New Drugs and Clinical Trial Rules 2019, What is New? Our Views from Ethical Perspective.

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 Harmonisation -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.