Supreme Court Declares Stem Cell Therapy for Autism as Unproven and Experimental
In a landmark judgment, the Supreme Court of India has firmly stated that stem cell therapy cannot be used for treating Autism Spectrum Disorder (ASD), as it lacks approval for clinical treatment. The court expressed strong disapproval over the Centre's failure to take appropriate action to prevent such unproven therapies.
Court's Stance on Medical Negligence and Professional Misconduct
A bench comprising Justices J B Pardiwala and R Mahadevan emphasized that doctors administering speculative, unproven, or experimental treatments on patients are committing professional misconduct and negligence. The bench highlighted that medical practitioners must adhere to a standard of reasonable care, skill, and knowledge expected in their field.
The bench articulated: "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."
It further explained that administering interventions lacking credible scientific evidence of safety and efficacy, or those not recommended by authoritative medical bodies, fails to meet this standard of care.
Regulatory Gaps and Centre's Inaction
The court noted that despite stem cells for therapeutic use in ASD being classified as "drugs" under the Drugs Act, 1940, this does not permit their administration as a clinical service. It criticized the Union government for allowing the situation to deteriorate without timely intervention, leading many parents to seek unproven treatments for their children with ASD.
The Supreme Court remarked: "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."
Directives for Future Regulations
To address these issues, the bench directed the establishment of comprehensive rules, regulations, and guidelines to govern stem cell-based clinical trials and research in India. It urged the Centre to consolidate and clarify the legal position to ensure better implementation and prevent clinics from violating statutory mandates.
The court's decision underscores the importance of evidence-based medicine and aims to protect patients from exploitative and ineffective treatments, setting a precedent for stricter oversight in medical practices.
