Section 122B(2) in The Drugs and Cosmetics Rules, 1945
(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).]
