Legislative Framework and Role of Judiciary in Clinical Trials in India

Author(s)	Himanshu Goyal
Country	India
Abstract	This research paper explores the legislative framework governing clinical trials in India and the role of the judiciary in ensuring their compliance. India has emerged as a preferred destination for clinical trials, primarily due to the country's large and diverse patient population. However, this has also brought to light several ethical and legal issues surrounding clinical trials. The paper begins by examining the regulatory framework for clinical trials in India, including the Drugs and Cosmetics Act, the Indian Council of Medical Research Guidelines, and the Clinical Trials Registry - India. The paper then delves into the role of the judiciary in overseeing clinical trials, particularly in cases of ethical violations and compensation claims. The research analyses landmark cases in the Indian legal system and their implications for clinical trial regulation.
Keywords	Clinical Trials, Drugs and Cosmetics Act, Clinical Trial Rules, ICMR.
Field	Sociology > Administration / Law / Management
Published In	Volume 5, Issue 2, March-April 2023
Published On	2023-03-23
Cite This	Legislative Framework and Role of Judiciary in Clinical Trials in India - Himanshu Goyal - IJFMR Volume 5, Issue 2, March-April 2023. DOI 10.36948/ijfmr.2023.v05i02.1994
DOI	https://doi.org/10.36948/ijfmr.2023.v05i02.1994
Short DOI	https://doi.org/gr2km3

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