Supreme Court Bans Stem Cell Therapy for ASD

Supreme Court Bans Stem Cell Therapy for ASD

The Supreme Court of India has delivered a highly significant and far-reaching decision regarding treatments for autism spectrum disorder (ASD). The Court clarified that stem cell therapy cannot be provided as a "clinical service" outside of approved clinical trials for ASD.

Basis for the Decision

The Supreme Court made this decision based on scientific evidence and patient safety considerations. The Court held that

¨     The effectiveness and safety of stem cell therapy in treating ASD have not yet been scientifically proven.

¨     Providing such therapy without sufficient evidence violates medical ethics and patients' rights.

¨     Such experimental treatments can pose serious risks, especially in the case of children.

Main Point

¨     A bench of Justices J.B. Pardiwala and R. Mahadevan criticized the central government for failing to act against those offering such therapy, due to which parents and guardians of children suffering from ASD are spending huge amounts of money and adopting an unproven method of treatment.

¨     At the same time, the Court directed the central government to establish a dedicated regulatory authority for stem cell research.

¨     The Court held that there is no solid evidence of safety and efficacy in such treatment and therefore it does not conform to the standards of proper care to be provided by medical practitioners to patients.

¨     There has also been a lapse on the part of the government in allowing stem cell therapy, which violates the New Drugs and Clinical Trial Rules, 2019 issued under the Drugs and Cosmetics Act, 1940 and the National Guidelines for Stem Cell Research, 2017 published by the Indian Council of Medical Research.

Supreme Court decisions

¨     Informed consent: For the validity of informed consent, clear scientific evidence on safety, effectiveness, risks and alternatives is required. Currently, sufficient evidence for stem cell therapy in autism is not available, making such clinical use ethically and legally inappropriate.

¨     Ethical limits on patient autonomy: The Court clarified that consent of the patient or guardian cannot justify treatments that are scientifically unproven, ethically inappropriate, or outside accepted medical practice.

¨     Violation of legal framework: Such acts violate the New Drugs and Clinical Trial Rules, 2019 as well as the National Guidelines for Stem Cell Research-2017 issued by the Indian Council of Medical Research (ICMR).

Stem cells

¨     Introduction: Stem cells are specialized types of cells that form specific cells such as blood, bone and muscles and play an important role in tissue regeneration and bodily functions.

Types of stem cells

¨     Embryonic stem cells: Can transform into any type of cell, obtained from embryos or cord blood.

¨     Tissue-specific stem cells: Arise only from cells of the related tissue, such as blood stem cells.

¨     Induced embryonic-like stem cells: Laboratory-created cells that behave like embryonic stem cells and are used in research and drug testing.

Stem cell therapy

¨     It is also called regenerative medicine and aims to repair damaged or diseased tissues using stem cells or substances derived from them.

¨     In India, stem cell-based treatment is permitted only under approved clinical trials, as its safety, effectiveness and long-term impact for many diseases are not fully established.

¨     Regulation of stem cell therapy in India is done under the National Stem Cell Research Guidelines, 2025, jointly prepared by the Indian Council of Medical Research (ICMR) and the Department of Biotechnology (DBT).

Autism (ASD)

¨     Autism Spectrum Disorder (ASD): It is a complex neurodevelopmental condition that affects brain development. Its main symptoms are abnormalities in social interaction, communication and behaviour, with wide variation in cognitive abilities.

¨     Globally, approximately 1 in every 100 children is affected by autism, although cases are often underreported in low- and middle-income countries.

¨     Early development of autism occurs due to a combination of genetic and environmental risk factors, and childhood vaccination does not increase the risk of autism.

¨     Individuals with autism may have co-occurring conditions such as epilepsy, depression, anxiety and sleep-related disorders, while their intellectual abilities may range from severe impairment to above-average levels.