22 September,2026 08:58 AM IST | Mumbai | Ritika Gondhalekar
India, hematopoietic stem-cell transplantation is a standard treatment for select blood cancers, bone-marrow disorders, and certain inherited or immune disorders. Representation Pic/iStock
After years of concerns over children with autism being subjected to expensive and unproven stem cell procedures, the Centre has finally drawn a sharper regulatory line. The Union Ministry of Health and Family Welfare (MOHFW) issued an advisory last week directing that stem-cell therapy be used as standard care only for conditions and indications specifically approved by the ministry. For autism spectrum disorder (ASD), therapeutic use has been restricted to approved clinical trials with the necessary regulatory clearances.
[popcorn number="Sept 17" desc="Day advisory was issued" class="Default"]
The September 17 advisory follows the Supreme Court's January 30 judgment in the PIL filed by Mumbai-based Yas Charitable Trust and others, which held that stem-cell therapy for autism cannot be offered as a routine clinical treatment and can only be undertaken within an approved and monitored research or clinical-trial setting.
Dr Uma Ladiwala, MD, neuroscientist and stem cell researcher and consultant for Yas Charitable Trust, who was involved in drafting the PIL against unethical stem cell therapy, said, "The ministry has complied with the directions of the SC ruling of January 2026. Prior to this, although the ICMR [Indian Council of Medical Research] Guidelines of 2017 were in place, there was a lack of clarity regarding implementation. From the MOHFW advisory regarding clarity on which conditions stem-cell therapy can be offered as standard therapy and those for which it cannot, there is no further room for doubt. The advisory states that, âThe Department of Health Research (DHR) has established a mechanism to facilitate and promote biomedical research and conduct of clinical trials in the country through ethics committees registered with DHR. The National Stem Cell Research Regulation Committee (NSRC) provides oversight of clinical stem cell research involving minimally manipulated stem cells. All proposals approved by an Institutional Ethics Committee for such research must be forwarded to NSRC before the research commences. Clinical trials and manufacture of regenerative medicine products that fall within the ambit of the Drugs and Cosmetics Act, 1940 and the New Drugs and Clinical Trials Rules, 2019 continue to be regulated by Central Drugs Standard Control Organisation'."
The MOHFW has also asked authorities to ensure compliance. Doctors violating the framework can face professional-misconduct proceedings, while clinical establishments may face penalties and cancellation of registration under the Clinical Establishments Act. The National Medical Commission (NMC) has separately reiterated that unauthorised prescription, administration, promotion or advertising of stem-cell therapy beyond approved indications can constitute professional misconduct.
Dr Pradeep Mahajan, regenerative medicine expert and founder of StemRx Hospital & Research Centre, said, "The NMC has reiterated that stem-cell therapy can be considered standard medical care only for specified, approved indications. The NMC's guidance also distinguishes established hematopoietic stem-cell transplantation from other cell-based approaches that remain under evaluation. In India, hematopoietic stem-cell transplantation is an established standard treatment for selected blood cancers, bone-marrow disorders, and certain inherited or immune disorders, including leukaemia, lymphoma, multiple myeloma, severe aplastic anaemia, thalassemia, and sickle-cell disease. Other stem-cell-based treatments remain investigational and must be evaluated through appropriate clinical-research pathways."
For families who approached the Supreme Court after experiencing the consequences of such treatment, the advisory is being seen as a long-awaited regulatory safeguard. KS Ganpathy, a petitioner and parent whose child underwent stem-cell therapy for ASD in 2011, said, "It is a good move. What happened to my son should not happen with someone else. Also, more ethical trails can be encouraged now and if something good comes out from that, most people can benefit. Those who have made a huge business out of this should be ashamed of misusing their knowledge and looting the poor and helpless."
Parul Kumtha, trustee and co-founder of the Forum for Autism, which has campaigned against the misuse of stem-cell therapy, had earlier highlighted the financial burden on families, saying many parents had mortgaged jewellery or property to fund such treatment. "This advisory is a milestone achievement for forums like ours who have been striving hard to help families with autistic patients. The legal community must ensure that this advisory is upheld and should not focus on finding unnecessary loopholes to help misusers fill their pockets. More parents' support groups should guide families well. Medical ethics committees and medical bodies must be more stringent to pull the ears of doctors in case of misconduct and should be strict about implementation of advisories and guidelines even if they belong to the same fraternity." "Re-establishment of an oversight committee not only for registered clinical trials, but to look into professional misconduct by practitioners of unethical stem-cell therapy is the need of the day," added Ladiwala.
