Recent Regulatory Amendment in Schedule Y: Impact on Bioequivalence Studies Conducted In India
- *Corresponding Author:
- Manoj Karwa
Clinical Research Department
Auriga Research Ltd., 3/15 Kirti Nagar Industrial Area
New Delhi – 110015, India
E-mail: [email protected]
Received Date: May 26 2013; Accepted Date: June 25, 2013; Published Date: July 01, 2013
Citation: Karwa M, Arora S, Agrawal SG (2013) Recent Regulatory Amendment in Schedule Y: Impact on Bioequivalence Studies Conducted In India. J Bioequiv Availab 5:174-176. doi: 10.4172/jbb.1000154
Copyright: © 2013 Karwa M, et al. This is an open-access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.
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.