Centre Tightens Rules for Advanced Gene, Cell Therapies
Cell, gene and stem cell-based therapies brought under central licensing to strengthen patient safety and regulatory oversight
- Centre amends Drugs Rules, 1945 to regulate advanced therapies.
- Cell, gene therapies and xenografts brought under CLAA framework.
- Move ensures uniform licensing and stricter regulatory oversight nationwide.
- Amendment aligns India’s regulatory system with global best practices.
GG News Bureau
New Delhi, 3rd July: The Centre has amended the Drugs Rules, 1945 to bring cell and stem cell-derived products, gene therapeutic products and xenografts under the Centrally License Approving Authority (CLAA) framework, strengthening regulatory oversight of advanced medical technologies.
The amendment expands the CLAA mechanism, which already covers critical products such as vaccines, large-volume parenterals and recombinant DNA-based medicines, to include emerging therapies that require enhanced scientific scrutiny.
According to the government, the move will ensure joint oversight by Central and State licensing authorities, bringing greater uniformity in regulatory standards across the country while improving patient safety.
The newly covered products include stem cell-based regenerative treatments, CAR-T cell therapies used for blood cancers such as leukemia and lymphoma, gene therapies for genetic disorders and cancer, and xenografts, including animal tissue-derived products such as heart valves used in cardiology and orthopaedics.
The government said the amendment strengthens India’s regulatory framework in line with global best practices while promoting innovation and facilitating the safe adoption of advanced healthcare technologies.
