Assuring quality of TB medicines in Nepal

In Nepal, approximately 69,000 people developed tuberculosis (TB) in 2018, nearly twice as high as previous estimates. Availability of poor-quality medicines contributes to drug-resistant TB, and likely contributes to the high prevalence of the disease in Nepal, where TB is one of the top ten causes of death in the country each year.

What’s at stake

Regulatory authorities and national quality control laboratories play a critical role in ensuring that medical products, including those used to prevent and treat TB, are safe, effective, and quality-assured. Yet, few countries can conduct medicine quality testing that delivers accurate and reliable results. Strengthening quality testing of TB medicines protects patients from poor-quality products, combats the spread of drug-resistant TB, and improves sustainability of laboratories and regulatory functions.

Strengthening quality testing of TB medicines protects patients from poor-quality products.

Map of Nepal
Map of Nepal

Project at-a-glance

Project goals and objectives

This Global Fund project, implemented by Save the Children in partnership with USP, aims to strengthen Nepal’s ability to treat people living with TB with quality-assured medicines. To support the project, USP is working to:

  • Improve regulatory oversight and capacity in Nepal to sustainably screen and test the quality of anti-TB medicines.
  • Strengthen the capacity of the national quality control laboratory to monitor the quality of TB medicines in circulation and identify and remove substandard and falsified products.

Progress

  • Identify, select, and initiate procurement of laboratory equipment and consumables, including beakers, test tubes, safety gear, reagents, and other products.

  • Assess the capabilities of laboratory and regulatory staff to perform quality testing of TB medicines and develop a plan to address gaps, opportunities, and challenges.
  • Initiate a series of trainings on good laboratory practices, good documentation practice, data analysis, standard operating procedure (SOP) development, equipment validation, and more.

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