The effectiveness of government initiatives aimed at removing centrally unapproved and banned antibiotic fixed-dose combination (FDC) drugs has been brought into question by a crucial analysis. It showed that in 2020, the majority (70%) of antibiotic formulations sold in India were discovered to be unapproved or banned, despite efforts to regulate these medications.
Fixed-dose combination drugs are formulations that contain a combination of two or more active pharmaceutical ingredients (APIs) in a fixed ratio within a single drug.
Published in the Journal of Pharmaceutical Policy and Practice, the analysis titled ‘Regulatory enforcement of the marketing of FDCs in India: a case study of systemic antibiotics’ was conducted by researchers from India, Qatar, and the UK.
According to the findings, the sale of FDCs accounted for 37.3% of total antibiotic sales in 2020, an increase from 32.9% in 2008. Despite a decrease in the total number of antibiotic FDC formulations in the market from 574 (in 2008) to 395 (in 2020), a significant majority of marketed formulations, 70.4% (278 out of 395), were identified as unapproved or banned.
Aashna Mehta, a health economist associated with the Public Health Foundation of India in New Delhi and a co-author of the paper, highlighted the persistent issue despite regulatory actions. She emphasized the importance of addressing this problem, particularly in the context of rising global antimicrobial resistance.
Mehta recommended periodic market surveys and reinforced enforcement measures. Rajeev Singh Raghuvanshi, Drugs Controller General of India was unavailable to comment on the findings.