Facts: A Public Interest Litigation (PIL) was filed raising concerns about the unregulated promotion and administration of stem cell therapy for Autism Spectrum Disorder (ASD) by various clinics across India. The petitioners argued that these therapies are being offered as a cure despite lacking scientific validation and violating existing legal frameworks. They highlighted the exploitation of vulnerable individuals and the absence of safety nets.
Procedural Posture: The Supreme Court of India heard the PIL, filed due to the alleged failure of respondents (Union of India & Ors.) to enforce existing regulations. The Court considered submissions from various parties, including the petitioners, Union of India, National Medical Commission (NMC), and private entities offering stem cell therapies. The Court also took note of an interim order by the Delhi High Court in Dalip Kaur v. Union of India, which permitted the continuation of stem cell treatment for specific patients, emphasizing patient autonomy.
Issue: 1. Are doctors/clinics/hospitals legally permitted to offer stem cell 'therapy' as a routine healthcare service for ASD? 2. Do the Drugs Act, 1940 and the New Drugs and Clinical Trial Rules (NDCT), 2019 provide a sufficient regulatory framework for stem cell therapies used in the treatment of ASD?
Holding: 1. No, stem cell therapies for ASD cannot be offered as a routine clinical service outside of an approved and monitored clinical trial/research setting. 2. The Drugs Act, 1940 and NDCT Rules, 2019, along with the National Ethical Guidelines, provide a regulatory framework, but it requires better consolidation and clarity.
Reasoning: The Court relied on established medical negligence jurisprudence, emphasizing the "Bolam Test" and the standard of reasonable care. It found that stem cell therapy for ASD lacks sufficient scientific evidence of safety and efficacy, and authoritative medical bodies do not recommend it as a routine treatment. The Court emphasized that medical practitioners must adhere to evidence-based medical norms and avoid speculative or unproven interventions. While acknowledging patient autonomy and the right to choose treatment, the Court clarified that this right is contingent on informed consent, which is impossible when adequate information about the treatment's efficacy and risks is lacking. The Court clarified the regulatory pathway for stem cell research, distinguishing between "stem cell derived products" and other stem cell therapies, and emphasized the importance of ethical oversight and adherence to ICMR guidelines. The Court also noted the dissolution of the National Apex Committee for Stem Cell Research and Therapy (NAC-SCRT) and urged the Union to clarify the regulatory mechanism and designate an authority for oversight.