The Union Ministry of Health and Family Welfare has issued an advisory to all States and Union Territories directing authorities and clinical establishments to strictly comply with the existing regulatory framework governing stem cell research and therapy. The September 16, 2026 advisory states that stem cell therapy can be offered as standard care in routine clinical practice only for disease conditions and indications approved by the Ministry.

The Health Ministry has specifically clarified that the therapeutic use of any type of stem cell for Autism Spectrum Disorder (ASD) must remain restricted to duly approved clinical trials. Such interventions cannot be offered as routine, standard or commercial clinical services without the required regulatory approvals. The advisory follows the Supreme Court’s January 30, 2026 judgment in Yash Charitable Trust and Others versus Union of India and Others.

Stem Cell Therapy Limited To Approved Indications

Under the existing regulatory framework, stem cell therapy can be used as standard care only for specific diseases and indications included in the list approved by the Health Ministry. Clinical establishments involved in stem cell research, treatment, promotion or administration are required to comply with the applicable rules.

The Ministry has directed State and District Regulatory Authorities as well as clinical establishments to ensure that these requirements are followed strictly. The advisory is intended to prevent therapies that have not been approved for routine clinical use from being presented or marketed as standard treatment.

The government has also reiterated that the regulatory framework applies to the use and promotion of stem cell interventions, making compliance necessary for establishments involved in administering or offering such treatments.

Autism Treatment Restricted To Clinical Trials

The Health Ministry has separately highlighted the use of stem cell therapy for Autism Spectrum Disorder. It has stated that therapeutic use of any type of stem cell for autism must remain limited to duly approved clinical trials.

Such trials are required to comply with the National Guidelines for Stem Cell Research, 2017, issued jointly by the Indian Council of Medical Research and the Department of Biotechnology, along with other applicable government directions issued from time to time.

The advisory makes clear that unproven stem cell interventions, including treatments offered for ASD, should not be provided as routine or standard clinical care or sold as commercial clinical services without the necessary approvals.

NMC Warns Against Professional Misconduct

The National Medical Commission has also reinforced the regulatory position through an advisory issued on September 5, 2026. The NMC said stem cell therapy may be offered as standard clinical care only for approved indications.

It further stated that unauthorised administration, prescription, promotion or advertisement of stem cell therapy beyond approved indications would constitute professional misconduct. State Medical Councils have been advised to examine complaints or cases of alleged violations brought to their notice.

The NMC’s position places responsibility not only on establishments administering stem cell therapy but also on registered medical practitioners involved in prescribing, promoting or advertising treatments outside approved indications.

Non-Compliance Could Lead To Penalties

The Health Ministry advisory also sets out the potential consequences of violating the regulatory framework. Referring to its January 30 judgment, the Supreme Court held that failure to comply with the statutory mandate must attract consequences.

These consequences include professional misconduct under Regulation 7.22 of the Indian Medical Council Regulations, 2002. The advisory also refers to action under Sections 32 and 40 of the Clinical Establishments (Registration and Regulation) Act, 2010, which provide for cancellation of registration and penalties.

The Ministry has therefore asked State and District Regulatory Authorities and clinical establishments to ensure strict adherence to the applicable framework governing stem cell research and therapy.

The NMC has separately advised State Medical Councils to initiate appropriate disciplinary action where professional misconduct by a Registered Medical Practitioner is established following due process. The latest advisories reinforce that stem cell therapies outside approved indications cannot be treated as routine clinical care without the required regulatory clearances.

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