NEW DELHI: The National Medical Commission (NMC) has issued an advisory declaring stem cell therapy illegal for the treatment of Autism Spectrum Disorder in compliance with a Supreme Court order.
The move is aimed at curbing illegal practices by private clinics in metropolitan and tier-2 cities that claim to treat autism and cerebral palsy using stem cell therapy, sources said.
According to the advisory issued on March 25 to all medical colleges, hospitals and registered medical practitioners, stem cell therapy can now be used only for 32 approved diseases.
These include Acute Myeloid Leukemia, Multiple Sclerosis, Thalassemia, Osteopetrosis, Multiple Myeloma, Aplastic Anaemia/Paroxysmal hemoglobinuria, Germ Cell tumours and Myelofibrosis.
The advisory has been issued based on the recommendations of the Indian Council of Medical Research (ICMR).
During a hearing on January 30, the Supreme Court delivered a judgment regarding stem cell therapy, following which ICMR Director General Dr Rajiv Bahl, on March 10, wrote to NMC Chairman Dr Abhijat Sheth, sharing a list of 32 diseases where stem cell therapy can be used.
"Any stem cell treatment not included in the list of standard care indications, or not approved by Central Drugs Standard Control Organisation (CDSCO) or Department of Health Research (DHR) shall be deemed illegal and liable to action in accordance with law," Dr Bahl said in the letter.
Referring to the judgment of the Supreme Court (dated February 3, 2026) concerning issues related to the use of stem cell therapy for the treatment of Autism Spectrum Disorder (ASD), Dr Bahl said this judgement has important implications for giving stem cell therapy in India.
"Stem cell therapies in routine practice shall be permitted only for disease conditions specified in the list of Union Health Ministry-approved indications as standard care.
Other than the approved indications, stem cell therapy is permissible only in the context of research," the letter said.
If stem cells have undergone more than minimal manipulation, the research will be regulated by the CDSCO, and if the cells have undergone less than minimal manipulation, the research will be regulated by the DHR.
In this case, in addition to the recommendations of the Institutional Ethics Committee (IEC) registered with DHR, the trials will have to be approved by the National Stem Cell Research Regulation Committee.
The levels of manipulation for stem cell therapy have been defined by CDSCO, it added.
The letter further said that stem cell research shall be permissible only as part of an approved clinical trial.
"This research will be required to comply with all ICMR ethical guidelines, including written informed consent, no cost to the patient and provision of compensation in case of injury or death.
Any stem cell treatment not included in the list of standard care indications, or not approved by CDSCO or DHR, shall be deemed illegal and liable to action in accordance with law," the letter said.
In the letter, he requested that an advisory be issued stating that, firstly, routine practice should be restricted only to the approved indications listed in ICMR/DHR/MoHFW guidelines.
Secondly, beyond the approved list of disease conditions, stem cell research needs to be conducted in compliance with ICMR Ethical Guidelines and with prior approval of either CDSCO or DHR, depending on the level of manipulation of stem cells, it added.
"Any deviation from the above shall be liable to regulatory and legal action in accordance with law," the letter said.