In a significant ruling that could reshape medical practice in India, the Supreme Court has held that stem cell therapy cannot be offered as a treatment for Autism Spectrum Disorder (ASD) outside approved research trials. The Court made it clear that promoting or administering such therapy as a cure amounts to professional misconduct, as there is no scientific proof backing its effectiveness.
The verdict came in a public interest litigation filed by Yash Charitable Trust and others, raising concerns over the unchecked use of stem cell therapy on children with autism across private clinics in the country.
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Background of the Case
The petitioners approached the Supreme Court alleging that several clinics were openly advertising stem cell therapy as a cure for autism, despite the absence of scientific validation. Families, often desperate for improvement in their children’s condition, were being charged large sums for procedures that lacked regulatory approval.
The petition highlighted that:
- Stem cell therapy for autism is not recognised as standard treatment
- Clinics were bypassing drug and clinical trial regulations
- Patients were not being informed that the therapy was experimental
- Authorities failed to enforce existing medical guidelines
The case also referenced earlier advisories issued by the Indian Council of Medical Research (ICMR) and the National Medical Commission (NMC), both of which had cautioned against such practices.
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What the Court Examined
A Bench of Justice J.B. Pardiwala and Justice R. Mahadevan examined:
- Whether stem cell therapy can legally be offered for autism
- Whether such treatment meets medical standards of care
- Whether patient consent alone makes such therapy lawful
- The role of regulatory bodies like NMC and ICMR
The Court also reviewed multiple expert reports, including the 2022 recommendations of the Ethics and Medical Registration Board (EMRB) and the ICMR’s Evidence-Based Status of Stem Cell Therapy (2021).
Court’s Observations
The Bench made it clear that medical treatment must be backed by science, not hope or commercial interest.
“A medical practitioner cannot offer a treatment which lacks credible scientific evidence or is expressly disapproved by expert medical bodies,” the Court observed.
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The judges noted that:
- No national or international guideline approves stem cell therapy for autism
- Available studies do not prove safety or effectiveness
- Such treatment remains experimental
- Advertising or offering it as a cure misleads vulnerable families
The Court rejected the argument that patient consent alone legitimises the therapy, stating that consent cannot validate an unproven or unsafe medical practice.
On Professional Misconduct
The judgment strongly upheld the recommendations of the Ethics and Medical Registration Board (EMRB), which had stated:
“Use, promotion or advertisement of stem cell therapy for Autism Spectrum Disorder amounts to professional misconduct.”
The Court agreed and held that:
- Doctors offering stem cell therapy for autism violate medical ethics
- Such conduct can attract disciplinary action
- Clinics cannot bypass regulations by calling it a “procedure” instead of a “drug”
The Bench emphasised that medical professionals are bound by the standard of care, not patient demand or commercial pressure.
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Court’s Final Decision
The Supreme Court ruled that:
- Stem cell therapy cannot be offered as a treatment for autism
- It may only be used in approved clinical trials, following due regulatory process
- Any promotion, advertisement, or routine clinical use is impermissible
- Regulatory authorities must enforce existing medical standards strictly
The Court concluded that public safety and medical ethics must prevail over unverified innovation, especially when vulnerable children are involved.
Case Title: Yash Charitable Trust & Ors. v. Union of India & Ors.
Case Number: Writ Petition (Civil) No. 369 of 2022
Decision Date: January 30, 2026
