India issues advisory to regulate stem cell therapy

The Indian government has issued an advisory to regulate stem cell therapy, stipulating that it may only be used as standard clinical care for disease conditions specifically approved by the Health Ministry.

Regarding Autism Spectrum Disorder (ASD), the advisory mandates that the therapeutic use of any stem cell type must be restricted to approved clinical trials in accordance with the National Guidelines for Stem Cell Research, 2017. The directive has been sent to all states and Union Territories that follow the Clinical Establishments (Registration and Regulation) Act, 2010.

The National Medical Commission (NMC) reiterated that unauthorized administration, prescription, promotion, or advertisement of stem cell therapy beyond approved indications constitutes professional misconduct. This move follows a Supreme Court judgment from January 2026, which held that non-compliance with statutory mandates should result in consequences, including penalties and the cancellation of registration.