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 ...

PRESENTATION AND SUBMISSION OF APPLICATION 1. In order to make regulatory review process as efficient for CDSCO as possible, the submission of applications for approval of clinical trials and new drugs to CDSCO ensuring conciseness, correctness, consistency and clarity. 2. A clear well-presented submission facilitates the evaluation process in a timely manner, whereas, a difficult-to-evaluation su ...