NEW DELHI: The Supreme Court on Friday ruled that administering stem cell therapy for Autism Spectrum Disorder (ASD) outside approved and monitored clinical trials is unethical and amounts to medical malpractice, citing a lack of scientific evidence and breach of medical standards.
A Bench of Justices JB Pardiwala and R Mahadevan said, “Therefore, every use of stem cells in patients outside an approved clinical trial is unethical and shall be considered as malpractice.” The court held that such interventions are not recognised as sound medical practice due to the absence of empirical support on safety and efficacy.
Regarding doctors’ duties, the court said that practitioners who offer such treatment as routine care fail to meet the reasonable standard of care owed to patients. A medical practitioner “cannot be said to meet the standard of reasonable care if he administers an intervention that lacks credible scientific evidence of safety and efficacy or where authoritative medical bodies unequivocally state that such a form of treatment is not recommended”, the judgment said.
The verdict came on a writ petition filed by Yash Charitable Trust and others, raising concerns over the promotion and administration of stem cell “therapy” for ASD by clinics nationwide. Petitioners alleged that although stem cell therapy remains experimental, it is being advertised and offered as a “treatment” or “cure” for ASD by clinics, in violation of existing laws.
Rejecting claims of legality under drug laws, the court said the mere classification of stem cells as “drugs” under the Drugs and Cosmetics Act, 1940, does not make their therapeutic use permissible as a clinical service. “Although the stem cells administered for therapeutic use in ASD are characterised as drugs under the Drugs Act, 1940, the same by itself is not determinative,” the Bench said.