INTRODUCTION 1. A number of communicable as well as non-communicable diseases place heavy burdens in terms of morbidity and mortality, and economic losses, onto the populations and health systems of the country. 2. In order to address the disease burden, it is of paramount importance that safe and effective new drugs are developed and available for prevention and treatment of various diseases. 3. ...

BACKGROUND 1. Import or manufacture for sale of drugs are regulated under Drugs and Cosmetics Act, 1940 and Drugs Rules, 1945 and New Drugs and Clinical Trials Rules, 2019. 2. Detailed requirements and guidelines for conduct of nonclinical and clinical studies and approval of new drug are specified in SECOND SCHEDULE of New Drugs and Clinical Trials Rules, 2019.