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

Roger Bate^1,2, Lorraine Mooney³, Kimberly Hess^4
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