Health Ministry issues advisory on stem cell therapy, warns against unproven treatments

The Health Ministry has told States and Union Territories to enforce existing stem cell therapy rules strictly. The advisory bars unapproved routine use, including in autism, and points to penalties for violations.Health Ministry warns against unproven stem cell treatmentsThe Union Ministry of Health and Family Welfare has issued an advisory to all States and Union Territories regarding the regulation of stem cell therapy. The advisory, dated September 16, 2026, asks authorities and clinical establishments to ensure strict compliance with the existing legal and regulatory framework governing stem cell research and therapy.The advisory states that stem cell therapy can be offered as standard care in routine clinical practice only for disease conditions and indications included in the list approved by the Ministry of Health and Family Welfare.The government has also specifically addressed the use of stem cell therapy for Autism Spectrum Disorder, or ASD. It has stated that the therapeutic use of any type of stem cell in autism must remain restricted to duly approved clinical trials. Such treatment should not be offered as routine, standard or commercial clinical services without the required regulatory approvals.The advisory has been issued in view of the judgment of the Supreme Court dated January 30, 2026, in the case of Yash Charitable Trust and Others versus Union of India and Others.Union Health Ministry issues advisory on regulation of Stem Cell TherapyStem Cell Therapy as Standard Care to be permitted only for disease conditions/indications included in Ministry-Approved ListTherapeutic use of Stem Cells for Autism Spectrum Disorder restricted to pic.twitter.com/bmrcBdvIhR— ANI (@ANI) September 17, 2026STEM CELL THERAPY ALLOWED ONLY FOR APPROVED INDICATIONSAccording to the Health Ministry, the existing framework allows stem cell therapy to be used as standard care in routine clinical practice only for specific disease conditions and indications that have been included in the Ministry-approved list.This means clinical establishments involved in stem cell research, treatment, promotion or administration are required to follow the applicable regulatory framework. The Ministry has asked concerned State and District Regulatory Authorities as well as clinical establishments to ensure that these requirements are followed strictly.The advisory aims to ensure that stem cell therapy is used within the established regulatory framework and that interventions that have not been approved for routine clinical use are not presented as standard treatment.STEM CELL THERAPY FOR AUTISM RESTRICTED TO CLINICAL TRIALSThe Health Ministry has specifically highlighted Autism Spectrum Disorder in its advisory.It states that the therapeutic use of any type of stem cell in autism is to remain restricted to duly approved clinical trials. These trials must follow 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 instructions issued from time to time.The advisory makes it clear that unproven stem cell interventions, including stem cell therapy for ASD, should not be offered as routine, standard or commercial clinical services.NMC WARNS AGAINST UNAUTHORISED STEM CELL THERAPYThe National Medical Commission has also reinforced the regulatory position through its advisory dated September 5, 2026.The NMC stated that stem cell therapy may be offered as standard clinical care only for approved indications. It further stated that unauthorised administration, prescription, promotion or advertisement for stem cell therapy beyond approved indications would constitute professional misconduct.The NMC has also advised State Medical Councils to examine cases of alleged violations that are brought to their notice.ACTION AGAINST NON-COMPLIANCEThe Health Ministry advisory also draws attention to the consequences of failing to follow the framework governing stem cell therapy.The Supreme Court, in its January 30, 2026 judgment, held that non-compliance with the statutory mandate must attract consequences. These include professional misconduct under Regulation 7.22 of the IMC Regulations, 2002.The advisory also refers to action under Sections 32 and 40 of the Clinical Establishments Registration and Regulation Act, 2010. These provisions provide for cancellation of registration and penalties.The Ministry has therefore requested State and District Regulatory Authorities and clinical establishments to ensure strict compliance with the applicable framework governing stem cell research and therapy.The NMC has further advised State Medical Councils to take appropriate disciplinary action where professional misconduct by a Registered Medical Practitioner is established after due process.- EndsPublished By: Smarica PantPublished On: Sep 17, 2026 10:31 IST