Suspension, cancellation, etc. of permission (1) If any person to whom permission has been granted under rule 52 fails to ci .ply with any of the conditions of permission or any of the provisions of the Act or ti e rules, the Central Licensing Authority may, — (a) issue warning letter giving details of deficiency found; or Central Drugs Standard Control Organization, Ministry of Health and Family Welfare, Govt. of India Page 51 of 248 (b) debar the investigator or sponsor including their employees, subsidiaries and branches, their agents, contractors and sub-contractors to conduct any clinical investigation for such period as it thinks fit; or (c) suspend the permission for such period as it thinks fit or cancel either wholly or partly the permission. (2) Any person who is aggrieved by the order passed under sub-rule (1), may file an appeal within thirty days of the receipt of such order before the Central Government, which may, after such enquiry and after giving an opportunity of being heard to the appellant, dispose of the appeal within a period of sixty days. 55. Medical management and compensation related to clinical investigation (1) Where any participant is injured on account of participation in clinical investigation, the sponsor permitted under rule 52 shall provide medical management to that participant. (2) Where an injury is caused to the participant in a clinical investigation of any investigational medical device and such injury is attributable to the use of investigational medical device, the sponsor permitted under rule 52 shall provide to that participant, medical management and such compensation in the manner as specified under rule 122DAB of the Drugs and Cosmetics Rules, 1945. (3) Where death of a participant is related to clinical investigation and is attributable to the use of an investigational medical device, the sponsor, permitted under rule 52 shall provide to the legal heir of that participant, such compensation, in such manner as specified under rule 122DAB of the Drugs and Cosmetics Rules, 1945.
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