India’s ban on antimicrobial fixed-dose combinations: winning the battle, losing the war?

Giorgia Sulis, Richeek Pradhan, Anita Kotwani, Sumanth Gandra

Research output: Contribution to journalArticlepeer-review

1 Scopus citations

Abstract

Background and objectives: India, the country with the largest market availability of antimicrobial fixed-dose combinations (FDCs), banned certain antimicrobial FDCs in September 2018. Our objective was to examine the impact of Government ban on the sales of antimicrobial FDCs. Methods: The sales patterns of 14 of the 26 banned antimicrobial FDCs were analyzed using monthly private sector drug sales data from IQVIA (a comprehensive and nationally representative drug sales database) between January 2018 and December 2019. We carried out descriptive analyses to evaluate the trend in sales over time for banned and non-banned antimicrobial FDCs using cumulative sales volumes. Results: Overall, the cumulative sales volume of banned antimicrobial FDCs declined by 75% between January and September 2018 and the same months of 2019, although some banned FDCs continued to be available in significant volumes. The effectiveness of the ban was offset by several pathways. First, the sales of combinations containing moieties belonging to the same drug-classes as the antimicrobials in the banned FDCs increased after the ban. Second, while certain formulations of particular combinations were banned, the sales of other non-banned formulation of these combinations increased. Third, in some cases, products containing new non-antimicrobial components added to the banned combinations remained available. Interpretation and conclusions: While sales of the banned antimicrobial FDCs decreased in 2019, we identified several mechanisms that counterbalanced the ban, including implementation failure, rising sales of congeners, and products with additional non-antimicrobial components.

Original languageEnglish
Article number33
JournalJournal of Pharmaceutical Policy and Practice
Volume15
Issue number1
DOIs
StatePublished - Dec 2022

Keywords

  • AWaRe framework
  • Antimicrobial resistance
  • Antimicrobials
  • Fixed-dose combinations
  • India
  • Pharmaceutical policy

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