The Bhutan Food and Drug Authority (BFDA), in its mandate to ensure the safety, efficacy, and quality of medicinal products, hereby publishes the National List of Irrational Fixed Dose Combinations (FDCs).
The combinations listed have been found to be irrational due to one or more of the following reasons:
- Contradictory or incompatible pharmacological actions,
- Increased risk of adverse drug reactions and toxicity,
- Absence of sufficient clinical or regulatory evidence to support combined use,
- Lack of dosing flexibility or therapeutic benefit over individual agents,
- Risk of promoting antimicrobial resistance or inappropriate polypharmacy.
The publication of this list is intended to guide all relevant stakeholders—including manufacturers, importers, healthcare professionals, and regulatory personnel—in promoting rational medicine use and ensuring public health safety.
Accordingly, stakeholders are advised to refrain from the manufacture, import, distribution, registration, sale, prescription, and use of the listed FDCs. The BFDA shall refer to this list when reviewing product registration applications, import approvals, and during post-marketing surveillance and enforcement activities.