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

ABSTRACT

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.

Expert opinion

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.

KEYWORDS:

• Antimicrobials
• Fixed Dose Combinations
• irrational
• probiotics
• topical antibiotics

Acknowledgments

This research did not receive any specific grant from funding agencies in the public, commercial, or not-for-profit sectors. The authors declare no conflict of interest.

Author contributions

Conceptualization and methodology: N Kaur, N Shafiq, S Malhotra, and V Verma.

Data acquisition, curation, formal analysis, and draft preparation: N Kaur, P Anand, N Shafiq, V Verma, and S Malhotra.

Writing, review, editing, and supervision: N Kaur, V Verma, N Shafiq, and S Malhotra.

Declaration of interest

The authors have no relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript. This includes employment, consultancies, honoraria, stock ownership or options, expert testimony, grants or patents received or pending, or royalties.

Reviewer disclosures

Peer reviewers on this manuscript have no relevant financial or other relationships to disclose.

Additional information

Funding

This paper was not funded.