The Union Health Ministry has issued comprehensive guidelines to promote safe and evidence-based use of regenerative medicines in India. The Centre for Evidence Based Guidelines under MoHFW issued 'Evidence based guidelines for the use of stem cell therapy' in 2025-2026, formulated using WHO and NICE methodologies to assess efficacy and safety across various disease indications.
Five specific regulatory documents have been published and are available in public domain: ICMR's 2023 'Guidelines for Umbilical Cord Blood Banking Collection, Processing, Testing, Storage, Banking and Release for Clinical Application'; the 2021 'National Guidelines for Hematopoietic Cell Transplantation (NGHCT)'; ICMR-DBT's 2019 'National Guidelines for Gene Therapy Product Development and Clinical Trials'; and the 2017 'National Guidelines for Stem Cell Research (NGSCR-2017)'.
The Department of Biotechnology supports fundamental and translational research for developing indigenous regenerative medicine technologies involving stem cell/in-vitro systems for various diseases including hematological and genetic disorders. BRIC-inStem, DBT's autonomous institute, has contributed to translational regenerative medicine advancements, including conducting India's first-in-human gene therapy clinical trial through its Centre for Stem Cell Research in collaboration with Christian Medical College, Vellore.
The Department of Health Research has established mechanisms to facilitate biomedical research and clinical trials through ethics committees registered with DHR. The National Stem Cell Research Regulation Committee (NSRC) provides oversight for clinical stem cell research involving minimally manipulated stem cells, requiring all Institutional Ethics Committee-approved proposals to be forwarded to NSRC before commencement. Clinical trials and manufacture of regenerative medicine products falling under the Drugs and Cosmetics Act, 1940 and New Drugs and Clinical Trials Rules, 2019 remain regulated by CDSCO.
ICMR promotes indigenous research and innovation in regenerative medicine through support for basic, preclinical and clinical research, development of indigenous technologies, and scientific evidence generation through various funding programs. DBT nurtures and supports development of cell and gene-based therapies to reduce high developmental costs through multidisciplinary research programs.