Section 122A(2) in The Drugs and Cosmetics Rules, 1945
(2)The importer of a new drug when applying for permission under sub-rule (1), shall submit data as given in [Appendix I or Appendix I-A or Appendix IB] [Substituted by Notification No. G.S.R. 918(E), dated 30.11.2015 (w.e.f 21.12.1945).] to Schedule Y including the results of local clinical trials carried out in accordance with the guidelines specified in that Schedule and submit the report of such clinical trials in the format given in Appendix II to the said Schedule: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 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.
