Microbial Product Quality in a Developing Country

Phil Geis, Ph.D.

A recent study of topical pharmaceuticals from Abia state Nigeria1 provides perhaps the worst case of failure to address microbiological quality.  Fifteen products were obtained from retail and tested for microbial content.  Each was found to be grossly contaminated – from 105 to 109 per ml – and many with pathogenic bacteria (e.g. Staphylococcus aureus).  As therapeutic products, these bring users with some degree of compromised health to be exposed via mucous membrane, eyes and respiratory systems.  So users would face significant risk from any of these products, and some would offer profound risk – nose drops contaminated with Corynebacterium diphtheria.  Recent relevant reports from other developing regions (Jordan, Pakistan) found much lesser levels of contamination and of lesser pathogenic risk.

For perspective, similar US/EU studies in the 60’s reporting about 25% contamination with microbes of lesser infectious risk drove significant and immediate regulatory and industry action.  This most recent report is uniquely concerning due to its coincidence with reemergence of diphtheria in Nigeria2 and report of microbial issues for other pharmaceutical products3.  Nigeria’s Ministry of Health did not respond to inquiry regarding this study.

  1. Braide W, Nwosu L, Offor-Emenike J, Popgbara LB, Awurum IN. 2012. Microbial quality of some  topical pharmaceutical products sold in Aba, Abia state, Nigeria.  Int J Pharma Ther 2: 26-37.
  2. Sadoh AE, Oladokun RE. 2012. Re-emergence of diphtheria and pertussis: implications for Nigeria. Vaccine. 2012 Nov 26:7221-8.
  3. Adeshina GO, Ajayi S, Onaolapo J. 2009. Microbiological quality of some commercially available paediatric anti-malarial and cough preparation in Ilorin, Nigeria. Nigerian J Pharma Sci. 8:109-17.

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