It’s an enormous health risk, say experts, as it can accelerate the problem of antimicrobial resistance, which is a grave public health issue
Azithromycin and Cefixime-ofloxacin were the first and second-most consumed antibiotic molecules in India according to a new study published in The Lancet this month.
The study also noted that although the per-capita private-sector consumption rate of antibiotics in India was relatively low compared to many countries, the country consumed a large volume of broad-spectrum antibiotics that should ideally be used sparingly.
“This, together with significant share of fixed-dose combinations (FDC) from formulations outside the national list of essential medicines (NLEM) and a large volume of antibiotics not approved by the central drug regulators, call for significant policy and regulatory reform,” the study concluded.
The research team was made up of scientists from the Boston University School of Public Health, Boston, United States and the Public Health Foundation of India, New Delhi.
They conducted a cross-sectional ecological analysis of private sector antibiotics sales in India during 2019.
“We used PharmaTrac, a national-level private-sector drug sales audit dataset created by the All-Indian Origin Chemists and Distributors Ltd used by government agencies for policy decisions, including price regulation, and by researchers,” the researchers wrote.
They noted that India did not have a formal system of antibiotic use surveillance like in the US and Europe though it was the largest antibiotic consumer in absolute volume.
The researchers used the metrics of ‘DDD’ and the World Health Organization AWaRe classification system.
‘DDD’ stands for Defined daily dose. It is a globally accepted standard measure of antibiotic use and is used sparingly in Indian studies, according to the researchers.
It is defined as the average maintenance dose per day of a drug for its main indication in adults. It provides a unit of measurement independent of price, currencies, package size and strength that helps in drug utilisation studies across population groups and time.
AWaRe is “a stewardship framework advocated by the WHO to measure and improve appropriate antibiotic use and that categorises antibiotics into Access, Watch, and Reserve groups.”
‘Access’ includes antibiotics recommended as first-line or second-line antibiotics. ‘Watch’ includes those antibiotics that have a high chance of resistance and are to be used only for specific indications. ‘Reserve’ includes antibiotics to be used only as a last resort.
Azithromycin was the most consumed ‘Watch’ antibiotic according to the study. The paper also noted that the “widespread use of antibiotic FDCs was a significant concern due to the decreased therapeutic efficiency and difficulty in dose-scheduling, resulting in either under-dosing or over-dosing.”
Despite this, Cefixime-ofloxacin was the most consumed discouraged FDC and also the most consumed formulation outside the NLEM.
The study noted:
With antibiotic resistance emerging as a global public health problem, it is 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.
"Azithromycin is a macrolide antibiotic and a highest priority critically important antimicrobial. Its misuse is of concern as it can contribute to accelerating the problem of antimicrobial resistance, which is a grave public health issue. It should be conserved for use in treatment of specific infections,” said Rajeshwari Sinha, Programme Manager, Sustainable Food Systems, Centre for Science and Environment, New Delhi.
She added that Azithromycin found use both in human and animal health.
“The human health sector must lead the efforts in reducing misuse of such antibiotics. Only then other sectors such as animal husbandry and fisheries will be motivated to tackle the antibiotic misuse problem in their respective sectors as well,” Sinha said.
“Standard treatment guidelines should be followed by doctors. Besides use in clinical conditions where they are needed, antibiotics are often used for viral infections or when the doctor is not clear whether it is a viral or bacterial infection.
“Even infections such as diarrhoea, common cold and others are treated with antibiotics though they are mostly viral,” Sangeeta Sharma, professor at the Institute of Human Behaviour and Allied Sciences, New Delhi and president, Delhi Society for Promotion of Rational Use of Drugs, told Down To Earth.
She added that ‘Track and Trace’ technology could help regulatory authorities in understanding which sector as well as who in that sector was utilising antibiotics. Schedule H1, restricting over-the-counter dispensing of some of the 3rd and 4th generation quinolones and cephalosporins antibiotics, should be implemented strictly. “You need interventions at multiple levels including doctor as well as regulatory,” Sharma said.
The study titled Consumption of systemic antibiotics in India in 2019 was published in The Lancet Regional Health - Southeast Asia in September 2022.
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