Government Bans 16 Irrational Fixed-Dose Combination Drugs

The government has banned 16 fixed-dose combination (FDC) drugs, including some antibiotic combinations and several skin-care products containing aloe vera and other herbal ingredients. The reason is that the claimed added benefits of these combinations lack scientific justification.

A fixed-dose combination contains two or more active ingredients in a single formulation. Some combinations are evidence-based and improve treatment, but others are called "irrational" because there is little or no scientific proof that the ingredients work better together than when used separately. For a combination to be rational, each component should add a meaningful therapeutic effect, have compatible properties, and show a clear clinical benefit over the individual medicines.

Health experts warn that irrational combinations can expose patients to unnecessary drugs, raise costs and — in the case of antibiotics — fuel antimicrobial resistance (AMR), where bacteria, viruses, fungi and parasites stop responding to the medicines meant to kill them. One banned product combined the antibiotic amoxicillin with serratiopeptidase, an enzyme that breaks down proteins. The enzyme can be degraded in the stomach, and no robust randomised trial has shown that adding it improves bacterial clearance or cure rates.

For aspirants, the key takeaways are the concept of a fixed-dose combination, the meaning of an "irrational" FDC, and the link between misuse of antibiotic combinations and the growing threat of antimicrobial resistance.