Conditions for permission After grant of permission referred to in rule 52, the following conditions shall be complied with by the applicant, namely:— (i) clinical investigation shall be initiated after approval of clinical investigation plan by the registered Ethics Committee; (ii) clinical investigation shall be conducted in accordance with the approved clinical investigation plan, Good Clinical Practices Guidelines issued by the Central Drugs Standard Control Organisation and provisions of the Seventh Schedule; (iii) clinical investigation shall be registered with the Clinical Trial Registry of India before enrolling the first participant for such clinical investigation; (iv) annual status report of each clinical investigation, as to whether it is ongoing, completed or terminated, shall be submitted to the Central Licensing Authority by the sponsor, and, in case of termination of any clinical investigation, the detailed reasons for the same shall be communicated to the Central Licensing Authority within thirty days of such termination;