Quality Considerations of Zambian Wholesalers and Regulatory Authorities to Increase Availability and Access to Quality Maternal Newborn, and Child Health Products .

This document combines document review and semi-structured key informant interviews with maternal, newborn, and child health (MNCH) wholesaler representatives and key government stakeholders to inform the findings on four focal areas—product sourcing, storage, distribution and quality oversight.

The majority of MNCH products and services are provided through the public sector, and as a result, the Government of Zambia is the primary client for wholesalers that supply MNCH commodities. Wholesaler representatives noted challenges in their macro-operating environment, including large and often delayed government payments. When sourcing MNCH products, wholesalers often noted quality as an important consideration; however, some wholesalers in Zambia may not have the capacity to conduct their own audits of manufacturers. They may instead rely upon other, less reliable quality assurance criteria and information, including achievement of WHO prequalification, self-reported certification of WHO Good Manufacturing Practices, Zambian pharmaceutical registration, manufacturer reports from the Zambia Medicines Regulatory Authority (ZAMRA), the number of other countries in which the product is registered, the number of years a supplier has been in operation, and the number and frequency of quality incidences or recalls. Overall, this assessment suggests that some domestic wholesalers consider quality as a factor in sourcing. However, with some exceptions, wholesalers in Zambia may not typically have the capacity to conduct their own audits of manufacturers, and instead may rely upon other information that may be less reliable for ascertaining quality which may lead to the inclusion of lower quality products in Zambia. As such, there is significant variation in wholesalers’ internal capabilities to ensure quality from sourcing to distribution.