(1) If any person to whom permission is granted under this part fails to comply with any of conditions of permission, the Central Licensing Authority may,-
(a) issue warning letter giving details of deficiency found; or
(b) debar the investigator, sponsor including their employees, subsidiaries and branches, their agents, contractors and sub-contractors to conduct any clinical investigation in future; or
(c) suspend the permission for such period as it thinks fit or cancel either wholly or partly to which it relates;
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(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, prefer an 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 or death related to clinical investigation.