New Delhi: India’s top medical regulator has barred the use of stem cell therapy for autism in routine clinical practice, issuing a firm advisory to doctors and hospitals across the country. The National Medical Commission or NMC released the directive recently, following a recent Supreme Court judgment in the case of Yash Charitable Trust and others versus Union of India. The order aims to curb the promotion of unproven interventions offered to families seeking support for Autism Spectrum Disorder.
Stem cell therapy involves specialised cells capable of developing into different cell types and repairing damaged tissues. While recognised for certain blood-related conditions, its role in neurodevelopmental disorders remains unestablished. In a communication to the regulator, Indian Council of Medical Research Director-General Dr Rajiv Bahl noted that the court ruling carries significant implications for clinical use of stem cells in India. The advisory now sets clear boundaries for practitioners and institutions nationwide.
NMC advisory on stem cell therapy and autism
Advisory issued after Supreme Court order
The NMC circulated its March 25 advisory to all medical colleges, hospitals and registered practitioners. The move follows the Supreme Court’s observations in the Yash Charitable Trust case, which highlighted the absence of robust scientific evidence supporting stem cell therapy for Autism Spectrum Disorder.
Therapy limited to 32 approved diseases
As per the directive, stem cell treatment in standard medical practice is permitted only for 32 government-approved conditions. These include serious blood disorders and cancers such as acute myeloid leukaemia, thalassemia, multiple myeloma, aplastic anaemia, myelofibrosis and germ cell tumours. Use beyond this list is not allowed.
Autism treatment using stem cells prohibited
The advisory clearly states that stem cell therapy cannot be offered as routine care for autism. Experts have consistently pointed to insufficient clinical proof of safety and effectiveness. Authorities noted that some clinics had promoted such procedures at high cost, raising ethical concerns.
Research allowed under strict regulation
Scientific study on stem cell applications may continue, but only within approved research frameworks. Trials must secure clearance from ethics committees and national regulators, obtain written informed consent, provide treatment free of charge during the study and ensure compensation in case of injury or death.
Warning to doctors and institutions
The NMC has instructed strict compliance. Any practitioner or institution offering stem cell therapy outside approved indications, including autism, may face regulatory and legal consequences.
The advisory reinforces that while stem cell science holds promise, its clinical use must remain evidence-based and carefully regulated.