Advisory on Regulation of Stem Cell Therapy:
The Union Ministry of Health and Family Welfare issued a comprehensive advisory to all States and Union Territories to strictly regulate stem cell therapy, mandating that it can be offered as a standard clinical care only for specific disease conditions approved by the Ministry.
- The advisory was issued in compliance with the Supreme Court’s January 2026 judgment in the Yash Charitable Trust & Ors. v. Union of India case, which underscored the need to penalize the unauthorized and unscientific use of stem cell therapies.
- Stem cell therapy can be offered as standard care in routine clinical practice only for disease conditions and indications included in the Ministry-approved list (e.g., specific blood cancers and haematologic disorders).
- Restrictions on Autism Spectrum Disorder (ASD) The therapeutic use of any type of stem cell for ASD is explicitly restricted to approved clinical trials.
- Unproven stem cell interventions for ASD must not be marketed as standard commercial treatments.
- Any clinical trial involving stem cells must strictly adhere to the National Guidelines for Stem Cell Research, 2017, jointly issued by the Indian Council of Medical Research (ICMR) and the Department of Biotechnology (DBT).
