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[Cites 0, Cited by 0] [Section 122DAB(5)] [Section 122DAB] [Entire Act]

Union of India - Subsection

Section 122DAB(5)(c) in The Drugs and Cosmetics Rules, 1945

(c)failure of investigational product to provide intended therapeutic effect; [where the standard care, though available, was not provided to the subject as per the clinical trial protocol.]