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. 3. As per the rules, for manufacture or import of new drugs, the manufacturers/ importer are required to obtain manufacturing/ import permission from CDSCO under the New Drugs and Clinical Trials Rules, 2019 before Licencing the product under the Drugs Rules, 1945.