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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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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