A large number of applications are being filed to the office of DCG (I) at CDSCO (HQ) by Pharmaceutical companies, both manufacturers and CRO’s on behalf of them, requesting for the approval to carry out Bioequivalence studies on Indian subjects for export purpose.
In view of the above, for easy processing of such applications and to bring uniformity in decision making the office of DCGI would like to ensure the uniformity of documents to be submitted to the Directorate for review and approval of BE-NOC’s to meet the requirement of guideline.
The Purpose of document is to harmonize the submission of documents for applications seeking for licence to import drug products to conduct bioequivalence study for export purpose. This will also facilitate the examiners/reviewers to take uniform decisions and thereby shorten the application processing time.
Bioavailability and Bioequivalence studies are required by regulations to ensure therapeutic equivalence between a pharmaceutical equivalent test product and a reference product. The focus of this guidance document is to import of drug products, if required and to conduct bioequivalence study in human subjects for export purpose.
The office of DCG(I) would like to ensure the demonstration of the safety and tolerability of generics against corresponding innovator drugs; to ensure they are comparable and safe for consumption by human subjects.
An Assessment of “interchangeability” between the investigational and the innovator product is carried out by a study of “in vivo equivalence” or “bioequivalence” (BE).
In view of the above, the office of DCGI would like to ensure the uniformity of documents to be submitted to this Directorate for review and approval of BE-NOC for export to meet tenets of Schedule Y of Drugs and Cosmetics Act 1940 & Rules 1945 and also Indian Good Clinical Practices (GCP) guidelines.
