With an aim to strengthen oversight of cutting-edge medical technologies, the centre has amended the Drugs Rules, 1945, bringing cell and stem cell-derived products, gene therapies and xenografts under the regulatory ambit of the Centrally Licence Approving Authority (CLAA).
Accordingly, these specialised biological products require joint regulatory oversight by both the central and state drug authorities before they can be manufactured or marketed in the country.
A senior health official from the Union Health Ministry said the measure is intended to ensure uniform regulatory standards, improve patient safety and keep pace with rapid scientific advances in regenerative medicine and gene-based therapies.
Until now, the CLAA framework covered a limited category of critical products such as vaccines, large-volume parenterals (intravenous solutions exceeding 100 ml) and recombinant DNA-based medicines. With the latest amendment, advanced therapies that have emerged over the past decade have also been brought under the same regulatory mechanism.
The officer said the amendment reflects the growing clinical use of these technologies and the need for closer scrutiny because of their complexity and potential risks.
Among the products now covered are cell and stem cell-derived therapies, including regenerative treatments designed to repair or replace damaged tissues. The amendment also includes advanced immunotherapies such as CAR-T cell therapy, which has shown promising results in the treatment of certain blood cancers, including leukaemia and lymphoma.
Gene therapeutic products, another category brought under the CLAA framework, include treatments that modify or replace defective genes to treat inherited disorders and several forms of cancer.
These therapies represent one of the fastest-growing areas of modern medicine, offering the possibility of addressing the underlying genetic cause of disease rather than merely controlling symptoms.
The notification also covers xenografts, which involve the use of animal-derived tissues or biological materials for transplantation into humans. Such products include biological heart valves and certain orthopaedic implants that are widely used in specialised surgical procedures.
According to the official, these technologies require a higher level of regulatory oversight because they involve sophisticated manufacturing processes, complex biological materials and long-term safety considerations. Unlike conventional medicines, advanced therapy products often require specialised handling, customised manufacturing and extensive monitoring after administration.
The inclusion of these products under the CLAA framework will establish a system of joint oversight by the Central Licensing Authority and State Licensing Authorities.
The official said this would help ensure greater consistency in licensing decisions and regulatory standards across the country, reducing variations in oversight between states.
The government also expects the amendment to strengthen India's regulatory ecosystem as the country witnesses growing investment in biotechnology, regenerative medicine and precision healthcare.
The official pointed out that while advanced therapies hold enormous promise for treating previously incurable diseases, they also pose unique scientific, ethical and regulatory challenges.
“Many of these products are personalised, involve genetic modification or use living cells, making quality control and long-term safety assessment significantly more complex than for conventional pharmaceutical products,” said the official.
The amended rules are expected to provide greater regulatory clarity for developers of advanced therapies while ensuring that patients receive products that meet uniform quality, safety and efficacy standards.
The detailed amendments have been notified through a Gazette notification under the Drugs Rules, 1945, said the official.
