Saturday, July 25, 2009

Section 23 (Prohibitions of Import, manufacture and sale of drug)

(1) No person shall himself or by any other person on his behalf--

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

(ii) any counterfeit drug;

(iii) any misbranded drug;

(iv) any adulterated drug;

(v) any substandard drug;

(vi) any drug after its expiry date;

(vii) any drug which is not registered or is not in accordance with the conditions of registration;

(viii) any drug which, by means of any statement, design or device accompanying it or by any other means, purports or claims to cure or mitigate .any such disease or ailment, or to have any such other effect, as may be prescribed;

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

(x) any drug in contravention of any of the provisions of this Act or any rule;

(b) manufacture for sale any drug except under, and in accordance with the conditions of, a licence 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 prohibited by or under this Act;

(e) import or export any drug for the import or export of which a licence is required, except under, and in accordance with the conditions of, such licence;

(f) supply an incorrect, incomplete or misleading information, when required to furnish any information under this Act or the rules;

(g) peddle, hawk or offer for sale any drug in a park or public street or on a highway, footpath or public transport or conveyance;

(h) import, manufacture for sale, or sell any substance, or mixture of substances, which is not a drug but is presented in a form or a manner which is intended or likely to cause the public to believe it to be a drug;

(i) sell any drug without having a warranty in the prescribed form bearing the name and batch number of the drug issued,--

(i) in the case of a drug manufactured in Pakistan, by the manufacturer holding a valid licence to manufacture drugs and permission to manufacture that drug or by his authorised agent;

(ii) in the case of an imported drug, by the manufacturer or importer of that drug or, if the drug is imported through an indentor by such indentor; and

(j) apply an incorrect batch number to a drug.

(2) Nothing in sub-section (1) shall apply to the manufacture or subject to prescribed conditions, of small quantities or any drug for the purpose of clinical trial examination, test, analysis or personal use.

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