The Union Health Ministry has reiterated that stem cell therapy cannot currently be offered as a routine or commercial treatment for Autism Spectrum Disorder (ASD) in India. The therapy can be used for autism only as part of a duly approved clinical trial.
The advisory was issued on September 16 to States and Union Territories that have adopted the Clinical Establishments (Registration and Regulation) Act, 2010. It follows a Supreme Court judgment in January that examined the use of stem cell therapy for autism.
Under the Health Ministry’s current framework, stem cell therapy can be provided as standard clinical care only for specific diseases or medical indications included in its approved list. Autism is not included among those indications.
This means clinics and healthcare providers cannot present stem cell therapy as an established treatment for autism outside the approved clinical research framework. Any use for ASD would need to meet the requirements applicable to an authorised clinical trial.
The advisory does not mean that scientific research into stem cells and autism has been stopped. Researchers can continue studying potential applications through appropriately approved clinical trials and research programmes.
The distinction between research and routine treatment is important because experimental therapies may not yet have sufficient evidence to establish their safety, effectiveness and long-term benefits for a particular condition.
For families seeking treatments for autism, the advisory therefore means that claims offering stem cell therapy as a routine or commercially available treatment should be viewed in the context of India's regulatory requirements.
The Health Ministry's position reinforces the need for approved clinical evidence before an experimental therapy can be offered as standard medical care for autism.