The Global Pandemic of Falsified Medicines: Laboratory and Field Innovations and Policy Implications
  • ISSN: 0002-9637
  • E-ISSN: 1476-1645



The availability of falsified antimalarial drugs can be reduced with effective drug regulatory agencies and proper enforcement. Fundamental to these agencies taking action, rapid identification must be made as soon as they appear in the market place. Since falsified antimalarials occur mostly in developing countries, performing drug analysis presents itself with unique challenges. A fundamental factor in choosing a useful technique is affordability and simplicity. Therefore, we suggest a three-tiered drug evaluation strategy for identifying a falsified drug in resource-poor areas. Tier I is a simple comparison of a tablet's weight and dimensions with official specifications. Tier II uses inexpensive photometric devices (laser and fluorescence) to evaluate a tablet. Suspicious samples from Tier I and II assessments are then subjected to a colorimetric assay for active ingredients identification and quantification. In this article, we evaluate a novel colorimetric assay for the simultaneous assessment of both lumefantrine and artemether in co-formulated Coartem tablets, and integrate the method with two novel, low-cost, fluorescence and laser photometric devices. Image analysis software is used for the assessments. Although artemether–lumefantrine is used as an example, the strategy may be adapted to other medicines.

[open-access] This is an open-access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.


Article metrics loading...

The graphs shown below represent data from March 2017
Loading full text...

Full text loading...



  1. World Health Organization, 2014. Malaria Fact Sheet No. 94. Available at: http://www.who.int/mediacentre/factsheets/fs094/en/. Accessed December 4, 2014. [Google Scholar]
  2. White NJ, , 1994. Artemisinin: current status. Trans R Soc Trop Med Hyg 88 (Suppl 1): S3S4.[Crossref] [Google Scholar]
  3. World Health Organization, 2010. Guidelines for the Treatment of Malaria, 2nd edition. Available at: http://whqlibdoc.who.int/publications/2010/9789241547925_eng.pdf?ua=1. Accessed December 4, 2014. [Google Scholar]
  4. World Health Organization, 2010. WHO List of Prequalified Medicinal Products. Available at: http://apps.who.int/prequal/query/ProductRegistry.aspx. Accessed December 4, 2014. [Google Scholar]
  5. Newton PN, Green MD, Mildenhall DC, Plançon A, Nettey H, Nyadong L, Hostetler DM, Swamidoss I, Harris GA, Powell K, Timmermans AE, Amin AA, Opuni SK, Barbereau S, Faurant C, Soong RC, Faure K, Thevanayagam J, Fernandes F, Kaur H, Angus B, Stepniewska K, Guerin PJ, Fernández FM, , 2011. Poor quality vital anti-malarials in Africa—an urgent neglected public health priority. Malar J 13: 352.[Crossref] [Google Scholar]
  6. Newton PN, Tabernero P, Dwivedi P, Culzoni MJ, Monge ME, Swamidoss I, Mildenhall D, Green MD, Jähnke R, de Oliveira M dos S, Simao J, White NJ, Fernández FM, , 2014. Falsified medicines in Africa: all talk, no action. Lancet Glob Health 2: e509e510.[Crossref] [Google Scholar]
  7. Hajjou M, Qin Y, Bradby S, Bempong D, Lukulay P, , 2013. Assessment of the performance of a handheld Raman device for potential use as a screening tool in evaluating medicines quality. J Pharm Biomed Anal 74: 4755.[Crossref] [Google Scholar]
  8. Dowell FE, Maghirang EB, Fernandez FM, Newton PN, Green MD, , 2008. Detecting counterfeit antimalarial tablets by near-infrared spectroscopy. J Pharm Biomed Anal 48: 10111014.[Crossref] [Google Scholar]
  9. Bate R, Hess K, , 2010. Anti-malarial drug quality in Lagos and Accra—a comparison of various quality assessments. Malar J 11: 157.[Crossref] [Google Scholar]
  10. de Veij M, Vandenabeele P, Krystyn Alter Hall KA, Fernandez FM, Green MD, White NJ, Dondorp AM, Newton PN, Moens L, , 2007. Fast detection and identification of counterfeit antimalarial tablets by Raman spectroscopy. J Raman Spectrosc 38: 181187.[Crossref] [Google Scholar]
  11. Institute of Medicine Buckley GJ, Gostin LO, , 2013. Countering the Problem of Falsified and Substandard Drugs. , eds. Washington, DC: The National Academies Press. [Google Scholar]
  12. Kaur H, Green MD, Hostetler DM, Fernandez FM, Newton PN, , 2010. Antimalarial drug quality: methods to detect suspect drugs. Therapy 7: 4957.[Crossref] [Google Scholar]
  13. Martino R, Malet-Martino M, Gilard V, Balayssac S, , 2010. Counterfeit drugs: analytical techniques for their identification. Anal Bioanal Chem 398: 7792.[Crossref] [Google Scholar]
  14. Kovacs S, Hawes SE, Maley SN, Mosites E, Wong L, Stergachis A, , 2014. Technologies for detecting falsified and substandard drugs in low and middle-income countries. PLoS ONE 26: e90601.[Crossref] [Google Scholar]
  15. Newton P, Proux S, Green M, Smithuis F, Rozendaal J, Prakongpan S, Chotivanich K, Mayxay M, Looareesuwan S, Farrar J, Nosten F, White NJ, , 2001. Fake artesunate in southeast Asia. Lancet 357: 19481950.[Crossref] [Google Scholar]
  16. Newton PN, Dondorp A, Green M, Mayxay M, White NJ, , 2003. Counterfeit artesunate antimalarials in southeast Asia. Lancet 362: 169.[Crossref] [Google Scholar]
  17. Nayyar GM, Breman JG, Newton PN, Herrington J, , 2012. Poor-quality antimalarial drugs in southeast Asia and sub-Saharan Africa. Lancet Infect Dis 12: 488496.[Crossref] [Google Scholar]
  18. Green MD, Nettey H, Villalva-Rojas O, Pamanivang C, Khounsaknalath L, Grande M, Newton PN, Fernandez FM, Latsamy V, Manolin O, , 2007. Use of refractometry and colorimetry as field methods to rapidly assess antimalarial drug quality. J Pharm Biomed Anal 43: 105110.[Crossref] [Google Scholar]
  19. Green MD, Mount DL, Wirtz RA, White NJ, , 2000. A colorimetric field method to assess the authenticity of drugs sold as the antimalarial artesunate. J Pharm Biomed Anal 24: 6570.[Crossref] [Google Scholar]
  20. Green MD, Mount DL, Wirtz RA, , 2001. Authentication of artemether, artesunate, and dihydroartemisinin antimalarial tablets using a simple colorimetric method. Trop Med Int Health 6: 980982.[Crossref] [Google Scholar]
  21. Ioset JR, Kaur H, , 2009. Simple field assays to check quality of current artemisinin-based antimalarial combination formulations. PLoS ONE 30: e7270.[Crossref] [Google Scholar]
  22. Jähnke RWO, Kallmayer HJ, Breyer C, Green MD, Rubeau V, Paulke A, , 2008. A Concise Quality Control Guide on Essential Drugs and other Medicines: Volume I on Colour Reaction Tests. Frankfurt, Germany: Global Pharma Health Fund. Available at: http://www.gphf.org/web/en/minilab/manuals.htm. Accessed November 29, 2014. [Google Scholar]
  23. Ofori-Kwakye K, Asantewaa Y, Gaye O, , 2008. Quality of artesunate tablets sold in pharmacies in Kumasi, Ghana. Trop J Pharm Res 7: 11791184.[Crossref] [Google Scholar]
  24. Nyarko EA, Nettey H, , 2013. Quality assessment of artemether/lumefantrine tablets sampled from pharmacies in Accra, Ghana, using the MVHimagePCv8.exe color software. Pharmacol Pharm 4: 567572.[Crossref] [Google Scholar]
  25. Ranieri N, Tabernero P, Green MD, Verbois L, Herrington J, Sampson E, Satzger RD, Phonlavong C, Thao K, Newton PN, Witkowski MR, , 2014. Evaluation of a new handheld instrument for the detection of counterfeit artesunate by visual fluorescence comparison. Am J Trop Med Hyg 91: 920924.[Crossref] [Google Scholar]
  26. Tukey JW, , 1977. Exploratory Data Analysis. Reading, MA: Addison-Wesley Publishing Company. [Google Scholar]
  27. Zlatkis A, Zak B, Boyle AU, , 1953. A new method for direct determination of serum cholesterol. J Lab Clin Med 41: 486. [Google Scholar]
  28. Green MD, Atieli F, Akogbeto M, , 2009. Rapid colorimetric field test to determine levels of deltamethrin on PermaNet surfaces: association with mosquito bioactivity. Trop Med Int Health 14: 381388.[Crossref] [Google Scholar]
  29. Green MD, Mayxay M, Beach R, Pongvongsa T, Phompida S, Hongvanthong B, Vanisaveth V, Newton PN, Vizcaino L, Swamidoss I, , 2013. Evaluation of a rapid colorimetric field test to assess the effective life of long-lasting insecticide-treated mosquito nets in the Lao PDR. Malar J 7: 57.[Crossref] [Google Scholar]
  30. Fernandez FM, Hostetler D, Powell K, Kaur H, Green MD, Mildenhall DC, Newton PN, , 2011. Poor quality drugs: grand challenges in high throughput detection, countrywide sampling, and forensics in developing countries. Analyst (Lond) 7: 30733082.[Crossref] [Google Scholar]

Data & Media loading...

  • Received : 22 Dec 2014
  • Accepted : 23 Feb 2015
  • Published online : 03 Jun 2015

Most Cited This Month

This is a required field
Please enter a valid email address
Approval was a Success
Invalid data
An Error Occurred
Approval was partially successful, following selected items could not be processed due to error