Stem Cell Therapy: Health Ministry directs states, UTs to ensure regulatory compliance, warns of action

New Delhi: In compliance with the Supreme Court's directives, the Union Ministry of Health and Family Welfare has recently issued an advisory to all 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 judgment dated 30 January 2026 of the Hon’ble Supreme Court in Yash Charitable Trust & Ors. v. Union of India & Ors., W.P. (C) No. 369 of 2022 [2026 INSC 96].

Issuing the advisory, the Ministry has reiterated the existing framework governing stem cell research and therapy and seeks to ensure that stem cell therapy is permitted as standard care in routine clinical practice only for disease conditions/indications included in the list approved by the Ministry of Health & Family Welfare.

Regarding Autism Spectrum Disorder (ASD), the advisory stipulates that the therapeutic use of any type of stem cell in autism is to remain restricted to duly approved clinical trials, in accordance with the National Guidelines for Stem Cell Research, 2017, issued jointly by Indian Council of Medical Research (ICMR) and the Department of Biotechnology (DBT) and other applicable Government instructions issued by the Government of India from time to time.

The Ministry has requested the States and Union Territories to widely disseminate the directions of the Hon’ble Supreme Court to all concerned State and District Regulatory Authorities and Government and private clinical establishments involved in stem cell research, treatment, promotion or administration, for strict compliance with the applicable framework.

The advisory also draws attention to the consequences of non-compliance with the framework governing stem cell therapy. The Hon’ble Supreme Court, in Para 151(xiii) of its judgment dated 30 January 2026, held that non-compliance with the statutory mandate must attract consequences, including professional misconduct under Regulation 7.22 of the IMC Regulations, 2002, as well as action under Sections 32 and 40 of the Clinical Establishments (Registration and Regulation) Act, 2010, which provide for cancellation of registration and penalty.

The Ministry has accordingly requested the concerned State and District Regulatory Authorities and clinical establishments to ensure strict compliance with the applicable framework governing stem cell research and therapy.

Advisory from the Union Health Ministry comes after the National Medical Commission (NMC) issued a similar advisory on September 5, 2026, and reiterated that stem cell therapy may be offered as standard clinical care only for the approved indications.

Medical Dialogues had earlier reported that through the advisory dated 05.09.2026, the Apex Medical Commission had warned against unauthorized administration, prescription, promotion, or advertisement of Stem Cell Therapy, warning that it would constitute professional misconduct on the part of doctors, medical institutes, SMC(s), and other stakeholders.

NMC had also advised the stakeholders that while Stem Cell Therapy may be offered as standard clinical care, it should be ONLY done for approved indications as listed in ICMR/DHR/MoHFW guidelines.

Further, the Commission had advised State Medical Councils to examine cases of alleged violations brought to their notice and, where professional misconduct by a Registered Medical Practitioner is established after due process, take appropriate disciplinary action in accordance with the applicable statutory and regulatory provisions.