The Union Ministry of Health and Family Welfare (MoHFW) has issued an advisory to States and Union Territories on the regulation of stem cell therapy, reiterating that such treatment can be offered as standard care only for disease conditions and indications approved by the Ministry.
The advisory, dated September 16, 2026, has been issued to all States and Union Territories that have adopted the Clinical Establishments (Registration and Regulation) Act, 2010, in the wake of a January 30, 2026 judgment of the Supreme Court in Yash Charitable Trust & Ors. v. Union of India & Ors., W.P. (C) No. 369 of 2022 [2026 INSC 96].
The Ministry has reiterated the existing regulatory framework governing stem cell research and therapy and directed that stem cell therapy should be permitted as standard care in routine clinical practice only for disease conditions or indications included in the list approved by the Health Ministry.
Stem cell therapy for autism restricted to clinical trials
The advisory specifically addresses the use of stem cells for Autism Spectrum Disorder (ASD). It states that therapeutic use of any type of stem cell for autism must remain restricted 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 (ICMR) and the Department of Biotechnology (DBT), along with other applicable government instructions.
The Ministry has emphasised that unproven stem cell interventions, including stem cell therapy for ASD, should not be offered as routine, standard or commercial clinical services outside the approved regulatory framework.
Directions to regulatory authorities and clinical establishments
The Health Ministry has asked States and Union Territories to widely disseminate the Supreme Court’s directions to State and District Regulatory Authorities as well as government and private clinical establishments involved in stem cell research, treatment, promotion or administration.
The authorities and establishments have been asked to ensure strict compliance with the applicable legal and regulatory framework.
The advisory also highlights the consequences of non-compliance. Referring to paragraph 151(xiii) of its January 30 judgment, the Supreme Court held that violations of the statutory mandate must attract consequences, including professional misconduct under Regulation 7.22 of the IMC Regulations, 2002.
The Court also referred to action under Sections 32 and 40 of the Clinical Establishments (Registration and Regulation) Act, 2010, which provide for cancellation of registration and penalties.
NMC reiterates restrictions on unauthorised stem cell therapy
The regulatory position was further reinforced by the National Medical Commission (NMC) in its advisory dated September 5, 2026.
The NMC reiterated that stem cell therapy may be offered as standard clinical care only for approved indications. It also stated that unauthorised administration, prescription, promotion or advertisement of stem cell therapy beyond the approved indications would constitute professional misconduct.
The NMC has advised State Medical Councils to examine cases of alleged violations brought to their notice. Where professional misconduct by a Registered Medical Practitioner is established after following due process, the councils have been asked to take appropriate disciplinary action under the applicable statutory and regulatory provisions. (DD NEWS)
