In line with a recent judgment by the Supreme Court of India, the National Medical Commission (NMC) has directed all medical colleges and institutions to strictly regulate the use of stem cell therapy. The advisory clarifies that such therapies can be used in routine clinical practice only for conditions officially approved by the Ministry of Health and Family Welfare.
The directive follows a request from the Indian Council of Medical Research, which urged the NMC to ensure that stem cell treatments are limited to indications listed under ICMR, the Department of Health Research (DHR), and MoHFW guidelines. Any application beyond these approved conditions is permitted only within the framework of a properly sanctioned clinical trial, adhering to ethical and regulatory standards.
The Supreme Court, in its January 30, 2026 ruling in the Yash Charitable Trust vs Union of India case, clearly stated that stem cell therapy is not approved for conditions such as Autism Spectrum Disorder. The Court emphasized that offering such treatments outside authorized clinical trials is unethical and constitutes medical malpractice due to insufficient scientific evidence regarding safety and effectiveness.
The bench, comprising Justices J.B. Pardiwala and R. Mahadevan, held that using stem cell therapy for ASD as a routine treatment falls below acceptable medical standards. It stressed that until robust scientific validation is available, such therapies must not be offered as standard care outside regulated research settings.
ICMR further clarified that any research involving stem cells must receive prior approval depending on the degree of cell manipulation. Studies involving substantially manipulated cells fall under the purview of the Central Drugs Standard Control Organisation (CDSCO), while those involving minimally manipulated cells are overseen by the DHR, along with approval from Institutional Ethics Committees and the National Stem Cell Research Regulation Committee.
Additionally, all stem cell research must comply with ICMR ethical guidelines, including obtaining informed consent, ensuring no cost to patients, and providing compensation in case of adverse outcomes. Any unauthorized use of stem cell therapy outside approved indications or without regulatory clearance will be considered illegal and subject to legal action.
The NMC has been asked to circulate this advisory widely among medical practitioners and institutions to ensure strict compliance with the Court’s directives and existing national guidelines.