A new research conducted by the The Lancet Regional Health-Southeast Asia has found out that Azithromycin 500mg tablet was the most consumed antibiotic formulation (7.6 per cent) in India, followed by cefixime 200 mg tablet (6.5 per cent) .
The research also found that widespread inappropriate human use of antibiotics has been identified as a significant driver of antibiotic resistance in India.2 Even though India is the largest antibiotic consumer in absolute volume,3 the country does not have a formal system of antibiotic use surveillance to guide an antimicrobial stewardship program akin to those found in the US and the Europe.
The study also shows that worldwide human consumption of antibiotics increased by 36% between 2000 and 2010.10 Brazil, Russia, India, China, and South Africa (BRICS) accounted for three-quarters of the increase despite collectively representing only 40% of the world's population. Among these countries, 23% of the retail sales volume was attributable to India, where regulations to control over-the-counter sales of antibiotics are poorly enforced. The WHO and various national commissions and reports from India have advocated using the national list of essential medicines (NLEM) as a critical tool to achieve health equity.11 The last edition of India's NLEM published in 2015 contains 28 antibiotics. Examining antibiotic consumption against NLEM will help understand the affordability of antibiotics and the market response to price regulations in India, as the National Pharmaceutical Pricing Policy (2012) requires the price control of essential medicines with specified dosage and strength.12
Fixed-dose combinations (FDCs) are a hallmark of the Indian drug market.13 Some specific combinations such as trimethoprim-sulfamethoxazole are clinically and pharmacologically efficient and combinations are required to prevent the emergence of resistance in diseases like tuberculosis and leprosy. However, the widespread use of antibiotic FDCs is a significant concern due to the decreased therapeutic efficiency and difficulty in dose-scheduling, resulting in either under-dosing or over-dosing.14 Previous reports, including an Indian parliamentary standing committee report and an Indian Council of Medical Research expert committee report, highlighted the growing number of “irrational” FDCs as a public health issue.15 However, previous studies have not examined the consumption of FDCs in India using the AWaRe classification.
In India, the drug regulatory responsibilities are distributed between the Central Drugs Standard Control Organization (CDSCO)—the national regulatory body for pharmaceuticals and medical devices—under the national government and the State Drug Regulatory Authorities (SDRAs) under the respective state governments. This means each Indian state can provide market approval even without CDSCO approval. Although the SDRAs in most states have limited technical capacity, the capacity widely varies between SDRAs, thereby diminishing the regulatory effectiveness.16 An analysis of the Indian drug market during 2007-12 showed that a considerable proportion of antibiotics are unapproved by the CDSCO.14 However, we did not find studies that used the AWaRe classification to assess the sales and consumption of antibiotics against the approval status.
In summary, measuring antibiotic consumption using DDD metrics and AWaRe classification across product type (FDCs/single formulations [SF]), essentiality (listed in NLEM/not listed), and central regulatory approval status (CDSCO approved/unapproved) would provide a comprehensive understanding on the level of appropriateness of antibiotic use in India.
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