Manual on Drugs and Cosmetics

This 11th Edition, 2025 of Manual on Drugs & Cosmetics by Ram Avtar Garg (Adv.) serves as a comprehensive and authoritative reference for legal practitioners, pharmaceutical professionals, compliance officers, and regulatory authorities engaged in the drugs and cosmetics sector.

The book consolidates the Drugs & Cosmetics Act, 1940 with all relevant rules, regulations, and allied laws, including recent amendments, notifications, and judicial interpretations. Presented in a practical and user-friendly manner, it provides a complete legal framework governing the manufacture, sale, distribution, and quality control of drugs, cosmetics, and medical devices in India.

The content spans the full scope of the Drugs & Cosmetics regulatory regime, including:

• Drugs & Cosmetics Act, 1940 with updated amendments

• Drugs & Cosmetics Rules, 1945 with latest changes

• Cosmetics Rules, 2020

• New Drugs and Clinical Trials Rules, 2019

• Medical Devices Rules, 2017 (as amended)

• Comprehensive coverage of related provisions under allied laws

• Relevant notifications, orders, and circulars issued up to date

• Case law references and judicial interpretations impacting the sector

• Guidelines for licensing, quality control, inspections, and compliance requirements

This edition is particularly suitable for:

• Legal practitioners specialising in pharmaceutical and cosmetic law

• Regulatory affairs professionals and compliance officers in the healthcare sector

• Policymakers and enforcement authorities overseeing drugs and cosmetics regulation

• Academicians, researchers, and students of law, pharmacy, and healthcare policy

• Industry stakeholders ensuring adherence to statutory and regulatory obligations

Whether used in litigation, compliance audits, academic study, or industry operations, this updated edition delivers the complete statutory, regulatory, and judicial framework of the Drugs & Cosmetics law as it applies in 2025.