Permission to import or manufacture fixed dose combination.- (1) An

(1) An application for permission to import or manufacture fixed dose combination of two or more drugs as defined in clause (c) of rule 122-E shall be made to the Licensing Authority as defined in clause (b) of Rule 21 in Form 44, accompanied by a fee of Rs. 15,000 and shall be accompanied by such information and data as is required in Appendix VI of Schedule Y. (2) The Licensing Authority after being satisfied that the fixed dose combination if approved to be imported or manufactured as finished formulation shall be effective and safe for use in the country, shall issue permission in Form 45 or Form 46, 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 fixed dose combination is inadequate, intimate the applicant in writing, and the conditions which shall be satisfied before grant of approval/permission could be considered.