Stem Cell Therapy for Autism Is Medical Malpractice, Says Supreme Court
The Supreme Court has ruled that giving stem cell therapy to treat Autism Spectrum Disorder (ASD) outside approved clinical trials amounts to medical malpractice. The Court made it clear that such treatment is unethical and illegal if offered as a routine medical service.
A Bench of Justice JB Pardiwala and Justice R Mahadevan held that stem cell therapy for autism lacks sufficient scientific evidence to prove its safety or effectiveness. Because of this, doctors cannot legally offer it as a treatment option to patients.
The Court clarified that stem cell use is permitted only within approved and monitored clinical trials, and that too solely for the purpose of advancing medical research. Offering it as a commercial therapy violates ethical and professional medical standards.
It also rejected the argument that classifying stem cells as “drugs” under the Drugs and Cosmetics Act, 1940 automatically makes their therapeutic use legal. According to the Court, such classification alone does not authorise their use as a clinical treatment for autism.
The judgment relied on guidelines issued by the National Medical Commission and the Indian Council of Medical Research, which clearly state that stem cell therapy for autism is not a recognised medical practice. Doctors providing such treatment, the Court said, fail to meet the reasonable standard of care owed to patients.

