Case in NewsStem Cell Therapy For Autism Disallowed as treatment, Supreme Court permits only regulated clinical trials . |
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Case Overview
Case Name: YASH CHARITABLE TRUST AND ORS. vs. UNION OF INDIA AND ORS.
In Yash Charitable Trust And ORS. v. Union Of INDIA And Ors., the Supreme Court examined the legality of offering Stem Cell Therapy as a treatment for Autism Spectrum Disorder (ASD) . The Bench comprising Supreme Court Justice JB Pardiwala and Justice R Mahadevan held that stem cell treatment for autism lacks scientific validation and cannot be offered as routine clinical care . The Court evaluated medical ethics, patient consent and the regulatory framework governing stem cell research in India .
Key Aspects
The Court addressed widespread concerns regarding unregulated promotion of stem cell treatment for autism and the exploitation of vulnerable patients .
- Stem cell therapy for ASD lacks empirical evidence and scientific consensus .
- Offering SCT as routine treatment amounts to medical malpractice .
- Patient consent cannot validate unproven or unethical treatment .
- Doctors offering SCT outside trials fail the “standard of care” .
Legal Insights
The judgment closely analysed statutory and ethical safeguards governing medical research and treatment .
- Drugs and Cosmetics Act, 1940: Stem cells qualify as “drugs” under Section 3(b)(i).
- NDCT Rules, 2019: Chapter IV regulates biomedical and health research involving stem cells .
- National Ethical Guidelines & NGSCR, 2017: Mandate stem cell use only in approved clinical trials .
- Samira Kohli v. Dr. Prabha Manchanda: Valid consent requires adequate, accurate medical information .
Court’s Verdict
The Supreme Court ruled that Stem Cell Therapy cannot be offered as a treatment for autism and may only be used within approved and monitored clinical trials . It directed the Union Government to clarify the regulatory position and prevent commercial exploitation . Existing patients may temporarily continue therapy until shifted to recognised clinical trial institutions with the Ministry of Health directed to act within four weeks .
Source – Supreme Court of India
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