SC directs Centre to create autism stem cell therapy registry portal

The Supreme Court has mandated the Centre to launch a comprehensive portal for registering autism patients who are undergoing stem cell therapy as part of efforts to standardise and monitor such treatments. The court also directed the government to issue a detailed protocol outlining rules governing clinical trials and research related to stem cell-based interventions for autism spectrum disorder.

The order reflects growing judicial concern over the lack of regulatory oversight in stem cell therapies being administered to patients in India. Such treatments remain controversial in the medical community, with many procedures operating in a regulatory grey area despite their significant cost and uncertain efficacy.

By establishing a centralised registry, the portal is expected to create transparency around which patients are receiving stem cell therapy, at which facilities, and under what protocols. This data collection mechanism will help authorities monitor outcomes and identify any adverse effects or fraudulent practices.

The protocol to be issued by the Centre is expected to delineate eligibility criteria for patients, qualifications required of medical practitioners administering the therapy, and standardised procedures for clinical trials. This regulatory framework will bring consistency to a field that has seen varying standards of practice across different states and private institutions.

The Supreme Court's intervention underscores the need for evidence-based medical regulation in India, particularly in emerging therapeutic areas where patient vulnerability and high costs create conditions for exploitation. The government has been given a specific timeline to comply with the court's directions regarding portal launch and protocol development.