ILBCO's Drugs & Cosmetics Act, 1940 & Drugs Rules, 1945, Cosmetics Rules, 2020, and Drugs & Cosmetics (Compounding of Offences) Rules, 2025 (9th Edition, 2026) by Rajan Nijhawan is an authoritative three-volume compendium offering an exhaustive treatment of India's pharmaceutical and healthcare regulatory framework. Spanning 3568 pages, this hardbound set provides a comprehensive consolidation of the principal Act, allied rules, and a wide array of connected legislations governing drugs, cosmetics, clinical trials, pricing control, medical professions, narcotics regulation, and public health standards.
The work incorporates the latest amendments up to 2025, including developments in drug price control mechanisms, clinical trials, telemedicine, assisted reproductive technologies, and professional regulatory bodies. With coverage of more than 500 cases, this edition serves as a dependable reference for understanding statutory interpretation, compliance requirements, enforcement mechanisms, and the evolving regulatory landscape affecting the pharmaceutical, cosmetics, and healthcare sectors in India.
Key Features:
- Complete and updated text of the Drugs & Cosmetics Act, 1940, and allied Rules, including the Cosmetics Rules, 2020, and Compounding of Offences Rules, 2025
- Detailed incorporation of amendments from 2011 to 2025, including recent regulatory and compliance changes
- Comprehensive coverage of the Drugs (Prices Control) Order, 201,3 andthe trade margin rationalisation framework
- Inclusion of allied legislations such as the Drugs and Magic Remedies Act, NDPS Act, Poisons Act, and Epidemic Diseases Act
- Integrated reference to healthcare regulatory statutes, including the National Medical Commission Act, National Commission for Homoeopathy Act, National Commission for Indian System of Medicine Act, and Allied and Healthcare Professions Act
- Coverage of emerging regulatory regimes, such as Surrogacy and Assisted Reproductive Technology laws, with relevant rules
- Inclusion of Telemedicine Practice Guidelines and a clinical regulatory framework
- Annotated case law digest covering more than 500 judicial decisions
- Systematic arrangement in three hardbound volumes for easy reference and long-term professional use
- Updated, practice-oriented presentation suitable for regulatory compliance and litigation reference
This three-volume set is ideally suited for pharmaceutical companies, regulatory affairs professionals, in-house compliance teams, drug inspectors, and legal practitioners dealing with pharmaceutical, cosmetics, and healthcare laws.
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