New Delhi: HL July 08, 2026
In a move aimed at strengthening the regulation of cutting-edge medical technologies, the Central Government has expanded the scope of the licensing framework under the Drugs Rules, 1945 to include cell and stem cell-derived products, gene therapy products, and xenografts. The decision is expected to create a uniform regulatory system for these advanced therapies across India.
With the amendment, these products will now come under the Centrally License Approving Authority (CLAA) framework, where both the Central and State drug regulators will jointly oversee licensing and regulatory compliance. Until now, the CLAA mechanism primarily covered selected high-risk products such as vaccines, large-volume intravenous solutions and recombinant DNA-based medicines.
The expanded framework reflects the growing role of advanced therapies in modern healthcare. Stem cell-based regenerative treatments and CAR-T cell therapies are increasingly being used to treat blood cancers, including leukemia and lymphoma. Gene therapies are emerging as promising treatment options for inherited genetic disorders and several forms of cancer, while xenografts—medical products derived from animal tissues, such as biological heart valves—are widely used in cardiology and orthopedic procedures.
Health authorities said these technologies involve highly specialized manufacturing processes and complex scientific standards, making stronger regulatory oversight essential to ensure patient safety, product quality and consistency.
The revised licensing system is also expected to bring greater uniformity in regulatory standards across all states, reducing variations in approval processes and improving monitoring of advanced biological products.
The government said the amendment is part of its broader effort to modernize India’s drug regulatory framework, align it with global scientific developments, and encourage the safe adoption of innovative healthcare technologies while maintaining high standards of public health protection.
