Section 69(6) in The Drugs and Cosmetics Rules, 1945
(6)[ Where an application under this rule is for the manufacture of drug formulations falling under the purview of new drug as defined in rule 122-E, such application shall also be accompanied with approval, in writing, in favor of the applicant, 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).]
