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Union of India - Section

Section 69 in The Drugs and Cosmetics Rules, 1945

69. [ Application for license to manufacture drugs other than those specified in Schedules C and C(1) to the Drugs and Cosmetics Rules. [Substituted by S.O. 1196, dated 6.5.1960 (w.e.f. 14.5.1960).]

- [(1) Application for grant [***] of license to manufacture for sale [or for distribution] [Inserted by G.S.R. 788(E), dated 10.10.1985 (w.e.f. 10.10.1985).] [of drugs, other than those specified in Schedules C and C(1) shall be made to the licensing authority appointed by the State Government for the purpose of this Part (hereinafter in this Part referred to as the licensing authority) and shall be made-(a)in the case of repacking of drugs excluding those specified in Schedule X for sale or distribution in Form 24-B;(b)in the case of manufacture of drugs included in Schedule X in Form 24-F;(c)in any other case, in Form 24.]
(2)[(a) Every application in Form 24-B 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 five hundred plus an inspection fee of rupees two hundred for every inspection [***] [Substituted by G.S.R. 601(E), dated 24.8.2001 (w.e.f. 24.8.2001).]
(b)Every application in Form 24-F shall be made up to 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 subsequent inspection [***] [Omitted 'or for the purpose of renewal of the license' by Notification No. G.S.R. 1337(E), dated 27.10.2017 (w.e.f. 21.12.1945).]
(c)Every application in Form 24 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 '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 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 the license' 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).][Substituted by G.S.R. 462(E), dated 22.6.1982 (w.e.f. 22.6.1982).]
(3) If a person applies for the renewal of a license after the expiry thereof but within six months of such expiry the fee payable for the renewal of such license shall be-(i) [ in the case of Form 24-B a license fee of rupees five hundred plus an additional fee at the rate of rupees two hundred and fifty per month or part thereof in addition to an inspection fee of rupees two hundred; [Substituted by G.S.R. 601(E), dated 24.8.2001 (w.e.f. 24.8.2001).](ii) in the case of Form 24-F a license fee of rupees six thousand plus an additional fee at the rate of rupees one thousand per month or part thereof in addition to an inspection fee of rupees one thousand;(iii) in the case of Form 24 a license fee of rupees six thousand plus an additional fee at the rate of rupees one thousand per month or part thereof in addition to an inspection fee of rupees one thousand and five hundred.]
(4)A fee of [rupees one thousand shall be paid] [Substituted by G.S.R. 601(E), dated 24.8.2001 (w.e.f. 24.8.2001).] for a duplicate copy of the license issued under clause (a), clause (b) or clause (c) of sub-rule (1) if the original is defaced, damaged or lost.
(5)[ Applications for manufacture of more than ten items of each category of drugs as [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. 26(E), dated 19.1.2006 (w.e.f. 19.1.2006).] or for manufacture of additional items of drugs by licensees in Form 24 or Form 24-F shall be accompanied by an additional fee at the rate of rupees three hundred for each additional item of drug. Applications in Form 24-B for license to manufacture for sale and distribution for repacking for more than ten items of each category or for manufacture of additional items of drugs shall be accompanied by additional fee of rupees one hundred for each additional item of drugs as categorized in Schedule M and M-III.]
(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).]