Section 75A in The Drugs and Cosmetics Rules, 1945
75A. [ Loan licenses. [Added by S.R.O. 1136, dated 15.6.1957.]
(1)Applications for the grant [*] of loan licenses to manufacture for sale [or for distribution] [Substituted by G.S.R. 788(E), dated 10.10.1985 (w.e.f. 10.10.1985).][of drugs specified in Schedules C and C(1) [excluding those specified in Part X-B and Schedule X] [Added by S.R.O. 1136, dated 15.6.1957.][shall be made in Form 27-A to the licensing authority 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] [Added by S.R.O. 1136, dated 15.6.1957.] 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).][Explanation. - For the purpose of this rule a loan license means a license which a licensing authority may issue to an applicant who intends to avail the manufacturing facilities owned by a licensee in Form 28.] [Substituted by Notification No. G.S.R. 724 (E) dated 7.11.2013 (w.e.f. 21.12.1945)](1A)[ The applicatiOn for grant [*] [Inserted by Notification No. G.S.R. 574 (E) dated 17.7.2012 (w.e.f. 21.12.1945)] of loan license to manufacture for sale or distribution of drugs in 'Large Volume Parenterals', 'Sera and Vaccine' and 'Recombinant DNA(r-DNA.) derived drugs' shall be made to the licensing authority appointed under this Part, in Form 27DA and be made upto ten items for each category of drugs categorized in Schedule M and accompanied by a license fee of six thousand rupees and an inspection fee of one thousand five hundred rupees 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).](2)[ The licensing authority, shall, before the grant of a loan license, satisfy himself that the manufacturing unit has adequate equipment, staff, capacity for manufacture and facilities for testing, to undertake the manufacture on behalf of the applicant for a loan license:[***] [Added by S.R.O. 1136, dated 15.6.1957.](3)[ Subject to the provisions of sub-rule (2), the application for manufacture of more than ten items of each category of drugs on a loan license, shall be accompanied by an additional fee at the rate of rupees three hundred for each additional item of drugs.(4)If the licensing authority is satisfied that a loan license is defaced, damaged or lost, he may, on payment of a fee of rupees one thousand, issue a duplicate copy of loan license.] [Substituted by G.S.R. 601(E), dated 24.8.2001 (w.e.f. 24.8.2001).][* * *] [Rule 75-B omitted by G.S.R. 944(E), dated 21.9.1988 (w.e.f. 21.9.1988).]
