2025.10.16_ G.S.R. 758(E)_ Inclusion of additional items under CLAA in Drugs Rules 1945

On October 16, 2025, the Ministry of Health and Family Welfare released draft amendments to the Drugs Rules, 1945, aimed at modernizing regulatory provisions for advanced therapies. The proposed changes broaden the terminology from “Recombinant DNA (r-DNA) derived drugs” to include “Cell or Stem Cell derived products, Gene therapeutic products or Xenografts.” These updates will apply across multiple sections, including Rule 75, Rule 76, and related forms such as 27D and 28D, ensuring comprehensive coverage of emerging biotechnological and regenerative medicine products. The amendments reflect the growing importance of cell-based and gene therapies in healthcare and aim to establish a robust regulatory framework for their manufacture and approval. Stakeholders are invited to provide feedback within 30 days of the notification date. This initiative underscores the government’s commitment to aligning drug regulations with global advancements in personalized and regenerative medicine.