Unproven treatments can land doctors in trouble. Supreme Court says experimental therapies amount to misconduct

In a strong message to the medical community, the Supreme Court has ruled that doctors who administer speculative or unproven treatments to patients may be guilty of professional misconduct and medical negligence. The observation came while hearing a case related to the use of stem cell therapy for Autism Spectrum Disorder (ASD), a treatment that has not yet received clinical approval.

As cited by TOI, the top court expressed concern over the lack of timely action by the Centre to curb such practices, warning that unchecked experimentation puts patients, especially children, at serious risk.

Stem Cell Therapy for Autism Not Approved, Says SC

A bench comprising Justices J B Pardiwala and R Mahadevan made it clear that stem cell therapy cannot be offered as a clinical treatment for ASD. The court noted that while stem cells may be categorised as “drugs” under the Drugs Act, 1940, this alone does not make their use clinically permissible.


The judges underlined that any treatment lacking solid scientific evidence of safety and effectiveness cannot be administered as routine medical care, especially when credible professional bodies have advised against it.

Doctors Must Follow Scientific Evidence, Not Speculation

The Supreme Court stressed that every medical practitioner owes a duty of reasonable care, skill and knowledge to their patients. According to the bench, a doctor fails this duty if they use an intervention that is experimental, unverified or expressly discouraged by authoritative medical institutions.

“A medical practitioner cannot be said to meet the standard of reasonable care if the treatment lacks credible scientific backing,” the court observed, reinforcing long-standing principles of medical negligence jurisprudence in India.

Centre Pulled Up for Inaction on Unapproved Treatments

The apex court also expressed displeasure over the Centre’s failure to act decisively against clinics offering stem cell therapy for autism. As per TOI, the judges said this inaction had allowed several clinics to continue promoting the treatment in violation of statutory norms.

The court noted that many parents and guardians, driven by hope and desperation, had opted for these unproven therapies at great financial cost, often sidelining approved and evidence-based treatments for ASD.

Supreme Court Calls for Clear Rules on Stem Cell Research

Highlighting the regulatory gap, the bench directed authorities to frame comprehensive rules, regulations and guidelines to govern stem cell-based clinical trials and research in India. The judges said a consolidated and clear legal position was urgently needed to prevent misuse and ensure patient safety.

The court warned that without strict oversight, experimental therapies could continue to be misrepresented as legitimate clinical solutions, undermining trust in the healthcare system.

Inputs from TOI