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