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Lifesaving umbilical cord product receives pre-qualification from West African Health Organization

July 30, 2020 by PATH

Chlorxy-G Gel, a 7.1% chlorhexidine digluconate gel manufactured in Nigeria, receives approval for introduction in 15 countries

The West African Health Organization (WAHO) has announced the prequalification of Chlorxy-G® Gel, a 7.1% chlorhexidine digluconate (CHX) gel manufactured by Drugfield Pharmaceuticals Limited in Ogun state, Nigeria. The use of 7.1% CHX during the first week of an infant’s life has been shown to help prevent umbilical cord infections that can cause life-threatening newborn sepsis.

The rates of preventable neonatal mortality in West Africa are among the highest in the world. The WAHO prequalification of Chlorxy-G for umbilical cord care is valid through 2025 and extends to all of the Economic Community of West African States (ECOWAS) member countries of Benin, Burkina Faso, Cape Verde, Côte d’Ivoire, The Gambia, Ghana, Guinea, Guinea Bissau, Liberia, Mali, Niger, Nigeria, Senegal, Sierra Leone, and Togo. WAHO has informed ECOWAS National Medicines Regulatory Authorities (NMRAs) that the Chlorxy-G product is approved for marketing authorization; market authorization has been received in Benin, Burkina Faso, and Cote d’Ivoire and is underway in several countries, including Mali, Mauritania, Niger, and Togo. This regulatory harmonization will jump-start access to this lifesaving product where it is needed most.

Drugfield Pharmaceuticals Ltd. is one of the first manufacturers in Africa to produce 7.1% CHX for umbilical cord care. “We are excited to help our local community and fellow WAHO member countries achieve the Sustainable Development Goal target of ending preventable deaths of newborns by producing this lifesaving product,” said Ekundayo Olakunle, founder and chief executive officer of Drugfield Pharmaceuticals Ltd. “And we are proud to collaborate with PATH to increase access to Chlorxy-G, a high-quality and affordable product, for our Francophone countries in West Africa.”

PATH is leading the introduction and scale-up of 7.1% CHX for umbilical cord care in Francophone West Africa as part of the INSPiRE project, coordinated by IntraHealth International, which focuses on integrating family planning, maternal and newborn health, and nutrition services in nine West African countries. As part of this work, PATH has been working with Drugfield Pharmaceuticals Ltd., country national health officials, and subnational providers to increase access to supply of high-quality chlorhexidine products like Chlorxy-G , engage stakeholders, and drive demand generation at the country level.

In collaboration with numerous international organizations, PATH has worked to introduce and expand access to this lifesaving innovation through advocacy and technical assistance over many years. Now, 7.1% CHX for umbilical cord care is available in more than 20 countries around the world.

A baby’s recently cut umbilical cord can be an entry point for bacteria that can cause life-threatening newborn sepsis. Optimal cord care at birth and in the first week of life, especially in settings with poor hygiene, is critical to averting neonatal deaths. Chlorhexidine digluconate in low concentrations has long been a low-cost antiseptic widely used for hand sanitizers, mouth wash, and preoperative skin preparation. Its novel formulation for umbilical cord care, 7.1% chlorhexidine digluconate (CHX), has a higher concentration of active ingredient than other currently marketed products and can reduce cord infection and neonatal sepsis.

Chlorxy-G® is a registered trademark of Drugfield Pharmaceuticals Limited.

About PATH

PATH is a global organization that works to accelerate health equity by bringing together public institutions, businesses, social enterprises, and investors to solve the world’s most pressing health challenges. Our team of innovators comprises more than 1,500 employees in offices in 20 countries. With expertise in science, health, economics, technology, advocacy, and dozens of other specialties, PATH develops and scales solutions—including vaccines, drugs, devices, diagnostics, and innovative approaches to strengthening health systems worldwide. We work in more than 70 countries to transform bold ideas into sustainable solutions that improve health and well-being for all, reaching over 150 million people, on average, each year.

About Drugfield Pharmaceuticals Limited

Drugfield Pharmaceuticals Limited was established in 1991 in Nigeria as a pharmaceutical multidosage company to help fill the void created by the departure of multinational manufacturing companies. Drugfield Pharmaceuticals was borne out of a family history of industry and automation of production processes to meet the expanding needs of the people.