Section 68A in The Drugs and Cosmetics Rules, 1945
68A. [ Grant [***] [Inserted by G.S.R. 923(E), dated 14.12.1992 (w.e.f. 14.12.1992).] of Licenses by the Central License Approving Authority.
(1)Notwithstanding anything contained in this Part, on and from the commencement of the Drugs and Cosmetics (9th Amendment) Rules, 1992, a license for the manufacture for sale or distribution of drugs as specified from time to time by the Central Government by notification in the Official Gazette, for the purpose of this rule, shall be granted [***] [Omitted 'or renewed as the case may be,' by Notification No. G.S.R. 1337(E), dated 27.10.2017 (w.e.f 21.12.1945).] by the Central License Approving Authority (appointed by the Central Government):Provided that the application for the grant [***] [Omitted 'or renewal' by Notification No. G.S.R. 1337(E), dated 27.10.2017 (w.e.f. 21.12.1945).] of such license shall be made to the licensing authority.(2)On receipt of the application for grant [***] [Omitted 'or renewal' by Notification No. G.S.R. 1337(E), dated 27.10.2017 (w.e.f. 21.12.1945).] of a license, the licensing authority shall,-(i)verify the statement made in the application form;(ii)cause the manufacturing and testing establishment to be inspected in accordance with the provisions of rule 79; and[***] [Omitted by Notification No. G.S.R. 1337(E), dated 27.10.2017 (w.e.f. 21.12.1945).](3)If the licensing authority is satisfied that the applicant is in a position to fulfill the requirements laid down in these rules, he shall prepare a report to that effect and forward it [along with the application and the license (in triplicate) to be granted [***] [Substituted by G.S.R. 89(E), dated 14.2.1996 (w.e.f. 14.2.1996).], duly completed] [Added by S.O. 2139, dated 5.6.1972 (w.e.f. 12.8.1972).][to the Central License Approving Authority:Provided that if the licensing authority is of the opinion that the applicant is not in a position to fulfill the requirements laid down in these rules, he may, by order, for reasons to be recorded in writing, refuse to grant [***] [Inserted by G.S.R. 923(E), dated 14.12.1992 (w.e.f. 14.12.1992).] the license, as the case may be.(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.
