Section 18 of the Drugs and Cosmetics Act, 1940 deals with Prohibition of Manufacture and Sale of Certain Drugs and Cosmetics.
Bare Text
18. Prohibition of manufacture and sale of certain drugs and cosmetics.—From such 2date 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) 3[manufacture for sale or for distribution, or sell, or stock or exhibit or offer for sale,] or distribute— [(i) any drug which is not of a standard quality, or is misbranded, adulterated or spurious; [(ii) any cosmetic which is not of a standard quality or is misbranded, adulterated or spurious;]] [(iii) any patent or proprietary medicine, unless there is displayed in the prescribed manner on the label or container thereof 3 [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 7[to prevent, cure or mitigate] any such disease or ailment, or to have any such other effect as may be prescribed; [(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) 3[sell or stock or exhibit or offer for sale,] or distribute any drug 9[or cosmetic] which has been been imported or manufactured in contravention of any of the provisions of this Act or any rule made thereunder; (c) 3 [manufacture for sale or for distribution, or sell, or stock or exhibit or offer for sale,] or distribute any drug 9[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 10[Central Government] may, after consultation with the Board, by notification in the Official Gazette, permit, subject to any conditions specified in the notification, the 11[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. 1. Ins. by Act 26 of 2008, s. 2 (w.e.f. 10-8-2009). 2. 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 9. Ins. by s. 14, ibid. (w.e.f. 27-7-1964). * * * * *
Simple Meaning
Section 18 is the central prohibition provision in Chapter IV. It prohibits manufacture for sale or distribution, sale, stocking, exhibition or offer for sale, and distribution of certain non-compliant drugs and cosmetics. It covers drugs that are not of standard quality, misbranded, adulterated or spurious, and also deals with licensing and other statutory restrictions.
Compliance Relevance
This section is one of the most important provisions for pharmacies, wholesalers, manufacturers and distributors. Many prosecutions and regulatory actions under drug law ultimately connect back to Section 18. It should be read with the definitions of misbranded, adulterated and spurious drugs, the powers of inspectors, the procedure for sampling and Government Analyst reports.
Related Provisions
Section 16, Section 17, Section 17A, Section 17B, Section 22, Section 23, Section 25, Section 27
Official Source
Verified from the official India Code PDF of the Drugs and Cosmetics Act, 1940. Readers should re-check the latest official text before professional reliance.