Abstract

Background: Access to safe and effective antibiotics is crucial in low- and middle-income countries (LMICs) coupled with reducing 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. Methodology: Data on registered antibiotics was collected from the Drug Regulatory Authority of Pakistan (DRAP) and the Pharmaguides. 257 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. 6 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 generics particularly Watch antibiotics in Pakistan poses a serious risk, exacerbated by current misuse of antibiotics. Improving regulatory frameworks and strengthening stewardship are critical to reducing AMR in Pakistan along with addressing uncontrolled registration by DRAP.