Section 122A(3) in The Drugs and Cosmetics Rules, 1945
(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).]
