Unapproved Stem Cell Therapy for Autism Is Unethical, Amounts to Medical Malpractice: SC

Unapproved Stem Cell Therapy for Autism Is Unethical, Amounts to Medical Malpractice: SC

The Supreme Court has ruled that administering stem cell therapy to treat Autism Spectrum Disorder outside the framework of approved and closely monitored clinical trials is unethical and constitutes medical malpractice.

A Bench comprising Justices J.B. Pardiwala and R. Mahadevan observed that such treatment cannot be considered a valid or accepted medical practice, as there is no reliable scientific data or empirical evidence to support its effectiveness.

"Therefore, every use of stem cells in patients outside an approved clinical trial is unethical and shall be considered as malpractice,” the Court ruled.

The Court added that stem cell therapy is permissible only within the confines of approved and rigorously monitored clinical trials conducted with the objective of advancing scientific knowledge.

It further clarified that merely classifying stem cells as “drugs” under the Drugs and Cosmetics Act, 1940 does not authorise their therapeutic use for treating autism as a routine clinical service.

“Although the stem cells administered for therapeutic use in ASD are characterized as drugs under the Drugs Act, 1940, the same by itself is not determinative of the fact that it is permissible to be administered as a clinical service,” the Court held.

Accordingly, the Court held that doctors who offer such treatment as a routine clinical service fall short of the reasonable standard of care owed to patients. The Bench emphasised that every medical practitioner is duty-bound to exercise the level of care, skill and knowledge expected of a prudent professional in the same field. This standard, it said, is violated when practitioners administer interventions that lack credible scientific support or are expressly discouraged by recognised medical authorities.

The Court observed that a medical practitioner cannot be said to have exercised reasonable care if they administer a treatment that lacks credible scientific evidence of safety and efficacy, or where authoritative medical bodies have unequivocally advised against such interventions.

While examining the regulatory framework, the Bench considered the recommendations of the Ethics and Medical Registration Board of the National Medical Commission dated December 6, 2022, along with the Ethical Guidelines for Biomedical and Social Science Research, the National Guidelines for Stem Cell Research, 2017, and the National Ethical Guidelines issued by the Indian Council of Medical Research.

The Court noted that these guidelines unequivocally state that stem cell therapy for autism is not recognised as a valid or relevant medical practice, owing to the absence of scientific backing and empirical evidence supporting its effectiveness.

 

Share this News

Website designed, developed and maintained by webexy