Legislative Framework of Clinical Trial in India: A Critical Appraisal

  • Dr. Ranjeet Mohanty and Pratyay Ghatak
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  • Dr. Ranjeet Mohanty

    Principal & Chief Executive at School of Law, Prativa IMTSOL, Mancheswar IE, Bhubaneswar, India

  • Pratyay Ghatak

    PhD scholar at Vellore Institute of Technology Chennai, Tamil Nadu, India

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Abstract

The word clinical trial is self-explanatory. The need to constantly update medical science is a must for the survival of humanity, however questions arise as to what extent clinical trials should be permitted or how the procedures of such experimentation have to carried on or the importance of ‘consent’ of persons subjecting themselves to the procedures. It is in this backdrop this article seeks to scrutinize, analyse and dissect clinical trials strictly from the humanitarian-legal point of view. This research has been undertaken with the objectives of understanding India’s current legal framework with respect to clinical trials, legislative lacuna and judicial perceptions and receptions of the same.

Keywords

  • Drug and Cosmetics Rules
  • clinical trial
  • ‘consent’ of persons
  • illegal and unethical trials

Type

Research Paper

Information

International Journal of Law Management and Humanities, Volume 9, Issue 1, Page 155 - 162

DOI: https://doij.org/10.10000/IJLMH.1111220

Creative Commons

This is an Open Access article, distributed under the terms of the Creative Commons Attribution -NonCommercial 4.0 International (CC BY-NC 4.0) (https://creativecommons.org/licenses/by-nc/4.0/), which permits remixing, adapting, and building upon the work for non-commercial use, provided the original work is properly cited.

Copyright

Copyright © IJLMH 2021