Section 122DA(2) in The Drugs and Cosmetics Rules, 1945
(2)An application for grant of permission to conduct,-(a)human clinical trials (Phase-I) on a new drug shall be made to the licensing authority in Form 44 accompanied by a fee of fifty thousand rupees and such information and data as required under Schedule Y;(b)exploratory clinical trials (Phase-II) on a new drug shall be made on the basis of data emerging from Phase-I trial, accompanied by a fee of twenty five thousand rupees;(c)confirmatory clinical trials (Phase-III) on a new drug shall be made on the basis of the data emerging from Phase-II and where necessary, data emerging from Phase-I also, and shall be accompanied by a fee of twenty-five thousand rupees:Provided that no separate fee shall be required to be paid along with application for import/manufacture of a new drug based on successful completion of phase clinical trials by the applicant:Provided further that no fee shall be required to be paid along with the application by Central Government or State Government Institutes involved in clinical research for conducting trials for academic or research purposes.
