Regulation of Clinical Trials and Rights of Participants in India: An Analysis

  • B. Sai Tanushya
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  • B. Sai Tanushya

    Student at School of Law at Christ (Deemed to be University), India.

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This paper shall begin with a brief introduction to a few infamous and unethical clinical trials conducted in India in the past. The author shall discuss the role of the Supreme Court of India in a bid to do away with unethical trials and promote the rights of participants in the country and also discuss whether the Court has been successful in mitigating the practice of unethical clinical trials. The author shall also briefly discuss a few aspects of the New Drugs and Clinical Trial Rules, 2019. This paper shall also throw light on why mere interpretations of the fundamental rights guaranteed by the Constitution of India, 1950 is not sufficient in ensuring the various rights of participants to trials and that there is a need for separate or amendment to existing legislations in order to enforce the same. The author shall also highlight some the loopholes in the current legislation pertaining to clinical trials in India by which these trials violate the rights of participants. The author shall conclude by stating why it is pertinent to regulate clinical trials more efficiently and to ensure the rights of participants of those trials in India.


Research Paper


International Journal of Law Management and Humanities, Volume 5, Issue 4, Page 848 - 857


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