Volume 96, Issue 5
  • ISSN: 0002-9637
  • E-ISSN: 1476-1645



Substandard and falsified antimalarial and antibiotic medicines represent a serious problem for public health, especially in low- and middle-income countries. However, information on the prevalence of poor-quality medicines is limited. In the present study, samples of six antimalarial and six antibiotic medicines were collected from 31 health facilities and drug outlets in southern Malawi. Random sampling was used in the selection of health facilities. For sample collection, an overt approach was used in licensed facilities, and a mystery shopper approach in nonlicensed outlets. One hundred and fifty-five samples were analyzed by visual and physical examination and by rapid prescreening tests, that is, disintegration testing and thin-layer chromatography using the GPHF-Minilab. Fifty-six of the samples were analyzed according to pharmacopeial monographs in a World Health Organization-prequalified quality control laboratory. Seven out-of-specification medicines were identified. One sample was classified as falsified, lacking the declared active ingredients, and containing other active ingredients instead. Three samples were classified as substandard with extreme deviations from the pharmacopeial standards, and three further samples as substandard with nonextreme deviations. Of the substandard medicines, three failed in dissolution testing, two in the assay for the content of the active pharmaceutical ingredient, and one failed in both dissolution testing and assay. Six of the seven out-of-specification medicines were from private facilities. Only one out-of-specification medicine was found within the samples from public and faith-based health facilities. Although the observed presence of substandard and falsified medicines in Malawi requires action, their low prevalence in public and faith-based health facilities is encouraging.

[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.


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  1. United Nations, General Assembly resolution 70/1. Transforming Our World: The 2030 Agenda for Sustainable Development, A/RES/70/1 (25 September 2015). Available at: http://undocs.org/A/RES/70/1. Accessed December 22, 2016. [Google Scholar]
  2. Wirtz VJ, Hogerzeil HV, Gray AL, Bigdeli M, de Joncheere CP, Ewen MA, Gyansa-Lutterodt M, Jing S, Luiza VL, Mbindyo RM, Moller H, Moucheraud C, Pecoul B, Rago L, Rashidian A, Ross-Degnan D, Stephens PN, Teerawattananon Y, 't Hoen EF, Wagner AK, Yadav P, Reich MR, , 2017. Essential medicines for universal health coverage. The Lancet 389: 403476.[Crossref] [Google Scholar]
  3. Nayyar GM, Breman JG, Herrington JE, , 2015. The global pandemic of falsified medicines: laboratory and field innovations and policy perspectives. Am J Trop Med Hyg 92: 27.[Crossref] [Google Scholar]
  4. 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]
  5. Renschler JP, Walters KM, Newton PN, Laxminarayan R, , 2015. Estimated under-five deaths associated with poor-quality antimalarials in sub-Saharan Africa. Am J Trop Med Hyg 92: 119126.[Crossref] [Google Scholar]
  6. Kelesidis T, Falagas ME, , 2015. Substandard/counterfeit antimicrobial drugs. Clin Microbiol Rev 28: 443464.[Crossref] [Google Scholar]
  7. Heymann DL, Chen L, Takemi K, Fidler DP, Tappero JW, Thomas MJ, Kenyon TA, Frieden TR, Yach D, Nishtar S, Kalache A, Olliaro PL, Horby P, Torreele E, Gostin LO, Ndomondo-Sigonda M, Carpenter D, Rushton S, Lillywhite L, Devkota B, Koser K, Yates R, Dhillon RS, Rannan-Eliya RP, , 2015. Global health security: the wider lessons from the west African Ebola virus disease epidemic. Lancet 385: 18841901.[Crossref] [Google Scholar]
  8. Almuzaini T, Choonara I, Sammons H, , 2013. Substandard and counterfeit medicines: a systematic review of the literature. BMJ Open 3: e002923.[Crossref] [Google Scholar]
  9. 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] [Google Scholar]
  10. World Health Organization (WHO), 2016. Essential Medicines and Health Products. Definitions of SSFFC Medical Products. Available at: http://www.who.int/medicines/regulation/ssffc/definitions/en/. Accessed December 22, 2016. [Google Scholar]
  11. WHO Media Centre, 2016. Substandard, Spurious, Falsely Labelled, Falsified and Counterfeit (SSFFC) Medical Products. Fact sheet. Updated January 2016. Available at: http://www.who.int/mediacentre/factsheets/fs275/en/. Accessed December 22, 2016. [Google Scholar]
  12. Hajjou M, Krech L, Lane-Barlow C, Roth L, Pribluda VS, Phanouvong S, El-Hadri L, Evans L, 3rd Raymond C, Yuan E, Siv L, Vuong TA, Boateng KP, Okafor R, Chibwe KM, Lukulay PH, , 2015. Monitoring the quality of medicines: results from Africa, Asia, and South America. Am J Trop Med Hyg 92: 6874.[Crossref] [Google Scholar]
  13. Kaur H, Clarke S, Lalani M, Phanouvong S, Guerin P, McLoughlin A, Wilson BK, Deats M, Plancon A, Hopkins H, Miranda D, Schellenberg D, , 2016. Fake anti-malarials: start with the facts. Malar J 15: 86.[Crossref] [Google Scholar]
  14. World Health Organization (WHO), 2016. Report of the Informal Technical Working Group on Draft Working Definitions of Substandard/Spurious/Falsely-Labelled/Falsified/Counterfeit (SSFFC) Medical Products. Fifth Meeting of the Member State Mechanism on Substandard/Spurious/Falsely-Labelled/Falsified/Counterfeit Medical Products, 23–25 November 2016. A/MSM/5/7. Available at: http://apps.who.int/gb/ssffc/e/a_msm5.html. Accessed January 5, 2017. [Google Scholar]
  15. 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]
  16. Chinele S, , 2015. Market awash with counterfeit medicine. The Daily Times of Malawi. February 2, 2015, 12. [Google Scholar]
  17. Khuluza F, , 2014. In-vitro evaluation of the quality of paracetamol and co-trimoxazole tablets used in Malawi based on pharmacopoeial standards. Malawi Med J 26: 3841. [Google Scholar]
  18. Abiiro GA, Mbera GB, De Allegri M, , 2014. Gaps in universal health coverage in Malawi: a qualitative study in rural communities. BMC Health Serv Res 14: 234.[Crossref] [Google Scholar]
  19. Ravinetto RM, Dujardin C, , 2016. The threat of poor quality antibiotics in increasing antimicrobial resistance. BMJ 354: i3618.[Crossref] [Google Scholar]
  20. World Health Organization (WHO), 2011. Survey of the Quality of Selected Antimalarial Medicines Circulating in Six Countries of Sub-Saharan Africa. Geneva, Switzerland: WHO. WHO/EMP/QSM/2011.1. Available at: www.who.int/medicines/publications/WHO_QAMSA_report.pdf. Accessed December 22, 2016. [Google Scholar]
  21. Pribluda VS, Barojas A, Coignez V, Bradby S, Dijiba Y, El-Hadri L, Hajjou M, Krech L, Phanouvong S, Smine K, Chibwe K, Lukulay PH, Evans L, 3rd, 2014. The three-level approach: a framework for ensuring medicines quality in limited-resource countries. Pharm Regul Aff 3: 1000117. [Google Scholar]
  22. World Health Organization (WHO), 2016. Guidelines on the conduct of surveys of the quality of medicines. WHO Expert Committee on specifications for pharmaceutical preparations (Fiftieth report). WHO Technical Report Series No. 996. Annex 7. Geneva, Switzerland: WHO. Available at: http://apps.who.int/medicinedocs/documents/s22404en/s22404en.pdf. Accessed December 22, 2016. [Google Scholar]
  23. 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] [Google Scholar]
  24. Khuluza F, Kigera S, Jaehnke RW, Heide L, , 2016. Use of thin-layer chromatography to detect counterfeit sulfadoxine/pyrimethamine tablets with the wrong active ingredient in Malawi. Malar J 15: 215.[Crossref] [Google Scholar]
  25. WHO Regional Office Africa, 2016. Malawi: Introduction to Country Context. Available at: http://www.aho.afro.who.int/profiles_information/index.php/Malawi:Introduction_to_Country_Context. Accessed December 22, 2016. [Google Scholar]
  26. WHO Regional Office for Africa, 2009. WHO Country Cooperation Strategy 2008–2013. Malawi. Available at: www.who.int/countryfocus/cooperation_strategy/ccs_mwi_en.pdf. Accessed December 22, 2016. [Google Scholar]
  27. World Health Organization (WHO), 2016. Development of Country Profiles and Monitoring of the Pharmaceutical Situation in Countries. Country Profile Data Malawi. Available at: http://www.who.int/medicines/areas/coordination/coordination_assessment/en/index1.html. Accessed December 22, 2016. [Google Scholar]
  28. Tabernero P, Parker M, Ravinetto R, Phanouvong S, Yeung S, Kitutu FE, Cheah PY, Mayxay M, Guerin PJ, Newton PN, , 2016. Ethical challenges in designing and conducting medicine quality surveys. Trop Med Int Health 21: 799806.[Crossref] [Google Scholar]
  29. World Health Organization (WHO), 2016. List of Prequalifed Quality Control Laboratories, 41st edition, 14 July 2016. Available at: http://apps.who.int/prequal/info_applicants/qclabs/prequal_quality_control_labs.htm. Accessed December 22, 2016. [Google Scholar]
  30. Global Pharma Health Fund, 2008. Manual Accompanying the GPHF Minilab™. Volume II. Thin-Layer Chromatographic Tests. Darmstadt, Germany: GPHF. [Google Scholar]
  31. Ministry of Health, Malawi, 2015. Malawi Standard Treatment Guidelines (MSTG), 5th Edition. Incorporating Malawi Essential Medicines List (MEML) 2015. Available at: http://www.medcol.mw/wp-content/uploads/2015/12/Malawi-Standard-Treatment-Guidelines-Essential-Medicines-List-2015.pdf. Accessed December 22, 2016. [Google Scholar]
  32. World Health Organization (WHO), 2015. Guidelines for the Treatment of Malaria, 3rd edition. Geneva, Switzerland: WHO Press. Available at: http://www.who.int/malaria/publications/atoz/9789241549127/en/. Accessed December 22, 2016. [Google Scholar]
  33. Ministry of Health, Malawi, 2009. Malawi Standard Treatment Guidelines (MSTG), 4th Edition. Incorporating Malawi Essential Medicines List (MEML) 2009. Available at: http://apps.who.int/medicinedocs/en/d/Js18801en/. Accessed December 22, 2016. [Google Scholar]
  34. World Health Organization (WHO), 2008. WHO Model Formulary. Available at: http://apps.who.int/medicinedocs/documents/s16879e/s16879e.pdf. Accessed December 22, 2016. [Google Scholar]
  35. Schwabe U, Pfaffrath D, , 2015. Arzneiverordnungs-Report 2015. Berlin and Heidelberg, Germany: Springer.[Crossref] [Google Scholar]
  36. 't Hoen EF, Hogerzeil HV, Quick JD, Sillo HB, , 2014. A quiet revolution in global public health: the World Health Organization, Prequalification of Medicines Programme. J Public Health Policy 35: 137161.[Crossref] [Google Scholar]
  37. World Health Organization (WHO), 2016. List of Prequalified Medicinal Products. Available at: http://apps.who.int/prequal/query/productregistry.aspx. Accessed December 22, 2016. [Google Scholar]
  38. Jähnke RWO, , 2004. Counterfeit medicines and the GPHF-Minilab for rapid drug quality verification. Pharm Ind 66: 11871193. [Google Scholar]
  39. MedCalc easy-to-use statistical software. Test for One Proportion. Available at: https://www.medcalc.org/calc/test_one_proportion.php. Accessed December 22, 2016. [Google Scholar]
  40. MedCalc easy-to-use statistical software. Comparison of Proportions. Available at: https://www.medcalc.org/calc/comparison_of_proportions.php. Accessed December 22, 2016. [Google Scholar]
  41. Tshilumba PM, Amuri SB, Kaghowa ER, Mbikay DM, Impele AB, Duez P, Ndoumba JB, , 2015. Survey of counterfeit oral antiinfectives medecine sold in Lubumbashi. Pan Afr Med J 22: 318.[Crossref] [Google Scholar]
  42. Tipke M, Diallo S, Coulibaly B, Storzinger D, Hoppe-Tichy T, Sie A, Muller O, , 2008. Substandard anti-malarial drugs in Burkina Faso. Malar J 7: 95.[Crossref] [Google Scholar]
  43. Kaur H, Allan EL, Mamadu I, Hall Z, Ibe O, El Sherbiny M, van Wyk A, Yeung S, Swamidoss I, Green MD, Dwivedi P, Culzoni MJ, Clarke S, Schellenberg D, Fernandez FM, Onwujekwe O, , 2015. Quality of artemisinin-based combination formulations for malaria treatment: prevalence and risk factors for poor quality medicines in public facilities and private sector drug outlets in Enugu, Nigeria. PLoS One 10: e0125577.[Crossref] [Google Scholar]
  44. Chikowe I, Osei-Safo D, Harrison JJ, Konadu DY, Addae-Mensah I, , 2015. Post-marketing surveillance of anti-malarial medicines used in Malawi. Malar J 14: 127.[Crossref] [Google Scholar]
  45. Yu H, Le HM, Kaale E, Long KD, Layloff T, Lumetta SS, Cunningham BT, , 2016. Characterization of drug authenticity using thin-layer chromatography imaging with a mobile phone. J Pharm Biomed Anal 125: 8593.[Crossref] [Google Scholar]
  46. Freye JE, , 2014. The International Drug Price Indicator Guide. Cambridge, MA: Management Sciences for Health, Inc. Available at: http://apps.who.int/medicinedocs/documents/s21497en/s21497en.pdf. Accessed December 22, 2016. [Google Scholar]
  47. Yeung S, Lawford HL, Tabernero P, Nguon C, van Wyk A, Malik N, DeSousa M, Rada O, Boravann M, Dwivedi P, Hostetler DM, Swamidoss I, Green MD, Fernandez FM, Kaur H, , 2015. Quality of antimalarials at the epicenter of antimalarial drug resistance: results from an overt and mystery client survey in Cambodia. Am J Trop Med Hyg 92: 3950.[Crossref] [Google Scholar]

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Supplemental Table

  • Received : 21 Dec 2016
  • Accepted : 07 Jan 2017
  • Published online : 20 Feb 2017

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