Comprehensive Outlook of Clinical Trial Laws in India

Dr. Navditya Tanwar

doi:10.55662/JLSR.2025.11402

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Dr. Navditya Tanwar Assistant professor, Himachal Pradesh National Law University, Shimla, India Author

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DOI:

https://doi.org/10.55662/JLSR.2025.11402

Keywords:

Drug Trials, Clinical Trials, Health, Human Rights

Abstract

Discovery of drugs and medical devices has elevated human health. But the process of drug discovery and development comes at a cost. Before any drug is put in market for human use, its efficacy and safety have to be determined. For this purpose, clinical trials are conducted on human because they are meant for human use only. Though it is tested on animals but the results that come out in context of animals generally do not translate in the same sense like it does on animals. Therefore, the process to assess the safety and efficacy of drugs, clinical trials are conducted. The clinical trials on humans are governed by Drugs & Cosmetic Act, 1940 and New Drugs and Clinical Trials Rules, 2019. The article delves into the efficacy of the mechanisms which is put in place. It is difficult because results of trials are unpredictable but at the same time they are necessary to determine the efficacy and safety of drugs and medical devices.

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References

Section 3 (f) of D&C Act, 1940.

GOI, “Report of the Expert Committee on a Comprehensive Examination of Drug Regulatory Issues, Including the problems of Spurious Drugs” (Ministry of Health & Family Welfare, 2003).

WP (Civil) No. 33 of 2012.

AIR 1963 SC 665.

(2005) 2 SCC 762.

(2011) 2 SCC 601.

Writ Petition(s) Civil no. (s.33/2012); W.P. (C) no. 79/2012(PIL-W).

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