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Evaluation of Fixed Dose Combinations (FDCs) considered as Irrational and where Showcause Notices were Issued to the Applicants for Submitting their Replies

Ministry of Health and Family Welfare MoH&FW

Working Papers from eSocialSciences

Abstract: The Expert Committee evaluated the FDCs in the interest of public health so that public health of people is not compromised. The committee noted that legacy products are available in the market which were licensed by SLAs without following due procedure as laid down under Drugs and Cosmetics Rules have not been evaluated for their rationality, safety and efficacy which exposed patients to unnecessary risk of adverse drug reactions.

Keywords: Drugs; FDCs; patients safety; drug toxicity; misuse of drug; issue of antimicrobial drug resistance; ingredients; abuse potential; India (search for similar items in EconPapers)
Date: 2016-04
Note: Institutional Papers
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