Mumbai, Jan 31: In a significant ruling aimed at curbing unethical medical practices, the Supreme Court of India has categorically barred the use of stem cell therapy as a clinical treatment for Autism Spectrum Disorder (ASD).
Declaring such interventions outside approved and regulated clinical trials to be unethical and legally impermissible, the court held that offering unproven stem cell treatments to autistic patients amounts to medical malpractice.
Concerns over unproven therapies
The judgment comes amid growing concerns over experimental therapies being marketed to vulnerable families without credible scientific backing.
No curative treatment for autism
Autism Spectrum Disorder is a complex neurodevelopmental condition for which no curative treatment currently exists. While stem cell research continues to show promise in several areas of medicine, the Supreme Court noted that authoritative scientific bodies have consistently stated that there is no reliable evidence proving stem cell therapy to be safe or effective for autism.
Informed consent not possible
A bench led by Justice Pardiwala emphasised that patients cannot claim experimental treatments as a matter of right. The court underlined that informed consent is valid only when it is based on adequate, accurate and evidence-backed information.
In cases involving stem cell therapy for autism, the absence of proven benefits and established safety makes genuine informed consent impossible.
Breach of medical ethics
The court observed that caregivers are often led to believe that stem cell interventions offer therapeutic improvement, despite the lack of scientific validation. Presenting an unproven intervention as treatment, it said, constitutes a serious breach of medical ethics.
The judgment clarified that although stem cells fall under the definition of “drugs” in the Drugs and Cosmetics Act, 1940, this classification does not automatically legitimise their clinical use as a medical service.
Directions for ongoing patients
Addressing the status of patients already undergoing such therapy, the Supreme Court directed that they should not be abruptly prejudiced. However, the continuation of stem cell therapy as routine treatment has been prohibited.
The court instructed the National Medical Commission (NMC), AIIMS and the Ministry of Health and Family Welfare to ensure that these patients are transitioned into properly approved, ethically monitored clinical trials until structured research protocols are in place.
Doctors warned of legal liability
Reaffirming established principles of medical negligence, the court ruled that doctors breach the reasonable standard of care when they administer treatments unsupported by credible scientific evidence or when authoritative medical bodies have advised against their use.
Any deviation from accepted professional standards, particularly involving experimental interventions presented as established therapy, exposes medical practitioners to legal liability.
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Alignment with global guidelines
The judgment aligns with the position of the Indian Council of Medical Research (ICMR), whose National Guidelines for Stem Cell Research classify stem cell therapy for autism as experimental and restrict its use to approved clinical trials.
International bodies, including the World Health Organization (WHO) and the International Society for Stem Cell Research (ISSCR), have similarly warned against premature clinical use due to unknown risks and long-term complications.
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