Stem cell 'therapies' for Autism Spectrum Disorder: SC grants 4 weeks to Centre for detailed report
In a verdict delivered on January 30, the apex court said that stem cell 'therapies' for ASD cannot be offered by medical practitioners as a clinical service outside an approved and monitored clinical trial or research setting.
The Supreme Court recently granted the Indian Centre four weeks to submit a comprehensive status report regarding the implementation of its directions concerning stem cell therapies for Autism Spectrum Disorder (ASD). In a verdict delivered on January 30, the apex court emphasized that stem cell therapies for ASD cannot be offered as clinical services outside of approved and monitored clinical trials or research settings. The court deemed such usage unethical and a form of malpractice.
This decision came about in response to a plea raised by several clinics across the country that were promoting, prescribing, and administering stem cell therapies for the treatment of ASD. The bench of Justices J B Pardiwala and R Mahadevan acknowledged that the issue at hand relates to the compliance of the court's directions issued in its judgment.
During the hearing on Thursday, the bench inquired whether the Centre needed more time to file an exhaustive compliance report. Solicitor General Aishwarya Bhati representing the Centre argued for three weeks instead of the initially proposed four weeks. The bench ultimately decided to grant the Centre four weeks to file a detailed status report, which would encompass all aspects of the matter.
This report would specifically address the manner in which the Union has addressed the court's judgment, the implementation of the issued directions, and the steps taken thus far.
In its January 30 verdict, the top court acknowledged that patients already undergoing stem cell therapies should not be left in apprehension about the discontinuation of the treatment. However, the court also maintained its stance that stem cell therapy for ASD should not be allowed to continue as a commercial enterprise acting as routine clinical treatment.
The court directed the secretary of the Ministry of Health and Family Welfare, along with officials from AIIMS and the National Medical Council, to find the best possible solution to ensure that patients could continue receiving therapy until they could be transferred to institutions conducting clinical trials.
It is essential to note that, while stem cells used for therapeutic purposes in ASD are classified as drugs under the Drugs Act of 1940, this fact alone does not determine their permissibility as clinical services.
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