Section 76(8) in The Drugs and Cosmetics Rules, 1945
(8)[ The licensee of pharmaceutical products shall comply with the requirements of 'Good Manufacturing Practices' as laid down in Schedule M and the licensee of Medical Devices and in-vitro diagnostics shall comply with the requirements of "Quality Management System" as laid down in Schedule M-III.] [Substituted by Notification No. G.D.R. 640(E), dated 29.6.2016 (w.e.f. 21.12.1945).]
