Section 122DAA in The Drugs and Cosmetics Rules, 1945
122DAA. [ [Omitted 'Definition of Clinical trial. - For the purpose of this Part, 'Clinical trial' means a systematic study of 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.' by Notification No. G.S.R. 826(E), dated 30.10.2015 (w.e.f. 21.12.1945).]
