Over half the antibiotic formulations India used in 2019 were unapproved

Despite being the largest antibiotic consumer in absolute volume globally, India lacks a formal system of antibiotic use surveillance

By Taran Deol
Published: Wednesday 07 September 2022
Photo: iStock

Over half the antibiotic formulations used in India in 2019 were not listed in the national list of essential medicines (NLEM), a new study published recently in The Lancet has found.

The study also noted that fixed-dose combinations (FDC) in India were not approved by the United States Food and Drug Administration (FDA) either. It cited an analysis from 2015 which showed the highest number of “not US FDA-approved” antibiotic FDCs were sold in India. The country was followed by China, Francophone West Africa, and Vietnam.

India also had a high rate of consumption of FDCs discouraged by the World Health Organization (WHO). “Combinations discouraged by the WHO constituted 48.7 per cent (836 million defined daily doses or DDD) of FDCs,” the study noted.

The Lancet study cited a 2019 analysis which found that between 2007 and 2012, there were 118 antibiotic FDC formulations on the India market, significantly higher than four in the United States and United Kingdom each.

“Considering that the drugs listed in NLEM are subject to a price control much more than the drugs not listed, our results indicate loopholes in the policy that incentivise manufacturers to shift to inappropriate FDCs with formulations outside of NLEM,” the study said. 

High consumption

Unrestricted over-the-counter sale of most antibiotics, manufacturing and marketing of many FDCs and overlap in regulatory powers between national and state-level agencies were the key reasons behind India’s high levels of antibiotic consumption, the study found.

This has fuelled antibiotic resistance — a public health challenge which first reared its head in the country’s hospitals in the 1950s, but has only grown due to the inappropriate use of antibiotics.

This has led to cures and treatments for some ailments becoming more expensive and sometimes even impossible. The emergence of multidrug-resistant tuberculosis since the 1980s serves as a prime example where daily intake of medicines is as high as six or seven, decreasing the chances of patients adhering to treatment.

India lacks a formal system of antibiotic use surveillance despite being the largest antibiotic consumer in absolute volume globally. Moreover, private companies are the only source to gauge India’s medicine sales and consumption data, the study noted.

While several studies have analysed and concluded that India’s antibiotic consumption is high, very few have done so using the AWaRe classification, “a stewardship framework advocated by the WHO to measure and improve appropriate antibiotic use.”

Under this, antibiotics are divided into three key categories. The first is ‘Access’, which includes antibiotics typically used as the first or second-line of treatment; the second is ‘Watch’, which includes broad-spectrum antibiotics which have a high chance of resistance and must only be used for specific indications; and third is ‘Reserve’, the last resort antibiotics.

In India, drugs which fall under the ‘Watch’ category, are used in high volumes, going against the reason behind its classification — to be used sparingly, the study found.

Of the 5,071 million DDD consumed in 2019, antibiotics falling under the ‘Watch’ category contributed 54.9 per cent (2,783 million) DDDs.

The global goal is to have at least a 60 per cent share for ‘Access’ antibiotic, and in India the ratio is nearly reversed. This category of drugs also constituted 72.7 per cent (1,750 million DDDs) of unapproved products.

Despite India having a low per-capita consumption of antibiotics compared to previously reported figures, overusing antibiotics remains a problem. This low figure could be a function of “persisting issues of lack of access to antibiotics or better availability of drugs in the public sector,” the study noted. 

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