Section 122A in The Drugs and Cosmetics Rules, 1945
122A. Application for permission to import new drug.
- [(1) (a) No new drug shall be imported, except under, and in accordance with, the permission granted by the licensing authority as defined in clause (b) of rule 21.(b)An application for the grant of permission to import a new drug shall be made in Form 44 to the licensing authority, accompanied by a fee of fifty thousand rupees:Provided that where a subsequent application by the same applicant for that drug, whether in modified dosage form or with new claims, is made, the fee to accompany such application shall be fifteen thousand rupees:Provided further that any application received after one year of the grant of approval for the import and sale of new drug, shall be accompanied by a fee of fifteen thousand rupees and such information and data as required by [Appendix I or Appendix I-A or Appendix IB] [Substituted by G.S.R. 900(E), dated 12.12.2001 (w.e.f. 12.12.2001).] of Schedule Y, as the case may be.](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.(3)[ The licensing authority, after being satisfied that the drug if permitted to be imported as raw material (bulk drug substance) or as finished formulation shall be effective and safe for use in the country, may issue an import permission in Form 45 and/or Form 45-A, subject to the conditions stated therein:Provided that the licensing authority shall, where the data provided or generated on the drug is inadequate, intimate the applicant in writing, and the conditions, which shall be satisfied before permission could be considered.] [Inserted by G.S.R. 900(E), dated 12.12.2001 (w.e.f. 12.12.2001).]
