Application for permission to conduct clinical trials for New

(1) No clinical trial for a new drug, whether for clinical investigation or any clinical experiment by any institution, shall be conducted except under, and in accordance with, the permission, in writing, of the Licensing Authority defined in clause (b) of Rule 21. (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 Rs. 50,000 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 Rs. 25,000; (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 Rs. 25,000: 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 phases 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. (3) The Licensing Authority after being satisfied with the clinical trials, shall grant permission in Form 45 or Form 45-A or Form 46 or Form 46-A, as the case may be, subject to the conditions stated therein: Provided that the Licensing Authority shall, where the data provided on the clinical trials is inadequate, intimate the applicant in writing, within six months from the date of such intimation or such extended period, not exceeding a further period of six months, as the Licensing Authority may, for reasons to be recorded in writing, permit, intimating the conditions which shall be satisfied before permission could be considered. Explanation.−For the purpose of these rules Investigational New Drug means a new chemical entity or a product having therapeutic indication but which have never been earlier tested on human beings.