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W. Clement Atlee*, P. Muralidharan and K. Kalaiselvan


A fixed-dose combination (FDC) product is one in which two or more drugs combined in a fixed ratio. The health ministry of India banned over 300 fixed dose combinations in 2016 because of their irrationality and unjustified combination. Although banned in many countries fixed dose combination like nimesulide with paracetamol is still available in India. Patient safety is more important than profit. Drug regulatory agencies must evaluate every fixed dose combination by their benefit/risk ratio by bioequivalence comparing studies between monotherapy and their fixed dose combination’s safety, efficacy and stability clinical data’sverificationandthe reasons for the combination before the product come into the market for selling. Post marketing surveillance must be followed and safety should be confirmed while in patient use of such fixed dose combinations. Awareness about banned FDC drugs among the consumers and physician’s knowledge about rational and irrational combinations of drugs before prescribing are vital in the future. Two drug fixed dose combinations like dapagliflozin and metformin and triple drug fixed dose combinations like glimepiride, pioglitazone and metformin are crucial in treating chronic diseases like diabetes. A pharmacist who is the responsible person in drug dispensingcan act as a link between doctors and the patients can inform doctors about the irrational fixed dose combinations and suggest only rational FDC as over the counter drugs to the consumers.

Keywords: Rational fixed-dose combinations; Medication adherence; Advantages of fixed-dose combinations; Patient compliance.

[Full Text Article]

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