CAR-T Cell Therapy
Mechanism and Indian Context
CAR-T (Chimeric Antigen Receptor T-cell) therapy is a form of adoptive immunotherapy in which a patient's own T-lymphocytes are extracted, genetically engineered in a laboratory to express a synthetic receptor targeting a cancer antigen, expanded in culture, and reinfused into the patient. It is a living therapy — not a conventional small-molecule drug — which is why existing drug regulatory frameworks designed for chemical entities have struggled to accommodate it. India became the first country in Asia to develop an indigenously manufactured CAR-T cell therapy: NexCAR19, developed jointly by IIT Bombay and Tata Memorial Hospital, received approval from the CDSCO in 2023 and is used against B-cell lymphomas and leukaemias.
- Target cancers: B-cell acute lymphoblastic leukaemia (ALL), diffuse large B-cell lymphoma (DLBCL), multiple myeloma (emerging)
- NexCAR19: India's first indigenous CAR-T therapy; approved 2023; priced significantly lower than imported equivalents (~₹40–42 lakh vs. ₹3–4 crore for foreign versions)
- Global context: FDA (US) first approved CAR-T therapies in 2017 (Kymriah, Yescarta)
- Challenge: "vein-to-vein" time (patient cell extraction to reinfusion) and cold-chain logistics make uniform regulation critical
● Tracked since February 06, 2026 · last seen July 02, 2026 · updates as the daily brief publishes