India To Overhaul Cell and Gene Therapy Regulatory Approach

India is making remarkable strides to transform its regulatory approach to cell and gene therapies (CGT), recognizing that rapidly approving therapies involves engaging more industry stakeholders and approving applications more quickly. At the CAR-T Summit 2025 that took place mid-April in Mumbai, the Drugs Controller General of India (DCGI) – Dr. Rajeev Raghuvanshi – noted that CGT was being pursued in a “mission mode” by the government and that the government was being supportive where possible through policy engagement, regulations, and incentives. For instance, CGT was separated from other Central Drugs Standard Control Organization (CDSCO) branches, thereby reducing layers of review.

Moreover, revised internal timelines now expect most CGT applications to be addressed in 15 days or less. This movement is happening in parallel with growing domestic innovation, such as India’s approval of its first indigenous CAR-T cell therapy NexCAR19, along with increased foreign interest exemplified by Miltenyi Biotec, a German biotech company with a focus on CGT products. The CDSCO has formally completed 11 reviews of CAR-T applications to date, and in addition, is presently converting CGT submissions to electronic submissions on its SUGAM portal — an online platform where applicants can apply for registration licenses and certificates. A draft guidance document on CGT development, which was developed with participation from regulators, industry, and researchers, is expected to be released in the next two months. In addition to these new government initiatives, India intends to also include non-government expertise in its Subject Expert Committees (SECs), starting with CGT, but likely expanding into other areas of therapy as well.

Written by: Ames Gross – President and Founder, Pacific Bridge Medical (PBM)