Fixed Dose Combination Product: Current Status Among Regulatory Agencies

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).