New Delhi, Sep 7 : A Lancet study has raised serious concerns about the excessive use of OTC (OTC) antibiotics in India in a report that states that the majority of these medications are not accepted by the drug regulator in India’s central government which has resulted in significant resistance to antibiotics in the country.The study, which was that was published in Lancet Regional Health Southeast Asia, concluded that the misuse of antibiotics is a major factor in the development of resistance to antibiotics in India.
The study was performed by Shaffi Fazaludeen Koya Veronika J.Wirtz, Sandro Galea and Peter C.Rockers from the Department of Epidemiology, Boston University School of Public Health together with Senthil Ganesh as well as Sakthivel Selvaraj of the Public Health Foundation of India, New Delhi.
“Largely unrestricted sales over-the-counter of many antibiotics, the production and marketing of several fixed dose combinations (FDC) and the overlap in the authority of regulatory authorities between the state and national agencies can complicate the availability of antibiotics, sales and use in the United States” the researchers wrote.
To arrive at this conclusion, the team analyzed the cross-sectional information from PharmaTrac which is a representative national private-sector sales data set gathered from a group of 9000 pharmacists from across India.
“We utilized the AWaRe (Access, Watch, Reserve) classification as well as the defined daily dosage (DDD) measures to determine the consumption per capita in the private sector of systemic antibiotics in different categories: FDCs and single formulations, approved vs.not approved and listed vs not included in the National List of essential drugs (NLEM),” said the study.
The results showed that the total DDDs consumed in 2019 was 5,071 million, which translates to 10.4 DDD per 1,000 population per day.
“Azithromycin 500 mg tablet was the highest popular formula (384 million DDDs, 7.6 per cent) and then followed by the cefixime 200 mg tablets (331 million DDDs, 6.5 per cent),” the researchers found.
The per-capita consumption rate of antibiotics in India is low in comparison to other nations, “India consumes a large quantity of broad-spectrum antibiotics, which should be only used in moderation”.
“This along with the substantial proportion of fixed dose drug combination (FDCs) made from formulations not approved by NLEM and a significant amount of antibiotics that are not approved by central regulators of drugs, is a call for significant policy and regulatory reforms,” the study noted.
India has no formal system for evaluating the use of antibiotics.
“We discovered 39 studies, the majority of which used geographically limited hospital-based survey data, as well as some national-level studies that used large volumes of prescription and sales data.
We did find one systematic review confined to the field of dentistry,” according to the Lancet study.
Based on a standardised measurement of daily doses that are defined This study provides the most recent private sector consumption of antibiotics.
“The research provides proof to policymakers to enhance the existing policies and to initiate new initiatives to meet the global goals of the appropriate usage of antibiotics” stated the researchers.
The restriction on the sale of unapproved products and expanding the Essential Medicines List to include more antibiotics enhancing the antibiotic stewardship programs in the private sector as well as increasing access to appropriate antibiotics through the public health system and tightening the lawful regulation of the sale of over-the-counter sales of antibiotics can help stop the inappropriate use of antibiotics, they said.
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