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



Ensuring that artemisinin-containing antimalarials (ACAs) are of good quality is a key component of effective malaria treatment. There are concerns that a high proportion of ACAs are falsified or substandard, though estimates are rarely based on representative data. During a nationally representative survey in Tanzania, ACAs were purchased from private retail drug outlets, and the active pharmaceutical ingredient (API) was measured. All 1,737 ACAs contained the labeled artemisinin derivative, with 4.1% being outside the 85–115% artemisinin API range defined as acceptable quality. World Health Organization (WHO) prequalified drugs had 0.1 times the odds of being poor quality compared with non-prequalified ACAs for the artemisinin component. When partner components of combination therapies were also considered, 12.1% were outside the acceptable API range, and WHO prequalified ACAs had 0.04 times the odds of being poor quality. Although the prevalence of poor quality ACAs was lower than reported elsewhere, the minority of samples found to be substandard is a cause for concern. Improvements in quality could be achieved by increasing the predominance of WHO prequalified products in the market. Continued monitoring of quality standards is essential.

[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...

Loading full text...

Full text loading...



  1. WHO, 2012. World Malaria Report. Geneva, Switzerland: World Health Organization.
  2. WHO, 2000. Management of Severe Malaria: A Practical Handbook. Geneva, Switzerland: World Health Organization.
  3. IOM, 2013. Countering the Problem of Falsified and Substandard Drugs. Washington, DC: Institute of Medicine.
  4. Attaran A, Barry D, Basheer S, Bate R, Benton D, Chauvin J, Garrett L, Kickbusch I, Kohler JC, Midha K, Newton PN, Nishtar S, Orhii P, McKee M, , 2012. How to achieve international action on falsified and substandard medicines. BMJ 345: e7381.[Crossref]
  5. 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]
  6. Mackey TK, Liang BA, , 2013. Improving global health governance to combat counterfeit medicines: a proposal for a UNODC-WHO-Interpol trilateral mechanism. BMC Med 11: 233.[Crossref]
  7. 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 south-east Nigeria. Malar J 8: 22.[Crossref]
  8. 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]
  9. Roberts Michelle, 2012. Third of Malaria Drugs ‘are Fake.’ Available at: www.bbc.co.uk/news/health-18147085.
  10. 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]
  11. Sabot OJ, Mwita A, Cohen JM, Ipuge Y, Gordon M, Bishop D, Odhiambo M, Ward L, Goodman C, , 2009. Piloting the global subsidy: the impact of subsidized artemisinin-based combination therapies distributed through private drug shops in rural Tanzania. PLoS ONE 4: e6857.[Crossref]
  12. Tougher S, Group ACT Ye Y, Amuasi JH, Kourgueni IA, Thomson R, Goodman C, Mann AG, Ren R, Willey BA, Adegoke CA, Amin A, Ansong D, Bruxvoort K, Diallo DA, Diap G, Festo C, Johanes B, Juma E, Kalolella A, Malam O, Mberu B, Ndiaye S, Nguah SB, Seydou M, Taylor M, Rueda ST, Wamukoya M, Arnold F, Hanson K, , , , 2012. Effect of the Affordable Medicines Facility–malaria (AMFm) on the availability, price, and market share of quality-assured artemisinin-based combination therapies in seven countries: a before-and-after analysis of outlet survey data. Lancet 380: 19161926.[Crossref]
  13. Littrell M, Gatakaa H, Evance I, Poyer S, Njogu J, Solomon T, Munroe E, Chapman S, Goodman C, Hanson K, Zinsou C, Akulayi L, Raharinjatovo J, Arogundade E, Buyungo P, Mpasela F, Adjibabi CB, Agbango JA, Ramarosandratana BF, Coker B, Rubahika D, Hamainza B, Shewchuk T, Chavasse D, O'Connell KA, , 2011. Monitoring fever treatment behaviour and equitable access to effective medicines in the context of initiatives to improve ACT access: baseline results and implications for programming in six African countries. Malar J 10: 327.[Crossref]
  14. Wafula F, Molyneux C, Mackintosh M, Goodman C, , 2013. Protecting the public or setting the bar too high? Understanding the causes and consequences of regulatory actions of front-line regulators and specialized drug shop operators in Kenya. Soc Sci Med 97: 220227.[Crossref]
  15. WHO, 2011. Fighting fake drugs: the role of WHO and pharma. Lancet 377: 1626.
  16. Covell G, , 1955. Developments in the chemotherapy of malaria during the last 40 years. R Soc Health J 75: 758760.[Crossref]
  17. Covell G, Coatney GR, Field JW, Singh J, , 1955. Chemotherapy of malaria. Monogr Ser World Health Organ 27: 1123.
  18. Charmot G, Amat-Roze J, Rodhain F, Le Bras J, Coulaud J, , 1991. Geographic approach to the epidemiology of chloroquine-resistance of Plasmodium falciparum in tropical Africa. Ann Soc Belg Med Trop 71: 187197.
  19. Payne D, , 1987. Spread of chloroquine resistance in Plasmodium falciparum . Parasitol Today 3: 241246.[Crossref]
  20. Amaratunga C, Mao S, Sreng S, Suon S, Fairhurst RM, , 2013. Slow parasite clearance rates in response to artemether in patients with severe malaria. Lancet Infect Dis 13: 113114.[Crossref]
  21. Noedl H, Se Y, Schaecher K, Smith BL, Socheat D, Fukuda MM, Artemisinin Resistance in Cambodia 1 Study Group, , 2008. Evidence of artemisinin-resistant malaria in western Cambodia. N Engl J Med 359: 26192620.[Crossref]
  22. Noedl H, Socheat D, Satimai W, , 2009. Artemisinin-resistant malaria in Asia. N Engl J Med 361: 540541.[Crossref]
  23. WHO, 2014. Status Report on Artemisinin Resistance. Global Malaria Programme. Geneva, Switzerland: World Health Organization.
  24. Ashley EA, Dhorda M, Fairhurst RM, Amaratunga C, Lim P, Suon S, Sreng S, Anderson JM, Mao S, Sam B, Sopha C, Chuor CM, Nguon C, Sovannaroth S, Pukrittayakamee S, Jittamala P, Chotivanich K, Chutasmit K, Suchatsoonthorn C, Runcharoen R, Hien TT, Thuy-Nhien NT, Thanh NV, Phu NH, Htut Y, Han K-T, Aye KH, Mokuolu OA, Olaosebikan RR, Folaranmi OO, Mayxay M, Khanthavong M, Hongvanthong B, Newton PN, Onyamboko MA, Fanello CI, Tshefu AK, Mishra N, Valecha N, Phyo AP, Nosten F, Yi P, Tripura R, Borrmann S, Bashraheil M, Peshu J, Faiz MA, Ghose A, Hossain MA, Samad R, Rahman MR, Hasan MM, Islam A, Miotto O, Amato R, MacInnis B, Stalker J, Kwiatkowski DP, Bozdech Z, Jeeyapant A, Cheah PY, Sakulthaew T, Chalk J, Intharabut B, Silamut K, Lee SJ, Vihokhern B, Kunasol C, Imwong M, Tarning J, Taylor WJ, Yeung S, Woodrow CJ, Flegg JA, Das D, Smith J, Venkatesan M, Plowe CV, Stepniewska K, Guerin PJ, Dondorp AM, Day NP, White NJ, , 2014. Spread of artemisinin resistance in Plasmodium falciparum malaria. N Engl J Med 371: 411423.[Crossref]
  25. Bate R, Tren R, Hess K, Attaran A, , 2009. Physical and chemical stability of expired fixed dose combination artemether-lumefantrine in uncontrolled tropical conditions. Malar J 8: 33.[Crossref]
  26. Ofori-Kwakye K, Asantewaa Y, Gaye O, , 2008. Quality of artesunate tablets sold in pharmacies in Kumasi, Ghana. Trop J Pharm Res 7: 839845.[Crossref]
  27. Lon CT, Tsuyuoka R, Phanouvong S, Nivanna N, Socheat D, Sokhan C, Blum N, Christophel EM, Smine A, , 2006. Counterfeit and substandard antimalarial drugs in Cambodia. Trans R Soc Trop Med Hyg 100: 10191024.[Crossref]
  28. Maponga C, Ondari C, , 2003. The Quality of Antimalarials: A Study in Selected African Countries. Geneva, Switzerland: World Health Organization.
  29. Sabaratova J, Toumi G, Ondari C, , 2011. Survey of the Quality of Selected Antimalarial Medicines Circulating in Six Countries of Sub-Saharan Africa. Quality Assurance and Safety: Medicines, essential medicines and pharmaceutical policies. Geneva, Switzerland: World Health Organization.
  30. Dondorp AM, Newton PN, Mayxay M, Van Damme W, Smithuis FM, Yeung S, Petit A, Lynam AJ, Johnson A, Hien TT, McGready R, Farrar JJ, Looareesuwan S, Day NP, Green MD, White NJ, , 2004. Fake antimalarials in southeast Asia are a major impediment to malaria control: multinational cross-sectional survey on the prevalence of fake antimalarials. Trop Med Int Health 9: 12411246.[Crossref]
  31. O'Connell KA, Gatakaa H, Poyer S, Njogu J, Evance I, Munroe E, Solomon T, Goodman C, Hanson K, Zinsou C, Akulayi L, Raharinjatovo J, Arogundade E, Buyungo P, Mpasela F, Adjibabi CB, Agbango JA, Ramarosandratana BF, Coker B, Rubahika D, Hamainza B, Chapman S, Shewchuk T, Chavasse D, , 2011. Got ACTs? Availability, price, market share and provider knowledge of anti-malarial medicines in public and private sector outlets in six malaria-endemic countries. Malar J 10: 326.[Crossref]
  32. Thomson R, Festo C, Johanes B, Kalolella A, Bruxvoort K, Nchimbi H, Tougher S, Cairns M, Taylor M, Kleinschmidt I, Ye Y, Mann A, Ren R, Willey B, Arnold F, Hanson K, Kachur SP, Goodman C, , 2014. Has Tanzania embraced the green leaf? Results from outlet and household surveys before and after implementation of the Affordable Medicines Facility–Malaria. PLoS ONE 9: e95607.[Crossref]
  33. Rutta E, Kibassa B, McKinnon B, Liana J, Mbwasi R, Mlaki W, Embrey M, Gabra M, Shekalaghe E, Kimatta S, Sillo H, , 2012. Increasing access to subsidized artemisinin-based combination therapy through accredited drug dispensing outlets in Tanzania. Health Res Policy Syst 9: 22.[Crossref]
  34. Kumaranayake L, Hongoro C, Lake S, Mujinja P, Mpembeni R, Soderlund N, Mendoza-Arana P, Goudge J, , 2003. Coping with private health markets—regulatory (in)effectiveness in sub-Saharan Africa. , eds. The New Public/Private Mix in Health: Exploring the Changing Landscape. Geneva, Switzerland: Alliance for Health Policy and Systems Research.
  35. AMFm Independent Evaluation Team, 2012. Independent Evaluation of the Affordable Medicines Facility–Malaria (AMFm) Phase 1. Multi-Country Baseline Report. Calverton, MD, and London: ICF International and the London School of Hygiene and Tropical Medicine.
  36. Jande M, Ngassapa O, Kibwage I, , 2000. Quality of sulfadoxine/pyrimethamine tablets marketed in Dar es Salaam, Tanzania. East Cent Afr J Pharm Sci 3: 2024.
  37. Hebron Y, Tettey JN, Pournamdari M, Watson DG, , 2005. The chemical and pharmaceutical equivalence of sulphadoxine/pyrimethamine tablets sold on the Tanzanian market. J Clin Pharm Ther 30: 575581.[Crossref]
  38. Minzi OM, Moshi MJ, Hipolite D, Massele AY, Tomson G, Ericsson O, Gustafsson LL, , 2003. Evaluation of the quality of amodiaquine and sulphadoxine/pyrimethamine tablets sold by private wholesale pharmacies in Dar es Salaam Tanzania. J Clin Pharm Ther 28: 117122.[Crossref]
  39. Kaur H, Goodman C, Thompson E, Thompson KA, Masanja I, Kachur SP, Abdulla S, , 2008. A nationwide survey of the quality of antimalarials in retail outlets in Tanzania. PLoS ONE 3: e3403.[Crossref]
  40. Newton PN, McGready R, Fernandez F, Green MD, Sunjio M, Bruneton C, Phanouvong S, Millet P, Whitty CJ, Talisuna AO, Proux S, Christophel EM, Malenga G, Singhasivanon P, Bojang K, Kaur H, Palmer K, Day NP, Greenwood BM, Nosten F, White NJ, , 2006. Manslaughter by fake artesunate in Asia—will Africa be next? PLoS Med 3: e197.[Crossref]
  41. Lawford HL, Tabernero P, Nguon C, DeSousa M, Rada O, Boravann M, Chandler CI, Wyk AV, Hostetler DM, Malik N, Swamidoss I, Green MD, Fernandez FM, Kaur H, Yeung S, Herrington JE, Nayyar GML, Breman JG, , 2015. Quality of antimalarials at the epicenter of antimalarial drug resistance: results from a nationwide random survey in Cambodia. , eds. The global pandemic of falsified medicines: laboratory and field innovations policies and perspectives. Am J Trop Med Hyg 92 (Suppl 6): 3950.
  42. Newton PN, Taberno P, Dwivedi P, Culzoni MJ, Monga ME, Swamidoss I, Mildenhall DC, Green M, Jahnke R, dos Santos de Oliveria M, Simao J, White NJ, Fernandez F, , 2014. Falsified medicines in Africa: all talk, no action. The Lancet Global Health 2: e509e510.[Crossref]
  43. Nosten F, White NJ, , 2007. Artemisinin-based combination treatment of falciparum malaria. Am J Trop Med Hyg 77: 181192.
  44. Bate R, Coticelli P, Tren R, Attaran A, , 2008. Antimalarial drug quality in the most severely malarious parts of Africa—a six country study. PLoS ONE 3: e2132.[Crossref]
  45. USP, 2007. Ensuring the Quality of Medicines in Resource-Limited Countries: An Operational Guide. Rockville, MD: United States Pharmocopeia.
  46. Kumaranayake L, Mujinja P, Hongoro C, Mpembeni R, , 2000. How do countries regulate the health sector? Evidence from Tanzania and Zimbabwe. Health Policy Plan 15: 357367.[Crossref]
  47. Stenson B, Tomson G, Syhakhang L, , 1997. Pharmaceutical regulation in context: the case of Lao People's Democratic Republic. Health Policy Plan 12: 329340.[Crossref]
  48. Hongoro C, Kumaranayake L, , 2000. Do they work? Regulating for-profit providers in Zimbabwe. Health Policy Plan 15: 368377.[Crossref]
  49. WHO, 2010. Assessment of Medicines Regulatory Systems in Sub-Saharan African Countries: An Overview of Findings from 26 Assessment Reports. Geneva, Switzerland: World Health Organization.
  50. Newton PN, Lee SJ, Goodman C, Fernandez FM, Yeung S, Phanouvong S, Kaur H, Amin AA, Whitty CJ, Kokwaro GO, Lindegardh N, Lukulay P, White LJ, Day NP, Green MD, White NJ, , 2009. Guidelines for field surveys of the quality of medicines: a proposal. PLoS Med 6: e52.[Crossref]

Data & Media loading...

Supplementary Data

Supplementary PDF

  • Received : 29 Aug 2014
  • Accepted : 05 Jan 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