Assessment of rationality of available fixed dose combinations of antibiotics in India.

Objective: India is among the largest consumers of antibiotics. Easy availability and growing sales of Fixed Dose Combinations (FDCs) of antibiotics can worsen Antimicrobial Resistance (AMR). There is lack of comprehensive data on available antibiotic FDC formulations, their dose strengths and adequacy of scientific evidence regarding their efficacy, safety and suitability for human use. In the present work, we aimed at addressing this knowledge gap.

Methods: Availability of FDCs was ascertained from the Current Index of Medical Specialties (CIMS) [Issue Jan-April 2020]. Customized data abstraction form was used to capture pertinent information for these FDCs. Assessment of rationality was done based on standard parameters.

Results: More than 90% of the existing FDCs were found to be irrational; with two third of them being unapproved and or banned from use in the country.

Conclusions: Although the regulatory agency has already taken cognizance of the seriousness of the matter; there is an urgent need to revisit these FDCs to promote prudent antibiotic use.

Unlabelled: High antibiotic use is associated with antimicrobial resistance; it is imperative that all factors which lead to high antibiotic use are adequately addressed. Easy availability of fixed dose combinations (FDCs) has begun to catch the attention of regulators in developing economies like India leading to a ban of 330 FDCs of which 19% were antibiotic combinations. The continuing presence and increasing sales of these irrational FDCs is a concern for effective antimicrobial stewardship.