Legal implications in clinical trials for cancer in India: A comprehensive analysis of regulatory and ethical challenges, navigating consent, compliance, and participant protection in oncology trials

• Author Details:   
• Anmol Mahani ^*
• Rudranath Zadu

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Background: Clinical trials for cancer play a critical role in developing new therapies and enhancing patient care. However, there are particular ethical and legal issues with these trials, especially with regard to participant safety, regulatory compliance, and patient consent. The New Drugs and Clinical Trials Rules, 2019 in India offer a framework that prioritizes data transparency, participant rights, and ethical oversight. This article explores the intricate regulatory environment and emphasizes how crucial strong ethical standards are when performing oncology trials.

Aims and Objectives: This review aims to assess the ethical and legal aspects of cancer trials in India, with a specific focus on informed consent and compliance with the New Drugs and Clinical Trials Rules, 2019.

Materials and Methods: The Drugs and Cosmetics Act of 1940, the New Drugs and Clinical Trials Rules of 2019, and the Indian Council of Medical Research (ICMR) guidelines are among the pertinent Indian laws and regulations that are reviewed in this study. Judicial precedents were also examined to assess their impact on clinical trial practices, with additional insights drawn from secondary literature on patient consent, ethics, and challenges specific to oncology.

Conclusion: Future improvements should focus on harmonising national regulations with global standards and enhancing participant protections, especially in complex fields like oncology.

Keywords: Clinical trials, Cancer research, Legal implications, Informed consent, Regulatory compliance, India, Research ethics, Patient rights.