Consumption of systemic antibiotics in India in 2019

Shaffi Fazaludeen Koya; Senthil Ganesh; Sakthivel Selvaraj; Veronika J Wirtz; Sandro Galea; Peter C Rockers

doi:10.1016/j.lansea.2022.100025

Consumption of systemic antibiotics in India in 2019

Lancet Reg Health Southeast Asia. 2022 Jun 22:4:100025. doi: 10.1016/j.lansea.2022.100025. eCollection 2022 Sep.

Authors

Shaffi Fazaludeen Koya¹, Senthil Ganesh², Sakthivel Selvaraj², Veronika J Wirtz¹, Sandro Galea¹, Peter C Rockers¹

Affiliations

¹ Boston University School of Public Health, Boston, MA, USA.
² Public Health Foundation of India, New Delhi, Delhi, India.

Abstract

Background: 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 fixed-dose combinations (FDC) and overlap in regulatory powers between national and state-level agencies complicate antibiotics availability, sales, and consumption in the country.

Methods: We analyzed cross-sectional data from PharmaTrac, a nationally representative private-sector drug sales dataset gathered from a panel of 9000 stockists across India. We used the AWaRe (Access, Watch, Reserve) classification and the defined daily dose (DDD) metrics to calculate the per capita private-sector consumption of systemic antibiotics across different categories: FDCs vs single formulations; approved vs unapproved; and listed vs not listed in the national list of essential medicines (NLEM).

Findings: The total DDDs consumed in 2019 was 5071 million (10.4 DDD/1000/day). Watch contributed 54.9% (2783 million) DDDs, while Access contributed 27.0% (1370 million). Formulations listed in the NLEM contributed 49.0% (2486 million DDDs); FDCs contributed 34.0% (1722 million), and unapproved formulations contributed 47.1% (2408 million DDDs). Watch antibiotics constituted 72.7% (1750 million DDDs) of unapproved products and combinations discouraged by the WHO constituted 48.7% (836 million DDDs) of FDCs.

Interpretation: Although the per-capita private-sector consumption rate of antibiotics in India is relatively low compared to many countries, India consumes a large volume of broad-spectrum antibiotics that should ideally be used sparingly. This, together with significant share of FDCs from formulations outside NLEM and a large volume of antibiotics not approved by the central drug regulators, call for significant policy and regulatory reform.

Funding: Not applicable.

Keywords: Antibiotics; Antimicrobial consumption; Antimicrobial stewardship; Drug approval; Drug combinations; Drug resistance; Formulary.