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 ...

ND & CT rules recognize the consideration of surrogate endpoints for approval of new drugs in certain situation where, the approval of a new drug may be based on the clinical data generated considering surrogate end-point rather than using standard outcome measures such as survival or disease progression which are reasonably likely to predict clinical benefit, or a clinical end point. 8. Surrogate ...

6. However, accelerated approval should be used for a drug that represent significant advances over existing treatment or in case there is an unmet medical need for the indication for which the drug is intended, orphan drug for rare disease etc. in accordance with the provision prescribed under Second Schedule of ND& CT Rules, 2019. 7. ND & CT rules recognize the consideration of surrogate endpoin ...

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 ...

10.As provided in the rules, surrogate marker should be considered as an interim data point and further clinical data should be generated following the approval of the new drug based on surrogate marker consideration that must unequivocally support the patients benefit. 11.Upon receipt of NDA the CDSCO should review the application to determine its completeness within timeline to be prescribed wit ...