Section 68A(4) in The Drugs and Cosmetics Rules, 1945
(4)If on receipt of the application and the report of the licensing authority referred to in sub-rule (3) and after taking such measures including inspection of the premises by the Inspector, appointed by the Central Government under section 21 of the Act, with or without an expert in the concerned field if deemed necessary, the Central License Approving Authority, is satisfied that the applicant is in a position to fulfill the requirements laid down in these rules, he may grant or renew the license, as the case may be:Provided that if the Central License Approving Authority is of the opinion that the applicant is not in a position to fulfill the requirements laid down in these rules, he may, notwithstanding the report of the licensing authority, by order, for reasons to be recorded in writing, reject the application for grant [***] [Omitted 'or renewal' by Notification No. G.S.R. 1337, dated 27.10.2017 (w.e.f. 21.12.1945).] of license, as the case may be.