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Union of India - Section

Section 69A in The Drugs and Cosmetics Rules, 1945

69A. [ Loan licenses [Amended by S.R.O. 2136, dated 15.6.1957.]

.] - [(1) Application for the grant [***] [Substituted by Notification No. G.S.R. 601(E) dated 24.8.2001 (w.e.f. 21.12.1945)] of loan licenses to manufacture for sale or for distribution of drugs other than those specified in Schedule C, Schedule C(1) and Schedule X shall be made up to 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 'categorized in Schedule M and Schedule M-III' by Notification No. G.D.R. 640(E), dated 29.6.2016 (w.e.f. 21.12.1945).] and shall be made in Form 24-A accompanied by a license fee of rupees six thousand and an inspection fee of rupees one thousand and five hundred to the licensing authority:[***] [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 25.] [Substituted by Notification No. G.S.R. 724 (E) dated 7.11.2013 (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.
(3)[ Subject to the provisions of sub-rule (2), application for manufacture of more than ten items for each category of drug on a loan license shall be accompanied by an additional fee of rupees three hundred per additional item [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).].]
(4)[ If the licensing authority is satisfied that a loan license is defaced, damaged or lost or otherwise rendered useless, he may, on payment of [a fee of rupees one thousand] [Added by S.O. 3868, dated 26.10.1968 (w.e.f. 2.11.1968).] [issue a duplicate license.] [Amended by S.R.O. 2136, dated 15.6.1957.][* * *] [Rule 69-B omitted by G.S.R. 944(E), dated 21.9.1988 (w.e.f. 21.9.1988).]