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 within which CDSCO either accepts the filing or sent its back to the applicant mentioning grounds for rejection. 12.After the NDA is accepted the various section of the application should undergo concurrent review. The non-clinical and chemical data should be reviewed in consultation with subject expert committee as per the standard procedures. 13.With the increasing globalization of drug development, it has also become important that data from global clinical trials (GCTs) can be accepted as the primary source of evidence to support marketing approval of new drug. 14.CDSCO recognize the global clinical trial data for considering the marketing approval of New drug under the provisions of the New Drugs and Clinical Trials Rules, 2019.