Regulatory overview on New Drugs and Clinical Trials Rules, 2019
Most clinical studies were carried out in the United States, Europe, and Japan up until 1995. In 1995, the first assessment of research in India was completed. A 2004 article suggested that India lacked the ideal research environment that the majority of clinical researcher’s demand. Clinical trials carried out in India significantly increased in 2009. A public interest litigation (PIL) was filed in 2012 accusing government, non-governmental, and independent investigators of conducting clinical studies improperly. The Drugs and Cosmetics Rules of 1945's Schedule Y, which govern clinical trials, were previously followed (D&C Rules). The Drugs and Cosmetics Act, 1940 (D&C Act) is the legal framework for the New Drugs and Clinical Trials Rules, 2019, or "NDCT Rules," which put an end to the protracted process of codifying the regulations that apply to clinical trials. Clinical trials, studies on bioequivalence and bioavailability, ethics committees, and investigational novel medications for human use will all be subject to the new regulations. As of 13-01-2o22, the Union Health Ministry has published a final notification revising the New Drugs and Clinical Trials (ND&CT) Rules, 2019 to include cell derived products as well as stem cell derived products under the definition of new medication.
2. Government of India Ministry of Health and Family Welfare (Department of Health) The Drugs and Cosmetics Act and Rules The Drugs and Cosmetics Act, 1940 (23 Of 1940) The Drugs and Cosmetics Rules, 1945 List of Abbreviations used; 2016.
3. Thorat SB, Banarjee SK, Gaikwad DD, Jadhav SL, Thorat RM. Clinical Trial: A Review. International Journal of Pharmaceutical Sciences Review and Research [Internet]. 2010 Apr [cited 2022 Dec 28];1(2):101-106. Available from:
4. Bio pharmaceutics Institute of India. Clinical Trial and Regulation; 2015.p.2–31.
5. Clinical Trials & Its Significance | JLI Blog [Internet]. James Lind Institute; 2020 Mar 03 [cited 2022 Dec 28]. Available from:
6. Phases of Drug Development Process, Drug Discovery Process | NorthEast BioLab [Internet]. [cited 2022 Dec 27]. Available from:
7. gajendra singh, Gaurav Agrawal, Vipul Gupta. drug regulatory affairs. 1st ed. 2019. 11–12 p.
8. Majumder K. A young researcher’s guide to a clinical trial and its registration. Editage Insights [Internet]. 2015 Jul [cited 2022 Dec 30]. Available from:
9. English RA, Lebovitz Yeonwoo, Giffin RB. Institute of Medicine (U.S.). Forum on Drug Discovery D. Transforming clinical research in the United States : challenges and opportunities : workshop summary. US: National Academies Press; 2010.p.131.
10. Vennu V, Saini PP. India’s Clinical Trial Regulatory Changes, Indian Researcher’s Awareness of Recently Changed Regulations, and the Impact of the New Drugs and Clinical Trial Rules: A Review. Indian J Pharm Sci [Internet]. 2020 [cited 2023 Jan 12];82(5):726-740. Available from:
11. Jadhav S, Ghooi R. New Drug and Clinical Trial Rules 2019- Two Steps Forward and One Back. Indian Journal of Pharmacy Practice. 2019 Aug 12;12(3):209-14.
12. Annapurna SA, Rao SY. New drug and clinical trial rules, 2019: An overview. Int J Clin Trials. 2020 Oct 20;7(4):278.
13. Dubey A, Kotian B, Shriram RG. New drugs and clinical trials rules, 2019: Towards fast-track accessibility of new drugs to the Indian population. Indian Journal of Pharmaceutical Education and Research. 2019 Oct 1;53(4):S451–9.
14. Thatte UM, Marathe P. Ethics Committees in India: Past, present and future. Vol. 8, Perspectives in Clinical Research. Medknow Publications; 2017. p. 22-30.
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