Section 122DA in The Drugs and Cosmetics Rules, 1945
122DA. Application for permission to conduct clinical trials for New Drug/ Investigational New Drug.
(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 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.(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. [Substituted by Notification No. G.S.R. 826(E), dated 30.10.2015 (w.e.f. 21.12.1945).] - For the purpose of these rules, -(a)"Clinical Trial" means a systematic study of any new drug(s) in human subject(s) to generate data for discovering and/or verifying the clinical, pharmacological (including pharmacodynamic and pharmacokinetic), and/or adverse effects with the objective of determining safety and/or efficacy of the new drug;(b)"Global Clinical Trial" means any clinical trial which is conducted as part of multi-national clinical development of a drug;(c)"Investigational New Drug" means a new chemical entity or a product having therapeutic indication but which has never been tested earlier on human being;(d)"New Chemical Entity" means an active substances in developmental stage which may be specified as a drug under the Act, after undergoing any clinical trial](4)[ No permission for conduct of clinical trial intended for academic purposes in respect of approved drug formulation shall be required for any new indication or new route of administration or new dose or new dosage form where,-(a)the trial is approved by the Ethics Committee; and(b)subject to the provisions of sub-rule 5, the data generated is not intended for submission to licensing authority.(5)The Ethics Committee shall however inform the licensing authority about the cases approved by it and also about cases where there could be an overlap between the clinical trial for academic and regulatory purposes and where the said authority does not convey its comments to the Ethics Committee within a period of thirty days from the date of receipt of communication from the Ethics Committee, it shall be presumed that no permission from the licensing authority is required.] [Inserted by Notification No. G.S.R. 313(E), dated 16.3.2016 (w.e.f. 21.12.1945).]
