The Role of Pre-Shipment Batch Testing in Ensuring Good Medicine Quality

Malaria World Journal, November 2012, Vol. 3, No. 12

4 Pages Posted: 18 Oct 2013

See all articles by Roger Bate

Roger Bate

American Enterprise Institute (AEI)

Kimberly Hess

Africa Fighting Malaria (US)

Date Written: 2012

Abstract

Most donor agencies only procure drugs approved by a Stringent Regulatory Authority or the World Health Organization (WHO) Prequalification Programme in an effort to ensure high quality. This study compares the quality of artemisinin-based combination therapies (ACTs) produced by WHO-approved manufacturers with non-approved manufacturers and suggests policy changes to improve quality of donor-procured drugs. The results of this study suggest that ACTs produced by WHO-approved manufacturers perform nearly five times better than those of non-approved manufacturers, but some approved ACTs have too little active pharmaceutical ingredient. The US President’s Malaria Initiative tests every batch of every drug it procures before distribution to recipient countries. Other donors should follow suit to ensure that drugs purchased with taxpayer dollars are of the highest quality.

Suggested Citation

Bate, Roger and Hess, Kimberly, The Role of Pre-Shipment Batch Testing in Ensuring Good Medicine Quality (2012). Malaria World Journal, November 2012, Vol. 3, No. 12, Available at SSRN: https://ssrn.com/abstract=2341397

Roger Bate (Contact Author)

American Enterprise Institute (AEI) ( email )

1150 17th Street, N.W.
Washington, DC 20036
United States

Kimberly Hess

Africa Fighting Malaria (US) ( email )

Washington, DC
United States

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