List of Refereed Journals published by UGC, New Delhi on 28-03-2017-- AJRC (Sr. No.-1025); AJM (Sr. No.-2497); RJET (Sr. No.-7220); RJPP (Sr. No.- 7232): RJPPD (Sr. No.- 7234); RJPT (Sr. No.-7235) (19-Apr-2017)        | List of Refereed Journals published by UGC, New Delhi on 11-01-2017-- Research Journal of Pharmacy and Technology (Sr. No.-275); Asian Journal of Management (Sr. No.-3986); Asian Journal of Research in Chemistry (Sr. No.-4008); Research Journal of Engineering and Technology (Sr. No.-31787); Research (22-Jan-2017)        |

Journal :   Research Journal of Pharmacy and Technology

Volume No. :   2

Issue No. :  3

Year :  2009

Pages :   

ISSN Print :  0974-3618

ISSN Online :  0974-360X


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Fixed Dose Combination Product: Current Status Among Regulatory Agencies



Address:   1RKDF College of Pharmacy Bhopal (M.P.). 2Dept. of Pharmacy, Bhopal University, Bhopal (M.P.). 3Kanak Manjari Institute of Pharmaceutical Science, Rourkela (Orissa).
DOI No: Not Available

ABSTRACT:
There is alarming increase in irrational Fixed dose combination drugs (FDCs) in recent years and pharmaceutical companies manufacturing these FDCs are luring physicians to prescribe by unethical means. Only a few drugs are lifesaving and essential, rests of the drugs are substitutes for each other. Some may be totally a dumping of drugs into patients without any clinical benefit. With the escalating cost of drugs, there is poor drug compliance, which further magnifies the problem, both for the prescriber as well the patient. Manufacturers of drugs having quickly tuned in to the potential golden egg are marketing fixed dose drug formulations for various diseases. It is high time that regulatory authorities, healthcare professionals, researchers and pharmaceutical companies have to join hands together to formulate guidelines for the FDCs to provide effective and safer drugs to the patients. Thus, in the present review we have compared current FDC policies of United State Food and Drug Administration (USFDA), European Union (EU) and, India (Central Drugs Standard Control Organization).
KEYWORDS:
Fixed dose combination drugs (FDCs), Regulatory agencies, Central Drugs Standard Control Organization (CDSCO), United State Food and Drug Administration (USFDA), European Union (EU).
Cite:
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