Back to Browse Journals » Research and Reports in Tropical Medicine » Volume 1

Medicine registration and medicine quality: a preliminary analysis of key cities in emerging markets

Authors Roger Bate, Lorraine Mooney, Kimberly Hess

Published Date December 2010 Volume 2010:1 Pages 89—93

DOI http://dx.doi.org/10.2147/RRTM.S15199

Published 8 December 2010

Roger Bate1,2, Lorraine Mooney3, Kimberly Hess4
1American Enterprise Institute, Washington, DC, USA; 2Professor, University of Buckingham, Buckingham, UK; 3Africa Fighting Malaria, Cambridge, UK; 4Africa Fighting Malaria, Washington, DC, USA

Background: The medicine registration process is not just a matter of formality but involves assessment of medicine quality and stability. It is perhaps the most important as well as the simplest aspect of medicine regulation. This study attempts to ascertain whether registered medicines perform better in simple quality tests than those that are either not registered or not known to be registered.
Methods: Over the past 30 months, 2065 essential medicines (for treatment of malaria, tuberculosis, and bacterial infections) were procured by covert shoppers from 11 African cities and from eight cities in a variety of middle-income nations. All samples were assessed using the Global Pharma Health Fund e.V. Minilab® protocol, which includes visual inspection, semiquantitative thin-layer chromatography, and disintegration testing, to identify whether they were substandard, degraded, or counterfeit.
Results: Where medicine registration data were available, 1940 medicines were identified, of which 1589 were registered and 351 were either unregistered or not known to be registered. The failure rate among registered medicines was 5% (79/1589) and 37.3% (131/351) amongst medicines that were either unregistered or not known to be registered. African cities had fewer medicines registered (71%, or 488/687) than Indian cities (86.9%, or 610/702) or other middle-income cities (89.1%, or 491/551). Samples from African cities performed far worse in quality tests (18.6% failed, or 128/687) than either samples from Indian cities (8.7% failed, or 61/702) or other middle-income cities (3.8% failed, or 21/551). There was also a notable disparity in failure rates by medicine type; 14.2% (101/710) of antimalarials failed testing, 10.1% (70/693) of antibiotics failed, and 7.3% (39/537) of antimycobacterials failed.
Conclusion: The results strongly indicate that medicine registration is an important component of better-quality medicines. Registered medicines performed better than unregistered medicines, and the result was strongly statistically significant.

Keywords: antimalarials, antibiotics, antimycobacterials, Africa, India

Download Article [PDF] 

Creative Commons License This work is published by Dove Medical Press Limited, and licensed under Creative Commons Attribution - Non Commercial (unported, v3.0) License. The full terms of the License are available at http://creativecommons.org/licenses/by-nc/3.0/. Non-commercial uses of the work are permitted without any further permission from Dove Medical Press Limited, provided the work is properly attributed. Permissions beyond the scope of the License are administered by Dove Medical Press Limited. Information on how to request permission may be found at: http://www.dovepress.com/permissions.php

Readers of this article also read:

Insight into 144 patients with ocular vascular events during VEGF antagonist injections

Mansour AM, Shahin M, Kofoed PK, Parodi MB, Shami M, Schwartz SG

Clinical Ophthalmology 2012, 6:343-363

Published Date: 6 March 2012

Fungus-mediated biological synthesis of gold nanoparticles: potential in detection of liver cancer

Chauhan A, Zubair S, Tufail S, Sherwani A, Sajid M, Raman SC, Azam A, Owais M

International Journal of Nanomedicine 2011, 6:2305-2319

Published Date: 12 October 2011

Atypical lymphocytes in malaria mimicking dengue infection in Thailand

Polrat Wilairatana, Noppadon Tangpukdee, Sant Muangnoicharoen, et al

Research and Reports in Tropical Medicine 2010, 1:37-43

Published Date: 28 September 2010

Antimalarial medicine diversion: stock-outs and other public health problems

Roger Bate, Kimberly Hess, Lorraine Mooney

Research and Reports in Tropical Medicine 2010, 1:19-24

Published Date: 2 September 2010

Role of aliskiren in cardio-renal protection and use in hypertensives with multiple risk factors

Eduardo Pimenta, Suzanne Oparil

Vascular Health and Risk Management 2009, 5:453-463

Published Date: 19 May 2009

Imaging of peripheral vascular disease

Mo Al-Qaisi, David M Nott, David H King, Sam Kaddoura, Mo Hamady

Reports in Medical Imaging 2009, 2:25-34

Published Date: 27 March 2009