Open Access Research Article

REGULATORY LOOPHOLES IN POST-TRIAL ACCESS AND INJURY COMPENSATION IN CLINICAL TRIALS: A CRITICAL HEALTH LAW ANALYSIS BY – VRINDA & ANUSHK GARG

Author(s):
VRINDA ANUSHK GARG
Journal IJLRA
ISSN 2582-6433
Access Open Access
Volume 3
Issue 7
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Abstract

ABSTRACT The modernisation of biomedical research regulation has prioritised expedited clinical trial approvals, cross-border data harmonisation, and pharmaceutical investment. However, this commercial acceleration has intensified systemic legal vulnerabilities regarding the protection of human research participants. Under contemporary health law regimes, most notably exemplified by India's New Drugs and Clinical Trials Rules, 2019, enacted under the Drugs and Cosmetics Act, 1940, serious normative and statutory ambiguities persist regarding post-trial access to investigational therapies and financial redress for research-related injuries. While international bioethical covenants such as the Declaration of Helsinki and CIOMS International Ethical Guidelines assert that participants who derive clinical benefit should not face abrupt therapeutic abandonment, domestic health laws frequently condition post-trial access upon discretionary approvals, narrow medical criteria, and coercive liability-waiver agreements. Furthermore, statutory compensation frameworks for trial-induced injuries suffer from acute evidentiary asymmetry. Regulatory formulas mechanistically compensate direct physical impairments while routinely excluding indirect adverse events, delayed sequelae, and mental health repercussions, while placing the evidentiary burden of establishing medical causation on vulnerable subjects. This research paper conducts an exhaustive health law critique of the substantive and procedural lacunae governing post-trial continuity and participant compensation. By analysing primary regulatory statutes, statutory amendments, administrative mechanisms of Institutional Ethics Committees, and pivotal judicial jurisprudence, this study exposes how current regulatory frameworks subordinate human rights to pharmaceutical expediency. It concludes by offering concrete, legally enforceable statutory recommendations in a separate section, including the establishment of an independent No-Fault Clinical Trial Compensation Tribunal, statutory prohibition of exculpatory post-trial liability waivers, mandatory pre-licensure expanded access covenants, and the codification of therapeutic continuity as an enforceable statutory entitlement.

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Authors: VRINDA & ANUSHK GARGRegistration ID: 1013276 | Published Paper ID: IJLRA13276 & IJLRA13277Year: Oct-2026 | Volume: 3 | Issue: 7Approved ISSN: 2582-6433 | Country: Delhi, IndiaPage No.: 312-333

Article Information

REGULATORY LOOPHOLES IN POST-TRIAL ACCESS AND INJURY COMPENSATION IN CLINICAL TRIALS: A CRITICAL HEALTH LAW ANALYSIS BY – VRINDA & ANUSHK GARG

Authors: VRINDA, ANUSHK GARG

  • 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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