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International Journal of Zoology and Applied Biosciences Research Article
Regulatory framework for clinical trials in India post-2019 reforms: A critical evaluation
Rajkiran Kolakota, Uriti Sri Venkatesh, Gembali Manojkumar, Ganasala Veera Gowtham
Year : 2026 | Volume: 11 | Issue: 4 | Pages: 196-199
Received on: 30/04/2026
Revised on: 25/05/2026
Accepted on: 22/06/2026
Published on: 01/07/2026
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Rajkiran Kolakota, Uriti Sri Venkatesh, Gembali Manojkumar, Ganasala Veera Gowtham( 2026).
Regulatory framework for clinical trials in India post-2019 reforms: A critical evaluation
. International Journal of Zoology and Applied Biosciences, 11( 4), 196-199.
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Abstract
India has emerged as a key global destination for clinical research; however, ethical concerns and regulatory uncertainties during the early 2010s exposed significant weaknesses in its clinical trial governance system. In response, the Government of India introduced the New Drugs and Clinical Trials (NDCT) Rules, 2019, replacing Schedule Y of the Drugs and Cosmetics Rules, 1945. The reforms aimed to enhance ethical oversight, streamline approval processes, define compensation mechanisms, and align Indian regulations with international standards such as ICH-GCP. This paper critically evaluates the post-2019 regulatory framework for clinical trials in India, examining structural reforms, approval timelines, ethics committee oversight, safety reporting, compensation provisions, and digital regulatory initiatives. The study also discusses the impact of these reforms on India’s clinical research landscape and identifies ongoing implementation challenges. The NDCT Rules have significantly strengthened transparency and participant protection; however, continuous capacity building and harmonization with evolving global standards remain essential.
Keywords
Clinical Trials, NDCT Rules 2019, CDSCO, Regulatory Reforms, Ethics Committee, India.
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© The Author(s) 2025. This article is published by International Journal of Zoology and Applied Biosciences under the terms of the Creative Commons Attribution 4.0 International License (creativecommons.org), which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.
