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 the joint regulatory supervision of the central and state regulators. These include vaccines, large volume parenterals and r-DNA-based medicines.
