Government brings stem cell, gene therapies under CLAA
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 the joint regulatory supervision of the central and state regulators. These include vaccines, large-volume parenterals and r-DNA-based medicines.
This set is being expanded with this amendment to cover additional emerging technologies, according to a statement by the health ministry. Cell or stem cell-derived products, including stem cell-based regenerative treatments and CAR-T cell therapies, are increasingly being used to treat blood cancers such as leukaemia and lymphoma.
Gene therapeutic products, such as gene replacement and gene editing products, are used in the treatment of genetic disorders and various types of cancers.
Xenografts are animal tissue-derived products, such as heart valves, which can be transplanted into humans and are used in cardiology and orthopaedics. As these technologies are highly complex, specialised and rapidly evolving, they need enhanced regulatory scrutiny to ensure patient safety, the statement said.
The inclusion of these products under the CLAA framework will facilitate a system of joint oversight by the central and state licensing authorities, thereby ensuring uniformity in regulatory standards across the country, it said. The amendment will increase regulatory rigour for emerging technologies and reinforce India’s regulatory framework in line with scientific advancements and global best practices, the ministry said.
This initiative reflects the government’s continued commitment towards safeguarding public health while promoting innovation and quicker adoption of the latest technologies in healthcare and life sciences sectors, it said.
