The Central Drugs Standard Control Organisation (CDSCO) has released the list of 139 drug formulations and their reference products permitted by DCGI to conduct bio-equivalence (BE) studies.
As per amended Drugs & Cosmetics (D&C) Rules, 1945 dated April 3, 2017, applicant shall submit the result of BE study along with the application for grant of a license of oral dosage form of drugs specified under category II and IV of the Biopharmaceutics Classification System (BCS).
CDSCO had issued guidelines dated October 13, 2017 to equip pharmaceutical companies on proper understanding about the BCS classification, requirement of BE study and the reference product to be used in such studies.
Further the matter was also deliberated in the meeting held on June 2, 2018 with state drugs controllers, experts and CDSCO officers.
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 bio-equivalent. If, in case, innovator product is not available, applicant may use Indian product approved by CDSCO as reference product,” stated Dr V G Somani, Drugs Controller General of India (DCGI) in a notice.
Total 12 workshops were also organised for providing training on conduct of Bio-availability (BA/BE) studies for BCS Class II and BCS Class IV drugs in different parts of the country. This was done in collaboration with the state drugs controllers and Indian pharmaceutical associations between August 3, 2019 and September 21, 2019.
