A study published in The Lancet Regional Health Southeast Asia revealed that in 2019, 47% of the antibiotics used in the private sector were not approved by the central drug regulator in India. The research revealed that azithromycin 500mg tablet was India′s most consumed antibiotic formulation (7.6%), followed by cefixime 200 mg tablet (6.5%) in 2019. The researchers at Boston University, US, and the Public Health Foundation of India, New Delhi, examined the private sector antibiotic use, which contributes to 85–95% of the total consumption in India, but the data did not include the drugs dispensed through public facilities.

The findings of the study showed higher consumption of broad-spectrum antibiotics. The study authors added that out of all the antibiotics used in 2019, 49% of the drugs were formulations listed in the national list of essential medicines(NLEM), followed by 34% of the fixed-dose combinations (FDC) and 47.1% of unapproved formulations. They also stated that the watch group of antibiotics, i.e., broad-spectrum antibiotics with a high chance of resistance and to be used for specific indications, constituted 72.7% of unapproved products, and combinations discouraged by the World Health Organization (WHO) constituted 48.7% of FDCs.

The researchers noted that cephalosporins, macrolides, and penicillins were the top three antibiotic classes among unapproved formulations. Another finding of the study revealed that 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, out of which, centrally unapproved formulations accounted for 47.1% (2,408 million) of total DDDs.