Health Ministry's Advisory on the Regulation of Stem Cell Therapy

On September 16, 2026, the Ministry of Health and Family Welfare issued an advisory to states and Union Territories that have adopted the 'Clinical Establishments (Registration and Regulation) Act, 2010' regarding the regulation of stem cell therapy.

Key Points

Standard Treatment: Stem cell therapy can only be used as a standard medical treatment for diseases/conditions approved by the Ministry of Health.
Provision for Autism: Any therapeutic use of stem cell therapy for Autism Spectrum Disorder (ASD) will remain restricted to clinical trials with the required regulatory approvals.
National Guidelines: This arrangement aligns with the National Guidelines for Stem Cell Research, 2017, jointly issued by the ICMR and the Department of Biotechnology (DBT).
Supreme Court Judgment: The advisory has been issued in the context of the Supreme Court's January 30, 2026 judgment in the case of Yash Charitable Trust & Ors. v. Union of India & Ors.
Legal Action: Violation of rules may lead to actions such as cancellation of registration and fines under Sections 32 and 40 of the Clinical Establishments Act, 2010, along with charges of professional misconduct.
NMC's Stance: In its advisory dated September 5, 2026, the National Medical Commission deemed the unauthorized use, prescription, promotion, or advertisement of stem cell therapy outside approved conditions as professional misconduct.