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 endpoint may be acceptable if there is a strong indication that they will result in subject benefit. 9. Surrogate endpoint may not be acceptable if there are only causally related to clinical outcome. 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.