Indians consume large amounts of unapproved antibiotics: Lancet study

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Globally, India remains one of the main drivers of antibiotic resistance. India has reported one of the highest rates sales volume of antibiotics for a country during the period 2018-20 according to some reports. The easy availability and over-prescription of antibiotics – even unapproved ones – has led to the development of antibiotic resistance. Sometimes antibiotic resistance can also make vaccines ineffective against certain pathogens. The World Health Organization (WHO) classifies growing antibiotic resistance as a “serious threat.”

A study published this month in The Lancet Regional Health – Southeast Asia now offers a picture of the causes and extent of this overuse in India. Based on an analysis of a private, nationally representative dataset on drug sales in India, the study uses data from the WHO Aware (Access, Surveillance, Reserve) drugs to examine the sale and consumption of antibiotics in the country. Watch and Reserve class antibiotics should be used sparingly as they are likely to cause antibiotic resistance. While the Watch class of antibiotics should be prescribed for specific diseases in limited doses as a first or second choice, the Reserve class of antibiotics are meant to be the “last resort” due to their very high likelihood of causing resistance. to antibiotics. But in India, they are over-prescribed – and even worse, many unapproved formulations make up a significant portion of Indian consumption.

While previous studies have also focused on how Indians report some of the highest antibiotic consumption in the world, they have not looked at the classification of drugs prescribed, nor specifics, such as their status. approved.

The researchers established interpretations based on three categories: unapproved drugs versus approved drugs, unique formulations versus Fixed dose combination (FDC) and medicines on the Indian National List of Essential Medicines (NLEM) versus those not on the list.

A study of India’s drug markets during the period between 2007 and 2012 revealed that a considerable proportion of antibiotics on sale were not approved by the Central Drugs Standard Control Organization – the national drug regulator. In India, FDCs – combinations of several drug formulations in a single dose – are commonly prescribed for diseases like tuberculosis and leprosy when there is a need to fight multiple bacteria. However, the increasing use of CDFs may lead to increasing resistance against several antibiotics, and lean on prefabricated suits can lead to overdosing or underdosing of the different components that make up the suit. Therefore, the scientists chose to classify their data according to these parameters.


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The present study, on data analysis, revealed that in 2019, Indians consumed 5.071 million Defined daily doses (DDD) — a standardized unit of measurement for drugs — antibiotics. Per day, this translates to 10.4 DDD per 1,000 inhabitants. The researchers further found that the “Watch” class of antibiotics – antibiotics with higher resistance potential, often prescribed as a second-choice drug – accounted for 54.9% of all DDDs.

Categorizing drugs according to their approval for use, the researchers observed that unapproved drugs contributed to nearly half of DDDs. “Watch for” antibiotics accounted for more than 72% of unapproved drugs sold. FDCs accounted for 34% of DDDs, and of these, WHO-discouraged combinations accounted for almost half of the total drugs sold.

The high number of DDDs from unapproved and discouraged drugs indicates the lack of proper oversight infrastructure for the sale and consumption of antibiotics in India. Most antibiotics in India are sold over the counter without a prescription. Earlier reports have look at how unapproved antibiotic combinations work freely in Indian markets. Health researchers have also complained that the Indian government is not doing enough to curb the sale of unapproved drugs and drug combinations. In 2020, even US drug regulators wrote to the Indian government expressing concern that these unapproved drugs are causing an increase in global antibiotic resistance.

One of the ways in which unapproved drugs can circumvent these regulations, the scientists write in their paper, is through the existence of multiple regulatory authorities. Researchers Explain in their study that “in India, drug regulatory responsibilities are divided between the Central Drugs Standard Control Organization (CDSCO)… under the national government and the National Drug Regulatory Authorities (SDRAs) under the state governments respective. This means that every Indian state can provide market approval even without CDSCO approval.

Interestingly, the most widely used antibiotic formulation in India in 2019 according to the study was azithromycin. During the Covid19 pandemic – which happened within the timeframe of the study – the drug, along with a few other antibiotic formulations, was recommended as a miracle cure for mild Covid19.

The study comes at a time when antibiotic resistance is a growing concern, with some studies even pointing to how it causes death in newborn babies. Although previous studies have also looked at the overuse of antibiotics in India, the use of the AWaRe model by the current study and the analysis of the percentages of consumption of approved and unapproved drugs can help to understand the full extent of the situation. The results of the study indicate that there is an urgent need for robust surveillance systems for antibiotic consumption.

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