Sulis Giorgia, Pradhan Richeek, Kotwani Anita, Gandra Sumanth
Department of Epidemiology, Biostatistics and Occupational Health, McGill University, Montreal, QC, Canada.
Department of Pharmacology, V. P. Chest Institute, University of Delhi, Delhi, India.
J Pharm Policy Pract. 2022 Apr 28;15(1):33. doi: 10.1186/s40545-022-00428-w.
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.
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.
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.
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.
印度是抗菌药物固定剂量复方制剂（FDCs）市场供应量最大的国家，于2018年9月禁止了某些抗菌FDCs。我们的目的是研究政府禁令对抗菌FDCs销售的影响。
利用IQVIA（一个全面且具有全国代表性的药品销售数据库）提供的2018年1月至2019年12月的月度私营部门药品销售数据，分析了26种被禁抗菌FDCs中14种的销售模式。我们进行了描述性分析，以使用累计销量评估被禁和未被禁抗菌FDCs随时间的销售趋势。
总体而言，2018年1月至9月与2019年同期相比，被禁抗菌FDCs的累计销量下降了75%，尽管一些被禁FDCs仍有大量供应。禁令的有效性被多种途径抵消。首先，禁令实施后，含有与被禁FDCs中的抗菌药物属于同一药物类别的部分的复方制剂销量增加。其次，虽然特定复方制剂的某些配方被禁，但这些复方制剂的其他未被禁配方的销量增加。第三，在某些情况下，含有添加到被禁复方制剂中的新非抗菌成分的产品仍可获得。
虽然2019年被禁抗菌FDCs销量下降，但我们发现了几种抵消禁令的机制，包括实施不力、同类产品销量上升以及含有额外非抗菌成分的产品。
