The Union Health Ministry has directed States and Union Territories to strictly enforce India’s existing regulatory framework for stem cell research and therapy. An advisory dated September 16, 2026, states that stem cell treatment may be provided as routine clinical care only for disease conditions and indications approved by the ministry.
The government has specifically clarified that stem cell therapy for Autism Spectrum Disorder must remain limited to duly approved clinical trials. Such interventions cannot be offered as routine, standard or commercial treatment without the necessary regulatory approvals. Trials must follow the National Guidelines for Stem Cell Research, 2017, issued by the Indian Council of Medical Research and Department of Biotechnology.
The advisory follows a January 30, 2026 Supreme Court judgment concerning regulation of stem cell therapy. It asks state and district authorities and clinical establishments to ensure compliance with the applicable rules.
The National Medical Commission also issued an advisory on September 5, stating that unauthorised administration, prescription, promotion or advertising of stem cell therapy beyond approved indications may constitute professional misconduct.
Authorities have been asked to act against violations. The framework provides for measures including disciplinary action, cancellation of clinical establishment registration and penalties in applicable cases. The government’s latest advisory aims to prevent unapproved stem cell interventions from being presented as established clinical treatments.
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