The Union Ministry of Health and Family Welfare has issued an advisory to all States and Union Territories on the regulation of stem cell therapy. Dated September 16, 2026, the advisory directs authorities and clinical establishments to strictly follow the existing legal and regulatory framework governing stem cell research and therapy.
The advisory clarifies that stem cell therapy can be provided as standard care in routine clinical practice only for diseases and indications that feature on the list approved by the Ministry of Health and Family Welfare.
The government has also specifically clarified the position on stem cell therapy for Autism Spectrum Disorder (ASD). It said the therapeutic use of any form of stem cell for autism must be limited to properly approved clinical trials. Such therapies cannot be offered as routine, standard or commercial clinical services without the necessary regulatory approvals.
The advisory follows a Supreme Court judgment dated January 30, 2026, in the case of Yash Charitable Trust and Others versus Union of India and Others.
STEM CELL THERAPY ALLOWED ONLY FOR APPROVED INDICATIONS
According to the Health Ministry, the current regulatory framework permits stem cell therapy to be used as standard care in routine clinical practice only for specified diseases and indications included in the Ministry's approved list.
Clinical establishments involved in stem cell research, treatment, promotion or administration are consequently required to comply with the relevant regulatory requirements. The Ministry has instructed State and District Regulatory Authorities, along with clinical establishments, to ensure that these provisions are followed strictly.
The advisory is intended to ensure that stem cell therapy remains within the established regulatory framework and that treatments not approved for routine clinical use are not promoted or presented as standard medical care.
STEM CELL THERAPY FOR AUTISM RESTRICTED TO CLINICAL TRIALS
The Health Ministry has specifically addressed the use of stem cell therapy in Autism Spectrum Disorder.
It stated that therapeutic use of any type of stem cell for autism must be confined 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, as well as other applicable government directions issued from time to time.
The advisory makes clear that unproven stem cell interventions, including stem cell treatments for ASD, must not be provided as routine, standard or commercial clinical services.
NMC WARNS AGAINST UNAUTHORISED STEM CELL THERAPY
The National Medical Commission has also reiterated the regulatory position through an advisory issued on September 5, 2026.
The NMC said stem cell therapy can be provided as standard clinical care only for indications that have received approval. It further stated that unauthorised administration, prescription, promotion or advertising of stem cell therapy beyond approved indications would amount to professional misconduct.
The commission has also directed State Medical Councils to examine complaints and cases involving alleged violations that are brought before them.
ACTION AGAINST NON-COMPLIANCE
The Health Ministry's advisory also highlights the possible consequences of violating the regulatory framework governing stem cell therapy.
In its January 30, 2026 judgment, the Supreme Court held that failure to comply with the statutory requirements must have consequences. These include professional misconduct under Regulation 7.22 of the IMC Regulations, 2002.
The advisory also cites Sections 32 and 40 of the Clinical Establishments Registration and Regulation Act, 2010. These provisions allow for measures including cancellation of registration and imposition of penalties.
The Ministry has therefore asked State and District Regulatory Authorities and clinical establishments to strictly comply with the applicable rules governing stem cell research and therapy.
The NMC has additionally advised State Medical Councils to initiate appropriate disciplinary proceedings when professional misconduct by a Registered Medical Practitioner is established following due process.
