Section 71B in The Drugs and Cosmetics Rules, 1945
71B. [ Conditions for the grant [***] [Added by G.S.R. 515, dated 24.3.1976 (w.e.f. 10.4.1976).] of a license in Form 25-A.
- Before a license in Form 25-A is granted [***] [Omitted 'or renewed' by Notification No. G.S.R. 1337(E), dated 27.10.2017 (w.e.f 21.12.1945).], 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 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. G.S.R. 570 (E) dated 7.8.2014 (w.e.f. 21.12.1945)]
