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



Little is known about the quality of antibiotics despite being in high demand globally. Thirty five samples (27 brands) of the antibiotics amoxicillin ( = 20; 16 brands) and co-trimoxazole ( = 15; 11 brands), manufactured in six countries (China, Ghana, India, Ireland, Nigeria, and United Kingdom), were purchased in Ghana, Nigeria, and the United Kingdom. Their quality was assessed using German Pharma Health Fund (GPHF) MiniLab as the screening tool—two capsules of amoxicillin (10%) and two tablets of co-trimoxazole (20%) failed the thin-layer chromatography (TLC) test. Definitive drug quality was measured using high-performance liquid chromatography–photodiode array detection (HPLC-PDA) for content of the stated active pharmaceutical ingredients (APIs) and bioavailability was determined with in vitro dissolution testing. All the samples of amoxicillin complied with U.S. Pharmacopeia (USP) tolerance limits, but 60% tablets of co-trimoxazole (purchased in Ghana and Nigeria) did not. There was disparity in the results obtained for co-trimoxazole and amoxicillin samples using the MiniLab TLC tests. This highlights the need to invest in techniques such as HPLC-PDA and dissolution testing alongside the screening tests for assessing drug quality.

[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. Currie CJ, Berni E, Jenkins-Jones S, Poole CD, Ouwens M, Driessen S, de Voogd H, Butler CC, Morgan CL, , 2014. Antibiotic treatment failure in four common infections in UK primary care 1991–2012: longitudinal analysis. BMJ 349: g5493.[Crossref]
  2. Gonzalo X, Drobniewski F, , 2013. Is there a place for beta-lactams in the treatment of multidrug-resistant/extensively drug-resistant tuberculosis? Synergy between meropenem and amoxicillin/clavulanate. J Antimicrob Chemother 68: 366369.[Crossref]
  3. Wright TI, Baddour LM, Berbari EF, Roenigk RK, Phillips PK, Jacobs MA, Otley CC, , 2008. Antibiotic prophylaxis in dermatologic surgery: advisory statement 2008. J Am Acad Dermatol 59: 464473.[Crossref]
  4. Wiktor SZ, Sassan-Morokro M, Grant AD, Abouya L, Karon JM, Maurice C, Djomand G, Ackah A, Domoua K, Kadio A, Yapi A, Combe P, Tossou O, Roels TH, Lackritz EM, Coulibaly D, Cock KMD, Coulibaly I-M, Greenberg AE, , 1999. Efficacy of trimethoprim-sulphamethoxazole prophylaxis to decrease morbidity and mortality in HIV-1-infected patients with tuberculosis in Abidjan, Côte d'Ivoire: a randomised controlled trial. Lancet 353: 14691475.[Crossref]
  5. Alahdab Y, Kalayci C, , 2014. Helicobacter pylori: management in 2013. World J Gastroenterol 18: 53025307.[Crossref]
  6. 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]
  7. 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]
  8. 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.
  9. Suda KJ, Hicks LA, Roberts RM, Hunkler RJ, Taylor TH, , 2014. Trends and seasonal variation in outpatient antibiotic prescription rates in the United States, 2006 to 2010. Antimicrob Agents Chemother 58: 27632766.[Crossref]
  10. Hadi U, van den Broek P, Kolopaking EP, Zairina N, Gardjito W, Gyssens IC, Study Group Antimicrobial Resistance in Indonesia: Prevalence and Prevention (AMRIN), , 2010. Cross-sectional study of availability and pharmaceutical quality of antibiotics requested with or without prescription (over the counter) in Surabaya, Indonesia. BMC Infect Dis 10: 203.[Crossref]
  11. Al-Shami A, Izham M, Abdo-Rabbo A, , 2011. Evaluation of the quality of prescriptions with antibiotics in the government hospitals of Yemen. J Clin Diagn Res 5: 808812.
  12. Newton PN, Green MD, Fernandez FM, , 2010. Impact of poor-quality medicines in the ‘developing’ world. Trends Pharmacol Sci 31: 99101.[Crossref]
  13. Kelesidis T, Kelesidis I, Rafailidis PI, Falagas ME, , 2007. Counterfeit or substandard antimicrobial drugs: a review of the scientific evidence. J Antimicrob Chemother 60: 214236.[Crossref]
  14. Seear M, Gandhi D, Carr R, Dayal A, Raghavan D, Sharma N, , 2011. The need for better data about counterfeit drugs in developing countries: a proposed standard research methodology tested in Chennai, India. J Clin Pharm Ther 36: 488495.[Crossref]
  15. Kyriacos S, Mroueh M, Chahine RP, Khouzam O, , 2008. Quality of amoxicillin formulations in some Arab countries. J Clin Pharm Ther 33: 375379.[Crossref]
  16. Newton PN, Green MD, Fernandez FM, Day NP, White NJ, , 2006. Counterfeit anti-infective drugs. Lancet Infect Dis 6: 602613.[Crossref]
  17. Global Pharma Health Fund, 2012. GPHF MiniLab® . Available at: www.gphf.org. Accessed May 17, 2014.
  18. Available at: http://www.usp.org/global-health-programs/promoting-quality-medicines-pqmusaid/pqm-news-resource-center/glossary-pqm-activities#trainingPrograms. Accessed March 3, 2015.
  19. Kaur H, Green MD, Hostetler D, Fernandez FM, Newton PN, , 2010. Antimalarial drug quality: methods to detect suspect drugs. Therapy 7: 4057.[Crossref]
  20. 2009. Map of Nigeria. Available at: http://en.18dao.net/Map/Nigeria. Accessed June 2, 2014.
  21. 2009. Map of Ghana. Available at: http://en.18dao.net/Map/Ghana. Accessed June 2, 2014.
  22. Available at: http://epi-info.software.informer.com/3.5/. Accessed August 25, 2014.
  23. The United States Pharmacopeia, 2000. USP 24: The National Formulary: NF 19: United States Pharmacopeial Convention. Rockville, MD: United States Pharmacopoeia.
  24. Butler MS, Blaskovich MA, Cooper MA, , 2013. Antibiotics in the clinical pipeline in 2013. J Antibiot (Tokyo) 66: 571591.[Crossref]
  25. Antimicrobial resistance: revisiting the “tragedy of the commons” interview; Professor John Conly on World Health Day 2011. Available at: http://www.who.int/bulletin/volumes/88/11/10-031110/en/. Accessed August 21, 2014.
  26. Levy SB, , 1994. Balancing the drug-resistance equation. Trends Microbiol 2: 341342.[Crossref]
  27. McKendry RA, , 2013. Nanomechanics of superbugs and superdrugs: new frontiers in nanomedicine. Biochem Soc Trans 40: 603608 [Review].[Crossref]
  28. Kumarasamy KK, Toleman MA, Walsh TR, Bagaria J, Butt F, Balakrishnan R, Chaudhary U, Doumith M, Giske CG, Irfan S, Krishnan P, Kumar AV, Maharjan S, Mushtaq S, Noorie T, Paterson DL, Pearson A, Perry C, Pike R, Rao B, Ray U, Sarma JB, Sharma M, Sheridan E, Thirunarayan MA, Turton J, Upadhyay S, Warner M, Welfare W, Livermore DM, Woodford N, , 2010. Emergence of a new antibiotic resistance mechanism in India, Pakistan, and the UK: a molecular, biological, and epidemiological study. Lancet Infect Dis 10: 597602.[Crossref]
  29. Almuzaini T, Choonara I, Sammons H, , 2013. Substandard and counterfeit medicines: a systematic review of the literature. BMJ Open 3: e002923.[Crossref]
  30. World Health Organization, 2011. Adapting WHO Normative HIV Guidelines for National Programmes: Essential Principles and Processes. Available at: http://whqlibdoc.who.int/publications/2011/9789241501828_eng.pdf. Accessed July 31, 2014.
  31. Federal Ministry of Health Nigeria, 2010. National Guidelines for HIV and AIDS Treatment and Care in Adolescents and Adults. Available at: http://www.who.int/hiv/pub/guidelines/nigeria_art.pdf. Accessed July 31, 2014.
  32. 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.
  33. Risha PG, Msuya Z, Clark M, Johnson K, Ndomondo-Sigonda M, Layloff T, , 2008. The use of MiniLabs® to improve the testing capacity of regulatory authorities in resource limited settings: Tanzanian experience. Health Policy 87: 217222.[Crossref]
  34. 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]
  35. Newton PN, Lee SJ, Goodman C, Fernández FM, Yeung S, Phanouvong S, Kaur H, Amin AA, Whitty CJ, Kokwaro GO, Lindegårdh 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...

  • Received : 27 Aug 2014
  • Accepted : 01 Feb 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