|
Unproven Stem Cell Therapy for Autism Treatment
The Union Ministry of Health & Family Welfare issues an advisory to regulate the use of stem cell therapy, stressing that unproven stem cell interventions are to be restricted. The advisory specifically addresses the application of stem cells for Autism Spectrum Disorder (ASD) treatment and links compliance to the statutory framework reinforced by a Supreme Court judgement.
Advisory on Regulation of Stem Cell Therapy for Autism:
| Dimension | Key Details |
|---|---|
| Approval status | Stem cell therapy is not approved as a routine standard of care. |
| Permitted use | Use of stem cell therapy is permitted only within duly approved clinical trials. |
| Mandatory compliance framework | All applications must comply with the National Guidelines for Stem Cell Research, 2017. |
| Scope of restriction | The restriction applies to the therapeutic use of all types of stem cells in the context of autism. |
| National Guidelines for Stem Cell Research, 2017 | The guidelines are jointly issued by the Indian Council of Medical Research (ICMR) and the Department of Biotechnology (DBT). |
| National Guidelines for Stem Cell Research, 2017 | The guidelines establish the framework for stem cell research and its translation into clinical applications. |
| Supreme Court case linked to advisory | The Ministry’s 2026 advisory is issued pursuant to the Supreme Court judgment in Yash Charitable Trust & Ors. v. Union of India & Ors.. |
| Supreme Court emphasis | The Court underscores the necessity of adhering to the statutory framework regulating stem cell therapy. |
| Consequences of non-compliance | Violations of statutory requirements may result in: professional misconduct under Regulation 7.22 of the Indian Medical Council (IMC) Regulations, 2002; cancellation of registration and imposition of penalties under Sections 32 and 40 of the Clinical Establishments Act, 2010. |
| National Medical Commission (NMC) advisory reaffirmation | Stem cell therapy is permitted as standard clinical care exclusively for indications that have received official approval. |
| Prohibited actions without authorisation | The following actions, when conducted without proper authorization, are prohibited: administration, prescription, promotion, and advertisement of stem cell therapy for unapproved indications. |
| Advertisement and professional misconduct | Advertisement of stem cell therapy for unapproved indications may constitute professional misconduct. |
| Role of State Medical Councils | State Medical Councils are instructed to investigate alleged violations, adhere to due process, determine the presence of professional misconduct, and implement appropriate disciplinary measures. |