Open Access Research Article

FROM PRODUCT TO PROCEDURE: RETHINKING THE LEGAL REGULATION OF STEM-CELL THERAPIES IN INDIA

Author(s):
SAKSHAM MISHRA SIDDHI MISHRA
Journal IJLRA
ISSN 2582-6433
Access Open Access
Volume 3
Issue 7
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Abstract

Stem-cell therapy presents one of the most difficult problems for contemporary health law because it occupies an uncertain space between scientific research, regulated medical products and clinical procedures. India does not lack legal instruments governing this field. The Drugs and Cosmetics Act 1940, the New Drugs and Clinical Trials Rules 2019, the National Guidelines for Stem Cell Research 2017, the National Ethical Guidelines for Biomedical and Health Research, professional ethics regulations and the Clinical Establishments Act 2010 collectively regulate different aspects of stem-cell research and treatment. Yet these instruments were not designed as one coherent framework for the complete movement of a cellular intervention from laboratory research to clinical practice. The Supreme Court’s decision in Yash Charitable Trust v Union of India in January 2026 exposed this structural difficulty while firmly rejecting the routine clinical administration of unproven stem-cell therapy for autism spectrum disorder. This article argues that the central problem is not the absence of regulation but a regulatory mismatch between product-oriented drug law and procedure-oriented medical practice. Minimally manipulated and autologous interventions demonstrate this problem particularly clearly. The article examines the classification of stem-cell interventions, the relationship between scientific evidence and the legal standard of care, the status of professional and ethical guidelines, institutional fragmentation, patient autonomy, and the implementation challenges that followed the Supreme Court’s decision. It argues for a coherent, tiered regulatory pathway connecting research, clinical trials, conditional access and established clinical care while preserving strong safeguards against the commercialisation of experimental medicine.  

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Authors: SAKSHAM MISHRA & SIDDHI MISHRARegistration ID: 1013338 | Published Paper ID: IJLRA13338 & IJLRA13339Year: Oct-2026 | Volume: 3 | Issue: 7Approved ISSN: 2582-6433 | Country: Delhi, IndiaPage No.: 893- 917

Article Information

FROM PRODUCT TO PROCEDURE: RETHINKING THE LEGAL REGULATION OF STEM-CELL THERAPIES IN INDIA

Authors: SAKSHAM MISHRA, SIDDHI MISHRA

  • Journal IJLRA
  • ISSN 2582-6433
  • Volume 3
  • Issue 7
Citation Download Paper Full Details Search on Google Search on Google Scholar

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International Journal for Legal Research and Analysis

  • AbbreviationIJLRA
  • ISSN2582-6433
  • AccessOpen Access
  • LicenseCC 4.0

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