Stem Cell Therapy for Autism is Medical Malpractice and Permissible only in Approved Clinical Trials: SC

The Supreme Court has held that administering stem cell therapy for Autism Spectrum Disorder (ASD) outside an approved and monitored clinical trial is unethical and amounts to medical malpractice.

The Court observed that such therapy lacks credible scientific evidence regarding its safety and efficacy and is not recognised as a valid medical treatment by authoritative bodies.

It clarified that merely classifying stem cells as “drugs” under the Drugs and Cosmetics Act, 1940 does not make their therapeutic use for autism permissible.

The Bench stressed that stem cell use is allowed only within approved clinical trials aimed at advancing medical science, and offering it as routine treatment breaches the standard of medical care.

[Yash Charitable Trust & Ors. v. UOI & Ors.]