(1)If any person to whom permission has been granted under rule 52 fails to comply with any of the conditions of permission or any of the provisions of the Act or these rules, the Central Licensing Authority may,-(a)issue warning letter giving details of deficiency found; or(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.
