Centre expands drug licensing framework to cover gene and cell therapies
Drugs Rules amendment brings stem cell-derived products, gene therapies and xenografts under CLAA framework
- Jul 2, 2026,
- Updated Jul 2, 2026 6:29 PM IST
The Centre has expanded the country's drug licensing framework to cover advanced cell and gene therapies, bringing stem cell-derived products, gene therapeutic products and xenografts under the Centrally Licence Approving Authority (CLAA) framework through an amendment to the Drugs Rules, 1945.
The government said the move would ensure uniform regulatory standards and strengthen oversight of emerging medical technologies.
The amendment expands the ambit of the CLAA, under which specified categories of critical drugs and biological products are jointly regulated by the Central and State licensing authorities.
Until now, the framework covered products such as vaccines, large-volume parenterals (intravenous solutions of more than 100 ml) and recombinant DNA-based medicines. The latest notification adds cell or stem cell-derived products, gene therapeutic products and xenografts to the list.
According to the Ministry of Health and Family Welfare, cell or stem cell-derived products include regenerative treatments and CAR-T cell therapies that are increasingly being used to treat blood cancers such as leukaemias and lymphomas. Gene therapeutic products include gene replacement and gene-editing therapies for genetic disorders and various types of cancers. Xenografts—animal tissue-derived products such as heart valves transplanted into humans—are used in cardiology and orthopaedics.
For patients, the amendment is expected to strengthen regulatory oversight rather than immediately change access to treatment.
By bringing these advanced therapies under the CLAA framework, the government aims to ensure that products such as CAR-T cell therapies, gene therapies and stem cell-derived treatments are evaluated under uniform regulatory standards through joint oversight by the Centre and states before they reach patients.
"Since these technologies represent highly complex, specialised and rapidly evolving areas of medical science, they need enhanced regulatory scrutiny to ensure patient safety," the government said. It added that the inclusion of these products under the CLAA framework would facilitate joint oversight by the Central and State Licensing Authorities, ensuring greater uniformity in regulatory standards across the country.
The government said the amendment would strengthen regulatory rigour for emerging technologies while reinforcing India's regulatory framework in line with scientific advancements and global best practices. It added that the move reflects its commitment to safeguarding public health while promoting innovation and facilitating the adoption of newer technologies in the healthcare and life sciences sectors.
The Centre has expanded the country's drug licensing framework to cover advanced cell and gene therapies, bringing stem cell-derived products, gene therapeutic products and xenografts under the Centrally Licence Approving Authority (CLAA) framework through an amendment to the Drugs Rules, 1945.
The government said the move would ensure uniform regulatory standards and strengthen oversight of emerging medical technologies.
The amendment expands the ambit of the CLAA, under which specified categories of critical drugs and biological products are jointly regulated by the Central and State licensing authorities.
Until now, the framework covered products such as vaccines, large-volume parenterals (intravenous solutions of more than 100 ml) and recombinant DNA-based medicines. The latest notification adds cell or stem cell-derived products, gene therapeutic products and xenografts to the list.
According to the Ministry of Health and Family Welfare, cell or stem cell-derived products include regenerative treatments and CAR-T cell therapies that are increasingly being used to treat blood cancers such as leukaemias and lymphomas. Gene therapeutic products include gene replacement and gene-editing therapies for genetic disorders and various types of cancers. Xenografts—animal tissue-derived products such as heart valves transplanted into humans—are used in cardiology and orthopaedics.
For patients, the amendment is expected to strengthen regulatory oversight rather than immediately change access to treatment.
By bringing these advanced therapies under the CLAA framework, the government aims to ensure that products such as CAR-T cell therapies, gene therapies and stem cell-derived treatments are evaluated under uniform regulatory standards through joint oversight by the Centre and states before they reach patients.
"Since these technologies represent highly complex, specialised and rapidly evolving areas of medical science, they need enhanced regulatory scrutiny to ensure patient safety," the government said. It added that the inclusion of these products under the CLAA framework would facilitate joint oversight by the Central and State Licensing Authorities, ensuring greater uniformity in regulatory standards across the country.
The government said the amendment would strengthen regulatory rigour for emerging technologies while reinforcing India's regulatory framework in line with scientific advancements and global best practices. It added that the move reflects its commitment to safeguarding public health while promoting innovation and facilitating the adoption of newer technologies in the healthcare and life sciences sectors.