Section 122E(i) in The Drugs and Cosmetics Rules, 1945
(i)all vaccines and Recombinant DNA (r-DNA) derived drugs shall be new drugs unless certified otherwise by the Licensing Authority under rule 21; [Substituted by G.S.R. 45(E), dated 24.1.2011 (w.e.f. 24.1.2011).]
