(1) If any person to whom permission is granted under sub-rule (5) of rule 52 fails to comply with any of conditions of permission, the Central Licensing Authority may suspend the permission for such period as it thinks fit or cancel either wholly or partly to which it relates.
(2) Any person who is aggrieved by the order passed under sub-rule (1), may within thirty days from the date of receipt of such order, appeal to the Central Government, and the Central Government may, after such enquiry into the matter, as is considered necessary and after giving an opportunity of being heard, pass such order in relation thereto as, it thinks fit.
Medical management and compensation for injury related to clinical performance evaluation.
55. Where any participant is injured on account of his participation in the clinical performance evaluation, the sponsor permitted under rule 52 shall provide medical management to that participant.
Performance evaluation of in vitro medical devices.