Section 122DAB in The Drugs and Cosmetics Rules, 1945
122DAB. [ Compensation in case of injury or death during clinical trial. [Inserted by Notification No. G.S.R. 53(E) dated 30.1.2013 (w.e.f. 21.12.1945)]
(1)In the case of an injury occurring to the clinical trial subject, he or she shall be given free medical management as long as required.](2)[ In case the injury occurring to the subject during the clinical trial, free medical shall be given as long as required or till such time it is established that the injury is not related to the clinical trial, whichever is earlier.] [Substituted by Notification No. G.S.R. 889(E) dated 12.12.2014 (w.e.f. 21.12.1945)](2A)[ In case there is no permanent injury, the quantum of compensation shall be commensurate with the nature of the non-permanent injury and loss of wages of the subject.] [Inserted by Notification No. G.S.R. 889(E) dated 12.12.2014 (w.e.f. 21.12.1945)](3)[ In the case of clinical trial related death of the subject, his/her nominee(s) would be entitled for financial compensation, as per tHe order of the Licensing Authority defined under clause (b) of rule 21, and the financial compensation will be over and above any expenses incurred on the medical management of such subject.(4)The expenses on medical management and financial compensation in the case of clinical trial injury or death of the trial subject shall be borne by the sponsor of the clinical trial.(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.(6)The Sponsor, whether a pharmaceutical company or an institution shall give an undertaking along with the application for clinical trial permission to the Licensing Authority defined in clause (b) of Rule 21, to provide compensation in the case of clinical trial related injury or death for which subjects are entitled to compensation.(7)In case the Sponsor fails to provide medical management for the injury to the subject and I or financial compensation to the trial subject for clinical trial related injury or financial compensation to the subject's nominee(s) in case of clinical trial related death of the subject, the Licensing Authority may after giving an opportunity to show cause why such an order should not be passed, by an order in writing, stating the reasons thereof, suspend or cancel the clinical trial and I or restrict Sponsor including his representative(s) to conduct any further clinical trials in the country or take any other action deemed fit under the rules.] [Inserted by Notification No. G.S.R. 53(E) dated 30.1.2013 (w.e.f. 21.12.1945)][122-DB. Suspension or cancellation of Permission/Approval. - If the importer or manufacturer under this Part fails to comply with any of the conditions of the permission or approval, the licensing authority may, after giving an opportunity to show cause why such an order should not be passed, by an order in writing stating the reasons therefor, suspend or cancel it.
