Steps taken for Promotion and Regulation of Regenerative Medicines

The Union Health Ministry has issued a series of evidence‑based guidelines and regulatory mechanisms to promote safe, indigenous regenerative medicines. Key documents include the 2025‑26 ‘Evidence based guidelines for the use of stem cell therapy’, ICMR’s 2023 umbilical cord blood banking guidelines, the 2021 National Guidelines for Hematopoietic Cell Transplantation, and earlier guidelines on gene‑therapy product development and stem‑cell research. The Department of Biotechnology (DBT) supports fundamental and translational research, with its autonomous institute BRIC‑inStem facilitating innovations such as India’s first‑in‑human gene‑therapy trial. The Department of Health Research (DHR) has set up ethics‑committee networks and the National Stem Cell Research Regulation Committee (NSRC) to oversee clinical stem‑cell studies, while CDSCO regulates products under the Drugs and Cosmetics Act and the 2019 NDCT Rules.