The National Medical Commission has tightened restrictions on stem cell therapy, directing all medical colleges, hospitals and registered medical practitioners to use it only for 32 approved diseases and warning that any violation will invite legal action. The move comes after a Supreme Court ruling that flagged the therapy’s promotion as a treatment or cure for autism spectrum disorder, despite its experimental status.
In its advisory issued on March 25, the NMC said stem cell therapy can be used in routine care only for a defined list of conditions notified by the Ministry of Health and Family Welfare and supported by national guidelines framed by bodies such as the Indian Council of Medical Research. The approved indications include diseases such as leukemia, lymphoma, multiple myeloma, thalassemia and certain severe bone marrow and immune disorders where stem cell transplant is already an established treatment.
For all other conditions, including autism spectrum disorder, the commission said stem cell therapy cannot be offered as treatment and will be allowed only as part of properly approved clinical trials. It said such research must follow strict ethical safeguards, including informed consent, no financial burden on patients and provisions for managing adverse events.
The advisory also makes clear that mesenchymal stem cell therapy, which is often marketed for a wide range of diseases, is not approved for any condition. The NMC said any stem cell therapy given for conditions outside the approved list or without the required regulatory permissions would be considered illegal and could lead to action against those involved.
The order is aimed at curbing unauthorised practices by private clinics that have been advertising stem cell therapy as a cure for autism and other conditions, particularly in metropolitan and tier-2 cities. The Supreme Court’s intervention followed concerns that stem cell therapy was being promoted despite a lack of scientific evidence supporting such claims.
Dr. Sheffali Gulati, professor and faculty-in-charge of the Child Neurology Division in the Department of Pediatrics at AIIMS, said the court’s order was necessary because stem cell therapy for autism spectrum disorder had been widely misused in India. She said clinics had aggressively marketed the treatment despite the absence of reliable data showing benefit, while risks such as infections, immune reactions, tumour formation and complications like seizures remained significant.
Families, she added, were often charged between Rs 4 lakh and Rs 15 lakh, turning the issue into one of exploitation of their vulnerability. The advisory now requires institutions to circulate the directions among doctors and ensure strict compliance, underscoring the regulator’s warning that any unauthorised use of stem cell therapy will not be tolerated.
The move sharpens the regulatory framework around a field that has drawn both medical interest and ethical scrutiny. By limiting routine use to approved diseases and pushing other applications into the research pathway, the NMC has sought to close the gap between emerging science and misleading commercial claims.
