Health Ministry Warns Against Unproven Stem Cell Therapy, Especially for Autism
The Health Ministry has directed States and clinical establishments to restrict stem cell therapy to approved indications and clinical trials, including for autism.
The Union Ministry of Health and Family Welfare has issued an advisory asking States, Union Territories and clinical establishments to strictly follow existing rules governing stem cell research and therapy. The September 16 advisory states that stem cell therapy can be used as routine clinical care only for disease conditions and indications approved by the ministry.
The government has specifically clarified the position on Autism Spectrum Disorder (ASD), stating that therapeutic use of any type of stem cell for autism must remain limited to duly approved clinical trials. Such interventions cannot be offered as routine, standard or commercial treatment without the necessary regulatory approvals.
The advisory follows a Supreme Court judgment dated January 30, 2026, in the Yash Charitable Trust and Others versus Union of India and Others case. It also refers to a September 5 advisory from the National Medical Commission, which said unauthorised administration, prescription, promotion or advertising of stem cell therapy beyond approved indications could amount to professional misconduct.
Authorities have been directed to enforce the applicable regulatory framework. The government has also highlighted potential action for violations, including professional disciplinary proceedings and measures under the Clinical Establishments Registration and Regulation Act, 2010.
The advisory aims to prevent unapproved stem cell interventions from being presented or promoted as established clinical treatments.
