India Expands Central Licensing Oversight to Gene and Stem Cell Therapies
New Delhi — The Indian government has amended the Drugs Rules, 1945, to bring cell- and stem cell-derived products, gene therapies and xenografts under the Centrally License Approving Authority framework, strengthening regulatory oversight of advanced medical technologies.
The change expands the range of critical drugs and biological products subject to joint supervision by central and state regulators under the Drugs and Cosmetics Act. Vaccines, large-volume parenteral products and recombinant DNA-based medicines are already covered by the framework.
The Ministry of Health and Family Welfare said the amendment is intended to establish consistent regulatory standards nationwide for rapidly evolving medical technologies.
The move will increase regulatory scrutiny of emerging treatments and align India’s regulatory system more closely with scientific advances and global practices, the ministry said.
Cell- and stem cell-derived products include regenerative treatments and CAR-T cell therapies, which are increasingly used to treat blood cancers such as leukemia and lymphoma.
Gene therapies, including gene-replacement and gene-editing treatments, are used for certain genetic disorders and cancers.
Xenografts are products derived from animal tissues that can be transplanted into humans. Examples include animal-derived heart valves used in cardiology and tissue products used in orthopedic procedures.
The ministry said the complexity and specialized nature of these technologies require enhanced oversight to protect patients.
“This initiative reflects the government’s continued commitment towards safeguarding public health while promoting innovation and quicker adoption of latest technologies in healthcare and life sciences sectors,” the statement noted. (Source: IANS)
