ABSTRACT
Drug discovery is an art and when using humans to evaluate safety, efficacy is an important parameter. An Institutional Ethical Committee (IEC) is the regulator which substantiates the requirements for clinical trial. Central Licensing Approving Authority (CLAA) is authorized by IEC as a protector of the use of unnecessary human trials and every protocol must be approved by the IEC before any study. The IEC is constituted of multi-disciplinary personalities and evaluates every study proposal, which has to be submitted by the investigator. After evaluation, the IEC approves the research proposal or informs the investigator of any shortcomings with directions to modify. New Drugs and Clinical Trials Rules 2019 (New Rules) were enforced on 21 September 2019 by the government of India, setting specific requirements for ECs and their excursion of power to monitor clinical trials.
