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.

POLICY ON NEW DRUG APPLICATION: 1. The content of New Drug Application (NDA) should be designed by the sponsor to answer general question as follows: i. Does the new drug provide a clinical benefit? ii. Is the associated risk outweighing the benefits for the proposed indication? iii. Can the product be manufactured ensuring quality and batch to batch consistency? 2. There should be a system that b ...

Such discussion to help the reviewers becomes acquainted with the information to be included in the NDA. 4. In case the sponsor intends to seek exemption of local clinical trial, clear request for the same should be made in the NDA alongwith rationale and justification and the relevant regulatory provision, under which the exemption is sought. 5. Similarly, in case the sponsor intends to seek app ...