Published Sep 17, 2026 | 1:40 PM ⚊ Updated Sep 17, 2026 | 1:40 PM
Representational image. Credit: iStock
The Union Health Ministry has directed that stem cell therapy may be offered as standard clinical care only for diseases and indications specifically approved by the ministry, and that its therapeutic use for autism must be restricted to duly approved clinical trials.
In an advisory issued on September 16, the Ministry of Health and Family Welfare reiterated the regulatory framework governing stem cell research and therapy and asked states and UTs to ensure strict compliance by government and private clinical establishments involved in stem cell research, treatment, promotion or administration.
The advisory has been issued in the wake of a January 30, 2026 judgment of the Supreme Court in the Yash Charitable Trust and Others vs Union of India and Others case.
The ministry said stem cell therapy can be used as standard care in routine clinical practice only for disease conditions or indications included in the list approved by the Ministry of Health and Family Welfare.
For Autism Spectrum Disorder (ASD), the ministry has made the position explicit. Therapeutic use of any type of stem cell for autism must remain restricted to duly approved clinical trials.
Such trials must 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.
This means stem cell interventions for autism that have not received the required regulatory approvals cannot be offered to patients as routine treatment.
The ministry has also asked states and UTs to widely circulate the Supreme Court’s directions among state and district regulatory authorities as well as government and private clinical establishments involved in stem cell research or treatment.
The advisory comes against the backdrop of concerns over the use of unproven stem cell interventions outside established regulatory and research frameworks.
The Supreme Court, in paragraph 151(xiii) of its January 30 judgment, held that non-compliance with the statutory requirements could attract consequences, including professional misconduct under Regulation 7.22 of the Indian Medical Council Regulations, 2002.
The court also referred to provisions of the Clinical Establishments (Registration and Regulation) Act, 2010, under which violations can lead to action including cancellation of registration and penalties.
The Union Health Ministry has accordingly asked state and district regulatory authorities and clinical establishments to ensure compliance with the applicable framework.
The National Medical Commission (NMC) has separately reinforced the position. In an advisory dated September 5, 2026, it said stem cell therapy may be offered as standard clinical care only for approved indications.
The NMC also said that unauthorised administration or prescription of stem cell therapy, as well as its promotion or advertisement beyond approved indications, would constitute professional misconduct.
State Medical Councils have been advised to examine complaints or cases involving alleged violations. Where professional misconduct by a registered medical practitioner is established following due process, the councils can take disciplinary action under the applicable statutory and regulatory provisions.
The latest directions therefore distinguish between approved clinical use of stem cells and experimental or unproven interventions. While approved therapies can be used for specified indications, their use for conditions such as autism remains confined to regulated clinical research unless and until the indication is approved for standard clinical care.
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(Edited by R Rajesh Kumar.)
