Over 47% Antibiotics Consumed in India Unapproved in 2019: Lancet Study

A new study published in The Lancet Regional Health-Southeast Asia has found that over 47% of antibiotic formulations used in India’s private sector in 2019 were not approved by the central drug regulator. Furthermore, the research revealed that azithromycin 500 mg tablets was the most consumed antibiotic formulation (7.6%) in India, followed by cefixime 200 mg tablets (6.5%) during the year.

Specifically, researchers at Boston University, USA, and the Public Health Foundation of India, New Delhi, examined the use of antibiotics in the private sector, which contributes to 8590% of total consumption in India, according to the news agency. PTI report. The data was collected from a panel of 9,000 stockholders who stock products from approximately 5,000 pharmaceutical companies, however, this data does not include drugs distributed in public facilities, although this is less than 1520% of all drug sales in the country according to studies. and national health accounts estimates, the report said.

Interestingly, the researchers found a lower rate of antibiotic consumption compared to previous estimates, but very high relative consumption of broad-spectrum antibiotics, which act against a wide range of disease-causing bacteria. The total defined daily dose (DDD) — the assumed average maintenance dose per day for a drug in adults — consumed in 2019 was 5,071 million (10.4 DDD/1,000/day), they said.

The study shows that formulations listed in the National List of Essential Medicines (NLEM) contributed 49%, while fixed dose combinations (FDC) contributed 34%, and unapproved formulations accounted for 47.1%. FDCs are combinations of two or more active drugs in a single dosage form. The study authors said that non-centrally approved formulations accounted for 47.1% (2,408 million) of total DDDs. Cephalosporins, macrolides, and penicillins were the top three classes of antibiotics among the unapproved formulations.

The Watch group of antibiotics accounted for 72.7% of unapproved products and combinations discouraged by the World Health Organization (WHO) accounted for 48.7% of FDCs. The watch includes broad-spectrum antibiotics with a high chance of resistance to be used only for specific indications.

Dr. Hari Kishan Boorugu, consultant physician and diabetologist, Yashoda Hospitals Hyderabad said PTI, we do not have proper surveillance systems that monitor the use of antibiotics in our country and the unreasonable use of antibiotics is rampant. The problem lies on multiple levels — the use of antibiotics by patients without a prescription, the irrational use of antibiotics by jokers and even by many qualified doctors.”

It is worth noting that the authors of the study noted in the journal that inappropriate use of antibiotics is a significant driver of antibiotic resistance in India. “Unrestricted over-the-counter sales of most antibiotics, production and marketing of many FDCs, and overlap in regulatory powers between national and state-level agencies complicate the availability, sales, and consumption of antibiotics in the country,” they said.

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