The advisory, issued on September 16 to States and Union Territories that have adopted the Clinical Establishments (Registration and Regulation) Act, 2010, follows a landmark Supreme Court judgment in January that examined the use of stem cells for autism.
The story so far: The Union Health Ministry has said that stem cell therapy for Autism Spectrum Disorder (ASD) cannot be offered as routine or commercial treatment and can be used only as part of a duly approved clinical trial.
What exactly has the government said?
The Health Ministry has reiterated that stem cell therapy can be offered as standard clinical care only for disease conditions or indications included in the Ministry’s approved list. Autism is not among those indications. Autism is a neurodevelopmental condition. There is currently no established stem cell treatment that has been shown to cure autism or to provide sufficient evidence of benefit to make it a standard treatment. The Indian Council of Medical Research (ICMR), in its evidence review on stem cell therapy for ASD, examined the available scientific evidence and concluded that it did not support using stem cells in addition to behavioural and supportive therapies. It recommended that stem cell therapy for autism should not be offered as standard or routine therapy and that its therapeutic use should be restricted to approved clinical trials. This distinction is important — a treatment being investigated in a clinical trial does not mean that it has been established as an effective treatment. A clinical trial is the mechanism through which safety and efficacy are tested. The court examined the scientific and regulatory position and held that, given the evidence available at present, stem cell therapy for ASD could not be offered by medical practitioners as a clinical service outside an approved and monitored clinical trial or research setting.
The petition raised concerns about the commercial promotion and administration of stem cell “therapy” for autism. The court also said that, until further research establishes stem cell therapy as a sound and relevant medical practice for ASD, offering it as routine clinical treatment would not meet the reasonable standard of care expected of medical practitioners.
Rather than abruptly discontinuing treatment, the court directed the Health Ministry to work out a mechanism, in consultation with AIIMS and the National Medical Commission, to provide the best possible solution and facilitate their continuation until they could be redirected to institutions conducting clinical trials. It therefore also addressed patients who were already undergoing such treatment before the judgment.
