Context
The Ministry of Health and Family Welfare (MoHFW) has directed that stem cell therapy can be offered as standard clinical care only for officially approved disease conditions. For Autism Spectrum Disorder (ASD), stem cell use remains restricted to approved clinical trials and cannot be offered as routine commercial treatment.
Explanation
- Stem cells are unspecialised cells capable of self-renewal and differentiation into specialised cell types, giving them potential in regenerative medicine.
- In India, stem cell research is governed by the National Guidelines for Stem Cell Research, 2017, issued jointly by the Indian Council of Medical Research (ICMR) and Department of Biotechnology (DBT).
- Stem cell therapy can be standard care only for indications approved by MoHFW; other therapeutic uses remain investigational.
- For ASD, therapeutic use of any type of stem cell is permitted only through approved clinical trials.
- The advisory follows the Supreme Court’s 2026 judgment in Yash Charitable Trust v. Union of India.
- States and Union Territories covered by the Clinical Establishments (Registration and Regulation) Act, 2010 must enforce these requirements.
- Unauthorised treatment, promotion or advertisement may invite professional disciplinary action, penalties or cancellation of clinical-establishment registration.
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Union Health Ministry Tightens Regulation of Stem Cell Therapy