Supreme Court Judgment on Stem Cell Therapy for Autism Spectrum Disorder (ASD)
The Supreme Court of India ruled on January 30, 2026, that stem cell therapies cannot be offered as a clinical service for Autism Spectrum Disorder (ASD) outside of approved clinical trials or research settings.
Key Points of the Judgment
- Criticism of Government: The court criticized the Union Government for not acting against clinics offering unproven stem cell therapies for ASD.
- Regulatory Oversight: Directed the government to establish a dedicated authority to oversee stem cell research across India.
Concerns Highlighted by the Court
- Lack of Scientific Evidence: There is insufficient scientific evidence on the efficacy and safety of stem cell therapies for ASD.
- Reasonable Standard of Care: Such therapies do not meet the "reasonable standard of care" required by medical professionals.
Issues
- Informed Consent: Consent is invalid if patients are not provided with adequate information about the treatment.
- Autonomy vs. Safety: Patient consent cannot justify procedures that are scientifically unvalidated and ethically impermissible.
- Government Lapses: Claimed the government allowed therapies violating regulations under the New Drugs and Clinical Trial Rules, 2019, and National Guidelines for Stem Cell Research, 2017.
