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Paper Title: A CRITICAL STUDY ON CLINICAL TRIALS UNDER THE NEW DRUGS AND CLINICAL TRIALS RULES, 2019 AND DATA EXCLUSIVITY UNDER TRIPS AGREEMENT: COMPARATIVE ANALYSIS OF THE US, EU, AND INDIA
Authors Name: Kavya. S , MB Swathi , Ra. Hinia Mirzha , Sandhiya Shree. U
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Published Paper Id: IJRTI2605171
Published In: Volume 11 Issue 5, May-2026
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Abstract: Clinical trials constitute an indispensable component of pharmaceutical innovation, ensuring the safety, efficacy, and quality of medicinal products before they are introduced into the market. In India, the enactment of the New Drugs and Clinical Trials Rules, 2019 (NDCTR, 2019) marked a significant shift in the regulation of clinical research by introducing stricter ethical safeguards, streamlined approval procedures, compensation mechanisms, and enhanced responsibilities for sponsors and ethics committees. Simultaneously, the increasing importance of intellectual property protection under the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS Agreement), particularly Article 39.3 concerning protection of undisclosed pharmaceutical test data, has intensified the debate surrounding data exclusivity and access to medicines. The present dissertation critically analyses the legal and ethical framework governing clinical trials under the NDCTR, 2019 and examines the concept of data exclusivity under the TRIPS Agreement through a comparative analysis of the United States, the European Union, and India. The study explores the conflict between pharmaceutical innovation and public health interests, particularly in relation to the availability of affordable generic medicines. The research evaluates whether India’s present legal framework sufficiently balances obligations under international intellectual property law with constitutional commitments towards public health and access to healthcare. The dissertation further analyses landmark judicial decisions such as Novartis AG v. Union of India, which shaped India’s approach towards pharmaceutical monopolies and public health safeguards. The study concludes that India has adopted a comparatively balanced regulatory approach by strengthening clinical trial governance while refraining from introducing TRIPS-plus data exclusivity obligations that may adversely affect access to medicines.
Keywords: Clinical Trials, NDCTR 2019, Data Exclusivity, TRIPS Agreement, Article 39.3, Pharmaceutical Regulation, Public Health, Generic Medicines, Intellectual Property Rights, CDSCO, FDA, EMA, Access to Medicines, Pharmaceutical Test Data
Cite Article: "A CRITICAL STUDY ON CLINICAL TRIALS UNDER THE NEW DRUGS AND CLINICAL TRIALS RULES, 2019 AND DATA EXCLUSIVITY UNDER TRIPS AGREEMENT: COMPARATIVE ANALYSIS OF THE US, EU, AND INDIA", International Journal for Research Trends and Innovation (www.ijrti.org), ISSN:2456-3315, Vol.11, Issue 5, page no.b622-b637, May-2026, Available :http://www.ijrti.org/papers/IJRTI2605171.pdf
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ISSN: 2456-3315 | IMPACT FACTOR: 8.14 Calculated By Google Scholar| ESTD YEAR: 2016
An International Scholarly Open Access Journal, Peer-Reviewed, Refereed Journal Impact Factor 8.14 Calculate by Google Scholar and Semantic Scholar | AI-Powered Research Tool, Multidisciplinary, Monthly, Multilanguage Journal Indexing in All Major Database & Metadata, Citation Generator
Publication Details: Published Paper ID: IJRTI2605171
Registration ID:212974
Published In: Volume 11 Issue 5, May-2026
DOI (Digital Object Identifier):
Page No: b622-b637
Country: Chennai, Tamil Nadu, India
Research Area: Other
Publisher : IJ Publication
Published Paper URL : https://www.ijrti.org/viewpaperforall?paper=IJRTI2605171
Published Paper PDF: https://www.ijrti.org/papers/IJRTI2605171
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ISSN: 2456-3315
Impact Factor: 8.14 and ISSN APPROVED, Journal Starting Year (ESTD) : 2016

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