Ensuring access to maternal health drugs is a key component of our Business Plan and we are undertaking a range of activities in support of this key objective, including technical assistance to generic manufacturers of uterotonics (oxytocin, misoprostol) and magnesium sulfate, as well as research and access to markets.
Provision of technical assistance to manufacturers of generic maternal health medicines
Concept Foundation has been working with manufacturers of generics maternal health (MH) products interested in and capable of pursuing the World Health Organization’s Prequalification (WHO PQ) of their products since 2009. This activity started under the Accessing Quality Assurance Supplies (AQAS) initiative funded by the Reproductive Health Supplies Coalition (RHSC) and continued, as of 2011, under the Quality Reproductive Health Medicines (QuRHM) programme supported by the UK’s Department for International Development (DFID). Since the end of the DFID grant in 2014, Concept Foundation has been funded by the United Nations Commission on Life-Saving Commodities for Women and Children (UNCoLSC) and Jhpiego to carry on this work, which includes:
- Technical support provided to manufacturers of oxytocin, misoprostol and magnesium sulfate Finished Pharmaceutical Products (FPPs) in order to both support prequalification and ultimately serve the market.
- Technical support for the conduct of bioequivalence (BE) studies.
- Technical assistance to meeting all aspects of WHO quality assurance (QA) requirements.
- Support on preparation of all Chemistry, Manufacturing and Controls (CMC) documentation required to submit a dossier to the WHO PQ programme.
More information can be found on WHO PQ procedures on our Resources page.
In this field, Concept Foundation documents the quality of maternal health products currently available in the world and identifies the need for additional data and studies in support of product introduction.
- “A survey of misoprostol products collected from 11 lower and middle income countries”: study funded by Gynuity Health Projects as part of a grant from the Bill & Melinda Gates Foundation (BMGF)
- A survey on “Providing quality-assured misoprostol and oxytocin products for the prevention of post-partum haemorrhage”: activities undertaken in Nepal and Nigeria on misoprostol under the grant from Gynuity Health Projects, 1 July 2013 – 31 December 2014, supplemented with funds from UNFPA Nigeria and UNFPA Nepal, which included support for oxytocin analyses.
- Study on storage conditions for oxytocin funded by the UNCoLSC:
- Stability data obtained on an anonymous basis from as many manufacturers as possible.
- Evidence provided for WHO statement on storage conditions. Statement developed and put out on website.
- Study on quality of oxytocin and misoprostol in Bangladesh: UNFPA Bangladesh is funding Concept Foundation to undertake a study on the quality of oxytocin and misoprostol currently available in Bangladesh.
Access to Markets
Access to markets
Concept Foundation advocates for broader recognition and use of appropriate maternal health drugs at both the national and international levels and works with partners to provide briefings, materials and advice to a range of organizations, policy-makers and health providers.
Advocacy on optimal procurement of affordable and quality-assured life-saving commodities for maternal health
Under a grant awarded by the UNCoLSC, Concept Foundation is conducting the following activities:
- Through electronic and face-to-face consultations with key stakeholders, roll out planning tools to support countries in ensuring access to quality-assured MNCH drugs from manufacturing facility to point of use, using uterotonics and magensium sulfate as examples.
- Plan and conduct regional consultations in West Africa (Nigeria, Ghana, Sierra Leone) and Southern Africa (Malawi, Mozambique, Zambia, Zimbabwe) to roll out and support use of quantification.
These meetings intend to bring together major procurement stakeholders from Southern and Western Africa as well as global partners to share experiences and shape plans to be implemented in order to scale up availability of affordable and quality-assured maternal health medicines in these regions. Concept Foundation is undertaking this work in collaboration with the WHO and other members of the Maternal Health Technical Resource Team (MHTRT) of the UNCoLSC.