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 ...

15.However, detailed guidance documents should be prepared providing the requirements and adequacy of global clinical data that can be considered for approval of any new drug in the country in both the cases where India was one of the participating countries in the global clinical trial or in cases where India was not a participating country. 16.The sponsor intending to submit NDA to CDSCO for mar ...