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The Drugs and Cosmetics Act

18Prohibition of manufacture and sale of certain drugs and cosmetic

From such 1date as may be fixed by the State Government by notification in the Official Gazette in this behalf, no person shall himself or by any other person on his behalf--

(a) 2[manufacture for sale or for distribution, or sell, or stock or exhibit or offer for sale,] or distribute

3[(i) any drug which is not of a standard quality, or is misbranded, adulterated or spurious;

4[(ii) any cosmetic which is not of a standard quality or is misbranded, adulterated or spurious;]]

5[(iii) any patent or proprietary medicine, unless there is displayed in the prescribed manner on the label or container thereof 2[the true formula or list of active ingredients contained in it together with the quantities thereof];]

(iv) any drug which by means of any statement design or device accompanying it or by any other means, purports or claims 6[to prevent, cure or mitigate] any such disease or ailment, or to have any such other effect as may be prescribed;

7[(v) any cosmetic containing any ingredient which may render it unsafe or harmful for use under the directions indicated or recommended;

(vi) any drug or cosmetic in contravention of any of the provisions of this Chapter or any rule made thereunder;]

(b) 2[sell or stock or exhibit or offer for sale,] or distribute any drug 8[or cosmetic] which has been imported or manufacutred in contravention of any of the provisions of this Act or any rule made thereunder;

(c) 2[manufacture for sale or for distribution, or sell, or stock or exhibit or offer for sale,] or distribute any drug 8[or cosmetic], except under, and in accordance with the conditions of, a licence issued for such purpose under this Chapter:

Provided that nothing in this section shall apply to the manufacture, subject to prescribed conditions, of small quantities of any drug for the purpose of examination, test or analysis :

Provided further that the 9[Central Government] may, after consultation with the Board, by notification in the Official Gazette, permit, subject to any conditions specified in the notifica tion, the 10[manufacture for sale or for distribution, sale, stocking or exhibiting or offering for sale] or distribution of any drug or class of drugs not being of standard quality.

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1. 1st April, 1947 for sub-clauses (i), (ii), (iv) and (v) of cl. (a) and cls. (b) and (c); 1st April, 1949 for sub-clause (iii) of cl. (a) in so far as it takes effect in Delhi, Ajmer and Coorg, see Notifn. No. 18-12-46-D, II, dated 11th February, 1947, Gazette of India, 1947, Pt. I, p. 189, as amended by notifn. No. F. 1-2/48-D (ii), dated 29th September, 1948; 1st April, 1953 for the States of H. P., Bilaspur, Kutch, Bhopal, Tripura, Vindhya Pradesh and Manipur, vide notifn. No. S.R.O. 664, dated the 30th March, 1953, Gazette of India, 1953, Pt. II, Sec. 3, p. 451

2. Subs. by Act 68 of 1982. s. 14, for certain words (w.e.f. 1-2-1983).

3. Subs. by s. 14, ibid, for cls. (i), (ii) and (iia) (w.e.f. 1-2-1983).

4. Subs. by Act 26 of 2008, s. 3, for sub-clause (ii) (w.e.f.10-8-2009).

5. Subs. by Act 11 of 1955, s. 9, for sub-clause (iii).

6. Subs by s. 9, ibid., for to cure or mitigate.

7. Subs. by Act 21 of 1962, s. 14, for sub-clause (v) (w.e.f. 27-7-1964).

8. Ins. by s. 14, ibid. (w.e.f. 27-7-1964).

9. Subs. by Act 11 of 1955, s. 9, for "State Government".

10. Subs. by Act 68 of 1982, s. 14, for "manufacture for sale, sale" (w.e.f. 1-2-1983).

11. The Explanation omitted by Act 68 of 1982, s. 14 (w.e.f. 1-2-1983).

MANUFACTURE. SALE AND DISTRIBUTSION OF DRUGS AND COSMETICS

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