DCGI releases list of Reference Products for conduct of BE Study, details

New Delhi: Through a recent notice, Drug Controller General of India has released the List of Products Permitted by DCG(I) and considered as Reference Product for BA/BE Studies 

In his adjoining notice, DR VG Somani, DCGI informed that Drugs & Cosmetics Rules, 1945 have been amended vide G.S.R. 327(E) dated 03.04.2017, providing that the applicant shall submit the result of bioequivalence study along with the application for grant of a licence of oral dosage form of drugs specified under category Il and IV of the biopharmaceutical classification system.

In order to have proper understanding about the BCS classification, the requirement of BE study and reference product to be used in such studies, earlier CDSCO had issued guidelines vide letter dated 13.10.2017. Further, the matter was also deliberated in meeting held on 02.06.2018 with State Drugs Controllers and various experts with CDSCO officers.

Further, 12 workshops for providing training on conduct of BA/BE studies for BCS Class ll & BCS Class IV drugs were conducted in different parts of the country in collaboration with the State Drugs Controllers & the Indian Drugs/Pharmaceutical Association Forum between 03.08.2019 to 21.09.2019.

In order to streamline further, in respect of conduct of BE study, list of a number of drugs falling under BCS Il & IV along with list of their reference products have been prepared taking information from various sources. The list will be expanded by including more drugs based on further available information in this regard.

It is expected that reference product for BA/BE studies should normally be the innovator's product, to which all generic versions should be shown to be bioequivalent. lf, in case, innovator product is not available, the applicant may use Indian product approved by CDSCO as the Reference product.

A copy of the list of drug formulations along-with list of products that could be used as reference product in BE study Is enclosed. Discrepancies in the list, if any, may please be forwarded to this office for updating the list, the notice added