The court says treatment must be confined to approved clinical trials and research protocols, as concerns grow over unproven therapies being marketed to families.
India’s Supreme Court has ordered the central government to build a dedicated online portal for people with autism spectrum disorder who are being considered for stem cell therapy, in a move aimed at stopping the treatment from being used outside lawful and monitored settings. The court said the therapy may be pursued only within approved clinical trials or research protocols, after expressing concern that it was being marketed and administered as if it were a routine service.
The direction follows earlier proceedings in which the Centre told the court that a multi-centre randomised controlled trial was planned in northern and southern India with funding from the Indian Council of Medical Research. While reviewing that proposal, the court found that there was no clear eligibility framework for patients with autism who might be enrolled, and no proper mechanism for families, caregivers and clinicians to register information in one place.
Under the new order, the portal will have to collect detailed records, including patient histories, the identity of the medical practitioners involved and the precise form of intervention being used. According to reporting by Hindustan Times, the court also required safeguards to protect confidentiality and data security, and told the health ministry to present the information in a clear and accessible way on its website.
The ruling is part of a broader effort to curb the promotion of unproven stem cell treatments for autism. NDTV reported that the Ministry of Health and Family Welfare issued an advisory on September 16, 2026, stating that such therapy is allowed only in approved clinical trials. The court has separately criticised clinics that offer it outside a legal framework, warning that families can be exposed to serious financial, medical and ethical risks when claims of a cure are made without solid evidence.
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