Section 76(10) in The Drugs and Cosmetics Rules, 1945
(10)[ the applicant shall submit the result of bio-equivalence study referred to in Schedule Y, along with the application for grant of a licence of oral dosage form of drugs specified under category II and category IV of the bio-pharmaceutical classification system.] [Inserted by Notification No. G.S.R. 327(E), dated 3.4.2017 (w.e.f. 21.12.1945).]
