Overview
- The Centre amended the Drugs Rules, 1945 on July 2, 2026 to add stem cell‑derived products, gene therapeutic products and xenografts to the Centrally Licence Approving Authority (CLAA) framework.
- CLAA gives joint central and state licensing authorities a role in approvals, imports, clinical trials and manufacture for high‑risk biologicals.
- The newly included categories cover regenerative and CAR‑T cell therapies, gene‑replacement and gene‑editing treatments, and animal‑tissue implants such as heart valves.
- The Health Ministry says the change is meant to strengthen regulatory rigour and patient safety by standardizing evaluation across states, and it is not expected to immediately restrict patient access.
- The move aligns India’s rules with scientific advances and global practice and could prompt clearer approval paths for developers while increasing oversight of hospitals, labs and importers.