New Delhi: The government has amended the Drugs Rules, 1945, to bring cell- or stem cell-derived products, gene therapeutic products and xenografts under the Centrally Licensed Approving Authority (CLAA) framework, a move aimed at strengthening regulatory oversight of advanced and emerging medical technologies.
Under the Drugs and Cosmetics Act, certain categories of critical drugs and biological products are subject to joint regulatory supervision by the central and state regulators. These include vaccines, large-volume parenterals and recombinant DNA (r-DNA)-based medicines.
This list is being expanded through the amendment to include additional emerging technologies, according to a statement issued by the Union Health Ministry.
Cell- or stem cell-derived products, including stem cell-based regenerative therapies and CAR-T cell therapies, are increasingly being used to treat blood cancers such as leukaemia and lymphoma.
Gene therapeutic products, including gene replacement and gene-editing therapies, are used to treat genetic disorders and various types of cancer.
Xenografts are animal tissue-derived products, such as heart valves, that can be transplanted into humans and are widely used in cardiology and orthopaedics.
As these technologies are highly complex, specialised and rapidly evolving, they require enhanced regulatory scrutiny to ensure patient safety, the statement said.
The inclusion of these products under the CLAA framework will facilitate joint oversight by the central and state licensing authorities, ensuring uniform regulatory standards across the country, it said.
The amendment will strengthen regulatory oversight of emerging technologies and reinforce India's regulatory framework in line with scientific advancements and global best practices, the ministry said.
The initiative reflects the government's continued commitment to safeguarding public health while promoting innovation and the faster adoption of advanced technologies in the healthcare and life sciences sectors, it added.
