Supreme Court bars stem cell therapy for autism, calls it medical malpractice

The Supreme Court of India has ruled that stem cell therapy cannot be offered as a treatment for Autism Spectrum Disorder, declaring its use outside approved clinical trials unethical and amounting to medical malpractice.

The judgment addresses growing concerns over experimental therapies being promoted to families seeking treatment options for autism, a condition for which no curative medical treatment currently exists.

The court held that stem cell interventions for autism lack credible scientific evidence of safety and efficacy and therefore cannot form the basis of valid medical consent. It ruled that patients do not have a right to demand experimental treatments and that consent is invalid if it is not based on adequate, evidence-backed information. The bench clarified that the classification of stem cells as drugs under the Drugs and Cosmetics Act does not make their clinical use automatically permissible.

Justice Pardiwala, delivering the verdict, stated that stem cell therapy is permissible only within approved, regulated, and monitored clinical trials, strictly for research purposes and not as routine medical treatment. Any use outside this framework was termed unethical.

The court also addressed the situation of patients already undergoing such therapy, directing that they should not be abruptly prejudiced. However, it ordered that their treatment must be shifted into properly approved clinical trials. The National Medical Commission, AIIMS, and the Ministry of Health and Family Welfare were directed to oversee this transition until structured research protocols are in place.

Reiterating principles of medical negligence, the court said doctors violate the standard of care if they administer treatments unsupported by scientific evidence, especially when authoritative bodies advise against such use. The ruling aligns with guidelines issued by the Indian Council of Medical Research, the World Health Organization, and the International Society for Stem Cell Research, all of which restrict stem cell use for autism to clinical research settings.

The judgment draws a clear line between scientific research and unethical medical practice, reinforcing patient safety and evidence-based care.