Section 76(7) in The Drugs and Cosmetics Rules, 1945
(7)[ 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 formulations, and under the conditions in which the formulations for administration and use are commended;(iii)are stable under the conditions of storage recommended; and(iv)contain such ingredients and in such quantities for which there is therapeutic justification;](v)[ have the approval, in writing, in favor of the applicant to manufacture drug formulations falling under the purview of new drug as defined in rule 122-E, 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).]
