Impact of rules for New Drug and Clinical Trial in India

  • Akanksha Rani M.pharm (Drug Regulatory affairs)
  • Vikesh Kumar Shukla


A good quality research requires the incorporation of good ethical practices throughout the conduct of the study. An efficient Ethics Committee will facilitate such a research at the site, and can achieve the major objective of ICH-GCP (International Conference on Harmonization-Good Clinical Practice) guidelines. Awareness of the changing rules among the stakeholders of clinical studies will ensure good clinical practice by safeguarding and protecting the rights, safety and well-being of the research participants. The draft of the New Drugs and Clinical Trials Rules was published in the Gazette of India by central government on March 19, 2019. Keeping abreast of the latest rules are essential for the uninterrupted conduct of clinical studies. We sought to give a summary of important changes in the new rules and to assess those rules from ethical perspective. India has a huge potential to attract drug discovery leader for the conducting clinical trials, in view of that the responsibility of the ethical regulation of clinical trial is a concern of Drug Controller General of India (DCGI). The DCGI takes all the decision regarding pharmaceutical-research and regulatory issues in India. The DCGI and their regularity team, ensures all the regulation for the clinical trial is taken with appropriate approval process. The present review will provide a platform to reader, about the approved trials in the past eight years and the current guidelines for the trial in India.

Keywords: Regulations, Approval, DCGI, Drug Controller General of India, Clinical Trial, India


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1. Ministry of Health and Family Welfare. Govt of India. Notification. The Gazette of India: Extraordinary, Part II, Section 3, Subsection (i) [Internet]. New Delhi: 2019 Mar 19 [cited 2019 Dec 20]; p. 1-264. Available from: / NewDrugs_CTRules_2019.pdf
2. Jesani A, Srinivasan S. New Drugs and Clinical Trials Rules, 2019: The market trumps ethics and participant rights. Indian J Med Ethics 2019; 4(2) NS: 89-91. DOI: 10.20529/ IJME.2019.020
3. Vaidyanathan G. India’s clinical trials rules to speed up drug approvals. Nature [Internet]. 2019 Apr 03 [cited 2019 May 20]. Available from:
4. Bhatt A. Evolution of clinical research: a history before and beyond James Lind. Perspect Clin Res. 2010; 1(1):6-10.
5. Gogtay NJ, Ravi R, Thatte UM. Regulatory requirements for clinical trials in India: what academicians need to know. Indian J Anaesth. 2017; 61(3):192-9.
6. Wandile P, Ghooi R. A Role of ICH- GCP in Clinical Trial Conduct. J Clin Res Bioeth. 2017; 8(1):1-5.
7. Otten A. The GATT TRIPS Agreement and health care in India. Natl Med J India. 1995; 8(1):1-3.
8. Choudhury K, Ghooi R. New rules for clinical trial-related injury and compensation. Indian J Med Ethics. 2013; 10(3):197-200.
9. Ghooi RB. Ensuring that informed consent is really an informed consent: role of videography. Perspect Clin Res. 2014; 5(1):3-5.
10. Ghooi RB. Accreditation - A solution for problems or a fresh problem? Perspect Clin Res. 2015; 6(3):123-4.
11. Ministry of Health and Family Welfare. GSR 104 (E) New Drugs and Clinical Trials Rules; 2018.
12. The Supreme Court Order of the Supreme Court of India regarding the Draft Drugs and Clinical Trials Rules. Available at:
13. World Medical Association, WMA Declaration of Helsinki – Ethical Principles for Medical Research Involving Human Subjects [Internet]. WMA [cited 2019 Dec 23]. Available from:
https://www.wma. net/policies-post/wma-declaration-of-helsinki-ethical-principles-for-medical-research-involving-human-subjects/
14. Indian Council of Medical Research. National Ethical Guidelines for Biomedical and Health Research involving Human Participants; 2017.
15. Chingarande GR, Moodley K. Disparate compensation policies for research related injury in an era of multinational trials: a case study of Brazil, Russia, India, China and South Africa. BMC Med Ethics. 2018; 19(1):8.
16. Urooj M, Husain GM, Khan MA, Kazmi MH. Compensation to clinical trial participants in India: A gap analysis. Int J Pharm Investig. 2017; 7(2):41-6.
17. Henry LM, Larkin ME, Pike ER. Just compensation: a no-fault proposal for research-related injuries. J Law Biosci. 2015; 2(3):645-68.
18. Gupta YK, Pradhan AK, Goyal A, Mohan P. Compensation for clinical trial-related injury and death in India: challenges and the way forward. Drug Saf. 2014; 37(12):995-1002.
19. Saxena R, Saxena P. Clinical trials: Changing regulations in India. Indian J Community Med. 2014; 39(4):197-202. doi:10.4103/0970-0218.143018.
20. Vijayananthan A, Nawawi O. The importance of Good Clinical Practice guidelines and its role in clinical trials. Biomed Imaging Interv J. 2008; 4(1):e5.
21. Reference document: Ministry of Health GSR Notification#227
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How to Cite
Rani, A., and V. K. Shukla. “Impact of Rules for New Drug and Clinical Trial in India”. International Journal of Drug Regulatory Affairs, Vol. 8, no. 1, Mar. 2020, pp. 25-30, doi:10.22270/ijdra.v8i1.379.

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