Post–shipment testing of condoms: Strengthening Quality Assurance for Reproductive Health commodities including male condoms and female condoms

In 2004, the National Drug Authority (NDA) established the post shipment testing policy for condoms in Uganda. The policy followed closely on quality concerns over a popular public sector condom brand, the “Engabu Condom”. The policy requires samples of all condom shipments to pass quality tests after arriving in the country and before distribution, in addition to the pre-shipment quality checks. According to MOH, the policy is a necessary precaution that helps to guarantee high-quality condoms for Ugandans and to win back trust in the condom. This notwithstanding, the policy has also increased costs for condom importers as well as lead times for condoms. While acknowledging the positive aspects of post shipment testing of condoms, stakeholders have at various forums expressed concern about the impact of Uganda’s post shipment policy on access to condoms. Some stakeholders have also suggested that Uganda should be moving towards investing in quality assurance systems rather than concentrate on quality control approaches as done in the post shipment testing of condoms.

While working with UNFPA and the MOH of, I organized a national symposium on improving Quality Assurance for Reproductive Health (RH) commodities especially male and female condoms. The symposium was organized within the framework for Reproductive Health Commodity Security in Uganda and in collaboration with the National Drug Authority (NDA). The symposium provided stakeholders with an opportunity to share knowledge and experiences and propose ways to strengthen the Quality Assurance system for RH commodities especially for male and female condoms. The major point of contention was whether NDA would rely on the robust prequalification and Quality Assurance measures put in place by UNPA/WHO/USAID to ease on the stringent requirement of mandatory post shipment testing of every batch of condoms that comes into the country.

The key output of the symposium was a set of recommendations to streamline the Uganda Quality Assurance policies and procedures for RH commodities with particular emphasis on male and female condoms: The NDP/A Act of Uganda should be reviewed to explicitly cover the regulation of medical devices including condoms; Develop a clear procedure with a feasible enforcement mechanism on management of commodities that have failed laboratory tests; Include national drug authorities in the QA and prequalification mechanisms and procedures of WHO/UNFPA and other agencies; Strengthen the capacity of National Drug Authority with a focus on acquiring more equipment and training of personnel; accredit the NDA; Facilitate information sharing by establishing / strengthening a multi stake holder National condom coordinating committee consisting MOH, Development Partners, NDA, and ware housing organizations to avoid delays during in-country handling of condoms; sufficient national budget allocation should be made for the NDA to independently execute sensitive work like post shipment testing without reverting to other stakeholders for financing; NDA should explore options for reducing the batches tested. I find these recommendations suitable for other regulatory agencies in developing countries that rely on Development Partners for Reproductive Health Commodity Security (RHCS).