Health Ministry Issues Advisory on Regulation of Stem Cell Therapy

The Ministry of Health & Family Welfare has issued an advisory on 16th September, 2026, to States and Union Territories that have adopted the Clinical Establishments (Registration and Regulation) Act, 2010, regarding the regulation of stem cell therapy. 

The advisory has been issued in view of the Supreme Court judgment dated January 30, 2026, in Yash Charitable Trust & Ors. v. Union of India & Ors. [2026 CaseBase(SC) 91]. 

Stem Cell Therapy as Standard Care 

The advisory reiterates the existing framework governing stem cell research and therapy. It states that stem cell therapy may be permitted as standard care in routine clinical practice only for disease conditions or indications included in the list approved by the Ministry of Health & Family Welfare. 

Stem Cell Use for Autism Restricted to Clinical Trials 

With regard to Autism Spectrum Disorder (ASD), the advisory states that therapeutic use of any type of stem cell in autism is to remain restricted to duly approved clinical trials. Such trials are to be conducted in accordance 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 issued from time to time. 

Accordingly, unproven stem cell interventions, including stem cell therapy for ASD, are not to be offered as routine, standard or commercial clinical services. 

Directions to Regulatory Authorities and Clinical Establishments 

The Ministry has requested States and Union Territories to 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 concerned authorities and establishments have been requested to ensure compliance with the applicable framework governing stem cell research and therapy. 

Consequences of Non-Compliance 

The advisory on stem cell therapy regulation refers to paragraph 151(xiii) of the Supreme Court's January 30, 2026 judgment in 2026 CaseBase(SC) 91, under which non-compliance with the statutory mandate must attract consequences. These include professional misconduct under Regulation 7.22 of the IMC Regulations, 2002, and action under Sections 32 and 40 of the Clinical Establishments (Registration and Regulation) Act, 2010, providing for cancellation of registration and penalty. 

NMC Advisory on Stem Cell Therapy 

The National Medical Commission (NMC), in its advisory dated 5th September, 2026, has also stated that stem cell therapy may be offered as standard clinical care only for approved indications. It further states that unauthorised administration, prescription, promotion or advertisement of stem cell therapy beyond approved indications would constitute professional misconduct. 

The NMC has advised State Medical Councils to examine alleged violations brought to their notice and, where professional misconduct by a Registered Medical Practitioner is established after due process, take appropriate disciplinary action under the applicable statutory and regulatory provisions.