Selecting an appropriate strategy to make quality 7.1 % chlorhexidine digluconate accessible for umbilical cord care

J Pharm Policy Pract. 2016 Apr 8;9:14. doi: 10.1186/s40545-016-0063-9. eCollection 2016.

Abstract

Achieving increased access to medicines in low- and middle-income countries is a complex issue that requires a holistic approach. Choosing an appropriate manufacturing strategy that can ensure a sustainable supply of these medicines is an essential component of that approach. The Chlorhexidine Working Group, a consortium of more than 25 international organizations, donors, and manufacturers led by PATH, has been working to increase access to 7.1 % chlorhexidine digluconate for umbilical cord care in low- and middle-income countries to reduce neonatal mortality due to infection. The working group initially considered two strategies for manufacture of this commodity: (1) production and global distribution by a multinational company; and (2) production and regional distribution by locally owned companies or subsidiaries of multinational companies based in low- and middle-income countries. Local production may be beneficial to public health and economic development in these countries, yet capability and capacity of pharmaceutical manufacturers, regulatory and legal provisions, and market factors must be carefully assessed and addressed to ensure that local production is the correct strategy and that it contributes to improved access to the medicine. To date, this effort to implement a local production strategy has resulted in successful registration of 7.1 % chlorhexidine digluconate for umbilical cord care by manufacturers in Bangladesh, Kenya, Nepal, and Nigeria. Additionally, the product is now available in domestic and export markets.

Keywords: Chlorhexidine; Cord care; Essential medicines; Local manufacturing; Neonatal mortality; Product availability; Quality assurance.