Ministry of Health’s Effort in Developing and Implementing a Quality Assurance Plan for Global Fund-Supported Antimalarial Drugs: A Case Study of Nepal in the Context of Malaria Elimination

Prakash Raj Pant and Bhim Acharya of the USAID Supported Maternal and Child Survival Program/Jhpiego (MCSP)and the Epidemiology and Disease Division, Ministry of Health, Nepal presented their case study of developing a quality assurance approach for the Global Fund supported provision of antimalarial drugs at the 7th Multilateral Initiative for Malaria Conference in Dakar. Below are their experiences.

Nepal is in the malaria elimination phase, with a target of 2026 through the Global Fund (GF) malaria grant in process for 2018–2021. The Maternal and Child Survival Program (MCSP) also supported GF HIV/AIDS, TB, and malaria grant implementation.

Quality assured antimalarials are a prerequisite for malaria elimination. This is Mandated by GF quality control policies on pharmaceuticals National Malaria Strategic Plan 2016 states: “quality assured antimalarials should be available at all points of service delivery”. Nepal National Drug Regulation Agency (NDRA) does not have a written quality assurance (QA) policy for GF pharmaceuticals

Developing and Implementing a Successful QAP requires the following Key considerations:

  • Effective coordination of National Malaria Control Program (NMCP) and stakeholders with NDRA
  • Approval of QAP by ministry of health (MOH) and GF
  • Presence of laboratories in the region that are prequalified by the World Health Organization or certified by ISO 17025
  • Advocacy among high-level MOH officials
  • Intersectoral collaboration among implementing partners
  • NDRA’s active role in scheduling inspections
  • Building the capacity of government entities by bilateral agencies (e.g., WHO, United States Agency for International Development) in the initial phase of QAP implementation
  • Budgeting for QA activities in grant funds

Next Steps in QAP Implementation start with identifying GF-approved laboratories in region for quality control testing of existing grant-funded products. Then partners must strengthen national medicine testing capacities, and seek accreditation of government laboratories by international bodies in 2–3 years. It is important to Mainstream grant-funded QA activities into the NDRA

Challenges in Resource-constrained countries like Nepal include weak pharmaceutical QA testing capacity of domestic laboratories with no accreditation from international bodies. There is inadequate attention of decision-makers in implementing QA policies.

Take-Home Messages from the experience in Nepal include the fact that QA of pharmaceuticals is a mandatory but often neglected area in many GF grant recipient countries. There is need to integrate QA measures into country’s mainstream drug regulation. Coordination with in-country stakeholders is critical.

This poster was made possible by the generous support of the American people through the United States Agency for International Development (USAID), under the terms of the Cooperative Agreement AID-OAA-A-14-00028. The contents are the responsibility of the Maternal and Child Survival Program and do not necessarily reflect the views of PMI, USAID, or the United States Government.

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