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



Good-quality antimalarials are crucial for the effective treatment and control of malaria. A total of 7,740 individual and packaged tablets, ampoules, and syrups were obtained from 60 randomly selected public ( = 35) and private outlets ( = 25) in Afghanistan. Of these, 134 samples were screened using the Global Pharma Health Fund (GPHF) MiniLab in Kabul with 33/126 (26%) samples failing the MiniLab disintegration test. The quality of a subsample ( = 37) of cholorquine, quinine, and sulfadoxine/pyrimethamine tablets was assessed by in vitro dissolution testing following U.S. Pharmacopeia (USP) monographs at a bioanalytical laboratory in London, United Kingdom. Overall, 12/32 (32%) samples of sulfadoxine/pyrimethamine and quinine were found not to comply with the USP tolerance limits. Substandard antimalarials were available in Afghanistan demonstrating that continuous monitoring of drug quality is warranted. However, in Afghanistan as in many low-income countries, capacity to determine and monitor drug quality using methods such as dissolution testing needs to be established to empower national authorities to take appropriate action in setting up legislation and regulation.

[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. Caudron JM, Ford N, Henkens M, Mace C, Kiddle-Monroe R, Pinel J, , 2008. Substandard medicines in resource-poor settings: a problem that can no longer be ignored. Trop Med Int Health 13: 10621072.[Crossref] [Google Scholar]
  2. Newton PN, Green MD, Mildenhall DC, Plancon 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 P, Kaur H, Angus B, Stepniewska K, Guerin PJ, Fernandez FM, , 2011. Poor quality vital anti-malarials in Africa: an urgent neglected public health priority. Malar J 10: 352.[Crossref] [Google Scholar]
  3. Tabernero P, Fernandez FM, Green M, Guerin PJ, Newton PN, , 2014. Mind the gaps–the epidemiology of poor-quality anti-malarials in the malarious world–analysis of the WorldWide Antimalarial Resistance Network database. Malar J 13: 139.[Crossref] [Google Scholar]
  4. United States Pharmacopeia, 2004. A Review of Drug Quality in Asia with Focus on Anti-Infectives. Available at: http://pdf.usaid.gov/pdf_docs/PNADH154.pdf. Accessed June 16, 2014. [Google Scholar]
  5. Kohler JC, Pavignani E, Michael M, Ovtcharenko N, Murru M, Hill PS, , 2012. An examination of pharmaceutical systems in severely disrupted countries. BMC Int Health Hum Rights 12: 34.[Crossref] [Google Scholar]
  6. Adimi F, Soebiyanto RP, Safi N, Kiang R, , 2010. Towards malaria risk prediction in Afghanistan using remote sensing. Malar J 9: 125.[Crossref] [Google Scholar]
  7. World Health Organization, 2013. Afghanistan Country Health Profile. Available at: http://www.who.int/malaria/publications/country-profiles/profile_afg_en.pdf. Accessed December 4, 2014. [Google Scholar]
  8. Kolaczinski J, Graham K, Fahim A, Brooker S, Rowland M, , 2005. Malaria control in Afghanistan: progress and challenges. Lancet 365: 15061512.[Crossref] [Google Scholar]
  9. World Health Organization, 2011. Afghanistan Country Profile: Malaria. Available at: http://www.who.int/malaria/publications/country-profiles/profile_afg_en.pdf. Accessed May 14, 2014. [Google Scholar]
  10. Leslie T, Mikhail A, Mayan I, Anwar M, Bakhtash S, Nader M, Chandler C, Whitty CJ, Rowland M, , 2012. Overdiagnosis and mistreatment of malaria among febrile patients at primary healthcare level in Afghanistan: observational study. BMJ 345: e4389.[Crossref] [Google Scholar]
  11. Awab GR, Pukrittayakamee S, Imwong M, Dondorp AM, Woodrow CJ, Lee SJ, Day NP, Singhasivanon P, White NJ, Kaker F, , 2010. Dihydroartemisinin-piperaquine versus chloroquine to treat vivax malaria in Afghanistan: an open randomized, non-inferiority, trial. Malar J 9: 105.[Crossref] [Google Scholar]
  12. Howard N, Shafi A, Jones C, Rowland M, , 2010. Malaria control under the Taliban regime: insecticide-treated net purchasing, coverage, and usage among men and women in eastern Afghanistan. Malar J 9: 7.[Crossref] [Google Scholar]
  13. Reynolds J, Wood M, Mikhail A, Ahmad T, Karimullah K, Motahed M, Hazansai A, Baktash SH, Anwari N, Kizito J, Mayan I, Rowland M, Chandler C, Leslie T, , 2013. Malaria “diagnosis” and diagnostics in Afghanistan. Qual Health Res 23: 579591.[Crossref] [Google Scholar]
  14. Peters DH, Noor AA, Singh LP, Kakar FK, Hansen PM, Burnham G, , 2007. A balanced scorecard for health services in Afghanistan. Bull World Health Organ 85: 146151.[Crossref] [Google Scholar]
  15. Harper J, Strote G, , 2011. Afghanistan pharmaceutical sector development: problems and prospects. Southern Med Review 4: 2939.[Crossref] [Google Scholar]
  16. World Health Organization, 2011. Spurious/Falsely-Labelled/Falsified/Counterfeit (SFFC) Medicines. Available at: http://www.who.int/medicines/services/counterfeit/faqs/QandAsUpdateJuly11.pdf. Accessed May 27, 2014. [Google Scholar]
  17. Sengaloundeth S, Green MD, Fernandez FM, Manolin O, Phommavong K, Insixiengmay V, Hampton CY, Nyadong L, Mildenhall DC, Hostetler D, Khounsaknalath L, Vongsack L, Phompida S, Vanisaveth V, Syhakhang L, Newton PN, , 2009. A stratified random survey of the proportion of poor quality oral artesunate sold at medicine outlets in the Lao PDR: implications for therapeutic failure and drug resistance. Malar J 8: 172.[Crossref] [Google Scholar]
  18. Newton PN, Fernandez FM, Plancon A, Mildenhall DC, Green MD, Ziyong L, Christophel EM, Phanouvong S, Howells S, McIntosh E, Laurin P, Blum N, Hampton CY, Faure K, Nyadong L, Soong CWR, Santoso B, Zhiguang W, Newton J, Palmer K, , 2008. A collaborative epidemiological investigation into the criminal fake artesunate trade in southeast Asia. PLoS Med 5: 209219.[Crossref] [Google Scholar]
  19. Leslie T, Kaur H, Mohammed N, Kolaczinski K, Ord RL, Rowland M, , 2009. Epidemic of Plasmodium falciparum malaria involving substandard antimalarial drugs, Pakistan, 2003. Emerg Infect Dis 15: 17531759.[Crossref] [Google Scholar]
  20. World Health Organization, 2011. Counterfeit and Substandard Drugs. Frequently Asked Questions. Available at: http://www.who.int/medicines/services/counterfeit/faqs/en/. Accessed May 27, 2014. [Google Scholar]
  21. Abdo-Rabbo A, Bassili A, Atta H, , 2005. The quality of antimalarials available in Yemen. Malar J 4: 28.[Crossref] [Google Scholar]
  22. Global Pharma Health Fund, 2012. GPHF Minilab® . Available at: www.gphf.org. Accessed May 17, 2014. [Google Scholar]
  23. Onwujekwe O, Kaur H, Dike N, Shu E, Uzochukwu B, Hanson K, Okoye V, Okonkwo P, , 2009. Quality of anti-malarial drugs provided by public and private healthcare providers in southeast Nigeria. Malar J 8: 22.[Crossref] [Google Scholar]
  24. Jahnke R, , 2008. A Concise Quality Control Guide on Essential Drugs and other Medicines: Volume II on Thin Layer Chromatographic Tests. Frankfurt, Germany: Global Pharma Health Fund, 5208. [Google Scholar]
  25. Ioset JR, Kaur H, , 2009. Simple field assays to check quality of current artemisinin-based antimalarial combination formulations. PLoS ONE 4: e7270.[Crossref] [Google Scholar]
  26. United States Pharmacopeia, USP 24, 2000. The National Formulary: NF 19: United States Pharmacopeial Convention. Rockville, MD: United States Pharmacopoeia. [Google Scholar]
  27. Almuzaini T, Choonara I, Sammons H, , 2013. Substandard and counterfeit medicines: a systematic review of the literature. BMJ Open 3: e002923.[Crossref] [Google Scholar]
  28. Newton PN, Green MD, Fernandez FM, , 2010. Impact of poor-quality medicines in the ‘developing’ world. Trends Pharmacol Sci 31: 99101.[Crossref] [Google Scholar]
  29. United States Pharmacopeia, 2009. Survey of the Quality of Selected Antimalarial Medicines Circulating in Madagascar, Senegal, and Uganda. Available at: http://apps.who.int/medicinedocs/documents/s17069e/s17069e.pdf. Accessed June 16, 2014. [Google Scholar]
  30. Gaudiano MC, Di Maggio A, Cocchieri E, Antoniella E, Bertocchi P, Alimonti S, Valvo L, , 2007. Medicines informal market in Congo, Burundi and Angola: counterfeit and sub-standard antimalarials. Malar J 6: 22.[Crossref] [Google Scholar]
  31. Keoluangkhot V, Green MD, Nyadong L, Fernandez FM, Mayxay M, Newton PN, , 2008. Impaired clinical response in a patient with uncomplicated falciparum malaria who received poor-quality and underdosed intramuscular artemether. Am J Trop Med Hyg 78: 552555. [Google Scholar]
  32. Bloland P, World Health Organization, , 2001. Drug Resistance in Malaria. Available at: http://www.who.int/csr/resources/publications/drugresist/malaria.pdf. Accessed June 16, 2014. [Google Scholar]
  33. World Health Organization, 2010. World Malaria Report, Summary. Available at: http://www.who.int/malaria/world_malaria_report_2010/worldmalariareport2010.pdf. Accessed June 16, 2014. [Google Scholar]
  34. World Health Orgainzation, 2010. Guidelines for the Treatment of Malaria, 2nd edition. Available at: http://whqlibdoc.who.int/publications/2010/9789241547925_eng.pdf. Accessed June 16, 2014. [Google Scholar]
  35. Kokic M, , 2006. WHO Calls for an Immediate Halt to Provision of Single-Drug Artemisinin Malaria Pills. Available at: http://www.who.int/mediacentre/news/releases/2006/pr02/en/. Accessed June 16, 2014. [Google Scholar]
  36. World Health Organization, 2013. Marketing Oral Artemisinin Monotherapies at Country Level. Available at: http://www.who.int/entity/malaria/monotherapy_NDRAs.pdf?ua=1. Accessed May 13, 2014. [Google Scholar]
  37. World Health Organization, 2013. Marketing of Oral Artemisinin-Based Monotherapy Medicines: Position Expressed by Manufacturers. Available at: http://www.who.int/malaria/monotherapy_manufacturers.pdf. Accessed May 13, 2014. [Google Scholar]
  38. Dondorp AM, Yeung S, White L, Nguon C, Day NP, Socheat D, von Seidlein L, , 2010. Artemisinin resistance: current status and scenarios for containment. Nat Rev Microbiol 8: 272280.[Crossref] [Google Scholar]
  39. Durrani N, Leslie T, Rahim S, Graham K, Ahmad F, Rowland M, , 2005. Efficacy of combination therapy with artesunate plus amodiaquine compared to monotherapy with chloroquine, amodiaquine or sulfadoxine-pyrimethamine for treatment of uncomplicated Plasmodium falciparum in Afghanistan. Trop Med Int Health 10: 521529.[Crossref] [Google Scholar]
  40. Beshir K, Sutherland CJ, Merinopoulos I, Durrani N, Leslie T, Rowland M, Hallett RL, , 2010. Amodiaquine resistance in Plasmodium falciparum malaria in Afghanistan is associated with the pfcrt SVMNT allele at codons 72 to 76. Antimicrob Agents Chemother 54: 37143716.[Crossref] [Google Scholar]
  41. Bouchaud O, Imbert P, Touze JE, Dodoo AN, Danis M, Legros F, , 2009. Fatal cardiotoxicity related to halofantrine: a review based on a worldwide safety data base. Malar J 8: 289.[Crossref] [Google Scholar]
  42. World Health Organization, 2011. Survey of the Quality of Selected Antimalarial Medicines Circulating in Six Countries of Sub-Saharan Africa. Available at: http://www.who.int/medicines/publications/WHO_QAMSA_report.pdf. Accessed June 16, 2014. [Google Scholar]
  43. Kaur H, Green MD, Hostetler D, Fernandez FM, Newton PN, , 2010. Antimalarial drug quality: methods to detect suspect drugs. Therapy 7: 4057.[Crossref] [Google Scholar]
  44. Kabanywanyi AM, Lengeler C, Kasim P, King'Eng'Ena S, Schlienger R, Mulure N, Genton B, , 2010. Adherence to and acceptability of artemether-lumefantrine as first-line anti-malarial treatment: evidence from a rural community in Tanzania. Malar J 9: 48.[Crossref] [Google Scholar]
  45. Goodman C, Brieger W, Unwin A, Mills A, Meek S, Greer G, , 2007. Medicine sellers and malaria treatment in sub-Saharan Africa: what do they do and how can their practice be improved? Am J Trop Med Hyg 77: 203218. [Google Scholar]

Data & Media loading...

  • Received : 25 Jun 2014
  • Accepted : 05 Jan 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