New Delhi, Jan 31(.) The Supreme Court has held that administering stem cell therapy for the treatment of Autism Spectrum Disorder (ASD) outside an approved and monitored clinical trial is unethical and amounts to medical malpractice.

The Court clarified that such therapy is permissible only within the framework of duly approved clinical trials aimed at advancing scientific knowledge.

A Bench comprising Justice J B Pardiwala and Justice R Mahadevan delivered the ruling in Yash Charitable Trust v. union of India, observing that stem cell therapy for autism is not recognised as a sound or relevant medical practice due to the absence of credible scientific support and empirical evidence regarding its safety and efficacy.

“Therefore, every use of stem cells in patients outside an approved clinical trial is unethical and shall be considered as malpractice,” the Bench held, adding that the therapy can be undertaken only as part of an approved and monitored clinical trial with the intent to advance science and medicine.

The Court further clarified that the mere classification of stem cells as “drugs” under the Drugs and Cosmetics Act, 1940, does not make their therapeutic use for autism permissible 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 judgment noted.

Emphasising the duty of care owed by medical practitioners, the Bench stated that doctors are required to exercise a reasonable degree of care, skill, and knowledge expected of a prudent practitioner in the field.

This standard, the Court held, is breached when practitioners administer interventions lacking credible scientific evidence or those expressly discouraged by authoritative medical bodies.

“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 Court observed.

On the regulatory framework, the Bench examined 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 formulated by the Indian Council of Medical Research.

The Court noted that these guidelines categorically state that stem cell therapy for autism is not recommended as routine clinical treatment and may be undertaken only within approved clinical trials.

Advocates Siddharth Nath, Prateek K. Chadha, Asjad Hussain, Anunay Chowdhary, Sreekar Aechuri, and Aniket Chauhaan appeared for the petitioners.

Additional Solicitor General Aishwarya Bhati, along with several advocates, represented the respondents.

. SNG .