Surge of branded generics and antimicrobial resistance: analyzing the antibiotic market dynamics in Pakistan through the WHO essential medicines and AWaRe lens

Abstract

Background: Access to safe and effective antibiotics is crucial in low- and middle-income countries (LMICs) coupled with reducing their overuse to reduce antimicrobial resistance (AMR). We sought to systematically analyze the extent of branded generic antibiotics in Pakistan, particularly Watch antibiotics, given concerns with AMR in Pakistan.

Research design and methods: Data on registered antibiotics was collected from the Drug Regulatory Authority of Pakistan (DRAP) and the Pharmaguides. Two hundred and fifty-seven antibiotics were analyzed using the AWaRe classification.

Results: Of these, 99 were registered in Pakistan including 91 single entities and 8 combinations, with 6,025 brands and 14,076 presentations. Distribution across AWaRe categories included Access - 37, Watch - 56, and Reserve - 6. Cephalosporins (2186 brands, 6447 presentations) and Quinolones (1333 brands, 2586 presentations) are the most prevalent, with ciprofloxacin (393 brands, 1158 presentations) leading in brand and presentation counts. Six antibiotics from the WHO Essential Medicines List lacked registered brands in Pakistan, while many available antibiotics were not included in the WHO framework.

Conclusion: Extensive availability of branded generic antibiotics, particularly Watch antibiotics, in Pakistan poses a serious risk, exacerbated by the current misuse of antibiotics. Improving regulatory frameworks and strengthening stewardship are critical to reducing AMR in Pakistan along with addressing uncontrolled registration by DRAP.

Keywords: AWaRe; Generics; Pakistan; antibiotics; antimicrobial resistance; branded generics; pharmaceutical policy; registration.