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Union of India - Section

Section 76A in The Drugs and Cosmetics Rules, 1945

76A. [ Forms of loan licenses to manufacture for sale or for distribution drugs specified in Schedule C and C1 excluding drugs specified in Schedule X or of Large Volume Parenterals, Sera and Vaccine and recombinant DNA (r-DNA) derived drugs, and conditions for the grant [***] [Substituted by Notification No. G.S.R. 574 (E) dated 17.7.2012 (w.e.f. 21.12.1945)] of such licenses.

- A loan license to manufacture for sale or for distribution of drugs specified in Schedules C and C(1), excluding drugs specified in Schedule X, and Large Volume Parenterals, Sera and Vaccine and Recombinant DNA (r-DNA) derived drugs specified in Part X-B shall be issued in Form 28A and a loan license to manufacture for sale or for distribution of Large Volume Parenterals, Sera and Vaccine and Recombinant DNA(r-DNA) derived drugs shall be issued in Form 28DA, and the] applicant shall, while applying for a license to manufacture patent or proprietary medicines, furnish to the licensing authority evidence and data justifying that the patent or proprietary medicines-
(i)contain the constituent ingredients in therapeutic/prophylactic quantities as determined in relation to the claims or conditions for which the medicines are recommended for use or claimed to be useful;
(ii)are safe for use in the context of the vehicles, excipients, additives and pharmaceutical aids used in the formulations and under the conditions in which the formulations for administration and use are recommended;
(iii)are stable under the conditions of storage recommended; and
(iv)contain such ingredients and in such quantities for which there is therapeutic justification.]
[Provided that the application for grant of a license for a drug formulation containing single active ingredient shall be made only in proper name.] [Inserted by Notification No. GSR 570 (E) dated 7.8.2014 (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).]
77. [ Duration of license. [Substituted by S.O. 1326, dated 19.4.1964 (w.e.f. 11.4.1964).]- An original license in[Form 28, Form 28-B and Form 28-D or renewed license in Forms 26, 26-F and Form 26-H][, unless sooner suspended or canceled shall be[valid for a period of five years on and from the date on which] [Substituted by S.O. 1326, dated 19.4.1964 (w.e.f. 11.4.1964).][it is granted or renewed:[Provided that if the application for the renewal of a license is made before its expiry, or if the application is made within six months of its expiry, after payment of additional fee, the license shall continue to be in force until orders are passed on the application and the license shall be deemed to have expired if the application for its renewal is not made within six months of its expiry.] [Substituted by S.O. 1326, dated 19.4.1964 (w.e.f. 11.4.1964).]