A group of academics from India, Qatar and the United Kingdom recently published a worrying new study in the Journal of Pharmaceutical Policy and Practice (2023, 16:39) on the volume of unapproved and even banned fixed dose combination (FDC) of antibiotics that are being sold in India. Using sales data of the pharmaceutical industry, the study documents that in the year 2020, 60.5% FDCs of antibiotics (comprising 239 formulations) were unapproved and another 9.9% (comprising 39 formulations) were being sold despite being banned in the country. That so many of these unapproved or banned FDCs contain antibiotics is alarming because of the increasing prevalence of antibacterial microbial resistance (AMR) in India.
FDCs are combinations of one or more known drugs and can be useful in the treatment of some diseases since the combination can improve patient compliance. For instance, if a patient has to take three different medications for a particular treatment, she may forget to take one. But if all three medications are combined into one tablet or one syrup, the chance of her forgetting to take one or two of the drugs is reduced. For diseases such as AIDS, it is well documented that FDCs have proven to be very useful in improving patient compliance, which at the end of day improves treatment outcomes.
Making FDCs, even though most consist of drugs with known safety and efficacy profile, is not an easy job. All drugs have side effects and when formulated together, there is a possibility that the active ingredient or even the excipients (inactive ingredients) may affect the way that each drug functions. For example, the drugs may interact in a way to reduce the therapeutic efficacy of each active ingredient, or, worse, the drugs may interact with each other to create a more toxic element, often called metabolites. This is why it is crucial that all FDCs go through a scientifically designed approval process where such interactions can be evaluated.
