Despite India having a low per-capita consumption rate of antibiotics, the country consumes a large volume of broadspectrum antibiotics that should ideally be used sparingly, according to a latest study.
In the study that appeared in Lancet, the authors said that inappropriate use of antibiotics is a significant driver of antibiotic resistance in India. “Largely unrestricted over-the-counter sales of most antibiotics, manufacturing and marketing of many fixed-dose combinations (FDC) and overlap in regulatory powers between national and state-level agencies complicate antibiotics availability, sales, and consumption in the country,” said Shaffi Fazaludeen Koya , Corresponding author at Department of Epidemiology, Boston University School of Public Health.
In the paper, the authors said that the total volume of anti-infectives sold in India in 2019 was 2807 million packs, of which systemic antibiotics constituted 2165 million packs (77.1%). They also identified 163 antibiotic preparations involving 85 antibiotic molecules. There were 1098 unique formulations and 10,100 unique products (brands). They also said that 73.5% of systemic antibiotic brands were oral preparations (57.8% solids and 15.7% liquids), and 26.5% were parenteral preparations. The authors pointed out that 45.5% of brands (18.8% of formulations) belonged to CDSCO approved category, 33.7% 10.5% of formulations) belonged to the NLEM and 42.9% of formulations (53.3% of brands) belonged to the Watch category and 25.1% of formulations (19.4% of brands) belonged to the discouraged group. In the study, the authors said that the total number of defined daily dose (DDDs) consumed was 5071 million, which means 10.4 DDD per 1000 population per day. Cephalosporins was the most used antibiotic class (1496 million DDDs, 29.5%). followed by penicillins (859 million, 17.0% and macrolides (835 million, 16.5%).
The authors analyzed cross-sectional data from Pharma Trac, a nationally representative private sector drug sales dataset gathered from a panel of 9000 stockists across India. They used AWaRe (Access, Watch, Reserve) classification and the defined daily dose (DDD) metrics to calculate the per capita private sector consumption of systemic antibiotics across different categories: FDCs vs single formulations; approved vs un approved; and listed vs not listed in the national list of essential medicines (NLEM).
The authors said that it was crucial to institute new regulations and strengthen existing ones to monitor and regulate the sale and use of antibiotics while improving access to appropriate antibiotics through the public health system.