Regulation of Stem Cell Therapy in India
The Union Health Ministry has issued directives to States and Union Territories to ensure that stem cell therapy is provided only for conditions approved by the Ministry. Specifically, its use for Autism Spectrum Disorder (ASD) is restricted to approved clinical trials.
Advisory Details
- The advisory reinforces the existing regulatory framework governing stem cell research and therapy, as per the Clinical Establishments (Registration and Regulation) Act, 2010.
- It follows the Supreme Court's judgment in the case of Yash Charitable Trust & Ors. v. Union of India & Ors on January 30, 2026.
- For ASD, therapeutic use of stem cells is confined to duly approved clinical trials, following the National Guidelines for Stem Cell Research, 2017 by the Indian Council of Medical Research (ICMR) and the Department of Biotechnology.
Concerns and Recommendations
- There is ongoing use of stem-cell interventions for autism despite a lack of established evidence for them as standard treatments.
- An ICMR review indicated that current evidence does not support stem cell therapy over behavioral and supportive therapies for ASD.
- The Ministry advises that stem cell interventions not approved for routine clinical use should not be offered as standard or commercial services.
Enforcement and Compliance
- States and Union Territories are urged to disseminate the Supreme Court’s directions to relevant state and district regulatory authorities and clinical establishments.
- The Supreme Court noted that violations of the statutory framework could lead to professional misconduct and penalties under the Clinical Establishments Act.
National Medical Commission Advisory
- The NMC advised on September 5 that stem cell therapy should only be offered for approved indications.
- Unauthorized administration or promotion of stem cell therapy beyond approved indications is deemed professional misconduct.
- State Medical Councils are tasked with examining allegations of violations and taking disciplinary action when misconduct is confirmed.
