14:I[94367,["/_next/static/immutable/chunks/4370mg0uq-myq.js","/_next/static/immutable/chunks/0q7ni_ir0mogv.js","/_next/static/immutable/chunks/0q9_4lzwjwc3f.js","/_next/static/immutable/chunks/1p8rnjckwz-06.js","/_next/static/immutable/chunks/3zikwth1q5z_-.js","/_next/static/immutable/chunks/0eigul57_x91p.js","/_next/static/immutable/chunks/3r0kxtkfnobr8.js","/_next/static/immutable/chunks/260mvqou7a4l3.js","/_next/static/immutable/chunks/14bkwvgoktej3.js"],"NewsDetailPage"] 15:T1a15,

The Union Ministry of Health and Family Welfare has sent an advisory to different States and Union Territories for regulating stem cell therapy and has once again stated that it can be provided only in cases that have been approved by the Ministry. The advisory is dated September 16, 2026, and comes in light of the Supreme Court order of January 30, 2026, in the case of Yash Charitable Trust & Ors. v. Union of India & Ors.

The advisory has special importance for Autism Spectrum Disorder (ASD). The Ministry has stated that stem cell therapy for autism can be performed only within the limits of the legally allowed clinical trials and cannot be made an alternative treatment as per the guidelines of the Indian Council for Medical Research (ICMR) and Department of Biotechnology (DBT).

Stem cell therapy pertains to the utilization of stem cells for therapeutic or research purposes, which can potentially be utilized to replace, repair, or alter dysfunctional cells or tissues. However, all interventions using stem cells have yet to be determined as safe and effective in clinical treatment.

This is how the government’s regulatory system distinguishes interventions either approved for standard procedure or for research purposes. In accordance with regulations, only approved interventions in stem cell therapy, as mentioned by the Ministry of Health and Family Welfare, can be applied in clinical practice. All other interventions utilizing stem cells fall under research interventions requiring various regulatory and ethical approvals.

For ASD, the Ministry has specifically reiterated that stem cell therapy should not be offered as an established clinical treatment. Its therapeutic use can take place only through appropriately approved clinical trials.

The National Medical Commission (NMC) has also reiterated this position in its September 5, 2026 advisory. The NMC stated that stem cell therapy can be provided as standard clinical care only for approved indications and that unauthorised administration, prescription, promotion or advertising beyond those indications may constitute professional misconduct.

The NMC's earlier recommendations on stem cell use in ASD also noted that available evidence had not been sufficient to establish stem cell therapy as a treatment for autism and that further well-designed research would be required to assess its safety and efficacy.

The legal framework mandates stem cell research to be carried out following recognized clinical trials. Depending on the type and extent of stem cell manipulation, different regulations will be applicable.

An ICMR/Department of Health Research communication on adherence to the judgment of the Supreme Court of India mentions that treatments that are not included in standard-care treatments are allowed only in research. Moreover, the communication details the regulations that involve either the Central Drugs Standard Control Organisation (CDSCO) or the Department of Health Research (DHR), depending on the degree of manipulation of stem cells.

Clinical trials should also follow ethical requirements, such as obtaining informed consent and ensuring patient safety, provision and compensation in cases when the patient dies or is injured due to research.

The Health Ministry has requested states and UTs to inform the Supreme Court’s directive to the regulatory authorities at the state and district levels as well as to the state-run and privately owned clinical organizations engaged in stem cell research, therapy, promotion or administration.

The advisory also indicates regulatory repercussions for non-compliance. This may include action under the relevant regulations on professional conduct and the Clinical Establishments (Registration and Regulation) Act, 2010, including registration processes and penalties.

Additionally, NMC has advised state medical councils to take action against complaints of violations of the regulations. If a registered medical practitioner is found guilty after due procedure, appropriate action should be taken against him/her in accordance with the mandatory rules and regulations.

The recent advisory calls for clarification between stem cell therapy based on evidence and approved methods and experimental methods in the field. It is not acceptable to present stem cell therapy not approved by the authorized bodies as a routine method of treatment used in practice.

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