Section 85E(2) in The Drugs and Cosmetics Rules, 1945
(2)[ The factory premises shall comply with the requirements and conditions specified in Schedule M-I:Provided that where the licensing authority considers it necessary or expedient so to do, it may having regard to the nature and extent of manufacturing operations, relax or suitably alter the said requirements or conditions in any particular case for reasons to be recorded in writing.] [Substituted by G.S.R. 570(E), dated 12.6.1987 (w.e.f. 12.6.1987).]