Drugs Rules Amended for Cell and Gene Therapies

The Government of India amended the Drugs Rules, 1945, on 2 July 2026 through the Ministry of Health and Family Welfare. The amendment, notified on 29 June 2026 and titled the Drugs (Eighth Amendment) Rules, 2026, brings advanced cell and gene therapies under the Centrally License Approving Authority framework.

Drugs Rules, 1945

The Drugs Rules, 1945, were framed under the Drugs and Cosmetics Act, 1940, which regulates the import, manufacture, distribution, and sale of drugs in India. The rules provide procedures for licensing, inspection, testing, labelling, and quality control of pharmaceutical products.

Advanced Cell and Gene Therapies

Advanced cell and gene therapies include cell- or stem cell-derived products, gene therapeutic products, and xenografts. CAR-T cell therapy is a form of immunotherapy used in some blood cancers, while gene replacement and gene editing treatments are used in selected genetic disorders and cancers.

Centrally License Approving Authority Framework

The Centrally License Approving Authority framework provides central licensing oversight for specified biological and advanced therapeutic products. The framework allows joint oversight by Central and State Licensing Authorities and applies uniform regulatory standards across India.

Gazette Notification and Public Consultation

The Ministry of Health and Family Welfare had issued a Gazette notification, G.S.R. 758(E), on 16 October 2025 for public objections and suggestions. The final amendment was issued after the consultation process and covers products such as animal-derived heart valves used as xenografts in cardiology.

Important Facts for Exams

• The Drugs and Cosmetics Act, 1940, is the parent law for the Drugs Rules, 1945.
• CAR-T cell therapy is a chimeric antigen receptor T-cell treatment used in oncology.
• Xenografts are tissues or organs transplanted from one species to another.
• Gazette notifications in India are used for notifying draft and final legal changes.

Regulatory Scope

The amendment covers advanced therapies that require specialised manufacturing, testing, and post-market monitoring. The regulatory change applies to products that use living cells, genetic material, or animal-derived biological material.