Unlock Advanced Research with PRISMAI Integrated with over 4 crore judgments and laws — designed for legal practitioners, researchers, students and institutions - Know your Kanoon - Doc Gen Hub - Counter Argument - Case Predict AI - Talk with IK Doc - ... Upgrade to Premium Document Options Get in PDF Print it! [Cites 0, Cited by 0] [Section 122DAB(5)] [Section 122DAB] [Entire Act] Union of India - Subsection Section 122DAB(5)(b) in The Drugs and Cosmetics Rules, 1945 (b)violation of the approved protocol, scientific misconduct or negligence by the Sponsor or his representative or the investigator;