In a landmark judgment delivered on January 30, 2026, the Supreme Court of India has ruled that doctors administering unproven medical treatments outside of approved clinical trials will be considered guilty of misconduct. The ruling came in a case concerning stem cell therapy for Autism Spectrum Disorder (ASD), with the court emphasizing that such therapies cannot be offered as routine clinical service but must be restricted to approved and monitored clinical trials or research settings.
The bench, comprising Justices J.B. Pardiwala and Justice R. Mahadevan, asserted that administering unproven therapies that lack credible scientific evidence of safety and efficacy constitutes a failure to meet the reasonable standard of care expected of medical professionals and, therefore, amounts to professional misconduct. The court further clarified that a doctor breaches the standard of care if they administer an intervention that lacks credible scientific evidence or if leading medical authorities do not recommend such treatment.
The judgment reiterated established principles of medical negligence, emphasizing that a doctor's conduct must align with practices accepted by the medical profession at the relevant time, based on available scientific knowledge. Experimental therapies, the court noted, can only be administered when supported by published research and conducted within approved clinical trial frameworks; otherwise, doctors could face professional misconduct proceedings.
The Supreme Court referred to regulatory and ethical guidelines, examining recommendations issued by the Ethics and Medical Registration Board (EMRB) of the National Medical Commission, along with the Evidence Based Stem Cell Therapy (EBSSCT) Guidelines 2021, National Guidelines for Stem Cell Research (NGSCR) 2017, and National Ethical Guidelines framed by the Indian Council of Medical Research (ICMR).
This ruling has significant implications for medical practice in India, potentially reshaping how experimental treatments are administered and regulated. It reinforces the importance of evidence-based medicine and ethical considerations in healthcare, protecting patients from potentially harmful or ineffective treatments offered without proper scientific validation. The Supreme Court emphasized that medical practitioners are bound by the duty to exercise a reasonable standard of care, skill, and knowledge expected of a prudent professional in the field.
