DCC Approves Amendment to Drug Rules for Licensing Stem Cell and Gene Therapy Products

The Drugs Consultative Committee (DCC) has approved amendments to Forms 27D, 27DA, 28D, and 28DA under the Drugs Rules, 1945, allowing manufacturers to apply for licenses for stem cell-derived products, gene therapies, and xenografts. Previously limited to vaccines and recombinant DNA drugs, these forms will now cover advanced therapies following stakeholder consultations and agreement from the Drugs Technical Advisory Board (DTAB).

This regulatory update will enable applications through State Licensing Authorities and the Central Licence Approving Authority. The changes aim to fill existing gaps, as there were no provisions for issuing manufacturing licenses for such innovative products.

The move is expected to facilitate the development and regulation of next-generation therapies in India’s evolving biopharmaceutical landscape.

08-07-2025