Section 76(9) in The Drugs and Cosmetics Rules, 1945
(9)[ The applicant shall make application for grant of license for a drug formulation containing single active ingredient only in proper name.] [Inserted by Notification No. G.S.R. 570 (E) dated 7.8.2014 (w.e.f. 21.12.1945)][ Explanation. - For the purpose of this rule, [Large Volume Parenterals Sera and Vaccines and Recombinant DNA (r-DNA) derived drugs,] [Inserted by G.S.R. 119(E), dated 11.3.1996 (w.e.f. 11.3.1996).][shall mean the sterile solutions intended for parenteral administration with a volume of 100 ml. or more (and shall include anti-coagulant solutions) in one container of the finished dosage form intended for single use.] [Inserted by G.S.R. 119(E), dated 11.3.1996 (w.e.f. 11.3.1996).][Added by G.S.R. 515, dated 24.3.1976 (w.e.f. 10.4.1976).]
