Stem Cell Therapy for Autism Restricted to Clinical Trials Only, Says Health Ministry

The Union Health Ministry has clarified that stem cell therapy for Autism Spectrum Disorder cannot be given as routine or commercial treatment and must stay restricted to approved clinical trials. Sent on September 16 to States and Union Territories that follow the Clinical Establishments Act, the advisory comes after a Supreme Court judgment in January on stem cell use for autism. The Ministry stated that stem cell therapy can be offered as standard clinical care only for conditions on its approved list, which covers 18 adult and 14 paediatric indications, but autism is not among them. The Indian Council of Medical Research previously reviewed the evidence and concluded it did not support using stem cells outside of clinical trials alongside behavioural therapies.

Court Ruling and Regulations

The Supreme Court decided the case of Yash Charitable Trust and others versus the Union of India on January 30, holding that medical practitioners cannot offer stem cell therapy for autism outside an approved and monitored research setting. The court directed the Health Ministry to work with AIIMS and the National Medical Commission to help patients already undergoing treatment continue until they can move to institutions running clinical trials. Meanwhile, the National Medical Commission warned in a September 5 advisory that unauthorized administration or promotion beyond approved indications counts as professional misconduct, leaving doctors open to disciplinary action by State Medical Councils. Clinical establishments face penalties and cancellation of registration under Sections 32 and 40 of the Clinical Establishments Act for non-compliance, as state and district authorities ensure the rules are enforced.