The Central Drugs Standard Control Organisation (CDSCO) reiterates that Bioavailability and Bioequivalence (BA-BE) Study of new drug in human subject must continue to be conducted in accordance with approved protocols, Good Clinical Practice Guidelines and under the provisions of the New Drugs and Clinical Trial Rules, despite the challenges faced due to outbreak of COVID-19.
Additional responsibilities lie with the sponsor, investigator and Ethics Committee to ensure rights, safety and well being of trial subjects.
Source: Central Drugs Standard Control Organization
