Stem cell therapy cannot be offered as a clinical service for autism: Supreme Court

Stem cell ‘therapies’ cannot be offered as a clinical service for Autism Spectrum Disorder (ASD), outside of an approved and monitored clinical trial or research setting, the Supreme Court held in a judgment on Friday (January 30, 2026).

A Bench of Justices J.B. Pardiwala and R. Mahadevan criticised the Union Government for its failure to act against those offering such therapies, which has led parents and guardians to seek an unproven method of treatment for their children suffering from ASD at a huge financial cost.

The court directed the government to constitute a dedicated authority for regulatory oversight over stem cell research across the country.

Lack of scientific evidence

The Bench held that the therapeutic use of stem cells in ASD cases, based on uncertain scientific knowledge or evidence about its effectiveness as a cure or the possible repercussions, would fail the “reasonable standard of care” that doctors owed their patients.

“There is a dearth of established scientific evidence on the efficacy and safety of therapeutic use of stem cells in ASD. As a result, the doctors do not have ‘adequate information’ to provide their patients in the first place,” the court observed.

The court clarified that parents, guardians, and caregivers cannot demand that stem-cell therapy be administered as a clinical service.

Informed consent not possible

“Even consent obtained from patients would not be valid as the prerequisite to disclose adequate information cannot be satisfied,” the court said.

Though consent is a mode of exercising patient autonomy, it cannot be “stretched to seek an entitlement to subject oneself to a clinical procedure that is scientifically unvalidated, ethically impermissible, and outside the bounds of reasonable medical practice”, the court reasoned

Besides, the court said, ‘consent’ means an “informed authorisation, grounded in adequate disclosure of the nature, procedure, purpose, benefits, effects, alternatives, substantial risks; and adverse consequences of refusing treatment”.

False hope

The judgment came on the basis of a series of petitions raising concerns about the rampant promotion, prescription and administration of stem cell therapy for the treatment of ASD by clinics across the country.

The petitioners argued that though stem cell therapy itself is in an experimental stage, it was being touted as a ‘treatment’ and ‘cure’ for ASD. They noted that people diagnosed with ASD and their caregivers unsuspectingly place their implicit faith in establishments offering stem cell therapy in the hope of a “miraculous cure”.

The petitions argued that there was also a lapse on the part of the government in allowing such stem cell therapies, which were in violation of the New Drugs and Clinical Trial Rules, 2019 promulgated under the Drugs and Cosmetics Act, 1940 and the National Guidelines for Stem Cell Research, 2017 published by the Indian Council of Medical Research.