Stem Cell Therapy Can't Be Used As Treatment For Autism; Can Be Used Only For Clinical Trial : Supreme Court

The Supreme Court today(January 30) held that offering Stem Cell Treatment(SCT) therapy as a clinical service for curing Autism Spectrum Disorder(ASD) amounts to malpractice. This is because the SCT as a treatment for ASD lacks scientific support and has not been recognised as a sound medical practice backed by empirical evidence. A bench comprising Justice JB Pardiwala and Justice R Mahadevan, however, added that SCT can still be approved for monitored clinical research trials.The bench framed two issues for consideration:1. Whether doctors/clinics/hospitals/institutions are legally permitted to offer stem cell 'therapy' as a routine healthcare service?Answer: A perusal of the EMRB-NMC Recommendations dated 06.12.2022, read with the EBSSCT, 2021, the NGSCR, 2017 and the National Ethical Guidelines respectively, formulated by the ICMR indicates that the therapeutic use of stem cells for treatment of ASD is not recommended as routine clinical treatment. These documents indicate that the therapeutic use of stem cells for the treatment of ASD is not recognized as a sound and relevant medical practice due to the lack of scientific support and empirical evidence regarding its efficacy. It is categorically mentioned therein that any stem cell use in patients must only be done within the purview of an approved and monitored clinical trial with the intent to advance science and medicine, and not offering it as therapy. "Therefore, every use of stem cells in patients outside an approved clinical trial is unethical and shall be considered as malpractice. Therefore, medical practitioners who offer such stem cell therapy as a routine clinical service and not in a research/clinical trial setting, could be said to be failing to meet the reasonable “standard of care” owed by them towards the patients as expounded by this Court in M.A. Biviji (supra) and V.P. Shantha (supra)."The Court also answered whether patient autonomy enables a person to give consent to an unproven treatment. "we are of the considered view that a treatment cannot be demanded by a patient as a matter of right. This Court's dictum in Samira Kohli (supra) underscores that adequate information as regards a particular treatment, is the bedrock and the consent thereto should be on the basis of such adequate information. It is undisputed that stem cell therapy for treatment of ASD does not fulfil the essentials of 'adequate information'. The validity of consent stems from the nature and information available about the treatment. In the absence of such knowledge, the patients may remain under therapeutic misconception and anticipate such results from an unproven treatment as may be expected from routine treatment and care."Following through with the medical treatment even when patients are under such misconception is, in our view, a gross violation of medical ethics, the Court said. It said that patients may have voluntarily opted for such procedure, yet, such choices does not amount to a valid consent to undergo the treatment due to the lack of "adequate treatment".2. Whether the Drugs Act, 1940 and the NDCT Rules, 2019, provide a framework for the regulation of research in stem cell therapies which are used for the treatment of ASD?Answer: Though autologous stem cells, such as those used for the therapy provided to persons with ASD, may not meet the criteria of being a 'new drug' under the NDCT Rules, 2019, yet they fall under the broader definition of “drugs” in the Drugs Act, 1940. "We say so because all stem cells fall within the purview of “drugs” as 'substances' under Section 3(b)(i) of the Drugs Act, 1940. Therefore, there is no gainsaying that the scheme of the Drugs Act, 1940 envisages providing protections being available in respect of stem cell therapy for ASD. We find that Chapter IV of the NDCT Rules, 2019, which relates to Biomedical and Health Research, provides such safeguards and the necessary regulatory pathway in respect of stem cell therapy for ASD."The regulatory framework is as follows:1. In case of administration of “stem-cell derived products”, the regulatory framework applicable to clinical trials of “new drugs” under the NDCT, 2019 read with the Drugs Act, 1940 and the Drugs Rules, 1945 is attracted. 2. The stem cells which have not undergone processing by means of substantial or more than minimal manipulation, would not be considered as “new drug” under the NDCT Rules, 2019. "In such circumstances, any research involving such stem cells is to be governed by the regulatory framework in place for “biomedical and health research” under Chapter IV of the NDCT Rules, 2019. Rules 15 and 16(4) respectively, thereof provide binding effect to the National Ethical Guidelines, which in turn provides in Clause 7.9.1 that any use of stem cells involving human participants (except for haemopoietic stem cell transplantation for haematological disorders) shall be undertaken as a clinical trial. Furthermore, Clause 4.2.4 of the National Ethical...

Stem Cell Therapy Can't Be Used As Treatment For Autism; Can Be Used Only For Clinical Trial : Supreme Court

Gursimran Kaur Bakshi

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