Indians using unlimited over-the-counter antibiotics, azithromycin most abused: Lancet
Posted: Date Posted – 1:15 PM Wed – 7 Sep 22
New Delhi: The Lancet study has raised major concerns about the widespread use of over-the-counter (OTC) antibiotics in India, saying most of these drugs have not been approved by the central medicines regulator, which has led to serious antibiotic resistance in the country.
The research, published in Lancet Regional Health-Southeast Asia, said inappropriate use of antibiotics is a significant driver of antibiotic resistance in India.
The study was led by Shaffi Fazaludeen Koya, Veronika J. Wirtz, Sandro Galea, and Peter C. Rockers of the Department of Epidemiology at Boston University School of Public Health, and Senthil Ganesh and Sakthivel Selvaraj of the Public Health Foundation of India, New Delhi. .
“The largely unlimited over-the-counter sales of most antibiotics, the manufacturing and marketing of numerous fixed-dose combinations (FDCs), and overlapping regulatory powers between national and state agencies complicate the availability, sales, and consumption of antibiotics. antibiotics in the country, a,” the researchers note.
To reach this conclusion, the team analyzed cross-sectional data from PharmaTrac, a nationally representative private sector drug sales dataset collected from a panel of 9,000 retailers across the country. India.
“We used the AWaRe (Access, Watch, Reserve) classification and Defined Daily Dose (DDD) measures to calculate private sector per capita consumption of systemic antibiotics in different categories: CDF versus single formulations; approved vs. unapproved; and listed vs. unlisted on the National Essential Medicines List (NLEM),” the study said.
The results showed that the total DDD consumed in 2019 was 5,071 million, or 10.4 DDD per 1,000 inhabitants per day.
“The 500 mg azithromycin tablet was the most consumed formulation (384 million DDD, 7.6 percent), followed by the 200 mg cefixime tablet (331 million DDD, 6.5 percent),” noted the researchers.
Although India’s private sector per capita antibiotic consumption rate is relatively low compared to many countries, “India consumes a large volume of broad-spectrum antibiotics which ideally should be used sparingly.”
“This, combined with a large share of fixed-dose combination (FDC) drugs from formulations outside the NLEM and a large volume of antibiotics not approved by central drug regulatory authorities, calls for policy reform and important regulatory issue,” the study notes.
India has no formal system to monitor the use of antibiotics.
“We found 39 studies, most of them using geographically limited hospital survey data, and a few nationwide studies using proprietary data on high-volume sales and prescriptions. We found one systematic review limited to dental practice,” the Lancet study said.
Using a standardized measure of defined daily doses, this study reports the most recent estimates of private sector antibiotic consumption in India.
“The study provides evidence for policy makers to strengthen existing policy measures and institute new efforts to achieve global goals for appropriate antibiotic use,” the researchers said.
Restrict the sale of unapproved formulations, expand the national essential medicines list to include more antibiotics, strengthen antibiotic stewardship programs in the private sector, expand access to appropriate antibiotics through the public health system and strengthening the legal regulation of over-the-counter antibiotic sales could help tackle the inappropriate use of antibiotics, they pointed out.