The Ministry of Health and Family Welfare has notified the New Drugs and Clinical Trials (Amendment) Rules, 2021 vide notification dated August 31, 2021. The Rules amend the New Drugs and Clinical Trials Rules, 2019 by amending the definition of bioavailability and bioequivalence study centre. Revised definition under Rule 2(1)(g) is as follows:
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.
*Tanvi Singh, Editorial Assistant has reported this brief.
