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Recent Regulatory Amendment in Schedule Y: Impact on Bioequivalence Studies Conducted In India

Manoj Karwa, Saurabh Arora and Shilpa Garg Agrawal

Bioequivalence studies are conducted for comparison of two medicinal products containing the same active ingredients, and these studies are mostly conducted in healthy subjects. The regulatory guidelines in terms of serious adverse events (SAEs) reporting, informed consent, compensation in case of injury or death for bioequivalence studies are similar as in clinical trials. Recently there have been three amendments in Schedule Y of the Drugs and Cosmetics Act. The first gazette notification is G.S.R. 53 (E) dated January 30, 2013, with insertion of Rule 122 DAB which specifies procedures to analyze the reports of SAEs occurring during clinical trials and payment of compensation in case of trial related injury or death as per defined timelines. The detailed process is described by addition of Appendix XII in Schedule Y. The second gazette notification is G.S.R. 63(E) dated February 01, 2013 with insertion of Rule 122 DAC which specifies conditions under which application for conduct of clinical trials shall be approved by licensing authority, which includes a very important point that the sponsors, their subsidiaries, agents, sub-contractors, and clinical trial sites shall allow inspectors authorized by CDSCO to inspect their premises. The third amendment is related to mandatory registration of the Ethics Committees (EC) in the Drug and Cosmetic act vide G.S.R. 72(E) dated February 08, 2013 with addition of Rule 122 DD.