Section 122B in The Drugs and Cosmetics Rules, 1945
122B. Application for approval to manufacture new drug [* * *] [The words " other than the Drugs classifiable under Schedules C and C(1)" omitted by G.S.R. 26(E), dated 19.1.2006 (w.e.f. 19.1.2006).]
.- [(1) (a) No new drug shall be manufactured for sale unless it is approved by the licensing authority as defined in clause (b) of rule 21.(b)An application for grant of approval to manufacture the new drug and its formulations shall be made in Form 44 to the licensing authority as defined in clause (b) of rule 21 and shall be accompanied by a fee of fifty thousand rupees:Provided that where the application is for permission to import a new drug (bulk drug substance) and grant of approval to manufacture its formulation/s, the fee to accompany such application shall be fifty thousand rupees only:Provided further 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 subsequent application shall be fifteen thousand rupees:Provided further also that any application received after one year of the grant of approval for the manufacture for sale of the 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 manufacturer of a new drug under sub-rule (1) when applying for approval to the licensing authority mentioned in the said sub-rule, 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 clinical trials carried out in the country in accordance with the guidelines specified in Schedule Y and submit the report of such clinical trials in the format given in Appendix II to the said Schedule.[(2-A) The licensing authority as defined in clause (b) of rule 21 after being satisfied that the drug if approved to be manufactured as raw material (bulk drug substance) or as finished formulation shall be effective and safe for use in the country, shall issue approval in Form 46 and/or Form 46-A, as the case may be, 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).](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.
