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  "title": "Drugs Act, 1976",
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  "text": "Page 1 of 29 \r\n \r\n \r\n \r\n \r\nTHE DRUGS ACT, 1976 \r\n \r\n \r\n \r\n \r\n \r\n   CONTENTS \r\n \r\nCHAPTER I \r\nINTRODUCTORY \r\n \r\n1.  Short title, extent and commencement \r\n \r\n2. Application of other laws not barred \r\n \r\n3.  Definitions \r\n \r\n  CHAPTER II \r\nADMINISTRATION AND ENFORCEMENT \r\n \r\n4.  Regulation and prohibition of import, etc., of drugs \r\n \r\n5.  Regulation of manufacture of drugs \r\n \r\n6.  Regulation of sale of drugs \r\n \r\n7.  Registration of drugs \r\n \r\n8. Pakistan National Formulary \r\n \r\n9.  Appellate Board \r\n \r\n9 A.  Appeals to the Provincial Appellate Authority \r\n \r\n10.  Expert Committees \r\n \r\n11.  Provincial Quality Control Board \r\n \r\n11 A.  Conflict of interest \r\n \r\n12.  Power to fix maximum prices of drugs, etc. \r\n \r\n13.  Directions to Provincial Governments \r\n \r\n\r\nPage 2 of 29 \r\n \r\n14.  Federal Drug Laboratory and institutes, etc. \r\n \r\n15.  Provincial Drug Testing Laboratory \r\n \r\n16.  Government Analysts \r\n \r\n17.  Inspectors \r\n \r\n18.  Powers of Inspectors \r\n \r\n19.  Procedure for Inspectors \r\n \r\n20.  Persons bound to disclose place where drugs are manufactured or kept \r\n \r\n21.  Disclosure of the name of the manufacturer \r\n \r\n22.  Reports of Government Analysts \r\n \r\nCHAPTER III \r\nPROHIBITIONS \r\n \r\n23.  Imports, manufacture and sale of drugs \r\n \r\n24.  Control of advertisement \r\n \r\n25.  Control of sampling \r\n \r\n26.  Control of printing of labelling \r\n \r\nCHAPTER IV \r\nOFFENCES, PENALTIES AND PROCEDURE \r\n \r\n27.  Penalties \r\n \r\n28.  Penalty for subsequent offence \r\n \r\n29.  Forfeiture \r\n \r\n30.  Cognizance of offences \r\n \r\n31.  Drug Courts \r\n \r\n32.  Pleas \r\n \r\n33.  Application of law relating to customs and powers of officers of customs \r\n \r\n34.  Offences by companies, etc. \r\n \r\n35.  Publication of offender’s name \r\n \r\nPage 3 of 29 \r\n \r\n36.  Powers to exempt \r\n \r\n37.  Inspectors to be public servants \r\n \r\n38.  Indemnity \r\n \r\n39.  Finality of orders, etc. \r\n \r\n40. Publication of result of test or analysis, etc. \r\n \r\n41.  Cancellation or suspension of licences \r\n \r\n42.  Cancellation or suspension of registration of registered drugs \r\n \r\nCHAPTER V \r\nMISCELLANEOUS \r\n \r\n43.  Power of Federal Government to make rules \r\n \r\n44.  Power of the Provincial Government to make rules \r\n \r\n45.  Repeal and Savings \r\nPage 4 of 29 \r\n \r\nTHE DRUGS ACT, 1976 \r\n \r\nACT No. XXXI OF 1976 \r\n[11th May, 1976] \r\nAn Act to regulate the import, export, manufacture, storage, distribution and sale of drugs \r\nWHEREAS it is expedient to regulate the import, export, manufacture, storage, distribution \r\nand sale of drugs; \r\nIt is hereby enacted as follows:⎯ \r\nCHAPTER I \r\nINTRODUCTORY \r\n \r\n1. Short title, extent and commencement.⎯ (1) This  Act may be called the Drugs Act, \r\n1976. \r\n(2) It extends to the whole of Pakistan. \r\n(3) It shall come into force at once. \r\n2. Application of other laws not barred. The provisions of this Act, shall be in addition to, \r\nand not in derogation of, the Dangerous Drugs Act, 1930 (II of 1930), and any other law for the time \r\nbeing in force. \r\n3. Definitions. ⎯ In this Act, unless there is anything repugnant in the subject or context, ⎯ \r\n(a)  “adulterated drug” means a drug⸻ \r\n(i)  which consists in whole or in part of any filthy, putrid or decomposed \r\nsubstance or which contains any foreign matter, vermin, worm, rodent \r\nor insect; or \r\n(ii)  which has been manufactured, packed, or held under unsanitary \r\nconditions whereby it 1[has] been contaminated with dirt, filth or any \r\nother foreign matter or whereby it may have been rendered injurious to \r\nhealth; or \r\n(iii)  the container of which releases any poisonous or deleterious substance \r\nwhich may render the contents injurious to health ; or \r\n(iv)  which bears or contains as an ingredient a  substance other than the \r\nprescribed substance ; or \r\n(v)  with which any substance has been mixed or packed so as to reduce its \r\nquality or strength or for which any substance has been substituted \r\nwholly or in part ; \r\n \r\n(b)  “Appellate Board” means the Board Constituted under section 9 ; \r\n \r\n \r\n1Subs. by Ordinance No. CXXVIII of 2002, s. 2.  \r\nPage 5 of 29 \r\n \r\n(c)  “batch” means a quantity of any drug produced during a given cycle of \r\nmanufacture ; \r\n \r\n(d)  “batch number” means a designation printed on the label of a drug that \r\nidentifies the batch and permits the production history of the batch, including \r\nall stages of manufacture and control, to be traced and reviewed ; \r\n \r\n(e)  “Central Licensing Board” means a Board set up under section 5 ; \r\n \r\n(f)  “counterfeit drug” means a drug the label or outer-packing of which is an \r\nimitation of, or resembles or so nearly resembles as to be calculated to \r\ndeceive, the label or outer-packing of a drug of another manufacturer ; \r\n \r\n(g)  “drug” includes ⎯ \r\n \r\n(i)  any substance or mixture of substances that is manufactured, sold, \r\nstored, offered for sale or represented for internal or external use in the \r\ntreatment, mitigation, prevention or diagnosis of disease, an abnormal \r\nphysical state, or the symptoms thereof in human beings or animals, or \r\nthe restoration, correction, or modification of organic functions in \r\nhuman beings or animals, not being a substance exclusively used or \r\nprepared for use in accordance with the ayurvedic, unani, \r\nhomoeopathic or biochemic system of treatment except those \r\nsubstances and in accordance with such conditions as may be \r\nprescribed ; \r\n \r\n(ii)  abortive and contraceptive substances, agents and devices, surgical \r\nligatures, sutures, bandages, absorbent cotton, disinfectants, \r\nbacteriophages, adhesive plasters, gelatine capsules and antiseptic \r\nsolutions ; \r\n \r\n(iii)  such substances intended to be used for the destruction or repulsion of \r\nsuch vermin, insects, rodents and other organisms as cause, carry or \r\ntransmit disease in human beings or animals or for disinfection in \r\nresidential areas or in premises in which food is manufactured, \r\nprepared or kept or stored ; \r\n \r\n(iv)  such pesticides as may cause health hazard to the public ; \r\n \r\n(v)  any substance mentioned as monograph or as a preparation in the \r\nPakistan Pharmacopoeia or the Pakistan National Formulary or the \r\nInternational Pharmacopeia or the British Pharmacopoeia or the British \r\nPharmaceutical Codex or the United States Pharmacopoeia or the \r\nNational Formulary of the United States, whether alone or in \r\ncombination with any substance exclusively used in the unani, \r\nayurvedic, homoeopathic or biochemic system of treatment, and \r\nintended to be used for any of the purposes mentioned in sub-clauses \r\n(i), (ii) and (iii) ; and \r\n \r\nPage 6 of 29 \r\n \r\n(vi)  any other substance which the Federal Government may, by \r\nnotification in the official Gazette, declare to be a “drug” for the \r\npurposes of this Act; \r\n \r\n(h)  “expiry date” means the date stated on the label of a drug after which the drug \r\nis not expected to retain its claimed efficacy, safety, quality or potency or after \r\nwhich it is not permissible to sell the drug ; \r\n \r\n(i)  “expert” means a specialist through university education and experience in the \r\nrelevant field ; \r\n \r\n(j)  “export”, with its grammatical variations and cognate expressions, means to \r\ntake out of Pakistan by sea, land or air ; \r\n \r\n(k)  “generic name” means the non-proprietary, scientific or official name of a \r\ndrug as approved by the Federal Government ; \r\n \r\n(l)  “Government Analyst” means a Federal Government Analyst or a Provincial \r\nGovernment Analyst appointed under section 16 ; \r\n \r\n(m)  “import”, with its grammatical variations and cognate expressions, means to \r\nbring into Pakistan by sea, land or air ; \r\n \r\n(n)  “Inspector” means a Federal Inspector or a Provincial Inspector appointed \r\nunder section 17 ; \r\n \r\n(o)  “label” means a display of written, printed or graphic matter upon the \r\nimmediate container, or the outside container or wrapper of a drug package; \r\n \r\n(p)  “labelling” means all labels and other written, printed or graphic matter \r\naccompanying any drug; \r\n \r\n(q)  “licensing authority” means such authority as may be prescribed; \r\n \r\n(r)  “manufacture”, in relation to a drug, means all operations involved in the \r\nproduction of the drug, including processing, compounding, formulating, \r\nfilling, packing, repacking, altering, ornamenting, finishing and labelling with \r\na view to its storage, sale and distribution, but does not include the \r\ncompounding and dispensing or the packing of any drug in the ordinary course \r\nof retail business or on a prescription of a registered medical practitioner or \r\ndentist or of a veterinarian and “to manufacture” shall be construed \r\naccordingly; \r\n \r\n(s)  “misbranded drug” means a drug ⎯ \r\n \r\n(i)  which is not labelled in the prescribed manner; or \r\n \r\n(ii)  on the label or labelling of which any word, statement, or other matter \r\nor information required by the rules to appear on the label or labeling \r\nPage 7 of 29 \r\n \r\nis not prominently placed with such conspicuousness (as compared \r\nwith other words, statements, designs, or devices on the label or \r\nlabelling) and in such terms as may render it likely to be read and \r\nunderstood by the ordinary individual under customary conditions of \r\npurchase and use; or \r\n \r\n(iii)  which is not labelled with such directions for use and such warnings \r\nagainst use in indications where its use may be dangerous to health, or \r\nagainst unsafe dosage or duration of administration or application, in \r\nsuch manner and form as are necessary for the protection of users or as \r\nmay be prescribed; or \r\n \r\n(iv)  the label or container of which, or anything accompanying which, \r\nbears any statement, design or device which makes any false claim for \r\nthe drug or which is false or misleading in any particular; or \r\n \r\n(v)  which is so coloured, coated, powdered or polished that damage is \r\nconcealed, or which is made to appear of better or greater therapeutic \r\nvalue than it really is; or \r\n \r\n(vi)  which is manufactured according to the specifications of a particular \r\npharmacopoeia or any other document as may be prescribed and the \r\nlabel does not bear the name of that pharmacopoeia or document; \r\n \r\n(t)  “prescribed” means prescribed by rules; \r\n \r\n(u)  “Provincial Quality Control Board” means a Board set up under section 11; \r\n \r\n(v)  “Registration Board” means a Board set up under section 7; \r\n(w)  “registered drug” means any drug registered under section 7; \r\n(x)  “rules” mean rules made under this Act; \r\n \r\n(y)  “Drug Court” means a Court established under section 31;  \r\n \r\n(z)  “specifications” when applied to a drug mean— \r\n \r\n(i)  such specifications as may be prescribed; or \r\n(ii)  when the specifications are not prescribed, the specifications as \r\ncontained in the most recent edition of any of the following \r\npublications, namely:— \r\n(1)  the Pakistan Pharmacopoeia; \r\n(2)  the International Pharmacopoeia; \r\n(3)  the European Pharmacopoeia; \r\n \r\nPage 8 of 29 \r\n \r\n(4)  the United States Pharmacopoeia; \r\n(5)  the British Pharmacopoeia; \r\n(6)  the British Pharmaceutical Codex; \r\n(7)  the United States National Formulary; and \r\n(8)  such other publication as may be prescribed: \r\nProvided that, if the specifications do not appear in the most recent edition of any \r\nsuch publication, the specifications appearing in the next preceding edition of such \r\npublication in which the specifications appear shall apply; or \r\n(iii)  if no specifications are either prescribed or contained, in any of the \r\npublications referred to in sub-clause (ii), the specification approved \r\nfor the purpose of registration under this Act; \r\n(za)  “sell” means sell, offer for sale, expose for sale, have in possession for sale \r\nand distribution and “to sell”, “sold” or “sale” shall be construed accordingly; \r\n \r\n(zb)  “spurious drug” means a drug— \r\n \r\n(i)  which purports to be a drug but does not contain the active ingredient \r\nof that drug; or \r\n \r\n(ii)  which purports to be the product of a manufacturer, place or country of \r\nwhom or of which it is not truly a product; or \r\n \r\n(iii)  which is imported or exported or sold or offered or exposed for sale \r\nunder a particular name while actually it is another drug; or \r\n \r\n(iv)  the label of which bears the name of an individual or company \r\npurporting to be its manufacturer or producer which individual or \r\ncompany is fictitious or does not exist; \r\n \r\n(zc)  “storage” means storage for sale and “to store” or “stored” shall be construed \r\naccordingly; and \r\n \r\n(zz)  “sub-standard drug” means a drug which is not of specifications. \r\n \r\nCHAPTER II \r\nADMINISTRATION AND ENFORCEMENT \r\n \r\n4. Regulation and prohibition of import, etc., of drugs.⎯ (1) The Federal Government \r\nshall regulate the import and export of drugs in the prescribed manner and for that purpose may \r\nmake such orders and issue such directions to the importers and exporters as it may deem fit. \r\n \r\n(2) If in the opinion of the Federal Government the public interest so requires, the Federal \r\nGovernment may, by notification in the official Gazette,— \r\nPage 9 of 29 \r\n \r\n(a)  direct that a drug or a class of drugs specified in the notification, or drugs \r\ngenerally, shall not be imported or exported otherwise than under the authority \r\nof a licence issued under this Act or except by an importer or exporter or \r\nthrough an indentor registered in accordance with the rules; \r\n \r\n(b)  direct that a drug or class of drugs specified in the notification shall not be \r\nimported except by an agency of Government so specified; or \r\n \r\n(c)  prohibit the import or export of any drug or class of drugs specified in the \r\nnotification. \r\n \r\n1[(3) Subject to sub-sections (1) and (2), only such drugs shall be imported which are on sale \r\nin the market of any of the western European countries, USA, Japan, Australia or any other country \r\nas may be prescribed] \r\n \r\n5. Regulation of manufacture of drugs.⎯ (1) The grant of licences to manufacture drugs \r\nshall be regulated in accordance with such conditions and procedure as may be prescribed, by a \r\nCentral Licensing Board to be set up by the Federal Government and consisting of such \r\nrepresentatives of the Federal Government and the Provincial Governments as may be prescribed. \r\n \r\n(2) The members of the Central Licensing Board shall exercise such powers, including the \r\npowers of an Inspector, as may be prescribed. \r\n \r\n(3) The Central Licensing Board shall 1[, with the approval of the Federal Government and by \r\nnotification in the official Gazette,] make regulations to regulate the conduct of its business. \r\n \r\n(4) Any member of the Central Licensing Board may, at any time, by writing under his hand \r\naddressed to the Federal Government, resign his office or shall vacate his office if the Federal \r\nGovernment, being of opinion that in the public interest it is necessary so to do, so directs. \r\n \r\n(5) Subject to subsection (4), a member of the Central Licensing Board shall hold office for \r\nthe prescribed period. \r\n6. Regulation of sale of drugs. The Provincial Governments shall regulate the sale of drugs \r\nin the prescribed manner and may for that purpose make such orders, and issue such directions to the \r\nimporters, manufacturers, stockists, retailers or other dealers of drugs, as they may deem fit. \r\n \r\n7. Registration of drugs.⎯ (1) The Federal Government shall cause all drugs to be \r\nregistered in accordance with such conditions and procedure as may be prescribed and for that \r\npurpose set up a Registration Board, consisting of such number of persons, possessing such \r\nqualifications, as may be prescribed. \r\n \r\nExplanation.⎯ In this section, “drugs” means drugs which are in the finished form ready for \r\nuse. \r\n \r\n(2) The members of the Registration Board shall exercise such powers, including the powers \r\nof an Inspector, as may be prescribed. \r\n \r\n \r\n1Added & ins. by Ordinance No. CXXVIII of 2002, ss. 3 & 4. \r\nPage 10 of 29 \r\n \r\n(3) The Registration Board shall 1[, with the approval of the Federal Government, and by \r\nnotification in the official Gazette,] make regulations to regulate the conduct of its business. \r\n \r\n(4) Any member of the Registration Board may, at any time, by writing under his hand \r\naddressed to the Federal Government, resign his office or shall vacate his office if the Federal \r\nGovernment, being of opinion that in the public interest it is necessary so to do, so directs. \r\n \r\n(5) Subject to sub-section (4), the members of the Registration Board shall hold office for the \r\nprescribed period. \r\n \r\n(6) The Federal Government shall, by notification in the official Gazette, fix the date after \r\nwhich no drug which is not registered shall be allowed to be exported, imported, manufactured, \r\nstored, distributed or sold. \r\n \r\n(7) A person applying for the registration of a drug shall furnish such information in respect \r\nof the drug as may be prescribed, including information relating to its efficacy, safety and quality, or \r\nas may be required by the Registration Board for the purpose of the evaluation of the drug. \r\n \r\n(8) Single-ingredient drugs shall be registered generally by their generic names while \r\ncompound drugs shall be registered generally by their proprietary names. \r\n \r\nExplanation .⎯ In this subsection, — \r\n \r\n(a)  “Single-ingredient drugs” means drugs containing one active ingredient; \r\n \r\n(b)  “compound drugs” means drugs containing more than one active ingredient. \r\n \r\n1[(9) The registration of a drug shall be subject to such conditions as may be prescribed.] \r\n \r\n(10) Where the Registration Board registers a drug, it shall inform the person applying for its \r\nregistration and the Provincial Governments of its having done so and of the conditions subject to \r\nwhich it has been registered. \r\n \r\n(11) If the Registration Board, on the basis of information received or an inquiry conducted \r\nby it, is of opinion that— \r\n(a)  the registration of a drug was procured by fraud or misrepresentation; or \r\n(b)  the circumstances in which a drug was registered no longer exist; or \r\n(c)  there has been a violation of the conditions subject to which a drug was \r\nregistered; or \r\n \r\n(d)  it is necessary in the public interest so to do; \r\n \r\n \r\n \r\n1Ins.& subs. by Ordinance No. CXXVIII of 2002, s. 5. \r\nPage 11 of 29 \r\n \r\nthe Registration Board may, after affording to the person on whose application the drug was \r\nregistered an opportunity of showing cause against the action proposed to be taken, cancel or \r\nsuspend the registration or specify any further condition s to which the registration shall be subject \r\nand inform such person and the Provincial Governments accordingly. \r\n \r\n(12) The Provincial Governments shall take all such steps as may be necessary to ensure \r\ncompliance with the conditions subject to which a drug is registered and to prevent the manufacture \r\nor sale of a drug — \r\n \r\n(a)  which has not been registered; or \r\n \r\n(b)  the registration of which has been cancelled or stands suspended. \r\n \r\n8. Pakistan National Formulary.— The Federal Government shall compile and publish in \r\nthe official Gazette Pakistan National Formulary comprising all drugs allowed to be imported, \r\nmanufactured or sold and such Formulary may be reviewed and modified from time to time. \r\n \r\n9. Appellate Board.— (1) The Federal Government shall, in accordance with the rules, \r\nconstitute an Appellate Board for the disposal of appeals preferred by persons aggrieved by any \r\ndecision of the Central Licensing Board or the Registration Board or the licensing authority or a \r\nBoard or Authority to which the powers of the Federal Government under section 12 have been \r\ndelegated under sub-section (3) of that section and for revision of any such decision on its own \r\nmotion. \r\n \r\n(2) The Appellate Board shall consist of such representatives of the Federal Government and \r\nthe Provincial Governments, including a Chairman, as the Federal Government may from time to \r\ntime appoint. \r\n \r\n(3) Subject to sub-section (4), the Chairman and other members of the Appellate Board shall \r\nhold office for the prescribed period. \r\n \r\n(4) The Chairman or any other member of the Appellate Board may, by writing under his \r\nhand addressed to the Federal Government, resign his office or shall vacate his office if the Federal \r\nGovernment, being of opinion that in the public interest it is necessary so to do, so directs.  \r\n(5) The members of the Appellate Board shall exercise such powers, including the powers of \r\nan Inspector, as may be prescribed. \r\n(6) The Appellate Board may appoint experts for the purposes of detailed study of any \r\nspecific matter before it. \r\n(7) The Appell ate Board shall 1[, with the approval of the Federal Government and by \r\nnotification in the official Gazette,] make regulations to regulate the conduct of its business. \r\n \r\n \r\n \r\n \r\n \r\n \r\n \r\n \r\n \r\n1Ins. by Ordinance No. CXXVIII of 2002, s. 6. \r\nPage 12 of 29 \r\n \r\n1[(8) The Appellate Board shall meet at least every month and shall decide any appeal \r\npreferred to it within sixty days of receipt of appeal unless the Board is prevented from doing so for \r\nsufficient cause to be recorded.] \r\n \r\n1[9A. Appeals to the Provincial Appellate Authority.— (1) Any person aggrieved by any \r\ndecision of the licensing authority may prefer appeal to the Provincial Appellate Authority. \r\n \r\n(2) The Provincial Government shall constitute a Provincial Appellate Authority for the \r\ndisposal of appeal preferred under sub-section (1) as may be prescribed.] \r\n \r\n10. Expert Committees.— (1) The Federal Government may constitute committees of \r\nexperts on Drugs Evaluation, on Pakistan Pharmacopoeia, on Advertising and on such other matters \r\nas may be necessary for the purposes of this Act. \r\n \r\n(2) Each committee constituted under sub-section (1) shall consist of such members as the \r\nFederal Government may appoint from time to time and each such member shall hold office during \r\nthe pleasure of the Federal Government. \r\n \r\n11. Provincial Quality Control Board.— (1) Each Provincial Government shall set up a \r\nProvincial Quality Control Board consisting of such members, including a Chairman, as that \r\nGovernment may appoint from time to time. \r\n \r\n(2) The Chairman and other members of the Provincial Quality Control Board shall hold \r\noffice during the pleasure of the Provincial Government, on such terms and conditions as that \r\nGovernment may determine. \r\n \r\n(3) The Provincial Government shall appoint a person to be the Secretary of the Provincial \r\nQuality Control Board and provide the Board with such staff as the Provincial Government may \r\nconsider necessary. \r\n(4) The Provincial Quality Control Board shall 1[, with the approval of the Provincial \r\nGovernment and by notification in the official Gazette,] make regulations to regulate the conduct of \r\nbusiness. \r\n(5) The following shall be the powers and functions of the Provincial Quality Control Board, \r\nnamely: — \r\n(a)  to inspect any premises where any drug is being, or is to be, manufactured or \r\nsold and to recommend to the appropriate authority the cancellation or \r\nsuspension of the licence to manufacture or sell drugs granted to any person \r\nwho is found to be contravening, or to have contravened, any of the provisions \r\nof this Act, or the rules; \r\n(b)  to scrutinize the reports of Provincial Ins pectors in respect of contraventions \r\nof this Act and reports of Government Analysts in respect of drugs sent to \r\nthem by Provincial Inspectors for test and analysis and issue instructions to the \r\nInspectors as to the action to be taken on such reports: \r\n \r\n \r\n \r\n1Added and ins. by Ordinance No. CXXVIII of 2002, ss. 6 ,7 & 8. \r\nPage 13 of 29 \r\n \r\nProvided that the Provincial Quality Control Board may specify the class of cases in which a \r\nProvincial Inspector may make a complaint to the Drug Court, or take any other action, without the \r\nspecific instructions of the Board; \r\n \r\n(c)  to exercise all the powers of an Inspector under this Act and the rules ; 1[*] \r\n \r\n(d)  to advise the Provincial Government on ways and means to ensure quality \r\ncontrol of drugs manufactured in the Province1[;] \r\n \r\n \r\n1[(e)  to ascertain the names of such directors, partners and employees of the \r\ncompany, corporation, firm or institution who are prima facie responsible for \r\nthe commission of any offence under this Act or the rules and allow an \r\nInspector to institute prosecution only against such persons; \r\n \r\n(f)  to conduct annual validation of all instruments in the provincial drug testing \r\nlaboratories and to recommend measures to upgrade such laboratories, if \r\nrequired; \r\n \r\n(g)  identify and accredit on payment of fee other laboratories in the Province with \r\nsuitable facilities and expertise; \r\n \r\n(h)  to conduct training programs to update Government Analysts and for \r\nimproving their knowledge according to latest analytical method and \r\ntechnology; and \r\n \r\n(i)  to submit a monthly report of decisions and activities to the Federal \r\nGovernment.] \r\n \r\n(6) The Provincial Quality Control Board may entrust any of its powers or functions under \r\nsub-section (5) to any one or more of its members. \r\n \r\n1[11A. Conflict of interest.— No person who is a member of the Appellate Board, Central \r\nLicencing Board, a Provincial Quality Board, the Registration Board or a member of Expert \r\nCommittee shall be a member of the any other board or committee of which he is a member to avoid \r\nany conflict of interest.] \r\n \r\n12. Power to fix maximum prices of drugs, etc.— (1) The Federal Government may, by \r\nnotification in the official Gazette,— \r\n \r\n(a)  fix the maximum price at which any drug specified in the notification is to be \r\nsold; and \r\n(b)  specify a certain percentage of the profits of manufacturers of drugs which \r\nshall be utilised, in accordance with the rules for purposes of research in \r\ndrugs. \r\n \r\n \r\n \r\n \r\n1Omitted, subs. added and ins. by Ordinance No. CXXVIII of 2002, ss. 8 & 9. \r\nPage 14 of 29 \r\n \r\n(2) For the purpose of the exercise of its powers under sub-section (1), the Federal \r\nGovernment may require a manufacturer, stockist, importer, exporter, retailer or other dealer in drugs \r\nto furnish such relevant information as may be necessary. \r\n \r\n(3) The Federal Government may, by notification in the official Gazette, delegate any of its \r\npowers under this section to any Board or other authority. \r\n \r\n13. Directions to Provincial Governments.— The Federal Government may give such \r\ndirections to a Provincial Government as may appear to the Federal Government to be necessary for \r\ncarrying into execution in the Province of any of the provisions of this Act or of any rule or order \r\nmade thereunder or for maintaining supplies of drugs of standard quality at reasonable prices or for \r\nthe achievement of uniformity in respect of any matter in different parts of Pakistan. \r\n \r\n14. Federal Drug Laboratory and institutes, etc.— The Federal Government shall, as soon \r\nas may be, establish a Federal Drug Laboratory and may also set up such other institutes and drugs \r\ntesting and research laboratories for the purposes of this Act as may be prescribed. \r\n \r\n15. Provincial Drugs Testing Laboratory.— Each Provincial Government shall, as soon as \r\nmay be, set up a Provincial Drug Testing Laboratory for such purposes as may be prescribed. \r\n \r\n16. Government Analysts.— The Federal Government or a Provincial Government may, by \r\nnotification in the official Gazette, appoint such persons it thinks fit, having the prescribed \r\nqualifications, to be the Federal Government Analysts or, as the case may be, Provincial Government \r\nAnalysts, for such areas and in respect of such drugs or classes of drugs as may be specified in the \r\nnotification: \r\n \r\nProvided that no person who has any financial interest in the manufacture, import, export or \r\nsale of drugs shall be so appointed: \r\n \r\nProvided further that a person serving under the Federal Government or another Provincial \r\nGovernment shall not be so appointed without the previous consent of that Government. \r\n \r\n17. Inspectors.— The Federal Government or a Provincial Government may, by notification \r\nin the official Gazette, appoint such persons as it thinks fit, having the prescribed qualifications, to be \r\nFederal Inspectors or, as the case may be, Provincial Inspectors for the purposes of this Act within \r\nsuch local limits as it may assign to them respectively: \r\n \r\nProvided that no person who has any financial interest in the manufacture, import, export or \r\nsale of any drug shall be so appointed: \r\n \r\nProvided further that a person serving under the Federal Government or another Provincial \r\nGovernment shall not be so appointed without the previous consent of such Government. \r\n18. Powers of Inspectors.⎯ (1) Subject to the provisions of section 19 and of any rules \r\nmade in this behalf, an Inspector may, within the local limits for which he is appointed, and in any \r\nother area with the permission of the licensing authority,— \r\n \r\n \r\nPage 15 of 29 \r\n \r\n (a)  inspect any premises wherein any drug is manufactured, the plant and process \r\nof manufacture, the means employed for standardising and testing the drugs \r\nand all relevant records and registers; \r\n \r\n(b)  inspect any premises wherein any drug is sold or is stocked or exhibited for \r\nsale or is distributed, the storage arrangements and all relevant records and \r\nregisters ; \r\n \r\n(c)  take samples of any drug which is being manufactured, or being sold or is \r\nstocked or exhibited for sale or is being distributed; \r\n \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 \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 \r\n(f)  seize such drug and all materials used in the manufacture thereof and any \r\nother articles, including registers, cash-memos, invoices and bills, which he \r\nhas reason to believe may furnish evidence of the commission of an offence \r\npunishable under this Act or any rules 1[:] \r\n \r\n1[Provided that where the contravention is such which can be \r\nremedied, the stocks shall not be seized upon undertaking in writing of the \r\nperson not to sell drug without remedying the defect, under intimation to the \r\nBoard concerned;] \r\n \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\ninvestigation of an offence under this Act or the rules: \r\n \r\nProvided that the exemptions 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 clause; \r\n \r\n(h)  lock and seal any factory, laboratory, shop, building, store-house or godown, \r\nor a part thereof, where any drug is or is being manufactured, stored, sold or \r\nexhibited for sale in contravention of any of the provisions of this Act or the \r\nrules; \r\n \r\n(i) forbid for a reasonable period, not exceeding 1[two] 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 Central Licensing \r\nBoard, the Registration Board or the licensing authority, as the case may be, \r\nspecify, any person in charge of any premises from removing or dispensing of \r\nany drug, article or other thing likely to be used in evidence of the commission \r\nof an offence under this Act or the rules; and \r\n \r\n1Subs. & added by Ordinance No. CXXVIII of 2002, s. 10. \r\nPage 16 of 29 \r\n \r\n(j)  exercise such other powers as may be necessary for carrying out the purposes \r\nof this Act or any rules: \r\n \r\nProvided that the powers under clauses (f) to (j) shall be exercisable only by an \r\nInspector specifically authorised in this behalf, by an order in writing, by the Government \r\nappointing him, subject to such conditions as may be specified in such order 1[.] \r\n \r\n1[*  *  *  *  *  *  *] \r\n \r\n(2) The provisions of the Code of Criminal Procedure, 1898 (Act V of 1898), in so far as they \r\nare not inconsistent with the provisions of this Act, shall apply to searches and seizures made under \r\nthis Act. \r\n \r\n19. Procedure for Inspectors.⎯ (1) Where an Inspector seizes any drug or any other article \r\nunder section 18, he shall tender a receipt therefor in the prescribed form. \r\n \r\n(2) Where an Inspector takes a sample of a drug for the purpose of test or analysis, he shall \r\nintimate such purpose in writing in the prescribed form to the person from whom he takes it and, in \r\nthe presence of such person unless he wilfully absents himself, shall divide the sample into 1[five] \r\nportions and effectively seal and suitably mark the same and permit such person to add his own seal, \r\nif any, and mark to all or any of the portions so sealed and marked: \r\n \r\nProvided 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 \r\nProvided further that, where the drug is made up in containers of small volume, instead of \r\ndividing a sample as aforesaid, the Inspector may, and if the drug be such that it is likely to \r\ndeteriorate or be otherwise damaged by exposure shall, take three or four, as the case may be, of the \r\nsaid containers after suitably marking the same and, where necessary, sealing them: \r\n \r\nProvided further that if the contents of one container are insufficient for the laboratory test \r\nand analysis, the Inspector may increase the number of the containers in order to make the sample \r\nsufficient for this purpose. \r\n \r\n(3) The Inspector shall restore one portion of a sample so divided or one container, as the \r\ncase may be, to the person from whom he takes it, and shall retain the remainder and dispose of the \r\nsame within seven days as follows :- \r\n(i)  one portion or sample he shall send to the Government Analyst concerned for \r\ntest and analysis; \r\n(ii)  the second he shall send to the Chairman Provincial Quality Control Board or \r\nthe Central Licensing Board or the Registration Board, as the case may be; \r\n1[*] \r\n(iii)  the third, where taken, he shall send to the warrantor, if any, named under the \r\nproviso to sub-section (3) of section 32 1[; and] \r\n \r\n \r\n \r\n \r\n1Subs. & omitted by Ordinance No. CXXVIII of 2002, ss. 10 & 11. \r\nPage 17 of 29 \r\n \r\n1[(iv)  the fourth, where taken, he shall send to the person purporting to be its \r\nmanufacturer or importer, as the case may be] \r\n \r\n(4) Where an Inspector seizes any drug containing any filthy or putrid substance, vermin, \r\nworm, rodent, insect or any foreign matter which is visible to the naked eye, and the sample is such \r\nthat it cannot or need not be divided, he shall effectively seal and suitably mark the same and permit \r\nthe person from whom he seizes the drug to add his own seal if any, and mark to it and shall produce \r\nthe same before the Drug Court or the Central Licensing Board or the Registration Board, as the case \r\nmay be, before which proceedings are instituted or action is initiated in respect of the drug. \r\n \r\n(5) Where an Inspector takes any action under section 18,— \r\n \r\n(a)  he shall as soon as practicable ascertain whether or not the drug contravenes \r\nany of the provisions of this Act and, if it is ascertained that the drug does not \r\nso contravene, he shall forthwith revoke the order passed under the said \r\nsection or, as the case may be, take such action as may be necessary for the \r\nreturn of the stock seized and payment for the samples taken, under intimation \r\nto the Board concerned ; \r\n \r\n(b)  if he seizes the stock of the drug, he shall, as soon as may be, inform the Board \r\nconcerned and take its order as to the custody thereof: \r\n \r\nProvided that where a Federal Inspector is not competent to take action under section 30, he \r\nshall as soon as may be report the matter and hand over the stock, if any, to the Provincial Inspector \r\nfor further action under this Act. \r\n \r\n(6) The Provincial Inspector on finding any contravention of this Act shall, unless the Board \r\notherwise directs, always refer the case to the Provincial Quality Control Board and seek orders as to \r\nthe action to be taken in respect of such contravention. \r\n \r\n(7) The Federal Inspector on finding any contravention of this Act for which he is authorized \r\nshall, unless otherwise directed, always refer the case to the Central Licensing Board or the \r\nRegistration Board or any other authority as may be specified for the purpose and seek any further \r\norders as to the action to be taken in respect of such contravention. \r\n \r\n20. Persons bound to disclose place where drugs are manufactured or kept.— Every \r\nperson for the time being in charge of any premises whereon any drug is being manufactured or is \r\nkept for sale or distribution shall, on being required by an inspector so to do, disclose to the Inspector \r\nthe place where the drug is being manufactured or is kept, as the case may be. \r\n \r\n21. Disclosure of the name of the manufacturer.— Every person, not being the \r\nmanufacturer of a drug or his agent for the distribution thereof, shall, if so required by an Inspector, \r\ndisclose to him the name, address and other particulars of the manufacturer or other person from \r\nwhom he acquired the drug. \r\n22. Reports of Government Analysts.— (1) The Government Analyst to whom a sample of \r\nany drug has been submitted for test and analysis under sub-section (3) of section19 shall deliver to \r\nthe Inspector submitting it a signed report in quadruplicate in the prescribed form and forward one \r\ncopy thereof to the authority as may be prescribed. \r\n \r\n \r\n1Added by Ordinance No. CXXVIII of 2002, s. 11.  \r\nPage 18 of 29 \r\n \r\n(2) The Government Analyst, as far as may be, shall submit the report referred to in sub-\r\nsection (1) within sixty days of the receipt by him of the sample of the drug and, if he is not able to \r\ndo so for reasons beyond his control, shall communicate the reasons to the Inspector in writing and \r\nshall endorse its copy to the 1[Central Licensing Board or, as the case may be, the Registration Board \r\nor the Provincial Quality Control Board] who shall have the sample tested from the same or any \r\nother Government Analyst or a Government Drug Testing Laboratory or any other Laboratory and \r\nshall ensure the receipt of results of such test and analysis within a further period as may be \r\nprescribed and shall make the test report available to the Inspector for further action. \r\n \r\n(3) On receipt of the report, the Inspector shall — \r\n \r\n(a)  deliver one copy thereof to the person from whom the sample was taken ; \r\n \r\n(b)  forward one copy to the warrantor, if any, named under the proviso to sub-\r\nsection (3) of section 32; \r\n \r\n(c)  forward one copy to the 1[Central Licensing Board or, as the case may be, the \r\nRegistration Board or the Provincial Quality Control Board] for its directions \r\nas to the action to be taken on the report; and \r\n \r\n(d)  retain the fourth copy for use in any prosecution or for any other purpose. \r\n \r\n(4) Notwithstanding anything contained in any other law for the time being in force, any \r\ndocument purporting to be a report signed by a Government Analyst shall be admissible as evidence \r\nof the facts stated therein without formal proof and such evidence shall be conclusive unless the \r\nperson from whom the sample was taken or the said warrantor has, within thirty days of the receipt \r\nof a copy of the report notified in writing to the Inspector or 1[Provincial Quality Control Board or, \r\nas the case may be, the Central Licensing Board or the Registration Board or the Drug Court] before \r\nwhich any proceedings in respect of the sample are pending that he intends to adduce evidence in \r\ncontroversion of the report. \r\n \r\n(5) Where a person has, under sub-section (4), notified his intention of adducing evidence in \r\ncontroversion of a Government Analyst’s report, 1[Provincial Quality Control Board or, as the case \r\nmay be, the Central Licensing Board or the Registration Board or the Drug Court] may, of its own \r\nmotion or in its discretion at the request either of the complainant or the accused, cause the sample of \r\nthe drug lying with the Board concerned under sub-section (3) of section 19 to be sent for test or \r\nanalysis to the Federal Drug Laboratory or any other laboratory specified for the purpose by the \r\nFederal Government which shall make the test or analysis and report in writing signed by, or under \r\nthe authority of, the person for the time being incharge of the Federal Drug Laboratory, or, as the \r\ncase may be, such other laboratory, the result thereof and such report shall be conclusive evidence of \r\nthe facts stated therein. \r\n \r\n(6) The cost of a test or analysis made by the Federal Drug Laboratory or other laboratory \r\nunder sub-section (5) shall be paid by the complainant or accused as the Drug Court or the Board \r\nconcerned shall direct. \r\n \r\n \r\n \r\n1Subs. by Ordinance No. CXXVIII of 2002, s. 12. \r\n \r\nPage 19 of 29 \r\n \r\nCHAPTER III \r\nPROHIBITIONS \r\n \r\n23. Import, manufacture and sale of drugs.— (1) No person shall himself or by any other \r\nperson on his behalf — \r\n \r\n(a)  export, import or manufacture for sale or sell \r\n \r\n(i) any spurious drug; \r\n \r\n(ii) any counterfeit drug; \r\n \r\n(iii) any misbranded drug; \r\n \r\n(iv)  any adulterated drug; \r\n \r\n(v)  any substandard drug; \r\n \r\n(vi)  any drug after its expiry date; \r\n \r\n(vii)  any drug which is not registered or is not in accordance with the \r\nconditions of registration; \r\n \r\n(viii)  any drug which, by means of any statement, design or device \r\naccompanying it or by any other means, purports or claims to cure or \r\nmitigate any such disease or ailment, or to have any such other effect, \r\nas may be prescribed; \r\n \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 labelling thereof; or \r\n \r\n(x)  any drug in contravention of any of the provisions of this Act or any \r\nrule; \r\n \r\n(b)  manufacture for sale any drug except under, and in accordance with the \r\nconditions of, a licence issued under this Act; \r\n \r\n(c)  sell any drug except under, and in accordance with the conditions of, a licence \r\nissued under this Act; \r\n(d)  import or export any drug the import or export of which is prohibited by or \r\nunder this Act; \r\n(e)  import or export any drug for the import or export of which a licence is \r\nrequired, except under, and in accordance with the conditions of, such licence; \r\n(f)  supply an incorrect, incomplete or misleading information, when required to \r\nfurnish any information under this Act or the rules; \r\nPage 20 of 29 \r\n \r\n(g)  peddle, hawk or offer for sale any drug in a park or public street or on a \r\nhighway, 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 drug but is presented in a form or manner which is intended or \r\nlikely to cause the public to believe it to be a drug; \r\n(i)  sell any drug without having a warranty in the prescribed form bearing the \r\nname and batch number of the drug issued,— \r\n \r\n(i)  in the case of a drug manufactured in Pakistan, by the \r\nmanufacturer holding a valid licence to manufacture drugs and \r\npermission to manufacture that drug or by his authorised agent ; \r\n \r\n(ii)  in the case of an imported drug, by the manufacturer or \r\nimporter of that drug or, if the drug is imported through an \r\nindentor by such indentor ; and \r\n \r\n(j)  apply an incorrect batch number to a drug. \r\n \r\n(2) Nothing in sub-section (1) shall apply to the manufacture or import, subject to prescribed \r\nconditions, of small quantities of any drug for the purpose of clinical trial, examination, test, analysis \r\nor personal use ; \r\n \r\n24. Control of advertisement.— No person shall himself or by any other person on his \r\nbehalf advertise, except in accordance with such conditions as may be prescribed,⎯ \r\n \r\n(i)  any drug ; \r\n \r\n(ii)  any substance used or prepared for use in accordance with the ayurvedic, \r\nunani, homoeopathic or biochemic system of treatment or any other substance \r\nor mixture of substances as may be prescribed ; \r\n \r\n(iii)  any remedy, treatment or offer of a treatment for any disease. \r\n \r\nExplanation.⎯ In this section, “advertise” means to make any representation by any means \r\nwhatsoever for the purpose of promoting directly or indirectly the sale or disposal of a drug, a \r\nsubstance or a mixture of substances, a remedy or a treatment except the display of sign boards for a \r\nclinic, a dispensary or a hospital or such other institution offering treatment. \r\n \r\n25. Control of sampling.— No person shall distribute or cause to be distributed any drug as \r\na sample except in accordance with such conditions as may be prescribed. \r\n26. Control of printing of labelling.— No person shall print any labelling in respect of any \r\ndrug which is required to be registered under this Act but is not so registered after the date fixed by \r\nthe Federal Government under sub-section (6) of section 7 or for a person who does not possess a \r\nlicence under this Act to manufacture that drug. \r\n \r\n \r\nPage 21 of 29 \r\n \r\nCHAPTER IV \r\nOFFENCES, PENALTIES AND PROCEDURE \r\n \r\n27. Penalties.— (1) Whoever himself or by any other person on his behalf⎯ \r\n \r\n(a)  exports, imports, manufactures for sale or sells any spurious drug or any drug \r\nwhich is not registered; \r\n \r\n(b)  manufactures for sale any drug without a licence ; or \r\n \r\n(c)  imports without licence any drug for the import of which a licence is required; \r\n \r\nshall 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 one lakh rupees: \r\n \r\nProvided 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 \r\n(2) Whoever himself or by any other person on his behalf⎯ \r\n \r\n(a)  imports, manufactures for sale or sells any counterfeit drug ; or \r\n \r\n(b)  gives to the purchaser a false warranty in respect of any drug sold by him that \r\nthe drug does not in any way contravene the provisions of section 23 and is \r\nnot able to prove that, when he gave the warranty, he had good and sufficient \r\nreason to believe the same to be true ; or \r\n \r\n(c)  applies or permits to be applied to any drug sold, or stocked or exhibited for \r\nsale, by him, whether on the container or a label or in any other manner, a \r\nwarranty given in respect of any other drug ; or \r\n \r\n(d)  imports, manufactures for sale or sells any drug under a name other than the \r\nregistered name ; or \r\n \r\n(e)  exports, imports, manufactures for sale or sells any drug with which any \r\nsubstance, which should not actually be its component, has been mixed or \r\npacked so as to reduce its quality or strength or for which any such substance \r\nhas been substituted wholly or in part; \r\n \r\nshall be punishable with imprisonment for a term which may extend to seven years, 1[or with \r\nfine which may extend to one lakh rupees, or with both]. \r\n \r\n(3) Whoever obstructs an Inspector in the exercise of any power conferred upon him by or \r\nunder this Act, or disobeys the lawful authority of any Inspector, shall be punishable with \r\nimprisonment for a term which may extend to one year, or with fine which may extend to ten \r\nthousand rupees, or with both. \r\n \r\n \r\n \r\n1Subs. by Ordinance No. CXXVIII of 2002, s. 13. \r\nPage 22 of 29 \r\n \r\n(4) Subject to the provisions of sub-section (1), sub-section (2) and sub-section (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 fifty thousand rupees, or with both. \r\n \r\n28. Penalty for subsequent offence.— (1) Whoever having been convicted of an offence \r\nunder sub-section (1) of section 27 is 1[convicted for a subsequent] offence under that sub-section \r\nshall be punishable with imprisonment for life or with imprisonment which shall not be less than five \r\nyears and with fine which may extend to two lakh rupees. \r\n \r\n(2) Whoever having been convicted of an offence under sub-section (2) of section 27 is \r\n1[convicted for a subsequent] offence under that sub-section shall be punishable with imprisonment \r\nfor a term which shall not be less than two years or more than ten years, or with fine which may \r\nextend to two lakh rupees, or with both. \r\n \r\n(3) Whoever having been convicted of an offence under sub-section (4) of section 27 is \r\n1[convicted for a subsequent] offence under that sub-section shall be punishable with imprisonment \r\nfor a term which may extend to seven years, or with fine which may extend to one lakh rupees, or \r\nwith both. \r\n \r\n29. Forfeiture.— (1) Where any person has been convicted under this Act, for contravening \r\nany such provisions of this Act or any rule as may be prescribed in this behalf, the Drug Court may \r\norder that the stock of drug or substance by means of or in relation to which the offence was \r\ncommitted or anything of a similar nature belonging to or in the possession of the accused or found \r\nwith such drug or substance, and if such contravention is punishable under sub-section (1) of section \r\n27, any implements used in manufacture or sale of such drug and any receptacles, packages or \r\ncoverings in which such drug is contained and the animals, vehicles, vessels or other conveyances, \r\nused in carrying such drug, be forfeited to the Federal Government or, as the case may be, the \r\nProvincial Government and, upon such order being made, such drug, substance, implements, \r\nreceptacles, packages or coverings, animals, vehicles, vessels or conveyances may be disposed of as \r\nthat Government may direct. \r\n \r\n(2) Without prejudice to the provisions of sub-section (1), where the Drug Court is satisfied, \r\non the application of an Inspector or otherwise, and after such inquiry as may be necessary, that a \r\ndrug contravenes the provisions of this Act, the Drug Court may order that such drug be forfeited to \r\nthe Federal Government or, as the case may be, the Provincial Government and, upon such order \r\nbeing made, such drug may be destroyed or otherwise disposed of as that Government may direct. \r\n(3) An Inspector shall release any drug or article seized by him under this Act when he is \r\nsatisfied that all the provisions of this Act and the rules with respect there to have been complied \r\nwith. \r\n30. Cognizance of offences.— (1) Subject to the provisions of section 19, no prosecution \r\nshall be instituted under this Chapter except— \r\n \r\n \r\n \r\n \r\n \r\n1Subs. by Ordinance No. CXXVIII of 2002, s. 14. \r\nPage 23 of 29 \r\n \r\n(a)  by a Federal Inspector, where the prosecution is in respect of a contravention \r\nof clause (h) of sub-section (1) of section 23 or section 24 or any of the \r\nprovisions of this Act or the rules relating to the import or export of drugs or \r\nthe manufacture for sale, or sale, of a drug which is not for the time being \r\nregistered or for the manufacture for sale of which a licence is not for the time \r\nbeing in force; or \r\n \r\n(b)  by a Provincial Inspector: \r\n \r\nProvided that, where the public interest so requires, the Federal Inspector may, with the prior \r\npermission of the Federal Government institute a prosecution for a contravention of any other \r\nprovision of this Act. \r\n \r\n(2) Notwithstanding anything contained in the Code of Criminal Procedure, 1898 (Act V of \r\n1898), — \r\n \r\n(a)  an offence punishable under this Chapter other than an offence mentioned in \r\nsub-section (1) of section 27, shall be non-cognizable, and \r\n \r\n(b)  no court other than a Drug Court shall try an offence punishable under this \r\nChapter. \r\n \r\n(3) Nothing contained in this Chapter shall be deemed to prevent any person from being \r\nprosecuted under any other law for any act or omission which constitutes an offence punishable \r\nunder this Chapter or to require the transfer to a Drug Court of any case which may be pending in \r\nany Court immediately before the establishment of the Drug Court. \r\n \r\n31. Drug Courts.— (1) The Federal Government may, by notification in the official Gazette, \r\nestablish as many Drug Courts as it considers necessary and, where it establishes more than one \r\nDrug Court, shall specify in the notification the territorial limits within which, or the class of cases in \r\nrespect of which, each one of them shall exercise jurisdiction under this Act. \r\n \r\n(2) A Drug Court shall consist of a person who is, or has been, or is qualified for appointment \r\nas, a Judge of a High Court, who shall be the Chairman, and two members being persons who, in the \r\nopinion of the Federal Government, are experts in the medical or pharmaceutical fields 1[:] \r\n1[Provided that for deciding applications of bail the Chairman and any one member shall \r\nconstitute full quorum of a Drug Court.] \r\n(3) A Drug Court shall sit at such place or places as the Federal Government may direct. \r\n \r\n(4) A Drug Court shall have all the powers conferred by the Code of Criminal Procedure, \r\n1898 (Act V of 1898), on a Court of Session exercising original jurisdiction. \r\n \r\n(5) A Drug Court shall not, merely by reason of a change in its composition, be bound to \r\nrecall and rehear any witness who has given evidence, and may act on the evidence already recorded \r\nby or produced before it. \r\n \r\n1Subs. & added by Ordinance No. CXXVIII of 2002, s. 15. \r\nPage 24 of 29 \r\n \r\n(6) A Drug Court shall, in all matters with respect to which no procedure has been prescribed \r\nby this Act, follow the procedure prescribed by the Code of Criminal Procedure, 1898 (Act V of \r\n1898), for the trial of summons cases by Magistrates. \r\n \r\n(7) A person sentenced by a Drug Court may prefer an appeal to a bench of the High Court \r\nconsisting of not less than two Judges within thirty days of the judgment. \r\n \r\n(8) The provisions of sections 5 and 12 of the Limitation Act, 1908 (IX of 1908), shall be \r\napplicable to an appeal referred to in sub-section (7). \r\n \r\n32. Pleas.— (1) Save as hereafter provided in this section, it shall be no defence in a \r\nprosecution under this Act to prove merely that the accused was ignorant of the nature, substance or \r\nquality of the drug in respect of which the offence has been committed or of the circumstances of its \r\nmanufacture or import, or that a purchaser, having brought only for the purpose of test or analysis, \r\nhas not been prejudiced by the sale. \r\n \r\n(2) A drug shall not be deemed to be misbranded or adulterated or substandard only by reason \r\nof the fact that there has been added thereto some innocuous substance or ingredient because the \r\nsame is required for the manufacture or preparation of the drug fit for carriage or consumption and \r\nnot to increase the bulk, weight or measure of the drug or to conceal its inferior quality or other \r\ndefect or there is a decomposed substance which is the result of a natural process of decomposition: \r\n \r\nProvided that such decomposition is not due to any negligence on the part of the \r\nmanufacturer of the drug or the dealer thereof and that it does not render the drug injurious to health \r\nor does not make it substandard. \r\n \r\n(3) A person, not being the manufacturer of a drug or his agent for the distribution thereof, \r\nshall not be liable for a contravention of section 23 if he proves— \r\n \r\n(a)  that he did not know, and could not with reasonable diligence have \r\nascertained, that the drug in any way contravened the provision of this Act and \r\nthat the drug while in his possession remained in the same state as when he \r\nacquired it ; and \r\n \r\n(b)  that he acquired the drug from a duly licensed manufacturer or his authorised \r\nagent or an importer or an indentor resident in Pakistan under a written \r\nwarranty in the prescribed form stating, in particular, the batch number of the \r\ndrug and signed by such person that the drug does not in any way contravene \r\nthe provisions of section 23 and that the drug while in his possession was \r\nproperly stored and remained in the same state as when be acquired it and that \r\nthe drug has been manufactured by a manufacturer holding a valid licence to \r\nmanufacture drugs and permission to manufacture that drug: \r\n \r\nProvided that a defence under clause (b) shall be open to a person only⎯ \r\n(i)  if he has, within seven days of the service on him of the \r\nsummons, sent to the Inspector a copy of the warranty with a \r\nwritten notice stating that he intends to rely upon it and giving \r\nthe name and address of the warrantor, and \r\n \r\nPage 25 of 29 \r\n \r\n (ii)  if he proves that he has, within the same period, sent written \r\nnotice of such intention to the said warrantor. \r\n \r\n33. Application of law relating to customs and powers of officers of customs.⎯ (1) The \r\nlaw for the time being in force relating to customs and to goods the import of which is prohibited by \r\nor under the Customs Act, 1969 (IV of 1969), shall, subject to the provisions of section 27 of this \r\nAct, apply in respect of drugs the import of which is prohibited under this Act, and officers of \r\ncustoms and officers to whom any of the functions of an officer of customs have been entrusted \r\nunder the said Act shall have the same powers in respect of such drugs as they have for the time \r\nbeing in respect of such goods as aforesaid. \r\n \r\n(2) Without prejudice to the provisions of sub-section (1), an officer of customs or a Federal \r\nInspector or any other person as may be authorised by the Federal Government in this behalf may \r\ndetain any imported package which he suspects to contain any drug the import of which is prohibited \r\nunder this Act, and shall forthwith report such detention to the licensing authority and, if required by \r\nit, forward the package or samples of any suspected drug found therein to a laboratory specified by \r\nit. \r\n \r\n34. Offences by companies, etc.— Where the person guilty of an offence under this Act, is a \r\ncompany, corporation, firm or institution, every director, partner and employee of the company, \r\ncorporation, firm or institution 1[with whose knowledge or consent the offence was committed shall \r\nbe guilty of the offence] \r\n \r\n35. Publication of offender’s name.— (1) If any person is convicted of an offence under \r\nthis Act, it shall be lawful for the Drug Court to cause the offender’s name, place of residence, the \r\noffence of which he has been convicted and the penalty which has been inflicted upon him, to be \r\npublished at the expense of such person in such newspapers or in such other manner as the Court \r\nmay direct. \r\n \r\n(2) The expenses of such publication shall be recoverable in the same manner as a fine is \r\nrecoverable. \r\n \r\n36. Powers to exempt.— Notwithstanding anything contained in this Act, the Federal \r\nGovernment may, if it is of opinion that the public interest so requires, at any time, of its own motion \r\nor on a representation made to it, by notification in the official Gazette, exempt any drug or class of \r\ndrugs from the operation of any of the provisions of this Act, subject to such conditions, if any, and \r\nfor such period, as may be specified in the notification. \r\n \r\n37. Inspectors to be public servants.— Every Inspector shall be deemed to be a public \r\nservant within the meaning of section 21 of the Pakistan Penal Code (Act XLV of 1860), and shall be \r\nofficially subordinate to such authority as the Government appointing him may specify in this behalf. \r\n38. Indemnity.— Except as otherwise expressly provided in this Act, no suit, prosecution or \r\nother legal proceeding shall lie against Government or any other authority or person for anything \r\nwhich is in good faith done or intended to be done under this Act or any rule. \r\n39. Finality of orders, etc.— Save as otherwise expressly provided in this Act, every order \r\npassed or decision given by any Board, a Drug Court or any other authority under this Act shall be \r\nfinal and shall not be called in question by or before any Court or other authority. \r\n \r\n1Subs. by Ordinance No. CXXVIII of 2002, s. 16. \r\n \r\nPage 26 of 29 \r\n \r\n40. Publication of result of test or analysis, etc.— (1) It shall be lawful for the Federal \r\nGovernment to publish, in such manner as it may deem fit, the result of any test or analysis of any \r\ndrug for public information and to pass such orders relating to the withdrawal of such drug from sale \r\nand its disposal as it may consider necessary. \r\n \r\n(2) The Federal Government may, if it considers it necessary in the public interest so to do, \r\npublish for public information, in such manner as it may deem fit, any information relating to a drug \r\nor to the use of a drug in specified circumstances. \r\n \r\n41. Cancellation or suspension of licences.— Where any person has been found to have \r\ncontravened any of the provisions of this Act, or the rules in respect of any drug and the \r\ncontravention is of such a nature that the import, export, manufacture or sale of any drug by such \r\nperson is, in the opinion of the licensing authority or the Central Licensing Board, likely to endanger \r\npublic health, that authority may, after giving such person an opportunity of being heard, cancel the \r\nlicence to import, export, manufacture or sell drugs issued to such person or suspend such licence for \r\na specified period. \r\n \r\n42. Cancellation or suspension of registration of registered drugs.— Where any person \r\nhas been found to have contravened any of the provisions of this Act, or the rules in respect of any \r\nregistered drug, the Registration Board may, after giving such person an opportunity of being heard, \r\ncancel the registration of such drug or suspend such registration for a specified period. \r\n \r\nCHAPTER V \r\nMISCELLANEOUS \r\n \r\n43. Power of Federal Government to make rules.— (1) Subject to section 44, the Federal \r\nGovernment may, by notification in the official Gazette, make rules for carrying out the purposes of \r\nthis Act. \r\n \r\n(2) In particular and without prejudice to the generality of the foregoing provision, such rules \r\nmay— \r\n(a)  prescribe the functions of the Federal Drug Laboratory and any other \r\nlaboratory set up under section 14 or specified under section 22 or section 33 \r\nand the procedure for the submission to any such laboratory of samples of \r\ndrugs for analysis or test, the forms of the laboratory’s reports thereon and the \r\nfees payable in respect of such reports; and such other matters as may be \r\nnecessary for any such laboratory to perform its functions; \r\n(b)  prescribe specifications, including the strength, potency, purity, quality or \r\nother property, of any drug, and the methods of test or analysis to be employed \r\nin determining whether a drug is of required specifications; \r\n \r\n(c)  prescribe the maximum proportion of any poisonous or other substance which \r\nmay be added to or contained in any drug, or extracted or omitted therefrom; \r\nprohibit the import, manufacture, sale or stocking or exhibition for sale or \r\ndistribution of any drug in which that proportion is exceeded and specify \r\nsubstances which shall be deemed to be poisonous; \r\n \r\n (d)  specify the drugs or classes of drugs for the import or export of which a \r\nlicence is required, the testing of such drugs, and prescribe the form and \r\nPage 27 of 29 \r\n \r\nconditions of such licences, the authority empowered to issue the same, and \r\nthe fees payable therefor; \r\n \r\n(e)  prescribe the places at which any specific drug or drugs may be imported \r\nprohibit their import at any other place, and control their import through any \r\nspecified agency; \r\n \r\n(f)  prescribe the evidence to be supplied, whether by accompanying documents or \r\notherwise, of the quality of drugs sought to be imported, the procedure of \r\nofficers, of customs in dealing with such evidence and the manner of storage \r\nat places of import of drugs detained pending admission; \r\n \r\n(g)  prescribe the forms of licences for the manufacture for sale of drugs or any \r\nspecified drugs or class of drugs, the form of application for such licences, the \r\nconditions subject to which such licence may be issued, the person under \r\nwhose signature the same be issued and the fees payable therefor; \r\n \r\n(h)  require the date of manufacture and the date of expiry of potency to be clearly \r\nand truly stated on the label and container of any specified drug or class of \r\ndrugs and prohibit the sale, stocking or exhibition for sale or distribution of the \r\nsaid drug or class of drugs after the expiry of a specified period from the date \r\nof manufacture or after the expiry date and prescribe the manner of disposal of \r\nsuch drug or class of drugs; \r\n \r\n(i)  prescribe the conditions to be observed in the packing in bottle, packages and \r\nother containers of drugs and prohibit the sale, stocking or exhibition for sale \r\nor distribution of drugs packed in contravention of such conditions; \r\n \r\n(j)  regulate the mode of packing and packaging, including its size, dimensions, \r\nfill and other specifications, the material used therefor and mode of labelling \r\npacked drugs and prescribe the matters which shall or shall not be included in \r\nsuch lebels or on the leaflets accompanying the drugs; \r\n \r\n(k)  require that the non-proprietary or chemical or accepted scientific name or the \r\nproprietary name of any specified drug or any ingredient thereof shall be \r\ndisplayed in the prescribed manner; \r\n \r\n(l)  prescribe the requirements and conditions in respect of good practices in the \r\nmanufacture and quality control of drugs; \r\n \r\n(m)  prescribe conditions for distribution of samples for sales promotion of drugs; \r\n \r\n(n)  prescribe the procedure for introduction in Pakistan of a new drug; \r\n \r\n(o)  prescribe terms and conditions of members of the Central Licensing Board and \r\nthe Registration Board; \r\n \r\n(p)  prescribe types of registration of drugs, the form of application for such \r\nregistration, the conditions subject to which such registration may be granted, \r\nPage 28 of 29 \r\n \r\nthe manner of registration and post-registration surveillance and deregistration \r\nof registered drugs and the fees payable therefor; \r\n \r\n(q)  prescribe conditions for registration of indentors, importers, wholesalers and \r\ndistributors within Pakistan and any establishment within any foreign country \r\nengaged in the manufacture for export of a drug and prescribe conditions \r\nproviding effective and adequate means, by arrangement with the Government \r\nof such foreign country or otherwise, to enable the licensing authority or the \r\nRegistration Board to determine from time to time whether drugs \r\nmanufactured in such establishment, if imported or offered for import into \r\nPakistan, shall be refused admission where the public interest so requires; \r\n(r)  prescribe the form of warranty for manufactured drugs; \r\n(s)  specify offences in relation to which the stock of drugs, articles or things shall \r\nbe liable to forfeiture under this Act; \r\n(t)  prescribe the qualifications, and regulate the procedure for exercise of powers \r\nand performance of functions, of Federal Inspectors; \r\n(u)  prescribe the laboratories to which the Federal Inspectors shall submit samples \r\nof drugs taken for the purpose of test and analysis and the form and procedure \r\nfor submitting the report of such test and analysis and the fee payable therefor, \r\nwhere so required; \r\n(v)  prescribe measures for securing and maintaining supplies of drugs at \r\nreasonable prices, conditions to be met in respect of manufacture, production, \r\npricing, keeping, movement and disposal of drugs and to fix prices, commis-\r\nsions, discount of the manufacturer, wholesaler, distributor, retailer or any \r\nother dealer of drugs, to control giving of bonus in cash or kind or in any other \r\nmanner to any of the said parties and for collecting or calling for any \r\ninformation, statistics, records or books with a view to regulating the matters \r\naforesaid; \r\n(w)  specify drugs which may be advertised and the conditions subject to which \r\nsuch drugs may be advertised; \r\n(x)  prescribe conditions subject to which small quantities of drugs may be \r\nimported or manufactured or exported for the purpose of examination, test or \r\nanalysis, clinical trial or personal use; and \r\n(y)  prescribe any other matter which is to be, or may be, prescribed by the Federal \r\nGovernment. \r\n \r\n(3) The power to make rules conferred by this section shall, except on the first occasion of the \r\nexercise thereof, be subject to the condition of previous publication. \r\n \r\nPage 29 of 29 \r\n \r\n44. Power of the Provincial Government to make rules.— (1) The Provincial Government \r\nmay by notification in the official Gazette, make rules in respect of the following matters, namely:— \r\n \r\n(a)  the establishment of laboratories for testing and analysing drugs; \r\n \r\n(b)  the qualifications and the procedure, for exercise of powers and performance \r\nof functions of Provincial Inspectors; \r\n \r\n(c)  the forms of reports to be given by Government Analysts and the manner of \r\napplication for test or analysis and the fees payable therefor; \r\n \r\n(d)  the conditions to regulate sale or storage or distribution of drugs or any \r\nspecific drug or class of drugs; \r\n \r\n(e)  the offences against this Act or any rule in relation to which the stock of drugs \r\nshall be liable to confiscation and destruction under this Act; \r\n \r\n(f)  the forms of licences for the sale or distribution of drugs or any specified drug \r\nor class of drugs, the authority empowered to issue the same, the form of \r\napplications for such licences, the fees payable therefor and the conditions \r\nsubject to which such licences may be issued; \r\n \r\n(g)  the procedure to be followed by the Provincial Quality Control Board; and \r\n \r\n(h)  any other matter which is to be or may be, prescribed by the Provincial \r\nGovernment. \r\n \r\n(2) The power to make rules conferred by this section shall, except on the first occasion of the \r\nexercise thereof, be subject to the condition of previous publication. \r\n \r\n45. Repeal and Savings.— (1) The Drugs Act, 1940 (XXIII of 1940), the Drugs (Generic \r\nNames) Act, 1972 (XXIV of 1972), and the Drugs Ordinance, 1976 (IV of 1976), are hereby \r\nrepealed. \r\n \r\n(2) Notwithstanding the repeal of the Drugs Act, 1940 (XXIII of 1940) by sub-section (1),— \r\n \r\n(a)  Any licence to manufacture for sale issued thereunder to any person, for the \r\nrevalidation of which an application has already been made to the Central \r\nLicensing Board within the date specified by the Federal Government shall \r\ncontinue to be valid until orders are passed by the said Board in this behalf. \r\n \r\n(b)  Any licence 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\nvalid for such periods as the Federal Government, or as the case may be the \r\nProvincial Government may by notification in the official Gazette, specify in \r\nthis behalf: \r\n \r\nProvided that in case of drugs to be imported or exported licences may continue to be issued \r\nunder the rules framed under the Drugs Act, 1940, till the rules under this Act are framed or as the \r\ncase may be, a date is fixed under sub-section (6) of section 7 in respect of drugs in the finished form \r\nready for use. \r\n \r\nRGN Dated: 20-02-2026",
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