Strict Statutory Limits on Non-Cord Blood Stem Cell Banking and Processing

Commercial stem cell banking is strictly circumscribed under national regulatory standards, specifically Clause 14 of the National Guidelines for Stem Cell Research, 2017, which limits commercial collection, storage, and banking exclusively to umbilical cord blood under licenses granted by the Central Drugs Standard Control Organisation (CDSCO). Commercial banking or processing of all other biological cellular tissues remains explicitly prohibited in the absence of specialized governmental notifications. Furthermore, pursuant to Section 3(f) of the Drugs and Cosmetics Act, 1940 and Rule 52 of the New Drugs and Clinical Trials Rules, 2019, the term "manufacture" broadly embraces any stage of processing, adopting, altering, or packaging cellular preparations for sale or clinical trials. Consequently, independent biotechnology enterprises and commercial processing vendors cannot escape legal liability by claiming they merely supply processed stem cells to end-user clinicians without personally administering the clinical intervention. (Yash Charitable Trust & Ors. Vs Union of India & Ors. | 2026 INSC 96).