New Delhi: The health ministry has reiterated that stem cell therapy for autism spectrum disorder (ASD) cannot be offered as routine or commercial clinical care and can be used only in duly approved clinical trials.
In an advisory to states, dated 16 September, the ministry said “therapeutic use of any type of stem cell in is to remain restricted to duly approved clinical trials, in accordance with the National Guidelines for Stem Cell Research, 2017, issued jointly by Indian Council of Medical Research (ICMR) and the Department of Biotechnology (DBT) and other applicable Government instructions issued by the Government of India from time to time.”
The directive seeks to prevent clinics from selling unproven treatments to families as standard treatment and to ensure that providers strictly comply with the existing framework or face penalties.
The advisory follows a 30 January 2026 order that directed the government to regulate stem cell treatments. It held that non-compliance would attract consequences, including professional misconduct under Regulation 7.22 of the IMC 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 penalty.
In line with this order, the National Medical Commission (NMC) stated in its 5 September 2026 advisory that stem cell therapy can be provided as routine care only for approved diseases. It stated that “unauthorized administration, prescription, promotion or advertisement of stem cell therapy beyond the approved indications would constitute professional misconduct.”
State medical councils have been directed to investigate complaints and “take appropriate disciplinary action in accordance with the applicable statutory and regulatory provisions”.
On 19 August, Mint that India has issued strict norms for stem cell therapies.
“Stem cells represent a complex and continuously evolving field in healthcare. The premise that these cells can differentiate into other cell types may lead some people to believe they can cure several common conditions,” said Dr Rajeev Jayadevan, a public health expert and former IMA president at Kochi Chapter.
“However, the reality is far more nuanced. Using them as unproven treatments carries not only the risk of failure, but also unexpected adverse health outcomes. Worldwide, strict regulations govern how and for what conditions stem cells can be used. As data from well-designed clinical trials emerge in the future, stem cell therapies are likely to gain regulatory approval for more conditions,” Jayadevan added.
