Section 122B(3) in The Drugs and Cosmetics Rules, 1945
(3)When applying for approval to manufacture a new drug under sub-rule (1) or its preparations to the State licensing authority, an applicant shall produce along with his application, evidence that the drug for the manufacture of which application is made has already been approved [in the name of the applicant] [Inserted by G.S.R. 26(E), dated 19.1.2006 (w.e.f. 19.1.2006).] by the licensing authority mentioned in rule 21:Provided that the requirement of submitting the results of local clinical trials may not be necessary if the drug is of such a nature that the [licensing authority in rule 21] [Substituted by G.S.R. 26(E), dated 19.1.2006 (w.e.f. 19.1.2006).] may, in public interest, decide to grant such permission on the basis of data available from other countries:Provided further that the submission of requirements relating to Animal Toxicology, Reproduction studies, Teratogenic studies, Perinatal studies, Mutagenicity and Carcinogenicity may be modified or relaxed in case of new drugs approved and marketed for several years in other countries if he is satisfied that there is adequate published evidence regarding the safety of the drug, subject to the other provisions of these rules.
