Establishing a Quality-Assured Supply of Chlorhexidine for Umbilical Cord Care through Local Production

Session: Critical Elements for Successful Introduction and Scale of Chlorhexidine for Umbilical Cord Care

Presenter: Mutsumi Metzler, PATH
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Background: The Chlorhexidine Working Group (CWG) has been implementing a local production strategy along with regional distribution in order to increase access to 7.1% chlorhexidine digluconate for umbilical cord care in sub-Saharan Africa and South Asia. Although local production has benefits for public health and economic development in low- and middle-income countries, several factors—such as capability and capacity of pharmaceutical industries, regulatory and legal provisions, and market dynamics—must be carefully assessed and addressed to ensure that local production contributes to improved access for this important medicine.

Methods: CWG members perform a feasibility assessment for local production, looking at in-county pharmaceutical industry capacity and capability as well as other factors that could affect affordability and sustainability of supplying chlorhexidine. Where local production is deemed feasible, the CWG elicits expressions of interest from manufacturers, followed by a GMP assessment of their facilities and monitoring of their progress in addressing corrective actions. The CWG then provides technical assistance to those manufacturers until the product is registered. Occasionally, ministries of health and other implementing organizations express a preference for local production regardless of whether or not it is the appropriate strategy. In such cases, the CWG engages in discussions with them, using the results from the CWG’s feasibility assessments to educate them.

Results: Efforts by the CWG have resulted in successful registration of 7.1% chlorhexidine digluconate in Nigeria for both domestic and export markets. CWG is establishing local production in Kenya, Pakistan, and Bangladesh. Additionally, the CWG has successfully guided key stakeholders in Madagascar and the Democratic Republic of Congo–countries without qualified pharmaceutical manufacturers–to import chlorhexidine from elsewhere.

Conclusion: Combined with careful assessments and selection of appropriate countries, local production along with regional distribution has resulted in increased availability of quality-assured 7.1% chlorhexidine digluconate.