In India, fixed-dose combinations (FDCs) have gained much popularity, so-called convenience and better adherence are provided, as well as multi-target action, in particular, both in such conditions as tuberculosis, diabetes, HIV, and hypertension. Ideally, by incorporating two or more drugs into one formulation, it is possible to ease the treatment process and improve the therapeutic response.
The problem is however, serious when there is irrationality, unsafeness and lack of adequate research in combinations.
The Indian market has some of the largest FDCs, but most of the formulations are not properly clinically justified. Multiple combinations of drugs do not have half-lives that match, overlapping side-effect effects, or show any documented synergistic advantage. These irrational FDCs may result in under-dose, toxicity, antimicrobial resistance, unforeseen interaction and decreased therapeutic efficacies.
It is also worried by the lack of uniform regulation and the existence of the thousands of state registered FDCs that had never been central scrutinized.
Although rational FDCs like anti-TB regimens or antiretroviral drugs or some combinations of antihypertive drugs are clinically useful, irrational FDCs remain a significant threat. Availability of over the counter drugs enhances abuse particularly in analgesics, antibiotics and cough cold drugs consisting of unnecessary multi-compounds.
India has made efforts to prohibit unsafe FDCs, but market availability and enforcement gaps have still been very cumbersome. To protect patients against detrimental combinations, it is important to reinforce regulatory oversight, provide scientific justification and awareness of prescriber guidelines.
FDCs are not necessarily bad, it is the quality regulation and the scientific reasoning that make the difference.
Do you feel that there should be more stringent nationwide bans on irrational FDCs in India to guarantee the safety of patients in spite of losing market shares?
MBH/PS