The evolving architecture of India’s clinical-trial rules, 2019-2026: a chronological appraisal and stakeholder analysis of the New Drugs and Clinical Trials Rules and their amendments

Abstract

India replaced the decades-old Schedule Y regime with the New Drugs and Clinical Trials (NDCT) Rules, 2019, promising a framework that would both speed up clinical research and protect the people who take part in it. Most published accounts examine one stakeholder at a time, most often the ethics committee, and treat the Rules as a static document, even though the framework has kept changing. This paper does two things at once. First, it reads the architecture of Indian clinical-trial regulation and its amendments as a single, continuous evolution: statutory timelines and deemed approval (2019), consolidation of the as-amended text (2022), a draft and then enacted registration regime for clinical research organisations (CROs) (2023-2024), digital onboarding through the SUGAM portal and a draft Indian Good Clinical Practice text aligning toward ICH E6(R3) (2025), and a 2026 cluster easing test-licence, bioavailability/bioequivalence and ethics-committee requirements, of which two amendments are now in force and two remain in draft. A consistent direction emerges toward predictability, speed and formalisation. Second, it asks whose interests that trajectory has served, reading the text alongside India-specific implementation evidence across sponsors, CROs, investigators and sites, ethics committees, participants, and the regulator. We argue that facilitation has outpaced protection. The compensation formula has lost about a third of its real value since 2013, and ethics committees carry expanded duties without commensurate capacity. We close with three concrete recommendations: revisit the compensation formula, mandate results disclosure, and resource ethics-committee oversight.