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[Cites 0, Cited by 0] [Section 122DA(2)] [Section 122DA] [Entire Act]

Union of India - Subsection

Section 122DA(2)(c) in The Drugs and Cosmetics Rules, 1945

(c)confirmatory clinical trials (Phase-III) on a new drug shall be made on the basis of the data emerging from Phase-II and where necessary, data emerging from Phase-I also, and shall be accompanied by a fee of twenty-five thousand rupees: