NEW DELHI: In a significant step towards strengthening the regulatory oversight of advanced and emerging medical technologies, the Centre has amended the Drugs Rules, 1945, to bring cell or stem cell-derived products, gene therapeutic products and others under the ambit of the Centrally License Approving Authority (CLAA) framework.
Under the Drugs and Cosmetics Act, certain specified categories of critical drugs and biological products are under the joint regulatory supervision of the central and state regulators.
These include vaccines, large volume parenterals (IV solutions > 100 ml) and r-DNA based medicines. This set is being expanded with the amendment to cover additional emerging technologies.
Cell or stem cell-derived products such as stem cell-based regenerative treatments and CAR-T cell therapies have seen increasing use in the treatment of blood cancers such as leukaemias and lymphomas.
Gene therapeutic products such as gene replacement and gene editing products have found use in treating genetic disorders and various types of cancers.
Xenografts are animal tissue-derived products, such as heart valves, which can be transplanted into humans. These have uses in cardiology and orthopaedics.
As these technologies represent highly complex, specialised, and rapidly evolving areas of medical science, they need enhanced regulatory scrutiny to ensure patient safety, officials 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.
The amendment will increase regulatory rigour for emerging technologies and reinforce India's regulatory framework in line with scientific advancements and global best practices.
“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,” the official said.