Centre issued new Drugs and Clinical Trials Rules, 2019

Health and Family Welfare Ministry have issued the Drugs and Clinical Trials Rules, 2019 with a motive to enhance clinical research in the country. The new rules will alter the regulatory landscape for the approval of new drugs and conduct of clinical trials in the country. These new rules will be applied to all new drugs, investigational new drugs for human use, clinical trial, bioequivalence study and Ethics Committee.