The Union Health Ministry has issued a fresh advisory to States and Union Territories on the regulation of stem cell therapy, emphasising compliance with the existing legal and medical framework. The advisory, dated September 16, 2026, reiterates that stem cell therapy can be offered as routine standard care only for disease conditions and indications approved by the Ministry.
The move follows a January 30, 2026 Supreme Court judgment concerning the regulation of stem cell therapy. The Health Ministry has asked relevant authorities and clinical establishments to ensure that the existing rules are strictly followed.
The advisory also specifically addresses the use of stem cells for Autism Spectrum Disorder (ASD). Such therapy is restricted to duly approved clinical trials and is not to be offered as routine or commercial treatment outside the applicable regulatory framework.
The National Medical Commission has separately reiterated that unauthorised administration, prescription, promotion or advertising of stem cell therapy beyond approved indications can constitute professional misconduct.
The latest advisory is part of wider efforts to strengthen oversight of advanced medical treatments and ensure that stem cell-based therapies are provided within approved scientific and regulatory standards.
The directive follows a January 30, 2026 Supreme Court judgment in the Yash Charitable Trust and Others versus Union of India case. The Health Ministry has asked state and district regulatory authorities to communicate the court’s directions to government and private clinical establishments involved in stem cell research, treatment, promotion or administration.
The government’s approved list includes specific conditions for which hematopoietic stem cell transplantation may be used as standard care, while the Department of Health Research states that mesenchymal stem cell transplantation is not recommended as standard care for any disease condition.
The latest move comes as India continues to strengthen oversight of advanced medical technologies. In July 2026, the government also expanded the centrally regulated licensing framework to cover cell and stem-cell-derived products, along with gene-therapy products and xenografts.