)

(r RE GISTERED No.s. 1033L:J'A

W,he (6a1ette of {puhirtrnEXTRAORDINARY

PUSLISIIED BY AUTHORITY

ISLAMABAD, TUESDAY, MAY 18, 1y,6

i1

PART IActs, Ordinances, Presiitrenlps Orders atrd Rtlgulrtiotrs

NATIONAL ASSEMBLY SECRETARIAT

Islannbad, the lSth May, 196

The following Acts of Parliament received ttre assent of the President on th6llth May, 1976, ar.d are hereby published for general information:-

ACT No. XXVI or 1976

An Acl to provide lor the rcgulntion and control ol lha prolession ol lourisl guides

\\rHERE4s it is necessary and expedient to provide for the regulation andcontrol of the profession of tourist guides;

It is heieby enacted as follows:-

1. Short title, extent a.nd commencement,-(1) This Act may be calted thePakislan Tourist Guides Act, 1976.

(2) It extends to the whole of Pakistan and applies to all toudst guideswherever they may be.

(3) It shall come into force at once.

2. Definitions.-In this Act, unless there is anything repugnant in the sub-ject or cantcxt,-

(a) " Committee " means ttre Tourist Guide Regulatory Commitree setr.rp under section 3 ;

(b) " licence " means lic€nc€ issued under section 4;(c) " prescribed " meaas prescribed by rules ;

(d) " rules " means rules made under rhis Act; and

(e) " tourist guide " meals a prson licensed as such under section 4.

(277)11977 Ex. Grz.)

Pfice : Ps. 87

+

Prnr ll THE GAZETTE OF PAKISTAN, EXTRA., MAY 18, 19?6 n9

ACT No. )Q(Xl or 1976

An Act to regulute the itnport, export, marutlaclure, slorage, d.istribution dssle ol bugs

(r6p

WHEREAS it is cxpedient Io regulate the import, export, manufacture, storage,distribution and sale of drugs ;

It is hereby enacted as follows:-

CHAPTER I

INTRODUCTORY

L Short title, €xtent atrd commenc€ment.-(l) This act may be called theDrugs Act, 1976.

(2) It extends to tbe whole of Pakistan.

(3) It shall come into force at once.

2. Application of other lans not barred.-The provisions of this Act, sballbe in addition to, and not in derogation of, the DaDgerous Drugs Act, 1930 (IIof 1930), and any other law for the time being in force.

3. Definitions.-In this Act, unless there is anything repugnam in tbesubject or context,-

(a) " adulterated drug " means a drug-(i)'which consists in whole or in part of any filthy, putrid or decom-

posed substance or which contains any foreign matter, vermin,worm, rodent or insect ; or

(ii) which has been manufactured, packed, or held under unsanitaryconditions whereby it may have been contaminated with dirt, filthor any other foreign matter or whereby it may have been renderedinjurious to health ; or

(iii) the cotrtainer of which releases any poisonous or deleterioussubstance which may render the contents injurious to health; or

(lr,) which bears or contains as an ingredient a substance other thanthe prescribed substance ; or

(r) with which any substance has been mixed or packed so as to reduc€its quality or strength or for which any substance has been substi-tuted wholly or in part ;

(6) " Appellate Board " means the Board constituted under section 9 ;

(c) "batch" means a quatrtity ofany drug produced during a giveocyclc of manufact ure ;

(d) " batch number " means a designation printed on the label of a drugthat identjfies the batch and permits the production history ofthe batch,including all stages of manufacture and coDtrol, to be traced and re-viewed :

(e) " Central Licrnsing Bcard " means a Board set up undor sectioa 5 ;

3OO TI{E GAZETTE OF PAKISTAN. F)i RA,, MAY 18, 1976 [P^RT I,0go

(n " coutrterfeit dnrg " means a drug the label or outer-packing of whichis an imitation of, or resembles or so ncarly resembles as to becalculated to deceive, the label or outer-packing of a drug of aaothermanufacturer ;

(c) "drug" includes-(i) any substance or mixture of substances that is manufactured, sol4

stored, ofiered for sale or represented for internal or external usein the trcatmeDt, mitigatjon, preventioD or diagnosis of disease,an abnormal physical state, or the symptoms thereof in humanbeings oranimals, or the restoration, correction, or modificationof organic functions in hurnan beings or animals, not being asubstance exclusively used o1 p1gp21ed lor use in accordancewith the ayurvedic, una:ri. homocopathic or biochemic system oftreatment except thcsc substaDces and in accordance with suchconditions as may be prescribed ;

(ri) abortive aDd contraceptive substances, agents and devices, surgicalligatures, sutures, bandages, absorbent cotton, disinfectantsrbacteriophages, adhesive plasters, gelatine capsules and antisepticsolutions;

(iii) such substances intended to be used for the dcstruction or repulsionof such vermin, insects, rodents and other organisms as cause!carry or transmit disease in human beings or animals or fordisinfection in residential areas or in premises in which food ismanufactured, prepared or kept or stored ;

(r'v) such pesticides as may cause health hazard to the public ;(v) any substanc€ mentioned as monograp[ or as a preparation in the

Pakistan Pharmacopoeia or the Pakistan National Formulary orthe International Pharmacopoeia or rhe British Pharmacopoeiaor the British Pharmaceutical Codex or the Unitcd States Phar-macofoeia or the National Formulary of the United Statcs,whether alone or in combiration with any substance exclusivelyused in the unani, ayurvedic, homoeopathic or biochemic systemof treatmeBt, and intended to be used for any of the purposesmentioned in sub-clauses (i), (ii) and (iii) ; and

(ri) any other substance which the Federal Government may, by' notification in the official Gazette, declare to be a " drug-" foithe purposes of this Act ;

(r) " expiry date " mcans the date statcd on the label of a drug after whicb' the drug is not-expected to.retain its claimed efficacy, safety, qualityor potency or after which it is not permissible to sell the drug ;

(i) " expert " means a specialist through university education and experiencein the relevant field ;

(j) "expon ", -whh its-grammatical variatioos and cognare expressioos,meaDs to take out of Pakistan by sea. land or air ; -

(ft) " generic name " means the non-proprietary, scientific or official nameofa drug as approved by tbe Federal Goveinment ;

(/) " Government Analyst " means a Fcderal Government Analvst ora Provincial Government Analyst appointed under section 16 ;

(z) " import ", with its rgrammatical variations aod cogtrate exprcssions,means to bring into Pakjstan by sea, land or air ;

(n) " Inspcctor " _mears. a Federal Inspector or a provincial Inspectolappointed *O.r ,.ction l7 i

es7)

(o) " label " means a display of written, printed or graphi: matterup.lnthe immediate container, or the outside container or wrapper ol adrug package ;

(p) ' labelling " mns ail Iabels and other written, printeci or gla;hi-:matter accompauying any drug ;

(9) " licensing authority " means such authority as may be prescribed ;

G) " manufacture ", in relation to a drug, means all operalions involvedin the productioo ofthe drug, including processin-e, compounding,lormulating, Slting, packing. repacking, altering, ornamenting. fi nishingand labelling with a view to its storage, sale ano distribution. but doeinot include the compounding and dispensing or the facking cf anydrug in the ordinary course of retail business or on a pres(.iirtian ofa re-gistered medicai practitioner or dentist or of a ' eierinaiian and" to mauufacture " shall be construed accordingly ;

(s) " misbranded drug " means a drug-(i) which is not labelled in the presctibed manner : or

(li) on the label or labelling of which any word, statemeitt, or othermatter or information requireo by the rule\ to appear on the labelor labclling is not prominently placed with such couspicuousness(as compared with other words, statements. <lesigns, or deviceson the label or labelling) and in such terms as may render it likelyto be read ano understo5o by the ordinary individuai under customaiyconditior,s cI purclrase ano use ; or

(iii) which is not labelled with such directions for use a:rd such war-nings against use in indications where its use may be dangerousto health, or against unsafe dosage or duration of administrationor application, in such manner and form as are necessary for theprotection of users or as may be prescribed ; or

(iy) the label or container of which, or anything accompanying which,bears any statement, design or device which makes any falseclaim for the drug or which is false or mislsading in any particular;OT

(v) which is so coloured, coated, powdered or polished tbat damageis concealed, or which is made to appear of better or greatertherapeutic value than it really is ; or

(ri) which is manufactured according to the speciflcatiotrs of a particu-lar pharmacopoeia or any other document as may be prescribedaud the label does not bear the name of that pharmacopoeia ordocument ;

(r) " prescribed " means prescribed by rules ;

(u, " Provincial Quality Control Board " means a Board set up undersection 11 ;

(v,) " Registration Board " mea.ns a Board set up under section 7 ;

(w) " registered drug " means any drug registered under section 7 ;

(x) " rules " mean rules made under this Act ;

(y) " DruS Court " meaDs a court established under scction 3l ;

P^Rr ll THE GAZETTE OF PAKISTAN. EXTRA., MAY 18. t976 30i

(asuW TIIE GAZETI'E OF PAKISI r\ll. F.XTRA.. M,\\. 18. l')75 U'^Rr I

1z) " specifications " when applied to a drug mean-(i) such specifications as may be prescribed ; or

(ii) when the specifications are not prescribed, the specifications ascontained in the most recent edition of irny of the follorving pub-lications, namely :-(l) the Pakistal Pharmacopoeia ;

(2) the lnternational Pharrnac,'poeia ;

(3) tbe European Pharmacopoeia :

(4) the United States Pharmacopoeia ;

(5) the British Pharmacopoeia ;

(6) the British Pharmaceutical Codex ;

(7) the United States National Formulary ; and

(8) such other publication as may be prescribed :

Provided that, if the specifications do not appear in the mostrecent edition of any such publication, the specifications appearingin the next prrceding edition of such publication in which thespecifications appear shall apply ; or

(iii) if no specifications are either prescribed or contained in any ofthe publications referred to in sub-clause (ii), the specificatiooapproved for the purpose of registration under this Act ;

(za) "sell " means sell, offer for sale, expose for sale, have in possession forsale and distribution and " to sell " " sold " or " sale " shallbe construed accordingly ;

(2!) " spurious drug " means a drug-(i) which purports to be a drug but does Dot contain the active in-

gredient of that drug; or

(ii) which purports to be the product of a manufacturer, place orcountry of whom or of which it is not truly a product ; or

(iii) which is imported or exported or sold or offered or exposed forsale under a particular name while actually it is another drug ; or

(ir) the label of which bears lhe name of an individual or compa-oypurporting to be its manufacturer or producer which individualor company is fictitious or does not exist ;

(r4 " storage " means storage for sale and " to store " or " stored " shallbe construed accordingly ; and

(rz) " sub-standard drug" means adrug which is not of specifcations.

CHAPTER II

ADMINISTRATIO^\ AND ENFORCEM ENT

4. Regulation rnd pfohibitior of import, erc., of drugs.- (l) The Federal\rovertrment shall rcgulale the imporr and export of drugs in rhi prescribed mannerend tor that purpose may make such orders and is:'ui such diiections to the im-porters and exporters as it may deem frt

,l*,f r"(2) If in the opinion of the Fcderal Governmen[ the public interest so re-

quires, the Federal Government may, by noti0cation in the oftcial Gazette,-

(a) direcr that a drug or a class of drugs specified in the notification, ordrugs generally. shall not be imported or exported otherwise tha-o utrderrhe authority of a licence issued under this Act or except by animporter or exportcr orthrough an indentor registered io accordancewith the rules ;

(6) direct lhat a drug or class of drugs specified in the notifrcation shallnot be imporied except by an agency of Government so spocified ; or

(c) prohibit the import or export of aoy drug or class of drugs sp€cifiedin the notitcation.

5. Regulotion of mandactu€ of drugs.{l) The gant of licenccs tomanufacture drugs shall be regulated in accordancc qrith such conditions andprocedure as may be prescribed, by a Central Licensing Board to be set up bythe Federal Government and consisting of such reprcsentatives of the FederalGovernment and the Provincial Governments as may b prescribed.

(2) The members of the C€ntral Licensing Board shall exercise such powers,includirg the powers of an Inspector, as may be prescribed.

(3) The Central Liensing Board shall make regulatioos to rcgulatc thcconduct of its business.

14) Any member of the Central Licensing B.rard may, at any time, by writingunder his hand addressed to the Federal Government, resign bis office or sballvacate his offic€ if the Federal Government, being of opinion that in the publicinterest it is necessary so to do, so directs.

(5) Subject to sub-section (4), a member of the Central Licensing Boardshall hold ofrce for the prescribed period.

6. Regulation of sale of drugs.- The Provincial Govemments shall regulatethe sale of drugs in the prescribed manner and may for that purpose make suchorders, and issue such directions to the importers, manufacturers, stockists, retailersor other dealers of drugs, as tirey may deem fit.

7. Registratiotr of drugs.- (l) The Federal Government shall cause alldrugs tr.r be registered in accordance with such conditions and procedure as may6. prc5c1ib:d and for lhat nurpose set up a Registration Board, consistins oisuch number of persons. possessing such qualifications, as may be prescrib&.

Explanolion.- lnlhis section, " drugs " means drugs which are in the finishedform ready for use.

(2) Tbe members of the Registration Board shall-_exercise such powers,including the powers of an Inspector, as may be prescribed.

(3) The Registration Board shall make regulations to regulate the conductof its business.

(4) Any meruircr of the Registration Board may, at-any time, by writingunder his hand nddresseti to the Federal Government, resign his office or shaiivacate his omc( i,'t!,c F.,1,:i.rl (lovcrumcnt, bcing of opinion that in the publisinterest it is nccc5saiJ :L; to ,irr, so directs.

3C4 I }{E, GAZETTE OF PAKISTAN, EXTRA,, MAY 18, 19?6 [PTNT I

(5) Subject to sub-section (4), the members of the Registration Board shallhold office for the prescribed period.

(6) The Federal Government shall, by notification in the official G2zette,fix the date after which no drug which is not registered shall be allowed to beexported, imported, manufactured, stored, distributed or sold.

Itg'-)

(7) A person applying for the registration of a drug sball furnish sucb in-formation in respect of the drug as may be prescribed, including information r€lat-ing to its emcacy, safety and quality, or as may be required by the RegistrationBoard for the purpose of the evaluation of the drug.

(8) Single-ingredieut drugs shall be registered generally by their genericnames while compound drugs shall be registered generally by their proprietarynames.

Explanotion.- ln this sub-section,-

(a) " single-ingredient drugs " meals drugs containing one active iDgre-dient ;

(D) " compound drugs " means drugs contajning more than one activeingredient.

(9) The registration of a drug shall be subjcct to such conditions, if any,as the Registration Board may specify at the time of its registration.

(10) Where the Registration Board registers a drug, it shall inform the personapplying for its registration and the Provincial Governqents of its having doneso-and ol the conditions subject to which it bas been registered.

(ll) If the Registration Board, on the basis of information re@ived or aDinquiry conducted by it, is of opinioo that-

(a) the registration of a drug was procured by fraud or misrepresenta-tion ; or

(b) the circumstances in which a drug was registered no longer exist ; or

(c) there has been a violation of the conditions subject to which a drugwas registered ; or

(d) it is necessary in the public interest so to do ;

ths Registration Board may, after affording to the person on whose .application thedrug ryas registered an opportunity of showing cause against the action proposedro be taken, cancel or suspend the registration or speciry any further conditionsto which the registration shall be subject and inform such person and the Pro-vincial Goverr,ments accordingly.

( I 2) The Provincial Governments shall take all such steps as may be neccssaryro er,sure compliance with the conditions subject to wbich a drug is registered andto Preleot the manufacture or sale of a drug-

(a) which has oot been registered ; or(D) the registration of which has been cancelled or stands suspended,

8. Pa[.istao National Formulary.- The Federal Government shall compileald publish in the ofrcial Gaz€tte PakiSan National Formulary comprising- allJru::s allow'r.i to be imported, mauufactured or sold ard such Formulary miy bereviewrd and modified from time to time.

Qs!)a^-

9. Appcllate Board.- (1) The Federal Government shall, in accordancewith ttre rules, constitute an Appellate Board forthe disposal of appeals preferredby persons aggrieved by aay decision ofthe Central Licensing Board or the Registra.tion Board or the licensing authority or a Board or Authority to which the powe$oftho Federal Government under s€ction l2 have been delegated under sub-scction(3) ofthat s€ction and tor revision of any such decision on its own motion.

(2) The Appellate Board shall consist of such representarives of the FederalGovernment and the Provincial Governments, including a Chairmal, as the FederalGovernment may from lime to time appoint.

(3) Subject to sub-section (4), the Chairman and other members of theAppellate Board sball hold office for the prescribed period.

(4) The Chairmal or any other member of the Appellate Board may, bywriting under his hand addressed to the Federal Government, resign his ofrce oishall vacate his office if the Federal Government, being of opinion tbat iu thepublic interest it is necessary so to do, so directs.

(5) The members of the Appellate Board shall exerciw such po\vers, includ-ing the powers of an Insp@tor, as may be prescribed.

(5) The Appellate Board may appoint experts for the purposes of detailedstudy of any sp€cific matter before it.

(7) The Appellate Board shall make regulations to regulate the conducf ofitsbusiness.

10. Expert Committees.-(1) Tbe Federal Government may constitute com.mittees of experts on Drugs Evaluation, on Pakistan Pharmacopoeia, on Adverti-sing and on such other matters as may be Decessary for the purposes of tbjs Act.

(2) Each committee constituted under sub-section (l) shall consist of suchmemb€rs as the Federal Goyernment may appoint from time to time and each suchmember shall hold ofrce during the pleasure of tbe Federal Government.

I l. Provinciel Quality Control Board.-(l) Each Provincial GoyernmeDt shallset up a Provincial Quality Control Board consisting of such members, includinga Chairman, as that Government may appoint from time to time.

(2) The Charrman and other members of the Provincial Quality Control Boardshall hold ofice during the pleasure of the Provincial Govemment, on such termsand conditions as tbat Government may delermine.

(3) The Provincial Governmetrt shall appoint a person to be the Secretary ofthe Provincial Quality CoDtrol Board and provide the Board with such stafl as theProvincial Government may consider necessary.

(4) The Provincial Quality Control Board shall make regulations to regulalethe conduct of its business.

(5) The following shall be the powers and funchons of the Provincial QualityControl Board, namelY :-

(d) to iuspect any premises whcre any drug is being, or is to be, manufac-tured or sold and to recommend to the approPriate autbority the can-cetiation or suspension of thc Irieuce to manufacture or selldrugs gran-ted to any per s,.u *i ho is found to be ci) rltra!'e ning. or to have contrave-ned, any of thc provisiotts of this Act, ()r the rules ;

t t$t)306 T.HE GAZETTE OF PAKISTAN, EXTRA., MAY 18, 1976 IPETT I

(D) to scrutinize the reporrs t) [ Pro\ ir]cial Insp@tors in respect ofcojitra\ en-tions t,f this Act and reports of Govcrnment Analystsin respectofdrugs sent to ihern by Provrucial Iuspcctcrs for tcst and rnalysis andissue instructions to the Inspccrors as to the action to be raken on suchreporis:

Provjdod rhat tllc l'rovincjal Quairty CoDlrol -Board may specifl'rhe class ofcases iu !r'hicb a Provincial Inspector may make a complainlto the Drug Court, or take any other action. withcut thc spscificinstructions of Lhc Board ;

(c) to exercise all the powers of an Inspector und6r this Act and therules ; and

(d) to advise the Provincial Government oD uays andmcaos to eDsurcqualitycontrol of drugs manufucturcd irl ths Province.

(6) The Provincial Qualrty Control Board may entrust any of its p"rlers ,,rfunctions under s.rb-seciion (5) to any ore or moro ofits members.

12. Power to fix maximum prices of drugs, etc,-(l) Tho Federal Governmentmay, by notification in the omcial Gazelte,-

(a) fix the maximum price at which any drug specified in the notincatioDisto be sold ; and

(6) specifo a ceftain percentage of the profits of manufacturers of drugswhich shall be utilised, in accordance with the rules for purposes ofresearch in drugs.

(2) For the purpose of the exercise of its powers undcr sub-section (1), tlreFederal Government may require a manufacturer. stockist. importer, exporter,retailer or other dealer in drugs to furnish such relevant information as may benetessary.

(3) The Federal Government may, by notification in the oftcial Gazette,delegate any ofits powers under this section to aDy Board or other authority.

13. Directions to Provincial Governments.-The Federal Govemment maygive such directions to a Provincial Government as may appear to the FederalGovornment to be neoessary for carrying into execution in the Province ofany oftheprovisions of this Act or of any rule or order made thereunder or for main-taining supplies ofdrugs ofstandard quality at reasonable prices or forthe acbieve-ment of uniformity in respect ofany matter in different parts ofPakistaD.

t4. F€deral Drug Laboratory and iEstitutes, etc.-The Federal Governmentshall, as soou as may be, establish a Federal Drug Laboratory and may also setup such.other institutss and drugs testiog and researc h laboratories for the purposesof this Ast as may be prescribod.

15. Provincial Drugs Testi[g Laboralory.-Each proviDcia] Govemmentslrall,.as sootr as may be, s€t up a Provincial Drug Testing Laboratory for sucbpurposes as may be proscribed.

16. Goyernmetrt Atralysts.-The Federal Government or a provincial Govern_ment may, by notification in the official Gazerte, appoint ..uch persons it rbirks0t, having thc prescribcd qualifications, to bc thc Federal Goverumeni

.(EBt'rnr Il THE GAZETTE OF PAKISTT\N, EXTRA,, MAY 18, 1976 307

Analysts or, as the case may be. Provincial Covernment ADalysts, for such arrasand in respect of such drugs or classes ofdrugs as may be specified ia the noti-tcation :

Provided thxl no pcrsou rvho hus any iirrancial intelesl in the manufacture,import, export or sale of drugs shail bc so appointed :

Provided further that a person serving under the Federal Gcvernment oranothor Provincial Government shall not be so appointed without the previousconseqt of that Government.

17. Inspectors.-The Federal Govcrnment cr a Provincial Government may,by norification in the official Gazette, appoiDt such persons as it thinks fit, havingthe prescribed qualifications, to be Federal Inspectors or, as tl:o case may be, Pro-vincial Inspectors for the purposes of this Act within such local limjts as it mayassign to them respectivoly :

Provided that tro persolr who has any financial interest In the manufacture,import, export or sale of any drug shall be so appointed :

Provided further that a person serving under the Federal Government cranother Provincial Govornmeut shall not be so appointed witi.out the previou(consetrt of such Government.

lE. Powers of Inspectors.-(l) Subject to the provisions of secticn l9 and ofany rules made in this behalf, an Itrspector may, within the local limits for which heis appointed, and in any other area with the permission of the licensing authority,-

(a) inspect any premises wherein any drug is manufactured, the plant andprocess of manufacture, the means employed lor standardising and tes-ting the drugs afld all relevant recr,rds and registers ;

(D) inspect any premises wherein any drug is sold or is stockeC or exhibiredfor sale or is distributed, the storage arrangements and all releyant re-cords and registers:

(c) take samples of any drug which is being manufactured, or beirg soldor is stocked or exhibited for sale or is being distributed ;

(d) enter and scarch, with such assistance, ifaly, as heco[5id91s 6scs5sary,any building, vessel or placc, in which he has roason to beueve that anoffence under this Act or any rules has been or is being committedr; may continue to be committed ;

(e) call any p€rsonto be presenl as witness in the c ourse of search or seizureor in connection with auy other mattcr wherc the presence of witnessesis necessary ;

( fl seize such druc and all matcrials uscd in the malufaclure rhereof andany other articles. including regi;ters. cash-mcmcs. inr.oices and bills,which he has reason to believe may furnish evidence ofthe commissionof an offence punishable under rhis Act or any rules :

(g) require any prson to appear before him at any reasc,l:rble tinc and placeto give rtatemcnt. assishnce r r inlcrnraiion rclating to or in connection*ith the investigation of an oflence undelhis Act or the rules :

Provided that rhe exemptions under sections 132 asd 133 of theCode of Civil Procedure, l90E (Act v trf I908), shall bc applicable torequisitions for attendance under lhi-. clause ;

(h) to:k and sr-r! itry factory, laborat )ry,sbop, building, storc-houseor godo\an, or a part thercJf, where an1' drug is or is tring

t

(16+.r308 THE GAZE ffE OF PAI(ISTAN, EXTRA., MAY 18. 1976 [P^Rr I

manufucturcd, stored, sold or exhibitod for sale in oontravention ofany ofthe provisions of lbis Act or the rules ;

(i) forbid for a reasonable period, uot exceeding four weeks or such furtherperiod, which shall not bc more than thrce months. as the Inspectormay, with the approval of the Provincial Quality Control Board, theCentral Liccnsing Board, the ReSistration Board or the licensingauthority, as (he case may be, specify. any person in charge of any pro-mises from rer,rcving o. dispensing of any drug, article or other tbinglikely to be used in evidence ofthe commission ofan offence under tbisAct or the rules : and

@ exercise such other powers as may be necessary for carrying out thepurposes of this Act or any rules :

Provided that the powers under clauses (f) to 0) shal.l beexercisable only by an Inspector specifically authorised in this behalf, byan order in writing, by the Government appointing him, subject to suchconditions as may be specified in such order :

Provided further thal the power uDder clause (h) may be exercisedby an ltrspector not aulhori5ed as xloresaid where the contrarentioo isof a provision which requires a licence to be obtained for the manufacture,storagc or sale of a drug.

(2) The provisions ofthe Code of Criminal Procedure, 1898 (Act V ofl898),in so far as lhey aronot inconsisteot with the provisions of this Ac1, shallapply to searches and seizures made under this Act.

19. Prcdure for Inspectors.-(1) Where an Inrp@tor seizes any drugor auy other art;cle u nder section I 8, he shall tender a rereipt therefor in the prescri-bed form.

(2) Where an Inspector takes a sample of a drug for the purpose oftest or analysis, be shall intimate such purpose itr writing in the prescribed form tothe person from whom he takes it and, in the presence of such person unless hewilfully absents himself, shall divide Lhe sample into four portious and cflectivelyseal and suitably mark the same and permit such person to addhisown seal. ifany,and mark to all or any of the portioDs so sealed and maiked ;

Provided tbat, rvhere the sample is taken from premises whereon the drug i5b€ing manufactured, it shall be necrssary to divide the sample into three porti6nsonly :

Provided_further that, wbere the dmg is made up in containers of small volume,instead of dividing a sample as aforesaid, the Inspector may, and if th;drug be_such that it is Iikely to deteriorate or be otherwise damaged by exposureshall, take three or four, as the case may be,_of the said containers after suitablymarking the same and, where necessary, sealing tbem 3

Provided furtter that if the contents of one container are insuftcied forthe laboratory test and analysis, the Inspector may incrcase the nutnber of thecontainers in order to make the sample sufficient for this purpose.

(3) The Inspector shall restore one portion of a sample so diyided or onecontainer, as the case may be, to thc person from whom he takes it, and shall rc_tain the remainder and dispose of the same wi(hin seven daysas follows :-

(i) one portion or sample he shall send to the Governmcnt Analystcon@roed for test and analysis ;

(r6sJp^Rr ll rHE GAZETTE OF PAKISTAN, EXTRA., MAY lE, 1975 309

(ii) The second he shall send to the Chairman, ProYincial Quality Cotrtrol' -Board or the Ccntral Licersing Board or the Regigration Board, asthe

case may be ; and

(iii) the third, where taken, he shall setrd to the warrantor, ifany, named underthe proviso to sub-section (3) of section 32.

(4) Where an Inspector seizes any drug containing any filthy or putridsubstance, vermin, worm, rodent, insect or any foreign matter which is visible tothe naked eye, and the sample is such that it caonot or need not be divided,he shall effectively seal and suitably mark the same and permit the person fromwhom he seizes the drug to add his own seal if any, and mark to it and shallproduce the same before the Drug Court or the Centlal Licensing Board or theRegistration Board, as the case may be, before whicb proceedings are institutedor action is initiated in respect ol the drug.

(5) Where atr Inspector takes aDy actlon under section 18,-(a) he sball as soon as practicable ascertain whether or not the drug con-

travenes any of the provisions of this Act and, if it is ascertain€d tbatthe drug does not so contravene, he shall forthwith revoke the orderpassed under the said section or, as the case may be, take such actioflas may be necessary for the return of the stock seized and payment forthe samples taken, under intimation to the Board concerned;

(b) if he seizes the stock of the drug, he shall, as soon as may be, inform theBoard concerned and take its order as to the custody thereof:

Provided that where a Federal Insp€stor is not competent to take actio[under s€ction 30, he shall as soon as may be report the malter atrdhand over the stock, if any, 10 the Provincial Inspector for furtheraction under this Act.

(6) The Provincial Insp€ctor on finding any conhavention of this Actshall, unless the Board otherwise directs, always refer the case to the ProvincialQuality Control Board and seek orders as to the action to be taken in resp€clof such contravention.

(7) The Federal Inspector on finding any contraventioD of this Act forwhich he is authorised shall, unless otherwise d ected, always refer the case tothe Central Licensing Board or the Registration Board or any other authority asmay be specified for the purpose and seek any further orders as to the action tobe taken in respect of such contravention.

20. Persons bound to ilixlose place where drugs are mandoctued or kepL-Every person for the time being in charge of any premises whereon any drug isbeing manufactured or is kept for sale or distribution shall, on being required byan Inspector so to do, disclose to the Inspector the place where the drug is beingmanufactured or is kept, as the case may be.

21. Disclosure oI the nare of the mandsctuer.-Every person, not beingthe manufacturer of a drug or his agent for the distribution thermf, shall, it sorequired by an Inspector, didose to him the name, addres and other particulamof the manufacturer or othe.r person ftom whom he acquired the drug.

22. Reporlt of GovemrEnt Amlysts.{1) The Government Analyst towhom a sample of any drug has been submitted for test and analysis under sub.section (3) of section 19 shall deliver to the I.nspector submitting it a sigredreDort in quadruplicate in the prescribed form and forward one mpy thereof tothi authoriity as may be prescribcd.

Ltq)310 THE GAZETTE or pertsteN, dxrna., MAy 18. lez6 [ p.^Rr I

(2) The Government Analyst, as far as may be, shall subnit the reportreferred to in sub-section (l) within sixty days of the rec€ipt by him of thesample of the drug and, if he is not able to do so for reasoos beyond bismntrol, sball communicate the reasons to the I$pector il writing and shalleodorse its copy to the Board concerned who shall have the samplo testcd fromthe same or any other Governmeot Analyst or a GoverDment Drug TestingLaboratory or any other l-aboratory and shall ensure the receipt of rcsults ofsuch test and analysis within a further period as may bc prescribed and shallmake tbe test report available to the Insp€ctor for further action.

(3) On receipt of the report, the Inspector shall-(a) deliver one copy thereof to the person from whom the sample was

taken ;

(6) forward one copy to the warrantor, if any, named under the lrorisoto sub-section (3) of section 32 ;

(c) forward one copy to the Board concerned for its directions as to theaction to be taken on the report ; and

(d) retah the fourth copy for use in any pros(cution or for any otherpurpose.

(4) Notwithstanding aoything contained in any other law for the timc beingin force, any document purporting to be a report signed by a Government Analystshall be admissible as evidence of the facts stated therein without formal prcol andsuch evidence shall be conclusive unless the person from whom the sample wastaken or the said warrantor has, within thirty days of the receipt of a copy ofthereport notifed in writing to the Inspector or the. Drug Court or, as the case may be,the Central Lioensing Board or the Registration Board before which any pro.oeedings in respect of the sample are pending that he intends to adduce evidencein cootroversion of the report.

(5) Where a person has, under sub.section (4), notified his intention of adduc-ing evidence in controversion of a Government Analyst's report, the Drug Courtor the Board concerned may, of its own motion or in its discretion at the requesteither of the complainaot or the accused, cause the sample of thc druglying with the Board concerned under sub-section (3) of section 19 tobe sent for test or analysis to the Federal Drug Laboratory or any other laboratoryspecified for the purpose by the Federal Government which shall make the te6t oranalysis and report in writing signed by, or under the authority of, the person forthe time being incharge of tbe Federal Drug Laboratory, or, as the case may be,such other laboratory, the result thereof and such report shall be conclusive evi-dence of the facts stated therein.

(6) The cost of a test or analysis made by the Federal Drug Laboratoryor otber laboratory under sub.section (5) shall be paid by the complainant oraccused as the Drug Court or the Board concerned shall direct.

CHAPTER III

PROHIBITIONS

23. Import, Eatrufrcture and sale of drugs._fl ) No person shall himsell orby any other person on his bebalf-

(a) export, import or manufacture for sale or sell-(i) any spurious drug ;

(ii) any counterfeit drut ;

(vit)P,rnr Il THE GAZETTE OF PAKISTAN, EXTRA., MAY 18' 1s76 311

(iri) any misbranded drug ;

(iv) any adulterated drug ;

(v) any substandard drug ;

(vi) any drug alter its expiry date ;

(vii) aly drug which is not registered or is not in accordance with theconditions of registratioD ;

(viii) an)' drug r.r'hich, by means of any statement, design or device ac-companying it or by any other means, purports or claims to cureor mirigate any such disease or ailment, ar to have any such othereffect, as may be prescribed ;

(ix) any drug if it is dangerous to health when used in the dosage orwith the frequency, or for the duration specified, recommendedor suggested in tbe labelling thereof ; or

(x) any drug in contr3vention of aDy ofthe provisions ofthis Act oranyrule ;

(b) manufacture for sale atry drug except under, and in acco,rdance withthe conditions of, a licencc issued under this Act ;

(c) sell any drug except under, and in accordance with the conditions of,a licence issued under this Act ;

(d) import or export any drug the import or export of which is prohibitedby or under this Acr :

(e) import or export any drug for the import or export of which a licenceis required, exc€pt under, and in accordancc with the conditions of,such lictnce ;

(f) supply an incorrect, incomplete or misleading information, whenrequired to furnish ar:y information under this Act or the rules ;

(g) p€ddle, bawk or ofer for sale any drug in a park or public street or ona highway, footpath or public transport or coaveyatrce ;

(i) import, manufacture for srle, or sell any substance, or mixture ofsubstances, which is not a drug but is presented in a form or manncawhich is intcnded orlikely to cause the public to believe itto bo a tI,

(r) s€ll any drug without having a warranty in the prescribed form beal.ing the name and batch Dumber of the drug issued,-(i) in the case of a drug m3nufactured in Palostan, by the manu-

facturer holding a valid licence to manufacture drugs and pcr-mission to manulacture that drug or by his authorised agent ;-

(,i) iD the case of an imported drug, by the manufacturer or impsftslof that drug or, if the drug is imported through en indcntbr bysuch indetrtor ; and

(i) apply an inconect balch number to a drug.

(2) Nothing in sub-section (l) shall apply to thc manufacturc o mtu'rt-subject to prescribed condition", of sm.r,, q.,aotities o.a ) drug forth- p-^ro.cof clinical trial, examination, test, aDalysis or personal use ;

(\68/312 THE GAZETTE OF PAKISTAN, EXTRA., MAY 1E, 1976 lP,rnt I

24. Control of advertisement.-No person shall himself or by any other penonon his behalf advertise, except in accordance with such conditions as may beprcscribed,-

(i) any drug ;

(ii) any substance used or prepared for use in accordance with theayurvedic, unani, homoeopathic or biochemic system of treatment orany other substance or mixture of substances as may be prescribed ;

(iii) any remedy, treatment or offer of a treatment for any disease.

Explanation.-In this ssction, " advertise " means to make any representatioD by any means whatsoever for the purpose of promoting directly or indirectlythe sale or disposal of a drug, a substance or a mixture of substances, a remedyor a treatment except the display of sign boards for a clinic, a dispensary or a hos'pital or such other institution offering treatment.

25. Control of sampling.-No person shall distribute or cause to be distribu-ted aDy drug as a samplc except in accordance with such conditions as may beprescribed.

26. Control of prioting of labelling.-No person shall print ary labelling ioresp@t of aoy drug which is required to be registered under this Act but is notso registered after the date firred by the Federal Governmeri undcr sub.section (6)of section Torforapersor whodoesnot possessa licence uDder(hisActto manu-facture that drug.

CIiAPTER IV

OFFENCES, PENALTIES AND PROCEDURE

27. Penalties.-(l) Whoever himself or by any other person on his behalf-

(a) cxports, imports, manufactures for sale or sells any spurious drug orsny drug which is not registcred ;

(b) manufactures for sale any drug without a licrnce ; or

(c) imports without licence any drug for the import of which a licrnce isrequired ;

rhall be punishable with imprisonment for a term which shall not be less thantBp$ryers or more than ten years and with fine which may extend to one lakhfu pees :

Provided that the Drug Court may, for any special reasons to be recorded,award a sentenc€ of imprisonment for a term of less thaq three years.

(2) Whoever himsell' or by any other person on his behalfl-(a) imports, maoufactufes for sale or sells any counterfeit drug ; or(b) gives to the purchas€r a false warranty in respect of any drug sold by

him thal the drug does not in any way contiavene th6 profrsions o'fseatioD 23 and is not able to prove that. when he save the warrantv-he had good and sufficient reason to believe the sim. ro be true ; 5i

, (c) applies or pcrn:its to be applied to any drug sold, o1 stocked or ex_hibited for ralc. by him, whether on th6 container or a label or in anyother manrrcr, a warran(y givcn in respect ci4ny other drug ; or

QqP,rnr ll ., THE GAZETIE OF PAKISTAN, EXTRA., MAY 18, 1976 313

(d) imports, manu.tactures for sale or sells any drug under a name otherthafl tle registered name ; or

(e) exports, imports, mangf461ur6s for sale or sells any drug with whichany substance, which should Dot actually bc its compoaent, has'becrmixed or packed so as to reduce its quatity or streagth or lor whichany such subsLanc€ has be€n substituted wholly or in part:

shall be punishabte with imprisotrment for a term which may extend to sevcDyears, and with fine which may extend to one lakh rup€es.

(3) Whoever obstructs an Inspector in the exercise of any power conlerrpdupon him by or under this Act, or disobeys the lawful authority of any Insp€ctor,shall be punishable with imprisonment for a term which may extend to oncyear, or with fine which may extend to ten thousand rupees, or E'ith botb.

(4) Subject to the provisions of sub-section (l), subsection (2) and sub-section (3), whoever himself or by any other person on his behalf contraven€saoy of the provisions of this Act or any rule shall !s purdstr.6le with imprison-metrt for a term which may extend to five years, or with fine which may extendto fifty tlousand rupe€s, or with both.

28. Peutt, for .r@rrcnt oleace.{l) Whoever haviog been convictedof an ofience under sub-section (l) of section 27 is again convicted of an offenceunder that sub-section shall be punishable with imprisonment for life or Fittrimprisonment which shall not be less than five years and with fine which mayextead to two lakh rupe€s.

(2) Whoever havilg been convicted of an ofterce under sub-section (2) ofs€ction 27 is again convicted of an offence under that sub,section sha[ be pudsh.able with iEprisonment for a term which shal1 not be less than two ycarr ormore than ten years, or with 6ne which may ext€nd to two lakh rup€es, or withboth.

(3) Whoever having been convicted oI a-n offence under sub-section (4) ofsectiotr 27 is again convicted of an offence under that sub-section shall !g punis[-able with imprisonmetrt for a term which may exteDd to seven years, or witlfi.ne which may exte4d to one lakh rupe€s, or with both.

29. Forfei@re.{l) Whero any person has been oonvicted under rhis Act,for contravening any such provisions of this Act or any rule as may bcprescribed in this behalf, the Drug Court may order ttrat the stock'of drug orsubstance by means of or in relation to which the offenrce was committed or any-thing of a similar nature l6l6nging to or in the possession of the accuscd orfound with such drug or substance, and if such contravention is pun,ishable undcrsub-section (l) of section 27, any implements used in manufacture or sale ofsuch drug atrd any receptacles, packages or coverings in which such drug iscontained and the admals, vehicles, vessels or other conveyarc€s, used ir carry-ing such drug, be forfeited to the Federal Govertrment or, as the casc may be,the Provincial Government and, upon such order being made, such dnrg, sub-stance, implements, receptacles, packages or coveri-ngs, animals, vehicles, vcssclsor conveyances may be disposed of as that Government may direct.

(2) Without prejudice to the provisions of sub-section (l), where the DrugCourt is satisfied, on the application of an Inspector or otherwise, and aftcr suchinquiry as may be necessary, that a drug contravenes the provisions of this Act,the Drug Court may order that such drug be forfeited to the Federal Gov€m-ment or, as the case may be, the ProYhcial Government and, upon such ordccbeing made, such drug may bc destroyed or otherwise disposed of as that Govqn-ment may diti.

(i\}l314 THB GAZETTE OF PAKISTAN, EXTRA., MAY 18, 1976 [Penr I

(3) An Inspector shall release ary drug or article seized by him under thrsAct when he is satisfled that all the provisions cf this Act and the rules witlrresp€ct there to have been complied rvith.

30. Cognizance of offetrc€s.-( I ) Subject to the provisions of section 19, noprosecution shall be instituted under this Chapter except-

(a) by a Federal Insp€ctor, where the proseculion is in resprxt of acontravention of clause (h) of sub-section (l) of section 23 or section24 or aoy of the provisions of this Act or the rules relating tothe import or export of drugs or the manufacturc for sale. or salc, ofa drug which is not for the time being registcred or for rhe manufaclurefor sale of whjch a licencc is not for the time being in f(,rcc ; cr

(D) by a Provincial Inspector:

Provided that, rvhcre the public interest so requires. the Federal lnspec-tor may, with the prior permission of the Federal Government, jnstirutea prosecution for a contravention of any other provision ofthis Act.

(2) Notwithstanding anything contained in thc Code of Criminal Procedure.1898 (Acr V of 1898),-

(a) an offencc punishable under this Chapter olher than an offence men-tioned in sub-section (l) of section 27, shall be non-cognizable, and

(b) no court other than a Drug Court shall try an offence punishable underthis Chapter.

(3) Nothing contained in this Ch3pler shall be deemed to prevent aDy personfrom being prJsecuted under any other law for any act or omission whlch cons-titutes an offence punishable under this Chapter or to requirc the trarsfer to IDrug Court of any case wbich may be pending in any court immediate)y beforethe establish;nent of the Drug Court.

31. Drug Courts.-(l) The Federal Government may. by notification in theomcial Gazette, establish as nrany Drug Courts as it considers necessary and, whereit ostablishes more than one Drug Court, shall specify in th€ notification the terri-torial limits within which, or the class ofcases in respert of which, each onc ofthem sball exercise jurisdiclion under tlrir Act.

(2) A Drug Court shallcoosist ofa person who is, or has been, or is qualifie(for appointmeDt as. a Judge of a High Court, rvho shall be the ChairmaD, and twomembars being persons who. in the opinion of the Federal Government, are ex-p€rts in the medical or pharnraceutical fields.

(3) A Drug Court shall sit at such placc or places as the Federal Cr,rcrr me: r

may direct.

(4) A Drug Court shall have all the powers conferred by tbe Code ofCriminalProcedure, 189E (Act V of 1898), on a Court of Session exercising originalj unsdicti on .

(5) A Drug Court shall not. nerely by reasor of a change in itscomposition,be bound to recall aud rehear any witness who has given evidelce, and hay acion the evidence already recorded by or produced before it.

(6) A Drug Court shall. iD all matl.ers with respect to which no procedurehas been prescribed by tlris Act, follow the -procedure prescribed by rhe Ccdeof Criminal Procedure, 1898 (Act V of t898). for the trial of summons cases byMagirtrates.

( \r!)P\Rr rl THE GAZETTE OF PAKISTAN, EXTRA., MAY lE, 1975 315

(7) A pJrson senl.enced by a Drug Court may prefer an appeal to a bench-,rl theHighCourtcorrsistingof not less r ban iwo Judges within thirty days of the .judgment.

(8) The provisions of sections 5 and 12 of the LimitatioD Act, l90t (lX of1908), shall be applicable to an appeal referre.d to il sub-section (7).

3l Pleas.-(l) Save as hereafier provided in this section. it shall be no de-lence in a prosecution under this Act to prove merely that the accused wasignorant of the nature, substance or quality of the drug iD resp€c t of which theoffence has been committed or of the circumstances of its manufacture or import,or that a purchaser, having bought only for the purpose of test or analysis, hasnot been prejudiced by the sale.

(2) A drug shall not be de€med to be misbranded or aduheratcd or substan-dard only by reason of the fact that there has been added thereto some innocuoussubntance or ingredient because the same is required for the manufactureor prepcration of the drug fit for carriage or consumption and notto incrcase the bulk, weight or measurc of the drug or to conceal itsirferior qualiry or other defect or there is a decompoeed substance which is thcresult of a natural proc€ss of decomposition :

Provided tlat such dccomposition is not due to a.ny negligenc€ on thepart of the manufacturer of the drug or the dealer thereof and that it does notronder the drug injurious to health or does not make it substandard.

(3) A person, not being the manufac'.urer of a drug or his agent for tbe dis-tri bution thereof, shall not be I iable for a cootravention of section 23 if he proves-

(a) that he did not know, and could not with reasonable diligence baveascertained, that the drug in any way contrsyened the provision of thisAct and that the drug while in his possession remained in thesame state as when he acquilcd it; and

(b) that he acquired the drug frcm a duly licensed manufacturer or hisauthorised agent or an importer or an indeDtor resident in Pakistanunder a written warrant-v in the prescribed form stating, in particular,the batch numbcr of the drug and signed by sucb person that the drugdoes not in any way contravcne the provisions of section 23 aDd thatthe drug while in his possessic,n was properly storcd and remainedin the samc state as when he acquired it and that lhc drug has beenmanuflactuted by a manufacturer holding a valid licence to manufac-ture drugs and permission to manufircturc that drlrs :

Provided that a dcfence undcr clause (b) shall be open to a person only-(i) if he has, within sevetr days of the service on him of the summons, seot

to thc Inspcctor a copy of the warranty withawritten notice statinEsthat he intends to rcly upon it and givirg the name and address of thewarrantor. anC

(ii) if hc proves that he has, within the same period, sent written noticeolsuch intention to thc said warrantor.

-11. Applicatioo of law relating to customs atrd porv€Is of officers of ctrttoDs.-,l) The law for th: time being i'r force relating to customs and to goods the im-port ol- which is prohibited by or under the Customs Act, 1969 (IV of 1969), shall,subjecl to thc provisions o[ secrion 27 of this Act, apply in rcspect .f '&ugr

( t1,316 lHE GAZETTE OF PAKISTAN, Exrne., MAY 18, re76 [PARr I

the import of which is prohibited under this Act, and officers of customsand officers to whom anl, of the functions of an oflicer of customs Lave beenentrusted under the said Act shall hare thc sanre porvers in respect of such drugsas they havc for th,i lime being in rcsp;ct ol such goods as aforesai.l.

(2) Without prejudice to the provisions of sub-scction ( l), an officer ol' cus-toms or a Federal Inspector or any other person as may be authorised by the FederalGovertrment in this behalf may detain any imported package which he suspectsto contain any drugthe import of which is prbhibited under this Act, and shallforthwith report such detention to the licensing authority and, if required by it,forward the package or samples of any suspected drug found therein to a labora-tory specified by ir.

34. Ofrences by companies, etc.-Where the person guilty of an offenceunder this Act, is a company, corporation, firm or institution, every director,partner and employee of the company, corporation, lirm or institution shall,rrnless he proves that the offence was committed without his knowledge orconsent. be gu,lty of the r ffence.

35. Publication of offender's name.-(l) If auy person is convicted of anoffence undcr this Act, it shall b€ lawful for the Drug Courr to cause thcoffender's name, place of residence, the oflence of which he has been convictedand thc penxlty rvhjch has been inflicted upon him, to be published at the ex-ponse of such person in such newspapers or in such other manncr as the C(-.urt maydirect.

(2) The expenscs o[ such publication shall bc recoverable io the slme manneras a frne is recoverable.

36. Powers to exempt.-Notwithstanding aoything contained i[ rhis Act,the Federal Government may, if it is of opinion that the public iDterest sorequires, at any time, of its own motion or on a representation made to it, b)notification in the offlcial Gazette, cxempt any drug or class of drugs from theoperation ol any of thc provisions of this Act, subject to such conditicns,ifany, and f,'r such period. as mry be spccificd io tlte notifcation.

37. Inspectors to be public serranls.-Every Inspector shall be deemed to b€a public servant wirhin thc meaning of section 2l of the Pa-kistan Penal Code(Act XLV of 1860), and shall be officially subordinate to such aulhority as the6overnment atFoinling him may specify in this behalf.

3E. Indemnity.-Except as otherwise expressly provided io this Act,oo suit, prosecution or other legal proceeding shall lie against Governmeot or anyother authority or person for anything which is in good faith done or intendedto be done under this Act or any rule.

39. Finality of orders, etc.-Save as otherwise expressly provided jn thisAct, every order pased or d,i:cision given by any Board, a brug Court or any otherauthority under this Act shall be flnaland shallnot be called in question by oi beforeany court or other authority.

40. Publication of result of test 6 analysis, etc.- (l) lr :lall be lan,ful forthe Federal Government to publish, in such manner as it may de"-m fit, the resultof any test or aoalysis of any drug for public information and to pass such ordersplatiqg to the withdrawal ofsuch drug from salc and its disposal as it maycolsider necessary.

Panr Il THE GAZETTE OF PAKISTAN, EXTRA., MAY 18, 1976 317

(tr3,

(2) The Federal GoYerDment may, if it considers it necessary in the publicintercst so to do, publish for public information, in such manner as it may deem fit,any information relating to a drug or to the use ofa drug in specified circumstan-ces.

41. Cancellatiotr or suspension of licences.-Wbere any person has beenfound to have contravened any ofthe provisions of this Act, or the rules inresp€ct of any drug and the contravention is of such a nature that the import,export, maruladure or sale of any drug by such person is, in the opinion of thelicensing authority or the Central Licensing Board, likely to endanger public healtb,tbat authority may, after giving such person an opportuDity of b€iDg heard, canc€lthe licence to import, export, manufacture or sell drugs issued to such personor suspend such licence for a specified period.

42. Cancellation or suspeosion of registration of registered drugs.-Where anyperson has been found to bave contravened any of the provisions of this Acr,or the rules itr respect of any registered drug, the Registration Board may, aftergiving such person an opportunity of being heard, cancel the registration of suchdrug or suspend such registration for a specified period.

CHAPTER V

MISCELLANEOUS

43. Power of Federal Governmetrt to make rules.-(l) Subject to section 44,the Federal Covernment may, by notification in the ofrcial Gazette, make rulesfor carrying out the purposes of this Act.

(2) In particular and without prejudice to the generality of the foregoingprovision, such rule maY-

(a) prescribe the functions of the Federal Drug Laboratory and any otheflaboratory set up under section 14 or specified under section 22 orsection 33 and the procedure for the submission to any such laboratoryof samples of drugs for analysis or test, the fonns oI the laboratory'sfeports thereon and the fees payable in respect of such reports; andsuch other matters as may be necessary for any such laboratory toperform ils futrctions;

(b) prescribe spciflcations, including the strength, potency, purity, qualityor other property, of any drug, and the methods of t.est or analysis tobe employed in determining whether a drug is of required specifications ;

(c) prescribe the maximum proportion of any poisonous or olher sub-stanc€ which rnay be added to or contain€d in any drug, or extractedor omitted therefrom; prohibit the import, ma.nufacture, sale or stoc.k-ing or exhibition for sale or distribution of any drug in which thatproportion is exceeded and specify substances which shall be deemedto be poisonous;

(d) specrfy the drugs or classes of drugs for the import or export of phich alicence is required, the testing of such drugs, and prescribe the formand conditions of such licences, the authority empowered to issue thesame, and the fees payable therefor;

(e) prescribe the places at which any specific drug or drugs may be im-ported, prohibit their import at any other place, and control theirimport through any specified agency;

ttz93I8 THE GAZETTE OF PAKISTAN, EXTRA., MAY 18, 1976 IPART I

(f) prescribe the evidencc to be supplied, whether by accompanyingdocuments or otherwise, of the quality of drugs sought to be im-ported, the procedure of officers, of customs in dealing with suchevidence a:rd the manner of storage at places of import of drugs de-tained pending admission ;

(g) prescribe the forms of licences for the manufacture for sale of drugsor any slrcified drugs or class of drugs, the form of application forsuch licences, the conditions subject to which such licence may be issued,the l)ersotr uuder whose signature the same be issued and the fccspayable therefor;

@) require t}le date of manufacturc and the date of expiry of potency tobe clearly arrd truly stated on the label and container of aly specifieddrug or class of drugs and prohibit the sale, stocking or exhibition forsale or distribution of thc said drug or class of drugs after the expiryof a specified period from the date of manufacture or after the expirydate and prescribe the mantrer of disposal of such drug or class ofdrugs ;

(i) prescribe the conditions to be obseryed in the packing in bottles,packages and other contailers of drugs and prohibit the sale, stockingor exhibition for sale or distribution of drugs packed in contlaventionoI such conditions;

O regulate the mode of packing and packaging, including its size, di-mensions, flll and other spccifications, the matedal used therefor ardrnode of labelling pa.cked drugs and prescribo the matters which shallor shall not bc included in such lebels or on the leaflets accomparyingthe drugs:

(k) require that the non-proprietary or chemical or acc€pted scientificname or the proprietary name of any specified drug or any ingredbntthereof shall be displayed in the prescribed mamer;

(l) prescribe the requirements and conditions in respect of good practicesin the manutacture aod quality control of drugs;

(m) prescribe conditions for distribution of samples for sales promotion ofdrugs ;

(n)

(o)

o)

prescribe the procedure for introduction in Pakistan of a new drug;prescribe terms and conditious of members oI thc Central LicensingBoard and the Registration Board;

prescribo types of registration of drugs, the form of application forsuch registration, the conditions subject to which such registrationmay be granted, the manner of registration and post-registrationsurveil[aace and deregis'tration ,rf registered drugs and the feespayable therefor ;

prescribe conditions for registration of indentors, importers, whole.salers and distributors within Pakistan and any establishment withinany foreign country engaged in the manufacture for export of a drugand prescribe conditions providing efrective and adequare lneans, b!arrangement with the Government of such foreigu country or other-wise, to enable the licensing authority or the Rcgistration Board to de-termine from time to timp whether drugs manufactured in such estab_lishmcnt, if imported or ofiered for import rnto Pakistan. shall bercfused admissioa where the public interest so requires:

(q)

(\75)PARr tl THE GAZETTE OF PAKISTAN, EXTRA., MAY 18. 1976 319

(t)

prescribe the form of warranty for manufactured drugs;

specify ofiences in relation to which the stock of drugs, articles orrhings shall be liable to forfeiture utrder this Act:prescribe rhe qualifications. aod regulate the procadure for exerciseof powers and performance of functions, of Federal Inspectors;

prescribe the laboratories to which the Federal Inspectors shall submitsamples of drugs raken for the purpose of test and analysis and theform and procedure for submitting the report of such test and analysisand the fee payable therefor, where so required;

prescribe measures for securing and maintaining supplies of drugs atreasonable prices, conditions to be met in respect of manufacture,production, pricing, keepitrg. movement and disposal of drugs andto fix pric€s, commissions, discount of lie manufacturer, wholesaler,distributor, retailer or any other dealer of drugs, to control giving ofbonus in cash or kind or in any other matrner to any of the said partiesand for collecting or calling for any informatiotr, statistics, records orbooks with a view to regulating the matters aforesaid ;

specify drugs which may be advertised and the conditions subject towhich such drugs may be advertised;

prescribe conditions subject to which small quantities of drugs may beimported or maoufactured or exported for the pulpose of exami-nation, test or analysis, clinical trial or Frsonal use; and

prescribe any other matter which is to be, or may be, prescribed bythe Federal Government.

(u)

(v)

G)

G)

(w)

(x)

(y)

(3) The power to make rules coDferred by this section shall, except on the6rst occasion of the exercise thereof, be subject to the condition of previous publi-cation.

44. Power of the Provtrcial Govertrm€nt to mak€ rd€s.-{l) The Provincia!Government may by notification in the ofrcial Gazette, mate rules in respect oftbe following matters. namely;-

(a) the establishment of laboratories for testing and analysing drugs;

(b) the qualifications and the procedure, for exercise of powers andperformance of functions of Provincial Inspectors:

(c) the forms of reports to be given by Government Aoalysts and themanner of application for test or ana[sis and the fees payabietherefor :

(d) the conditions to regulate sale or storage or distribution of drugs orany specific drug or class of drugs;

(e) the ofiences against this Act or any rule in relation to which thestock of drugs shall be liable to confiscation and destruction underthis Act ;

(f) the forms of licences for the sale or distribution of drugs or any speci-fred drug or class of drugs, the authority empowered to issue thesame, the form of applications for such licences, the fees payabletherefor and the cotrditions subject to which such liccuces may beissued ;

3m EXTRA., MAY lE, 1976 [Penr I

(g) the procedure to be fo.llowed by the Provincial Quality Controt Board;and

(h) any ottrEr matter wbich is to be or may be, prescribed by the Provin-cial Governmetrt.

(2) The power to make rules conlerred by this seotion shall, except otr thefust occasion of the exercise thereof, be subject to the condition of previouspublication.

45. Repeal anil Savirys,-(l) The Drugs Act, 1940 (XXIII of 1940), theDrugs (Generic Names) Act, 1972 (XXry of 1972), and the Drugs Ordinance,1976 (IV of 1976), are hereby repealed.

(2) Notwithstanding the rep€al of the Drugs Act, 1940 (XXIII of 1940), bysub-section (1),-

(a) Any licence to manufacture for sale issued thereunder to atry person,for the reyalidation of which an application has already been madeto the Central Licensing Board within the date specified by theFederal Govemment shall continue to be valid until rorders arepassed by tbc said Board in this behalf.

(b) Any licence for import or export or sale of drugs issued thereutrderto any person, shall, unless it expires earlier under the terms thereof,continue to be valid for such periods as the Federal Government, or asthe case may be the Proyincial Governm€nt may by noti-0cation inthe official Gazette, specify in this behalf:

hovided that in case of drugs to be imported or exportedlicencrs may continue to be issued under the rules framed underthe Drugs Act, 1940, till the rules under this Act are framed or as thecase may be, a date is fixed under sub-section (6) of section ? inresp€ct of drugs in the finished form ready for use.

ACT No. XXXII or 1976

An Act to repeal the Emigration Ordinqnce, 1976, and to reviye llv EntigretioaAct, 1922

(lrzrTHE CAZETTE OF PAKIST{N

WHEREAS it is expedient to repeal the Emi1976), and to revive the Emigration Act, 1922 (Y

ft is enacted as follows:-l. Short title atrd commencernent -(l) This Act may be calted the Emigra-

tion Act, 1976.

(2) It shall come into.force at once.

2. Repeal of Ordingtrce II of 1976 and revival of Act vtr of I922.-TheEmigration Ordinance, 1976 (II of 1976), is hereby re;ealed and shall be deemednever to have come into force and the Emigarion Act, L922 (yII of l9Z2\,shall stand reviyed as if it had never been repealed.

gration Ordinance, ry76 (ll olII ol 1922) :

M. A, HAQ,Seerctaqt.

PRINTED BY THE MANACER, PRINTING CORPORATION oF PAKISTAN PREss, ISLAIV,T.BADPUBLISHED BY THE MANAGER OF PUBLICATIONS, KARNCIN