Fixed dose combinations- to prescribe or not to prescribe: a dilemma of medical profession

Mayank Prakash Nigam, Vinson L. G. Fernandes, Padmanabh V. Rataboli


Background: Fixed dose combinations (FDCs) refer to products containing two or more ingredients used for a particular indication in a single dosage form. Prescribing FDCs has become a routine affair in medical practice. There has been increase in the irrational FDCs in the recent past by leaps and bounds. The pharmaceutical companies are luring the physicians to prescribe their products even when they are not needed by the patients. The Indian laws too are not properly defined to grant marketing approvals of FDCs. Hence the rationality of a FDC has become one of the most controversial and debatable issues in general practice.

Methods: We hence decided to analyze the existing FDCs in Indian market and study their rationality.

Results: We observed that, although many brands of FDCs available are essentially rational as per WHO and Indian essential drugs lists, the irrational FDCs easily outnumber the rational ones. Hundreds of rational FDCs are also available which are not included in WHO or Indian essential drugs lists. A few FDCs with incorrect doses were also noted. Irrational FDCs not only cause more adverse drug reactions but the antibiotic FDCs are responsible for increasing the chances of resistance. A few of these are discussed for their irrationality.

Conclusions: It is the need of the hour to raise our voice against the growing list of irrational FDCs and try to reduce the magnitude of this problem by sensitizing the undergraduates, the interns as well as the practitioners regarding their efficacy, safety, suitability, rationality and cost benefit.


Fixed dose combinations, Drug combinations, Irrational combinations, Essential drug combinations, Rational combinations

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