Newer FDCs in Indian Market are they Rational or Irrational

‘The person who takes medicine must recover twice,

once from the disease and once from the medicine’.

~William Osler

Combination products, also known as fixed dose drug combinations (FDCs), are combinations of two or more active drugs in a single dosage form. Rational drug therapy means the use of the right medicines in the right manner (dose, route, frequency of administration, duration of therapy) in the right patient at the right cost and at the right time as defined by the WHO.^[1] In past few decades, the FDCs are mushrooming in the pharmaceutical market, although various opinions have been expressed regarding the rationality of FDCs.

Pharmaceutical companies manufacturing these FDCs are luring physicians to prescribe their products even if they are needed by the patients. This may be due to the implementation of product patents companies find various alternatives to sustain themselves in market place and combination products for newer indications play a major role. Instead of investing in research and producing newer drug molecules, companies are manufacturing the double or triple drug FDCs, which the pharmaceutical companies are manufacturing by just mixing the two or three drugs and making it as so called novel drugs and adopting the marketing techniques. Unfortunately, many FDCs being introduced in India are usually irrational. The most pressing concern with irrational FDCs is that they expose patients to unnecessary risk of adverse drug reactions.^[2,3]

The drug comes to market even with pending approvals by DGCI.

Indian markets get flourished with the FDCs as the drug patent ends and without any rational studies and research. The only studies which are presented are post marketing studies.

Irrational FDCs also impose unnecessary financial burdens on consumers. Medical practitioners who patronize such combinations could be the centre of controversy when subjected to litigation in consumer forums, as these combinations do not find mention in standard text or reference books and reputed medical journals. Pharmaceutical manufacturers, however, continue to reap the benefits of huge sales and, therefore, continue to promote combinations with vigour. The time has come for all practitioners and consumers to raise this matter vociferously through all possible avenues. Drug regulatory bodies should take urgent action to mitigate the free flow of irrational FDCs.

FDCs are mainly promoted to enhance compliance by decreasing the number of required pills. Increasing requirement of drugs when more than one disease is found in a patient justifies the use of FDCs to improve compliance.^[4] Consequently, a relook and rationalisation are required when FDCs are prescribed to patients so that their benefit outweighs the risk involved in prescribing unnecessary and irrational FDCs.^[5]

It is the need of the hour to raise our voice against the growing list of FDCs in the Indian market and try to reduce the magnitude of this problem by sensitising the undergraduates, the interns as well as the practitioners regarding the efficacy, safety, suitability, rationality and cost benefit of FDCs available for patient use.