The Department of Health and Family Welfare through notification dated the 31st August, 2021 has issued the New Drugs and Clinical Trials (Amendment) Rules, 2021.The rules has revised the definition of bioavailability and bioequivalence study centre.
Bioavailability and bioequivalence study center means a center created or established to undertake bioavailability study or bioequivalence study of a drug for either clinical part or analytical part or for both clinical and analytical part of such study.
