Drugs and Cosmetics Act, 1940 · Chapter IV: Manufacture, Sale and Distribution of Drugs and Cosmetics
Section 18: Prohibition of manufacture and sale of certain drugs and cosmetics
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) [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 [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 [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) [sell or stock or exhibit or offer for sale,] or distribute any drug [or cosmetic] which has been imported or manufacutred in contravention of any of the provisions of this Act or any rule made thereunder;
(c) [manufacture for sale or for distribution, or sell, or stock or exhibit or offer for sale,] or distribute any drug [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 [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 [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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Source: India Code (indiacode.gov.in), the consolidated text published by the Legislative Department, Government of India. Text as updated on India Code on 15 October 2026. Words in square brackets [ ] were inserted or substituted by later amending Acts, and *** marks words omitted by an amendment. The amendment footnotes are not reproduced here. Official text on India Code.
Supreme Court judgments citing the section 18
- Syngenta Limited v. Controller of Patents and Designs
- S. Athilakshmi v. The State Rep. by the Drugs
- Hasmukhlal D. Vora & Anr. v. The State of Tamil Nadu
- Union of India & Anr. Etc. v. Bgp Products Operations Gmbh and Hagene Immermatt Weg. & Anr. Etc.
- State Rep. by the Drugs Inspector v. Manimaran
- The State of Goa and Anr. v. M/S. Colfax Laboratories.Ltd. and Anr.
- Dr. (Miss) Aletta Grace Bell v. Dr. (Miss) S. Tirkey and Anr.
- State of Karnataka v. Pratap Chand & Ors.
- Mohd. Shabir v. State of Maharashtra
- Swantraj & Ors. v. State of Maharashtra