Section 122DA(3) in The Drugs and Cosmetics Rules, 1945
(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]
