Supreme Court mandates online registry for autism patients receiving stem-cell therapy

A bench comprising Justices JB Pardiwala and R Mahadevan instructed the Union to establish a dedicated online portal for Autism Spectrum Disorder patients who began stem-cell therapy, mandating registration of patients, guardians, clinicians and clinics within six weeks. The portal must capture medical records, treatment specifics and practitioner details while safeguarding data confidentiality. The order reaffirms the Supreme Court's earlier January 30 decision prohibiting routine stem-cell therapy, allowing it only within approved clinical trials, and demands a comprehensive protocol explaining the applicable regulatory regime.

The Centre reported no trial applications to date but plans a multicenter randomized controlled trial funded by the Indian Council of Medical Research at two tertiary hospitals within six months, though the trial lacks clear criteria for current patients. Until the trial is operational, existing patients may continue therapy as a temporary arrangement, without implying endorsement of the treatment. The court also ordered the Ministry of Health to clearly state on its website that stem-cell therapy for autism is not permissible as a clinical service outside regulated research and invited input from the Parents’ Forum for Stem Cells in Autism and Cerebral Palsy on trial design and monitoring of excluded patients.