Antibiotic resistance is becoming increasingly prevalent in India due to several reasons, including the inappropriate use of antibiotics. The availability, sales, and consumption of antibiotics in the country have become complicated due to manufacturing and marketing of many fixed-dose combinations, and unrestricted over-the-counter sales of most antibiotics, according to a new study published in The Lancet Regional Health Southeast Asia. 


In 2019, the average consumption of antibiotics was 10.4 defined daily doses per 1,000 persons, per day. The defined daily dose is the assumed average maintenance dose per day for a drug used for its main indication in adults. 


There is a high use of broad-spectrum antibiotics and unapproved formulations in India. This is a public health concern, according to the study. A broad-spectrum antibiotic is one which acts against Gram-positive or Gram-negative bacteria, or one which acts against a wide-range of disease-causing bacteria, including rickettsiae and pleuropneumonia-like organisms. 


This is the first published study analysing private-sector consumption of sysentic antibiotics in India using defined daily dose metrics and the AWaRe classification system. The study also reports India's most recent private-sector consumption estimates, and provides policy measures to achieve the global targets of appropriate use of antibiotics. 


Why Is Antibiotic Resistance A Health Challenge?


Antibiotic resistance is a public health challenge that initially appeared in hospitals in the 1950s. The growing inappropriate use of antibiotics over the subsequent decades led to the emergence of multi-drug resistant bacteria. As a result, the cure for several infections has become more expensive, and in some cases, impossible.


Moreover, antibiotics are misused in the poultry and animal industry as growth promoters. Since very few new antibiotic classes are being manufactured, it is important to optimise the appropriate use of available antibiotics. 


How Was The Study Conducted?


A team of researchers from the Boston University School of Public Health, Boston, and Public Health Foundation of India, New Delhi, analysed cross-sectional data from PharmaTrac, as part of the study. PharmaTrac is a nationally representative private-sector drugs sales dataset gathered from a panel of 9,000 stockists (retailers that stock goods of a particular type for sale) across India, according to the study. 


In order to calculate the per capita private-sector consumption of systemic antibiotics across different categories, the researchers used the AWaRe (Access, Watch, Reserve) classification and the defined daily dose metrics. Systemic antibiotics are absorbed and distributed throughout the body. 


What Are Access, Watch, And Reserve Group Antibiotics?


According to the World Health Organization (WHO), antibiotics are classified into three groups: Access, Watch, and Reserve. The Access group includes antibiotics that have activity against a wide range of commonly encountered susceptible pathogens while also showing lower resistance potential than antibiotics in the other groups. 


The Watch group includes antibiotics that have higher resistance potential. The antibiotics are at a relatively high risk of selection of bacterial resistance. As many as 110 antibiotics are included in this group. 


The Reserve group includes antibiotics and antibiotic classes that should be reserved for treatment of confirmed or suspected infections due to multidrug-resistant organisms. Antibiotics in this group should be considered "last retort" options. 


The researchers calculated the per-capita consumption of systemic antibiotics across different categories including fixed-dose combinations, single formulations, approved and unapproved antibiotics, and listed and non-listed antibiotics in the national list of essential medicines (NLEM). 


What Did The Study Find?


The researchers found that the total defined daily doses consumed in 2019 was 5071 million. The average consumption was 10.4 defined daily doses per 1,000 persons, per day. 


Antibiotics in the Watch group accounted for 54.9 per cent of the annual defined daily dose consumption. Meanwhile, antibiotics in the Access group contributed to 27 per cent of the annual defined daily dose consumption. In other words, the number of defined daily doses of Watch group antibiotics consumed in India in 2019 was 2,783, while the number of defined daily doses of Access group antibiotics consumed in India in the same year was 1,370 million.


The formulations listed in the NLEM accounted for 49 per cent of the annual defined daily doses consumed. The value was equal to 2,486 million defined daily doses.


Fixed-dose combinations accounted for 34 per cent of the total defined daily dose consumption. The value was equal to 1,722 million defined daily doses. 


Unapproved formulations accounted for  47.1 per cent of the annual defined daily dose consumption. In other words, people in India consumed 2,408 million defined doses of unapproved formulations in 2019. 


According to the study, Watch antibiotics constituted 72.7 per cent of unapproved products, and combinations discouraged by the WHO constituted 48.7 per cent of fixed-dose combinations. 


Highest Consumed Antibiotics


Azithromycin was found to be the most consumed antibiotic molecule, followed by cefixime. 


The study also found that the Azithromycin 500 milligram tablet was the most consumed formulation, followed by a cefixime 200 milligram tablet. 


According to the study, Azithromycin was the most consumed Watch antibiotic, and linezolid was the most consumed Reserve antibiotic. The researchers found cefixime-ofloxacin to be the most consumed discouraged fixed-dose combination. 


Also, cefixime-ofloxacin 200/200 milligram tablet was the most consumed formulation outside the NELM. It was followed by the cefpodoxime 200 milligram tablet.


Significance Of The Study


The per-capita private-sector consumption rate of antibiotics in India is relatively low compared to many countries. However, India consumes a large volume of broad-spectrum antibiotics, the study found. Ideally, these broad-spectrum antibiotics should be used sparingly. 


People in India were also found to consume a significant share of fixed-dose combinations from formulations outside NELM, and a large volume of antibiotics not approved by central drug regulators. 


Private-sector antibiotic use contributes to 85 to 90 per cent of the total consumption in India, according to the study. 


The researchers found that even with a relatively low overall rate of consumption indicating access issues, a high proportion of broad-spectrum antibiotic use in India is a public health concern. 


This highlights the importance of significant policy and regulatory reform, the authors noted in the study.


"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," the researchers concluded.