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Saurabh Arora
Saurabh Arora
India
Publications
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Short Article
Recent Regulatory Amendment in Schedule Y: Impact on Bioequivalence Studies Conducted In India
Author(s): Manoj Karwa, Saurabh Arora and Shilpa Garg AgrawalManoj 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,.. View More»
DOI: 10.4172/jbb.1000154