Section 122DAB(5) in The Drugs and Cosmetics Rules, 1945
(5)Any injury or death of the subject occurring in clinical trial due to following reasons shall be considered as clinical trial related injury or death and the subject or his/her nominee(s), as the case may be, are entitled for financial compensation for such injury or death:(a)adverse effect of investigational product(s);(b)violation of the approved protocol, scientific misconduct or negligence by the Sponsor or his representative or the investigator;(c)failure of investigational product to provide intended therapeutic effect; [where the standard care, though available, was not provided to the subject as per the clinical trial protocol.](d)use of placebo in a placebo-controlled trial; [where, the standard care, though available, was not provided to the subject as per the clinical trial protocol.] [Inserted by Notification No. G.S.R. 889(E) dated 12.12.2014 (w.e.f. 21.12.1945)](e)adverse effects due to concomitant medication excluding standard care, necessitated as part of approved protocol;(f)for injury to a child in-utero because of the participation of parent in clinical trial;(g)any clinical trial procedures involved in the study.
