India Revises Bioequivalence Guidelines

In a move to ensure standards of quality, efficacy and safety in medical products, India’s Central Drug Standard Control Organization has revised its guidelines on bioequivalence and bioavailability for pharmaceuticals. The revisions will become part of Schedule Y of the Drugs and Cosmetics Act and new drug applications will have to meet these requirements.

The revisions indicate how a comparative study should be executed, the design requirements, study population, the characteristics that need to be studied, facts of the bioanalytical methodology required, and parameters for statistical evaluation of the results.

Drugs subject to bioequivalence tests include: oral immediate release drug formations with systemic action; non-oral and non-parenteral drug formulations designed to act by systemic absorption; sustained or otherwise modified release drug formulations designed to act by systemic absorption; fixed-dose combination products with systemic action; and non-solution pharmaceutical products which are for non-systemic use and intended to act without systemic absorption.