Centre amends Drugs Rules, 1945 to regulate advanced cell and gene therapies

On July 2, 2026, Ministry of Health revealed updates to Drugs Rules, 1945, aimed at improving oversight of advanced medical technologies, including gene therapies and stem cell-derived products. This regulatory shift seeks to create a unified standard under Centrally Licence Approving Authority, prioritizing patient safety while aligning with global best practices.

BRIC Team

Jul 2, 2026 · 1 min read · 2 views

Centre amends Drugs Rules, 1945 to regulate advanced cell and gene therapies

Key Takeaways

•On July 2, 2026, the Indian government announced amendments to the Drugs Rules, 1945, enhancing oversight of advanced medical technologies.
•The new regulations integrate stem cell-derived products and gene therapies into the framework of the Centrally Licence Approving Authority (CLAA).
•Innovative therapies like CAR-T cell treatments are now included in the regulatory structure to address blood cancers such as leukemias and lymphomas.
•The Ministry stated, 'This amendment will increase regulatory rigour for emerging technologies and reinforce India’s regulatory framework in line with scientific advancements.'
•Joint oversight by Central and State Licensing Authorities aims to ensure uniformity in regulatory standards for advanced therapies across India.

Regulatory Changes for Advanced Therapies

Central government overhauled Drugs Rules, 1945, to tighten control over advanced medical tech. Stem cell-derived products,gene therapies now fall under Centrally Licence Approving Authority (CLAA). Ministry confirmed this Thursday,July 2,2026.

Previously, oversight of critical drugs,biologicals like vaccines,r-DNA medicines was split between Central,State authorities. Now,cutting-edge treatments like CAR-T cell,gene-editing products are included. These therapies have advanced in fighting blood cancers such as leukemias,lymphomas .

Ministry emphasized need for strict regulation given rapid changes in these fields. Stem cell-based regenerative treatments,xenografts — animal tissues used in heart valve transplants — now under CLAA for consistent standards across India.

"Amendment will tighten regulation on emerging technologies,align India's rules with scientific progress,global norms," Ministry said. Central-State oversight aims for consistent standards,addressing need for stricter governance in advanced therapies.

As medical treatments evolve,government's move signals commitment to safety,responsible integration of new therapies into healthcare system…

#India