \r\nto searches and seizures made under this Act. \r\n \r\nPROCEDURE FOR INSPECTORS \r\n(1) Where an Inspector seizes any therapeutic good or any other article under this Schedule \r\nhe shall tender a receipt therefore in the prescribed form. \r\n(2) Where an Inspector takes a sample of a therapeutic good for the purpose of test or \r\nanalysis, he shall intimate such purpose in writing in the prescribed form to the person from whom \r\nhe takes it and, in the presence of such person unless he willfully absents himself, shall divided the \r\nsample into four portions and effectively seal and suitable mark the same and permit such persons to \r\nadd his own seal, if any, and mark to all or any of the portions so sealed and marked: \r\n \r\nPage 31 of 32 \r\n \r\n Provided that, where the sample is taken from premises whereon the drug is being \r\nmanufactured, it shall be necessary to divide the sample into three portions only: \r\n Provided further that, where the therapeutic good is made up in containers of small volume, \r\ninstead of dividing a sample as aforesaid, the Inspector may, and if the therapeutic good be such that \r\nit is likely to deteriorate or be otherwise damaged by exposure shall, take three or four, as the case \r\nmay be, of the said containers after suitably marking the same and, where necessary, sealing them: \r\n Provided also that if the contents of one container are insufficient for the laboratory test and \r\nanalysis, the Inspector may increase the number of the containers in order to make the sample \r\nsufficient for this purpose. \r\n(3) The Inspector shall return one portion of a sample so divided or one container, as the case \r\nmay be, to the person from whom he takes it, and shall retain the remainder and dispose of the same \r\nwithin seven days as follows, namely, — \r\n(a)  one portion of sample he shall send to the Government Analyst concerned for \r\ntest and analysis; \r\n(b)  the second he shall send to the Chairman, Provincial Quality Control Board or \r\nthe Licensing Board or the Registration Board, as the case may be; and \r\n(c)  the third, where taken, he shall send to the warrantor, if any, named under \r\nproviso to sub-section (3) of Section 32 of The Drugs Act, 1976 (XXXI of \r\n1976). \r\n(4) Where an Inspector seizes any therapeutic good containing any filthy or putrid substance, \r\nvermin, worm, rodent, insect or any foreign matter which is visible to the naked eye, and the sample \r\nis such that it cannot or need not be divided, he shall effectively seal and suitably mark the same and \r\npermit the person from whom he seizes the therapeutic good to add his own seal, if any, and mark to \r\nit and shall produce the same before the Drug Court, or the Provincial Quality Control Board, or the \r\nLicensing Board or the Registration Board, as the case may be, before which proceedings are \r\ninstituted or action is initiated in respect of the drug. \r\n(5) Where an Inspector takes any action under section this Schedule,⸻ \r\n(a)  he shall as soon as practicable ascertain whether or not the therapeutic good \r\ncontravenes any of the provisions of this Act and, it is ascertained that the \r\ndrug does not so contravene, he shall forthwith revoke the order passed under \r\nthe said section or, as the case may be, take such action as may be necessary \r\nfor the return of the stock seized and payment for the samples taken, under \r\nintimation to the Board concerned; \r\n(b)  if he seizes the stock of the therapeutic good he shall, as soon as may be \r\ninform the Board concerned and take its order as to the custody thereof: \r\n  Provided that where a Federal Inspector is not competent to take action \r\nunder Schedule-IV, he shall as soon as may be, report the matter and hand \r\n \r\nPage 32 of 32 \r\n \r\nover the stock, if any, to the Provincial Inspector for further action under this \r\nAct or The Drugs Act, 1976. \r\n(6) The Provincial Inspector on finding any contravention of this Act or the Drugs Act, 1976 \r\n(XXXI of 1976) shall, unless the Board otherwise directs, always refer the case to the Provincial \r\nQuality Control Board and seek orders as to the action to be taken in respect of such contraventions. \r\n(7) The Federal Inspector on finding any contravention of this Act or the Drugs Act, 1976 \r\n(XXXI of 1976) for which he is authorized shall unless otherwise directed, always refer the case to \r\nthe Licensing Board or the Registration Board or any other authority as may be specified for the \r\npurpose and seek any further orders as to the action to be taken in respect of such contravention. \r\n \r\nSCHEDULE-VI \r\n[See Section 2(i)] \r\n (1) The Drugs Act, 1976 (XXXI of 1976). \r\n(2) Rules made under the Drugs Act, 1976 (XXXI of 1976).",
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