Supreme Court ruled that stem cell therapy for Autism Spectrum Disorder cannot be provided as a clinical service outside approved clinical trials

Supreme Court ruled that stem cell therapy for Autism Spectrum Disorder cannot be provided as a clinical service outside approved clinical trials

¨     Supreme Court ruled that stem cell therapy for Autism Spectrum Disorder (ASD) cannot be provided as a clinical service outside approved clinical trials.

¨     A bench of Justices J.B. Pardiwala and R. Mahadevan criticized the central government for failing to act against those offering such therapy, due to which parents and guardians of children suffering from ASD are spending huge amounts of money and adopting an unproven method of treatment.

¨     At the same time, the Court directed the central government to establish a dedicated regulatory authority for stem cell research.

¨     The Court held that there is no solid evidence of safety and efficacy in such treatment and therefore it does not conform to the standards of proper care to be provided by medical practitioners to patients.

¨     There has also been a lapse on the part of the government in allowing stem cell therapy, which violates the New Drugs and Clinical Trial Rules, 2019 issued under the Drugs and Cosmetics Act, 1940 and the National Guidelines for Stem Cell Research, 2017 published by the Indian Council of Medical Research.

Supreme Court decisions

¨     Informed consent: For the validity of informed consent, clear scientific evidence on safety, effectiveness, risks and alternatives is required. Currently, sufficient evidence for stem cell therapy in autism is not available, making such clinical use ethically and legally inappropriate.

¨     Ethical limits on patient autonomy: The Court clarified that consent of the patient or guardian cannot justify treatments that are scientifically unproven, ethically inappropriate, or outside accepted medical practice.

¨     Violation of legal framework: Such acts violate the New Drugs and Clinical Trial Rules, 2019 as well as the National Guidelines for Stem Cell Research-2017 issued by the Indian Council of Medical Research (ICMR).

stem cells

¨     Stem cells are specialized types of cells that form specific cells such as blood, bone and muscles and play an important role in tissue regeneration and bodily functions.