Key Points
New Delhi: Government initiatives to remove centrally unapproved and banned antibiotic fixed-dose combination (FDC) drugs have remained largely ineffective, and in 2020, most of the antibiotic formulations sold in India were unapproved or banned, a crucial analysis has found...
The analysis, titled Regulatory enforcement of the marketing of FDCs in India: a case study of systemic antibiotics and carried out by researchers from India, Qatar and the UK, was published Friday in the Journal of Pharmaceutical Policy and Practice...
In India, of the 4.5 billion standard units of antibiotic FDC drugs sold in 2020, the paper said, 41.5 per cent were combinations listed as not recommended by the World Health Organization (WHO)...
Our study establishes that despite regulatory initiatives and measures since 2007 to control sales, hundreds of unapproved antibiotic FDC formulations remained on the Indian market accounting for over 700 million of the 4.5 billion standard units sold in 2020, the analysis paper said...
Given recent research findings of high sales in 2019 of FDCs not recommended by WHO and of 13 of the 20 top-selling systemic antibiotic FDCs in 2020 being expressly not recommended by the WHO, the higher overall market share of systemic antibiotic FDCs in 2020 (37 per cent) compared to 2008 (33 per cent) is a cause for serious public health concern, the researchers wrote...
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70% of antibiotic FDC drugs in the market are banned, unapproved. It’s a public health hazard
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