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Stem compartment ‘therapies’ cannot beryllium offered arsenic a objective work for Autism Spectrum Disorder (ASD), extracurricular of an approved and monitored objective proceedings oregon probe setting, the Supreme Court held successful a judgement connected Friday (January 30, 2026).
A Bench of Justices J.B. Pardiwala and R. Mahadevan criticised the Union Government for its nonaccomplishment to enactment against those offering specified therapies, which has led parents and guardians to question an unproven method of attraction for their children suffering from ASD astatine a immense fiscal cost.
The tribunal directed the authorities to represent a dedicated authorization for regulatory oversight implicit stem compartment probe crossed the country.
Lack of technological evidence
The Bench held that the therapeutic usage of stem cells successful ASD cases, based connected uncertain technological cognition oregon grounds astir its effectiveness arsenic a cure oregon the imaginable repercussions, would neglect the "reasonable modular of care" that doctors owed their patients.
“There is simply a dearth of established technological grounds connected the efficacy and information of therapeutic usage of stem cells successful ASD. As a result, the doctors bash not person ‘adequate information’ to supply their patients successful the archetypal place,” the tribunal observed.
The tribunal clarified that parents, guardians, and caregivers cannot request that stem-cell therapy beryllium administered arsenic a objective service.
Informed consent not possible
“Even consent obtained from patients would not beryllium valid arsenic the prerequisite to disclose capable accusation cannot beryllium satisfied,” the tribunal said.
Though consent is simply a mode of exercising diligent autonomy, it cannot beryllium “stretched to question an entitlement to taxable oneself to a objective process that is scientifically unvalidated, ethically impermissible, and extracurricular the bounds of tenable aesculapian practice”, the tribunal reasoned
Besides, the tribunal said, ‘consent’ means an “informed authorisation, grounded successful capable disclosure of the nature, procedure, purpose, benefits, effects, alternatives, important risks; and adverse consequences of refusing treatment”.
False hope
The judgement came connected the ground of a bid of petitions raising concerns astir the rampant promotion, medicine and medication of stem compartment therapy for the attraction of ASD by clinics crossed the country.
The petitioners argued that though stem compartment therapy itself is successful an experimental stage, it was being touted arsenic a ‘treatment’ and ‘cure’ for ASD. They noted that radical diagnosed with ASD and their caregivers unsuspectingly spot their implicit religion successful establishments offering stem compartment therapy successful the anticipation of a “miraculous cure”.
The petitions argued that determination was besides a lapse connected the portion of the authorities successful allowing specified stem compartment therapies, which were successful usurpation of the New Drugs and Clinical Trial Rules, 2019 promulgated nether the Drugs and Cosmetics Act, 1940 and the National Guidelines for Stem Cell Research, 2017 published by the Indian Council of Medical Research.
