SC Slams 'Experimental' Autism Stem Cell Therapy, Calls for Regulatory Framework

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The Supreme Court has ruled that medical practitioners cannot offer stem cell therapy for Autism Spectrum Disorder (ASD) without proven research, labeling it 'unethical' and a potential case of professional misconduct. The court emphasized that patients cannot give informed consent for unproven treatments, citing the lack of credible scientific evidence supporting the therapy's safety and efficacy. In a 99-page judgment, the court highlighted the need for a regulatory framework to oversee stem cell research, proposing a law that defines stem cells and their derivatives, outlines procedures for clinical trials, and provides guidelines for medical practitioners. The court also suggested the establishment of a dedicated authority to monitor and regulate stem cell research, citing the need for 'clear and well-defined powers of regulatory oversight.' The court's decision comes after a public interest litigation filed by two bodies and two individuals, who questioned the indiscriminate commercial use of stem cell therapy for ASD in the absence of clinical trials or proven research. The petitioners also highlighted the lack of regulatory oversight over stem cell research, which they said enables manipulation of patients' vulnerabilities by errant medical practitioners. In a significant development, the court has asked the Ministry of Health and Family Welfare to propose a way forward for patients who have already consented to the treatment, in consultation with officials from AIIMS and the National Medical Commission. The court has kept the matter for hearing after the Centre comes out with a solution. The court's ruling has significant implications for the use of stem cell therapy in India, where several clinics and hospitals have openly endorsed the treatment despite the lack of proven research. The court's decision is a major setback for parents who have sought this treatment for their children, but it is also a step towards ensuring that patients receive safe and effective treatment.