A new study published in The Lancet Regional Health Southeast Asia revealed that over 47% of antibiotic preparations used in India’s private sector in 2019 were not approved by the central drug regulatory authority. Further, the study found that the most consumed antibiotic preparation throughout the year in India was Azithromycin 500mg tablets (7.6%), followed by Cefixime 200mg tablets (6.5%).
Notably, researchers from Boston University in the US and the Public Health Foundation of India, New Delhi, looked at antibiotic use in the private sector, which accounts for 85-90% of India’s total consumption. PTI The data was collected from a panel of 9,000 stockists who stock products from around 5,000 pharmaceutical companies, according to the report, but does not include medicines dispensed in public facilities, which, however, account for less than 15-20% of total drug sales in the country, according to studies and National Health Accounts estimates.
Interestingly, the researchers found that although the rate of antibiotic consumption was lower than previous estimates, the relative consumption of broad-spectrum antibiotics, which act against a wide range of pathogens, was very high. The total number of defined daily doses (DDDs) (assumed to be the average daily maintenance dose of a drug in adults) consumed in 2019 was 5.071 billion (10.4 DDDs/1000/day), the researchers said.
According to the study, preparations listed on the National List of Essential Medicines (NLEM) accounted for 49 percent, fixed-dose combinations (FDCs) 34 percent, and unapproved preparations 47.1 percent. FDCs are combinations of two or more active drugs in a single dosage form. “Central unapproved preparations accounted for 47.1 percent (2.48 billion) of the total DDDs. Cephalosporins, macrolides, and penicillins were the top three antibiotic classes among unapproved preparations,” the study authors said.
Antibiotics in the monitoring group accounted for 72.7% of unapproved products, and combinations not recommended by the World Health Organization (WHO) accounted for 48.7% of FDCs. The monitoring group includes broad-spectrum antibiotics for which resistance is more likely to develop and are used only for specific indications.
Dr Hari Kishan Bhourgu, consultant physician and diabetologist, Yashoda Hospital Hyderabad, said, “The number of cases has increased dramatically. PTI“There is no proper monitoring system in our country to monitor antibiotic use and irrational use of antibiotics is rampant. The problem is at multiple levels: use of antibiotics by patients without prescriptions, irrational use of antibiotics by quack doctors and even use of antibiotics by many qualified doctors.”
It is worth noting that the study authors point out in the journal that inappropriate use of antibiotics is a major contributing factor to antibiotic resistance in India. “Near-unlimited over-the-counter availability of most antibiotics, the manufacture and sale of many FDCs, and overlapping regulatory mandates of national and state-level agencies complicate the availability, sale, and consumption of antibiotics in India,” the authors said.
(With inputs from PTI)
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