New Delhi: Central government has amended the Drugs Rules, 1945 to bring advanced cell therapies, gene therapeutic products and xenografts under the Centrally License Approving Authority (CLAA) framework, strengthening regulatory oversight of emerging medical technologies across India.
The amendment expands the list of products that require joint regulation by the Central and State licensing authorities under the Drugs and Cosmetics Act. Earlier, the CLAA framework covered critical products such as vaccines, large-volume parenterals and recombinant DNA-based medicines. Now, it will also regulate advanced therapies that use cutting-edge biotechnology.
Officials said the move will establish uniform regulatory standards across the country. Moreover, it will increase scrutiny of complex medical products while improving patient safety and public confidence.
Cell or stem cell-derived products include regenerative treatments and CAR-T cell therapies. Doctors increasingly use these therapies to treat blood cancers such as leukaemia and lymphoma. Likewise, gene therapeutic products support gene replacement and gene-editing treatments for inherited disorders and several forms of cancer.
Advanced cell therapies to receive uniform regulatory oversight
The amendment also covers xenografts, which use animal tissue-derived products such as heart valves for transplantation in humans. These products have important applications in cardiology and orthopaedics and require rigorous quality control because of their specialised nature.
The government said these technologies continue to evolve rapidly and demand stronger scientific evaluation before manufacturers can market them. Therefore, the expanded CLAA framework will enable both Central and State regulators to monitor licensing through a coordinated approval process.
Furthermore, the revised rules align India’s regulatory framework with international scientific standards and global best practices. The government said the amendment balances innovation with patient protection while supporting the safe adoption of advanced healthcare technologies.
Officials added that the reform reflects the Centre’s continued commitment to strengthening public health safeguards without slowing medical innovation. The amended framework will also encourage responsible growth in India’s biotechnology and life sciences sectors by creating a transparent and consistent regulatory environment for developers and manufacturers.
The notification detailing the amendments has been published in the official Gazette and is available on the government’s website.
