Survey of the Quality of Medicines Identified by the United Nations Commission on Life-saving Commodities for Women and Children. 2015
(2016; 144 pages)

Abstract

The survey focused on selected medicines from the list of 13 life-saving commodities as identified by the UN Commission on Life-Saving Commodities for Women and Children (UNCoLSC). As a primary objective, it aimed to identify products of good quality already available in selected EWEC countries. This information should help responsible authorities in the surveyed countries as well as other EWEC countries to meet the requirements of the Commission’s recommendation No. 4, i.e. that by 2015 quality-certified and affordable products from at least three manufacturers per commodity are marketed in each of the 49 EWEC countries. The secondary objective was to evaluate the quality of target medicines collected at the first level of the distribution chain. This approach was chosen so that the results would reflect as closely as possible the quality of products as released from manufacturing sites, with minimal influence of potentially inappropriate conditions during storage or transportation in countries.

The survey was organized by the WHO Prequalification Team (WHO PQT) in cooperation with the National Medicines Regulatory Authorities / Ministries of Health of Burkina Faso, Kenya, Madagascar, Nepal, Nigeria, Tajikistan, Tanzania, Uganda, Viet Nam and Zimbabwe. A total of 204 samples of the following medicines were collected and tested:

  • oxytocin injection,
  • magnesium sulfate injection,
  • gentamicin injection,
  • procaine benzylpenicillin injection,
  • ampicillin injection,
  • ceftriaxone injection,
  • dexamethasone phosphate injection,
  • amoxicillin dispersible tablets,
  • zinc sulfate dispersible tablets/syrup,
  • levonorgestrel tablets, and
  • mifepristone tablets.

In total, medicines produced by 106 manufacturers from 22 countries were collected in the survey. Products of some manufacturers were available in several countries, some manufacturers produced several of the target medicines. Testing was performed in three WHO-prequalified laboratories according to the monographs of the International Pharmacopoeia, British Pharmacopoeia, US Pharmacopeia, or a laboratory validated method.

The survey provided a snapshot picture of the quality of the sampled products and generated information about the availability of the target medicines in selected countries. The results were discussed with regulatory authorities of the participating countries. The authorities adopted necessary regulatory actions and participated in the formulation of recommendations.

 
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