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Drugs and Cosmetics Act, 1940

10. Prohibition of import of certain drugs or cosmetics. – From such date (Note: 1st April, 1947, for clauses (a), (b), (c), (e) and (f) and 1st April, for clause (d), see Notification No. 18-12-46-D-I, dated 11th February, 1947, Gazette of India, 1947, Gazette of India, 1947 Pt. I.p.189 as amended by Notification No. F-1-2/48-D(1), dated 29th September, 1948. 1st April, 1953, for the States of Himachal Pradesh, Bilaspur, Kutch, Bhopal, Tripura, Vindhya Pradesh and Manipur vide Notification No. S.R.O. 666, dated 30th March, 1953, Gazette of India, 1953, Pt. II. Sec.3, p.451) as may be fixed by the Central Government by notification in the Official Gazette in this behalf, no person shall import –

(a) Any drug [(Note: Ins. by Act 21 of 1962, sec.8 (w.e.f. 27-7-1964)) or cosmetic] which is not of standard quality ;

[(b) (Note: Subs. by Act 21 of 1962, sec.8, for clause (b) (w.e.f. 27-7-1964)) Any misbranded drug [(Note: Subs. by Act 68 of 1982, sec.7, for "or misbranded cosmetic" (w.e.f. 1-2-1983)) or misbranded or spurious cosmetics];]

[(bb) (Note: Ins. by Act 13 of 1964, sec.9 (w.e.f. 15-9-1964)) Any [(Note: Subs. by Act 68 of 1982, sec.7, for "adulterated" (w.e.f. 1-2-1983)). adulterated or spurious] drug ;]

(c) Any drug [(Note: Ins. by Act 21 of 1962, sec.8 (w.e.f. 27-7-1964)) or cosmetic] for the import of which a licence is prescribed, otherwise than under, and in accordance with, such licence ;

[(d) (Note: Subs. by act 11 of 1955, sec.5, for clause (d)) Any patent or proprietary medicine, unless there is displayed in the prescribed manner on the label or container thereof [(Note: Subs. by Act 68 of 1982, sec.7, for certain words (w.e.f. 1-2-1983)) the true formula or list of active ingredients contained in it together with the quantities thereof];

(ee) Any consmetic containing any ingredient which may render it unsafe or harmful or use under the directions indicated or recommended;


Provided further that the Central Government may, after consultation with the Board, by notification in the Official Gazette, permit, subject to any condition specified in the notification, the import of any drug or class of drugs not being of standard quality.

10A. Power of Central Government to prohibit import of drugs and cosmetics in public interest. – Without prejudice to any other provision contained in this Chapter, if the Central Government is satisfied that the use of any drug or cosmetic is likely to involve any risk to human beings or animals or that any drug does not have the therapeutic value claimed for it or contains ingredients and in such quantity for which there is no therapeutic justification and that in the public interest it is necessary or expedient so to do then, that Government may, by notification in the Official Gazette, prohibit the import of such drug or cosmetic.

11. Application of law relating to sea customs and powers of Customs Officers. – (1) The Law for the time being in force relating to sea customs and to goods, the import of which is prohibited by section 18 of the Sea Customs Act, 1878 (Note: Now see the Customs Act, 1962.) shall, subject to the provisions of section 13 of this Act, apply in respect of drugs [(Note: Ins. by Act 21 of1962, sec.9 (w.e.f. 27-7-1964)) and cosmetics] the import of which is prohibited under this Chapter, and officers of Customs and officers empowered under that Act to perform the duties imposed thereby on a Customs Collector and other officers of Customs, shall have the same powers in respect of such drugs [(Note: Ins. by Act 21 of 1962, sec.9 (w.e.f. 27-7-1964)) and cosmetics] as they have for the time being in respect of such goods as aforesaid.

[(2) (Note: Subs. by Act 11 of 1955, sec.6, for sub-section (2)) Without prejudice to the provisions of sub-section (1), the Customs Collector or any officer of the Government authorised by the Central Government in this behalf, may detain any imported package which he suspects to contain any drug [(Note: Ins. by Act 21 of 1962, sec.9 (w.e.f. 27-7-1964)) or cosmetic] the import of which is prohibited under this Chapter and shall forthwith report such detention to the Drugs Controller, India, and if necessary, forward the package or sample of any suspected drug [ (Note: Ins. by Act 21 of 1962, sec.9 (w.e.f. 27-7-1964)) or cosmetic] found therein to the Central Drugs Laboratory.]

12. Power of Central Government to make rules. – (1) The Central Government may, [(Note: Subs. by Act 68 of 1982, sec.9, for "after consultation with the Board" (w.e.f. 1-2-1983)) after consultation with or on the recommendation of the Board] and after previous publication by notification in the Official Gazette, make rules for the purpose of giving effect to the provisions of this Chapter :

Provided that consultation with the Board may be dispensed with if the Central Government is of opinion that circumstances have arisen which render it necessary to make rules without such consultation, but in such a case the Board shall be consulted within six months of the making of the rules and the Central Government shall take into consideration any suggestions which the Board may make in relation to the amendment of the said rules.]

(2) Without prejudice to the generality of the foregoing power, such rules may—

(a) Specify the drugs or classes of drugs [(Note: Ins. by Act 21 of 1962, sec.10 (w.e.f. 27-7-1964)) or cosmetics or classes of cosmetics] for the import of which a licence is required, [(Note: Subs. by Act 68 of 1982, sec.9, for certain words (w.e.f. 1-2-1983)) and prescribe the form and conditions of such licences, the authority empowered to issue the same, the fees payable therefore and provide for the cancellation, or suspension of such licence in any case where any provision of this Chapter or the rules made there under is contravened or any of the conditions subject to which the licence is issued is not complied with;

(b) Prescribe the methods of test of test or analysis to be employed in determining whether a drug [(Note: Ins. by Act 21 of 1962, sec.10 (w.e.f. 27-7-1964)) or cosmetic] is of standard quality ;

(c) Prescribe, in respect of biological and organ metallic compounds, the units or methods of standardization ;

13. Offences. – (1) Whoever himself or by any other person on his behalf imports, -

(a) Any drug deemed to be adulterated under section 9A or deemed to be a spurious drug under section 9B or any spurious cosmetic referred to in section 9D or any cosmetic of the nature referred to in clause (ee) of section 10 shall be punishable with imprisonment for a term which may extend to three years and a fine which may extend to five thousand rupees ;

(b) Any drug or cosmetic other than a drug or cosmetic referred to in clause (a), the import of which is prohibited under section 10, or any rule made under this Chapter, shall be punishable with imprisonment for a term which may extend to six months, or with fine which may extend to five hundred rupees, or with both ;

(c) Any drug or cosmetic in contravention of the provisions of any notification issued under section 10A, shall be punishable with imprisonment for a term which may extend to three years, or with fine which may extend to five thousand rupees, or with both.

(2) Whoever having been convicted of an offence –

(a) Under clause (a) or clause (c) of sub-section (1), is again convicted of an offence under that clause, shall be punishable with imprisonment for a term which may extend to five years, or with fine which may extend to ten thousand rupees, or with both ;

(b) Under clause (b) of sub-section (1), is again convicted of an offence under that clause, shall be punishable with imprisonment for a term which may extend to one year, or with fine which may extend to one thousand rupees, or with both.

(3) The punishment provided by this section shall be in addition to any penalty to which the offender may be liable under the provisions of section 11.

14. Confiscation.- Where any offence punishable under section 13 has been committed, the consignment of the drugs [(Note: Ins. by Act 21 of 1962, sec.11 (w.e.f. 27-7-1964)) or cosmetics] in respect of which the offence has been committed shall be liable to confiscation.

15. Jurisdiction. – No Court inferior to that [(Note: Subs. by Act 68 of 1982, sec.11, for certain words (w.e.f. 1-2-1983)) of a Metropolitan Magistrate or of a Judicial Magistrate of the first class] shall try an offence punishable under section 13.

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