Section 76(7)(v) in The Drugs and Cosmetics Rules, 1945
(v)[ have the approval, in writing, in favor of the applicant to manufacture drug formulations falling under the purview of new drug as defined in rule 122-E, from the licensing authority as defined in clause (b) of rule 21.] [Inserted by G.S.R. 311(E), dated 1.5.2002 (w.e.f. 1.5.2002).]