Section 150C(2) in The Drugs and Cosmetics Rules, 1945
(2)Before approval in Form 37 is granted [***] [Omitted 'or renewed' by Notification No. G.S.R. 1337(E), dated 27.10.2017 (w.e.f. 21.12.1945).], the following conditions shall be complied with by the applicant:-