The Supreme Court on Friday prohibited the administration of stem cell therapy (SCT) as a routine clinical intervention for Autism Spectrum Disorder (ASD), noting that it lacked empirical validation and was not recognised within the framework of accepted medical practice.
The Bench of Justice JB Pardiwala and Justice R Mahadevan observed that the therapy may only be undertaken within the context of regulated and monitored clinical research.
Upon consideration of the recommendations issued by the Ethics and Medical Registration Board (EMRB) of the National Medical Commission (NMC) dated December 6, 2022, in conjunction with the Ethical Guidelines for Biomedical and Stem Cell Research, 2017, and the National Ethical Guidelines formulated by the Indian Council of Medical Research (ICMR), the Court concluded that therapeutic use of stem cells for ASD was not endorsed as routine treatment.
The Bench pointed out that these guidelines explicitly prescribed that any clinical application of stem cells must occur solely within the ambit of approved research protocols designed to generate scientific knowledge and medical advancement.
The administration of SCT outside a regulated trial infringed established ethical norms and fell below the “standard of care” owed to patients, it noted, referencing precedents including M.A. Biviji v. State of Maharashtra and V.P. Shantha v. Indian Medical Association, which delineate the responsibilities of medical practitioners in adhering to recognized therapeutic standards.
On the issue of patient autonomy, the Court held that the right to consent was contingent upon adequate disclosure of information. Drawing upon Samira Kohli v. Dr. Prabha Manchanda, it was observed that consent to unproven interventions could not be considered valid in the absence of adequate information. Patients consenting to SCT for ASD may be subject to therapeutic misconception, erroneously assuming the procedure’s efficacy in line with established treatments. The continuation of treatment under such conditions constitutds a breach of medical ethics.
The Court further examined the applicability of the Drugs and Cosmetics Act, 1940, and the New Drugs and Clinical Trials (NDCT) Rules, 2019.
While autologous stem cells may not qualify as “new drugs” under the NDCT Rules, they were nonetheless encompassed within the statutory definition of “drugs” under Section 3(b)(i) of the Drugs Act. The administration and research of stem cell therapies fell within the regulatory ambit established by the Act and the NDCT Rules, it added.
The Bench clarified that stem cell-derived products were subject to the clinical trial framework applicable to new drugs under the NDCT Rules and the Drugs Act, whereas minimally manipulated stem cells not qualifying as new drugs must comply with the regulatory provisions for biomedical and health research under Chapter IV of the NDCT Rules.
This included binding adherence to the National Ethical Guidelines, which mandate that SCT involving human participants, excepting haematopoietic stem cell transplantation for hematological disorders, be conducted exclusively within clinical trial settings.
The Bench directed the Union government to consolidate and clarify its policy regarding SCT for ASD to prevent the administration of unproven therapies outside approved trials.
Patients currently receiving SCT were advised to be rerouted to institutions conducting regulated clinical research, with the Ministry of Health and Family Welfare, in consultation with AIIMS and the National Medical Commission, tasked to provide a solution within four weeks.
Filed by Yash Charitable Trust, an NGO based in Mumbai, along with Dr. Vibha Krishnamurthy, the Forum for Medical Ethics Society represented by Dr. Sanjay Nagral, and KS Ganpathy, a parent of a child subjected to SCT for ASD, the petition sought enforcement of statutory provisions under the Drugs and Cosmetics Act, 1940, and the NDCT Rules, 2019.
The plea highlighted that SCT for ASD was widely promoted despite the absence of clinical validation. ASD, characterised by deficits in communication, social interaction, and repetitive behaviors, currently lacks a curative intervention, with existing therapies such as behavioral, occupational, and speech therapies remaining the standard of care. The petition emphasised that clinics offering SCT exploit patient vulnerability and charge substantial fees without evidence-based justification.
The Court noted that the Committee on Stem Cell Use in Autism Spectrum Disorder, constituted by the EMRB-NMC on December 6, 2022, confirmed that international guidelines did not recommend SCT for ASD, reinforcing the therapy’s experimental status.
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