Drugs and Cosmetics Act, 1940 | Along with Drugs Rules, 1945, Drugs (Control) Act, 1950, Cosmetics Rules, 2020 and Drugs and Cosmetics (Compounding of Offences Rule) 2025

This 2026 edition of The Drugs and Cosmetics Act, 1940 (Act 23 of 1940) presents the updated Bare Act along with short comments and the latest amendments and subordinate legislation governing drugs and cosmetics in India. The edition incorporates amendments introduced by the Jan Vishwas (Amendment of Provisions) Act, 2026 (Act 8 of 2026), dated 7-4-2026, with certain provisions coming into force w.e.f. 30-6-2027 vide S.O. 3286(E), dated 22-6-2026, and the remaining provisions w.e.f. 1-7-2026 vide S.O. 3362(E), dated 23-6-2026.

Along with the principal Act, the book includes the relevant Rules and allied legislation, including:

• The Drugs Rules, 1945, as amended vide GSR 713(E), dated 6-8-2026, w.e.f. 7-8-2026
• The Drugs (Control) Act, 1950
• The Cosmetics Rules, 2020, as amended vide GSR 513(E), dated 29-7-2025, w.e.f. 29-7-2025
• The Drugs and Cosmetics (Compounding of Offences) Rules, 2025, notified vide GSR 259(E), dated 24-4-2025, w.e.f. 25-4-2025
• Short comments accompanying the Bare Act for convenient reference

The content covers the principal statutory framework relating to the manufacture, sale, distribution, import, quality, licensing, testing, regulation, and control of drugs and cosmetics, including:

• Definitions and statutory classifications of drugs and cosmetics
• Standards of quality and misbranded, adulterated, and spurious drugs and cosmetics
• Prohibition and regulation of manufacture and sale
• Licensing requirements and regulatory controls
• Import of drugs and cosmetics and restrictions on prohibited products
• Government Analysts, Inspectors, and laboratory procedures
• Powers of inspection, sampling, seizure, and enforcement
• Offences, penalties, and prosecution provisions
• Regulation of manufacture and distribution of drugs and cosmetics
• Rules governing pharmaceutical and cosmetic products
• Compounding of specified offences and related procedures
• Recent amendments and regulatory changes incorporated in the 2026 edition

This edition is ideally suited for law students preparing for university examinations and competitive tests, advocates and legal practitioners dealing with pharmaceutical and regulatory matters, pharmaceutical manufacturers and distributors, regulatory affairs professionals, compliance officers, drug inspectors, and academicians teaching health and regulatory law.