Section 122DAB(7) in The Drugs and Cosmetics Rules, 1945
(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.
