75. [ Forms of application for license to manufacture for sale or distribution of drugs specified in Schedules C, C(1) [excluding those specified in Part X-B and Schedule X] [Substituted by G.S.R. 462(E), dated 22.6.1982 (w.e.f. 22.6.1982).].
- [(1) Applications for the grant [*] [Substituted by G.S.R. 462(E), dated 22.6.1982 (w.e.f. 22.6.1982).] of license to manufacture for sale or distribution of drugs specified in Schedules C and C (1) [excluding those specified in Part X-B and Schedule X] [Substituted by G.S.R. 28(E), dated 22.1.1993 (w.e.f. 22.1.1993).],[shall be made to the licensing authority in Form 27, and shall be made upto ten items for each category of drugs [referred to in Schedule M relating to pharmaceuticals products and Schedule M-III relating to medical devices and in-vitro diagnostics] [Substituted by G.S.R. 462(E), dated 22.6.1982 (w.e.f. 22.6.1982).] and [shall be accompanied by a license fee of rupees six thousand and an inspection fee of rupees one thousand and five hundred for every inspection [*] [Substituted by G.S.R. 601(E), dated 24.8.2001 (w.e.f. 24.8.2001).]][***] [Omitted by Notification No. G.S.R. 1337(E), dated 27.10.2017 (w.e.f. 21.12.1945).](2)[ Application for grant [*] [Substituted by G.S.R. 462(E), dated 22.6.1982 (w.e.f. 22.6.1982).] of license to manufacture for sale or distribution of drugs specified in Schedules C, C(1) and X shall be made to the licensing authority in Form 27-B, and [shall be made upto ten items for each category of drugs [referred to in Schedule M relating to pharmaceuticals products and Schedule M-III relating to medical devices and in-vitro diagnostics] [Substituted by G.S.R. 601(E), dated 24.8.2001 (w.e.f. 24.8.2001).] and shall be accompanied by a license fee of rupees six thousand and an inspection fee of rupees one thousand and five hundred for every inspection [*] [Omitted 'or for the purpose of renewal of licenses' by Notification No. G.S.R. 1337(E), dated 27.10.2017 (w.e.f 21.12.1945).]]][***] [Omitted by Notification No. G.S.R. 1337(E), dated 27.10.2017 (w.e.f. 21.12.1945).](3)[ The application for grant [*] [Inserted by G.S.R. 119(E), dated 11.3.1996 (w.e.f. 11.3.1996) as corrected by G.S.R. 513(E), dated 6.11.1996.] of license to manufacture for sale or for distribution of drugs in [Large Volume Parenterals, Sera and Vaccines and Recombinant DNA (r-DNA) derived drugs,] [Substituted by G.S.R. 26(E), dated 19.1.2006 (w.e.f. 19.1.2006).][shall be made to the licensing authority appointed under this Part in Form 27-D and [shall be made upto ten items for each category of drugs categorized in Schedule M and shall be accompanied by a license fee of rupees six thousand and an inspection fee of rupees one thousand and five hundred for every inspection [*] [Inserted by G.S.R. 119(E), dated 11.3.1996 (w.e.f. 11.3.1996) as corrected by G.S.R. 513(E), dated 6.11.1996.]]:[***] [Omitted by Notification No. G.S.R. 1337(E), dated 27.10.2017 (w.e.f. 21.12.1945).](4)[ A fee of rupees one thousand shall be paid for duplicate copy of the license issued under sub-rule (1), sub-rule (2) or sub-rule (3), as the case may be, if the original license is defaced, damaged or lost.(5)If the licensee applies for manufacture of more than ten items of each category of drugs, the application shall be accompanied by an additional fee at the rate of rupees three hundred for each additional item of drugs [referred to in Schedule M relating to pharmaceuticals products and Schedule M-III relating to medical devices and in-vitro diagnostics] [Substituted by G.S.R. 601(E), dated 24.8.2001 (w.e.f. 24.8.2001).].](6)[ Where an application under this rule is for the manufacture of drug formulations falling under the purview of new drug as defined in rule 122-E, such application shall also be accompanied with approval, in writing, in favor of the applicant, from the licensing authority as defined in clause (b) of rule 21.] [Inserted by G.S.R. 311(E), dated 1.5.2002 (w.e.f. 1.5.2002).]
