Case Note & Summary
This Public Interest Litigation was filed by Yash Charitable Trust and others before the Supreme Court, raising concerns about the rampant promotion and administration of stem cell therapy for Autism Spectrum Disorder (ASD) by various clinics across India. The petition alleged that such therapy is still at an experimental stage yet is being touted as a cure, in violation of the Drugs and Cosmetics Act, 1940, the New Drugs and Clinical Trial Rules, 2019, and the National Guidelines for Stem Cell Research, 2017 issued by the Indian Council of Medical Research. The petitioners claimed that individuals with ASD and their families, unaware of the scientific and legal nuances, fall victim to cost-intensive procedures lacking safety nets. The petition, filed on 06.05.2022 and first listed on 20.05.2022, provided an illustrative list of clinics offering stem cell treatments. It noted that on 04.08.2017, the Ministry of Health and Family Welfare informed the Lok Sabha about 59 entities engaged in such practices, but enforcement was lacking. During the proceedings, several developments occurred: the Ethics and Medical Registration Board of the National Medical Commission issued recommendations on 06.12.2022, declaring the use of stem cells in ASD as professional misconduct; the National Apex Committee for Stem Cell Research and Therapy was dissolved on 03.03.2024; and the Delhi High Court, in an interim order dated 31.08.2023 in Dalip Kaur v. Union of India, permitted certain patients to continue stem cell treatment at their own risk, emphasizing patient autonomy. The core legal issues before the Supreme Court included the maintainability of the PIL, the nature of stem cell therapies, their permissibility as a service, the right to choose treatment in light of consent and autonomy, and whether stem cells fall under the definition of a drug under the Drugs Act, thereby requiring clinical trial approval. The court examined submissions from the petitioners, who argued that the therapy is unproven and its commercialisation is illegal and harmful, and from the respondents, including the Union of India and the National Medical Commission, though their arguments were not fully detailed in the available excerpt. The court’s analysis was structured to assess the regulatory framework, the significance of various expert recommendations, and the consequences of non-compliance. As the judgment text provided is incomplete, the final decision and ratio decidendi are not available. However, from the headings, it appears the court intended to lay down a regulatory pathway and emphasize the need for compliance with the Drugs Act and clinical trial rules.
Issue of Consideration
Legal permissibility of administering stem cells for palliative and/or curative treatment of Autism Spectrum Disorder by clinics
Law Points
- Stem cell therapy for ASD is at experimental stage and not proven
- Promotion of unapproved therapies violates Drugs Act and NDCT Rules
- Patient autonomy does not override lack of safety and efficacy data
- Use of stem cells for therapeutic purposes requires clinical trial approval under regulatory framework
