Anti-Infective Medicine Quality: Analysis of Basic Product Quality by Approval Status and Country of Manufacture

Research and Reports in Tropical Medicine (3):57-61, 2012

5 Pages Posted: 29 Aug 2012 Last revised: 17 Oct 2013

Roger Bate

American Enterprise Institute (AEI)

Lorraine Mooney

Africa Fighting Malaria (UK)

Kimberly Hess

Africa Fighting Malaria (US)

Julissa Milligan

American Enterprise Institute (AEI)

Amir Attaran

University of Ottawa - Department of Epidemiology and Community Medicine; University of Ottawa - Common Law Section

Date Written: 2012

Abstract

Background: Some medicines for sale in developing countries are approved by a stringent regulatory authority (SRA) or the World Health Organization (WHO) prequalification program; many of these are global brands. This study ascertains whether medicines approved by SRAs or the WHO perform better in simple quality tests than those that have not been approved by either.

Methods: Over the past 4 years, 2652 essential drugs (products to treat malaria, tuberculosis, and bacterial infections) were procured by covert shoppers from eleven African cities and eight cities in a variety of mid-income nations. All samples were assessed using the Global Pharma Health Fund eV MinilabĀ® protocol to identify whether they were substandard, degraded, or counterfeit.

Results: The failure rate among SRA-approved products was 1.01%, among WHO-approved products was 6.80%, and 13.01% among products that were not approved by either. African cities had a greater proportion of SRA- or WHO-approved products (31.50%) than Indian cities (26.57%), but they also experienced a higher failure rate (14.21%) than Indian cities (7.83%). The remainder of cities tested had both the highest proportion of approved products at 34.46% and the lowest failure rate at 2.70%. Products made in Africa had the highest failure rate at 25.77%, followed by Chinese products at 15.74%, Indian products at 3.70%, and European/US products, which failed least often, at 1.70%. Most worrying is that 17.65% of Chinese products approved by the WHO failed.

Conclusion: The results strongly indicate that approval by either an SRA or the WHO is correlated with higher medicine quality at a statistically significant level. The comparatively high failure rates among WHO-approved products suggest there may be some weakness in post-marketing surveillance of these products, especially of Chinese-made WHO-approved products. The discrepancy between the failure rate of WHO-approved products from India (2.39%) and China (17.65%) is cause for concern. It is possible that more of the failures originating in China are counterfeit products, but this cannot be ascertained without greater help from the manufacturers themselves.

Keywords: stringent regulatory authority, World Health Organization prequalification program, product approval, counterfeit, India, China

Suggested Citation

Bate, Roger and Mooney, Lorraine and Hess, Kimberly and Milligan, Julissa and Attaran, Amir, Anti-Infective Medicine Quality: Analysis of Basic Product Quality by Approval Status and Country of Manufacture (2012). Research and Reports in Tropical Medicine (3):57-61, 2012. Available at SSRN: https://ssrn.com/abstract=2138438

Roger Bate

American Enterprise Institute (AEI) ( email )

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

Lorraine Mooney

Africa Fighting Malaria (UK) ( email )

Cambridge
United Kingdom

Kimberly Hess

Africa Fighting Malaria (US) ( email )

Washington, DC
United States

Julissa Milligan

American Enterprise Institute (AEI) ( email )

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

Amir Attaran (Contact Author)

University of Ottawa - Department of Epidemiology and Community Medicine ( email )

451 Smyth Road
Ottawa, Ontario K1H 8M5
Canada

University of Ottawa - Common Law Section ( email )

57 Louis Pasteur Street
Ottawa, K1N 6N5
Canada
613-562-5800 ext: 2015 (Phone)
613-562-5659 (Fax)

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