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New Delhi: Observing that doctors administering speculative, unproven or experimental treatments on patients amounts to professional misconduct and negligence, Supreme Court on Friday said stem cell therapy cannot be used for Autism Spectrum Disorder (ASD) as it has not been approved for clinical treatment and expressed displeasure that the Centre has not taken suitable action to prevent it.A bench of Justices J B Pardiwala and R Mahadevan also directed putting in place rules, regulations and guidelines to govern stem cell-based clinical trials and research in the country.“A medical practitioner who administers speculative, unproven or experimental treatment even when credible professional bodies have expressly advised against the use of such an intervention, may be held liable on count of professional misconduct. We say so because the administration of such a treatment would fail to satisfy the standard of reasonable care necessitated under the established medical negligence jurisprudence in India,” the bench said.It said every medical practitioner owes to his or her patient a duty to exercise a reasonable degree of care, skill and knowledge expected of a prudent practitioner in the field. “A medical practitioner cannot be said to meet the standard of reasonable care if he administers an intervention that lacks credible scientific evidence of safety and efficacy, or where authoritative medical bodies unequivocally state that such form of treatment is not recommended,” the bench said. The court noted that although stem cells administered for therapeutic use in ASD are characterised as “drugs” under the Drugs Act, 1940, yet the same by itself is not determinative of the fact that it is permissible to be administered as a clinical service. It said if a medical intervention is characterised as unproven, experimental, obsolete or lacking justification by the scientific community, then such an intervention cannot be allowed by doctors.“It is unfortunate that the Union has let the matter worsen without any suitable and timely intervention. Such inaction has led to several parents/guardians seeking an unproven method of treatment for their children suffering from ASD, incurring huge financial cost and in alternative to other approved treatments,” the Supreme Court said.It said, “It cannot be denied that various clinics, in flagrant violation of the statutory mandate, continued to recommend and perform stem cell therapy as a routine clinical treatment for ASD because there was lack of executive action against the same. Therefore, we urge the Union to consolidate and clarify the position of law for enabling better implementation of the same in this regard at the earliest.”
