The story so far: The Union Health Ministry has said that stem cell therapy for Autism Spectrum Disorder (ASD) cannot be offered as routine or commercial treatment and can be used only as part of a duly approved clinical trial. The advisory, issued on September 16 to States and Union Territories that have adopted the Clinical Establishments (Registration and Regulation) Act, 2010, follows a landmark Supreme Court judgment in January that examined the use of stem cells for autism. 

The Health Ministry has reiterated that stem cell therapy can be offered as standard clinical care only for disease conditions or indications included in the Ministry’s approved list. Autism is not among those indications.

For ASD specifically, the Ministry has said that therapeutic use of any type of stem cell must remain restricted to duly approved clinical trials, following the National Guidelines for Stem Cell Research, 2017, and other applicable regulatory requirements. It should not be offered as a routine, standard or commercial clinical service.

The advisory is an attempt to ensure enforcement of an existing regulatory framework, particularly after the Supreme Court ruling.

Autism is a neurodevelopmental condition. There is currently no established stem cell treatment that has been shown to cure autism or to provide sufficient evidence of benefit to make it a standard treatment.

The Indian Council of Medical Research (ICMR), in its evidence review on stem cell therapy for ASD, examined the available scientific evidence and concluded that it did not support using stem cells in addition to behavioural and supportive therapies. It recommended that stem cell therapy for autism should not be offered as standard or routine therapy and that its therapeutic use should be restricted to approved clinical trials.

This distinction is important — a treatment being investigated in a clinical trial does not mean that it has been established as an effective treatment. A clinical trial is the mechanism through which safety and efficacy are tested.

The issue came before the Supreme Court in Yash Charitable Trust & Ors. v. Union of India & Ors., decided on January 30, 2026.

The petition raised concerns about the commercial promotion and administration of stem cell “therapy” for autism. The court examined the scientific and regulatory position and held that, given the evidence available at present, stem cell therapy for ASD could not be offered by medical practitioners as a clinical service outside an approved and monitored clinical trial or research setting.

The court also said that, until further research establishes stem cell therapy as a sound and relevant medical practice for ASD, offering it as routine clinical treatment would not meet the reasonable standard of care expected of medical practitioners.

The court recognised the difficult situation faced by families of people with autism who may look for experimental treatments when conventional interventions do not produce the hoped-for results.

It therefore also addressed patients who were already undergoing such treatment before the judgment. Rather than abruptly discontinuing treatment, the court directed the Health Ministry to work out a mechanism, in consultation with AIIMS and the National Medical Commission, to provide the best possible solution and facilitate their continuation until they could be redirected to institutions conducting clinical trials.

No, that is not what this latest advisory states. The latest advisory does not say that stem cells can never be used clinically. It draws a distinction between approved standard care and experimental use.

The Ministry’s current approved list covers 18 adult and 14 paediatric indications. These include several blood cancers and blood disorders, as well as conditions such as multiple sclerosis and systemic sclerosis. For these indications, the relevant treatment is haematopoietic stem cell transplantation performed appropriately; the Ministry’s list specifically states that mesenchymal stem-cell transplantation is not recommended for any disease condition. 

Autism is not on this list.

The 2017 National Guidelines for Stem Cell Research also make a fundamental distinction between established haematopoietic stem-cell transplantation and experimental applications. They state that, apart from approved indications, stem-cell use in humans must be within an approved and monitored clinical trial. 

The advisory states that this therapy cannot be simply prescribe or administer as a routine therapy/treatment.

If stem cells are being investigated for ASD, the treatment has to be part of a properly designed and approved clinical trial. Such research requires the appropriate regulatory and ethical approvals. Depending on the nature and manipulation of the stem cells, different regulatory requirements apply.

This is the key difference between research and treatment being that a clinic cannot describe an experimental intervention as an established therapy and charge patients for it as ordinary clinical care.

The Health Ministry has asked State and District regulatory authorities to ensure compliance and to disseminate the Supreme Court’s directions to government and private clinical establishments involved in stem cell research, treatment, promotion or administration. 

The National Medical Commission (NMC), in an advisory dated September 5, has separately reiterated that stem cell therapy can be offered as standard clinical care only for approved indications. It has said that unauthorised administration, prescription, promotion or advertisement beyond those indications would constitute professional misconduct. State Medical Councils have been asked to examine complaints and take disciplinary action where professional misconduct is established following due process. 

There can also be consequences for clinical establishments. The Health Ministry has referred to Sections 32 and 40 of the Clinical Establishments Act, which provide for cancellation of registration and penalties in applicable jurisdictions. 

The advisory does not mean that research into stem cells and autism has stopped. It means that such research has to remain research until there is convincing evidence that establishes safety and efficacy.

For parents, perhaps the most important distinction is between a clinic saying that stem cells are being studied for autism and saying that stem cells are an established treatment for autism.

The first is a legitimate area of scientific investigation, subject to approvals. The second is not supported by the present evidence or India’s regulatory framework. ICMR’s assessment remains that stem-cell therapy should not be offered as routine treatment for ASD. 

The September advisory puts renewed emphasis on enforcing the distinction between an experimental intervention being tested under scientific oversight and a commercial treatment being sold to families as established care.