Last Updated on July 1, 2025
Bio-Equivalence and Bio-Availability (BE/BA) Studies Centers
The regulatory oversight of Bio-equivalence and bio-availability studies centers is within the scope of Clinical Studies Committee (CSC) under the Bio Study Rules, 2017. BE/BA Centers are required to comply the International Council for Harmonization (ICH) -Good Clinical Practices (GCP) and Good Laboratory Practices (GLP).
Application for licensing of BE/BA Centers are submitted on Form–I to the Clinical Study Committee of DRAP. The license of BE/BA center once approved by the Clinical Studies Committee is valid for 03 years unless it is revoked, suspended or cancelled earlier.
Following Bio-Equivalence and Bio-Availability (BE/BA) Studies Centers are licensed by the DRAP:-