Health Ministry Restricts Stem Cell Therapy for Autism to Approved Trials

The Union health ministry has reiterated that stem cell therapy for autism spectrum disorder cannot be offered as routine or commercial clinical care, and may be used only within duly approved clinical trials.

In an advisory to states dated 16 September, the ministry said the therapeutic use of any type of stem cell in autism must remain restricted to approved trials, in line with the National Guidelines for Stem Cell Research, 2017, issued jointly by the Indian Council of Medical Research and the Department of Biotechnology, along with other applicable government instructions.

The directive is aimed at stopping clinics from marketing unproven treatments to families as standard care, and at ensuring providers follow the existing framework or face penalties.

The move follows a Supreme Court order of 30 January 2026 directing the government to regulate stem cell treatments. The court held that non-compliance would attract consequences, including professional misconduct under Regulation 7.22 of the Indian Medical Council 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 a penalty.

Acting on that order, the National Medical Commission said in an advisory dated 5 September 2026 that stem cell therapy can be provided as routine care only for approved diseases. It stated that unauthorised administration, prescription, promotion or advertisement of such therapy beyond approved indications would amount to professional misconduct.

State medical councils have been asked to look into complaints and take appropriate disciplinary action under the applicable statutory and regulatory provisions.

Public health expert Dr Rajeev Jayadevan, a former president of the IMA's Kochi chapter, said stem cells are a complex and continuously evolving area of healthcare. The idea that these cells can turn into other cell types may lead some people to believe they can cure several common conditions, he said, but the reality is far more nuanced. Using them as unproven treatments carries not only the risk of failure but also unexpected adverse health outcomes, he added.

Strict regulations govern how and for which conditions stem cells can be used worldwide, Jayadevan noted, adding that as data from well-designed clinical trials emerge, stem cell therapies are likely to win regulatory approval for more conditions.