Drugs and Cosmetics Act 1940 / Section 18

Section 18 Drugs and Cosmetics Act 1940 - Prohibition of Manufacture and Sale

Section 18 of the Drugs and Cosmetics Act, 1940 regulates the manufacture for sale or distribution, sale, stocking, exhibition, offering for sale and distribution of drugs and cosmetics. It prohibits specified categories of non-compliant products and generally requires the activities covered by clause (c) to be carried on under, and in accordance with, a licence issued under Chapter IV.

In brief: Section 18 is a central compliance provision for drugs and cosmetics manufactured or sold in India. It addresses product quality and authenticity, prohibited claims, unsafe cosmetic ingredients, contraventions of Chapter IV or the rules, unlawfully imported or manufactured products, and licensing.

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Section 18 - Prohibition of manufacture and sale of certain drugs and cosmetics

From such date 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 the true formula or list of active ingredients, together with their quantities, is displayed on the label or container in the prescribed manner;

(iv) any drug which, through a statement, design, device or other means, purports or claims to prevent, cure or mitigate a prescribed disease or ailment, or to have another prescribed effect;

(v) any cosmetic containing an ingredient that may render it unsafe or harmful when used according to the indicated or recommended directions;

(vi) any drug or cosmetic in contravention of Chapter IV of the Act or any rule made under that Chapter.

(b) sell, stock, exhibit or offer for sale, or distribute any drug or cosmetic imported or manufactured in contravention of the Act or the rules made under it.

(c) manufacture for sale or distribution, sell, stock, exhibit or offer for sale, or distribute any drug or cosmetic except under, and in accordance with the conditions of, a licence issued for that purpose under Chapter IV.

The provision above is presented in reader-friendly form. For authoritative wording, amendments and footnotes, refer to the official India Code text linked below.

What Section 18 means

1. Quality and identity controls

Clause (a)(i) prohibits manufacture for sale or distribution, sale, stocking, exhibition, offering for sale or distribution of a drug that is not of standard quality or is misbranded, adulterated or spurious. Clause (a)(ii) applies corresponding controls to cosmetics.

2. Labelling of patent or proprietary medicines

Clause (a)(iii) requires the prescribed disclosure of the true formula or list of active ingredients and their quantities on the label or container of a patent or proprietary medicine.

3. Prohibited therapeutic claims

Clause (a)(iv) restricts drugs promoted through statements, designs, devices or other means as preventing, curing or mitigating diseases or ailments, or producing other effects, where such claims fall within the prescribed prohibition.

4. Unsafe cosmetics

Clause (a)(v) prohibits a cosmetic containing an ingredient that may make the product unsafe or harmful when used in accordance with its indicated or recommended directions.

5. Wider statutory and licensing compliance

Clause (a)(vi) covers contraventions of Chapter IV or rules made under it. Clause (b) restricts dealing in drugs or cosmetics imported or manufactured contrary to the Act or rules. Clause (c) establishes the licence-based requirement for the activities specified in that clause.

Important connected definitions and provisions

Section 18 should be read with the definitions and standards that determine whether a product falls within a prohibited category. In particular:

The Act's general definitions in Section 3 are also relevant, including the statutory meanings of expressions such as "drug", "cosmetic", "manufacture" and "patent or proprietary medicine". The precise regulatory requirements are supplemented by rules made under the Act, including the Drugs Rules, 1945 and, for matters within their scope, the New Drugs and Clinical Trials Rules, 2019.

Licence requirement and statutory exceptions

Section 18(c) generally prohibits manufacture for sale or distribution, sale, stocking, exhibition, offering for sale or distribution of a drug or cosmetic except under, and in accordance with, the conditions of the licence required under Chapter IV.

The first proviso creates a limited exception for manufacture, subject to prescribed conditions, of small quantities of a drug for examination, test or analysis. This is not a general exemption from regulatory requirements; the prescribed conditions must still be satisfied.

The second proviso empowers the Central Government, after consultation with the Drugs Technical Advisory Board, to permit by Official Gazette notification, and subject to specified conditions, the manufacture for sale or distribution, sale, stocking, exhibition, offering for sale or distribution of a drug or class of drugs that is not of standard quality.

Regulatory note: The Drugs Rules, 1945 contain detailed licensing, manufacture, sale, labelling and related requirements. New drugs and clinical trials are additionally governed, where applicable, by the New Drugs and Clinical Trials Rules, 2019. Current notifications and amendments should be checked before acting on a regulatory requirement.

Penalties and enforcement

A contravention of Section 18 can attract the penalty provisions in Chapter IV. For drugs, Section 27 prescribes penalties for specified contraventions relating to manufacture, sale and other dealings in drugs. For cosmetics, Section 27A contains the corresponding penalty framework. The applicable provision and punishment depend on the nature of the product and contravention.

Enforcement should also be read with Section 21 on Inspectors, Section 22 on powers of Inspectors, Section 23 on procedure of Inspectors and Section 25 on reports of Government Analysts.

Legislative history retained from the earlier text

The section has been amended over time. The earlier page recorded, among other changes, amendments by Act 11 of 1955, Act 21 of 1962, Act 68 of 1982 and Act 26 of 2008. The 2008 amendment revised clause (a)(ii), with effect from 10 August 2009, to include the statutory treatment of adulterated cosmetics. Historical commencement notifications and amendment footnotes should be verified against the official consolidated Act when required for litigation, compliance or historical research.

Official resources

For the authoritative Act and current regulatory materials, use the official Government of India sources:

This page is a general legal information resource. For a specific licence, prosecution, product classification, compliance issue or regulatory proceeding, the current Act, applicable rules, notifications and facts should be examined together.