Over 47% antibiotic used in India unapproved in 2019, azithromycin most consumed: Lancet study

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

Notably, the researchers at Boston University, US and Public Health Foundation of India, New Delhi, examined the private sector antibiotic use, which contributes to 85–90% of the total consumption in India, as per news agency PTI report. The data were gathered from a panel of 9,000 stockists who store products from approximately 5,000 pharmaceutical companies, however, these data did not include the drugs dispensed through public facilities, though this is less than 15–20% of all drug sales in the country as per studies and national health accounts estimates, the report said.

Interestingly, the researchers found a lower consumption rate of antibiotics 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 were 47.1%. FDCs are the combinations of two or more active drugs in a single dosage form. The study authors said, “centrally unapproved formulations accounted for 47.1% (2,408 million) of total DDDs. Cephalosporins, macrolides, and penicillins were the top three antibiotic classes among unapproved formulations.”

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

Dr. Hari Kishan Boorugu, Consultant Physician & Diabetologist, Yashoda Hospitals Hyderabad told PTI, “we do not have proper surveillance systems monitoring antibiotic usage in our country and irrational antibiotic usage is rampant. Problem lies at multiple levels -- antibiotic usage by patients without prescription, irrational usage of antibiotics by quacks 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. "Largely unrestricted over-the-counter sales of most antibiotics, manufacturing and marketing of many FDC and overlap in regulatory powers between national and state-level agencies complicate antibiotics availability, sales, and consumption in the country," they said.

(With inputs from PTI)