1. COUNTERFEITING OF DRUGS AND THE NECESSITY OF QC SYSTEMS IN DEVELOPING COUNTRIES: THE KENYAN EXPERIENCE By Isaac O. Kibwage

2. Authors: G.N. Thoithi 1, K.O. Abuga 1, H.K. Chepkwony 2 and I. O. Kibwage* 1 Department of Pharmaceutical Chemistry, University of Nairobi, Kenya. 2 National Quality Control Laboratory (NQCL), Nairobi, Kenya

3. Quality of Medicines  Quality of medicines  Impact of quality on consumers  Kenyan mass media reports – drug quality concerns  Poor quality  Expired products  Counterfeits  Lack of adequate policy  Limited market surveillance

4. Daily Nation, Monday May 2, 1988 PSK Symposium1988: Debate on quality of locally produced medicines stopped by PSK chairman

5. Kenya Times, Tuesday May 3, 1988

6. Africa Health Market Letter, Vol. 6 No. 4, April 1992 VLIR, KUL – UON Project for QC of drugs

7. Sale of non- registered loperamide & sulfadoxine/pyrimeth amine in the Kenyan market. Chief pharmacist admitted dispensing malpractices and the presence briefcase imports in the country Sunday Standard, Nov. 9, 1997

8. Sale of non-registered loperamide & sulfadoxine/pyrimethamine in the Kenyan market. Chief pharmacist admitted dispensing malpractices and the presence briefcase imports in the country Sunday Standard, Nov. 9, 1997

9. Specialties authorized for the Kenyan market:1982-2007 Category Number of Specialties Total Registered 19570 Newly Registered Drugs in 2007 643 Re-registered in 2007 1126

10. Historical Background DARU:Established in 1977 Work started in1980 VLIR funded KUL-UoN project was a major boost NQCL:Established in 1993 Takeoff slow - inadequate facilities 2004 – Enhanced budgetary allocation + donor funding WHO certification in the process

11.  Central Medical Stores  Government and Private Hospitals  Pharmaceutical industry  Pharmacy and Poisons Board  Community Pharmacies  Doctors, Dentists and patients Sources of Drugs

12. 1. Local Manufacturers 2. Imported  India  China  Israel  Far East  Western/ Eastern Europe

13. Results for DARU Period: 1980 - 2007 Jan 1980- Jun 1981 Jul 1981- Dec 1982 1983 -86 1987 -90 1991 -95 1996- 2000 2001 -05 2006 -07 Number of drugs analyzed 182191379127262261379101 Local drugs (%) 6565715459603724 Imported drugs (%) 3535294641406376 Overall failed drugs 23.126.731.421.617.621.16.18.9

14. Results for DARU Period: 1980 - 2007 Jan 1980- Jun-81 Jul 1981- Dec-82 1983 -86 1987 -90 1991 -95 1996 - 2000 2001 -05 2006 -07 Local drugs failure (%) -514624202590 Imported drugs failure (%) -1531201416516.7

15. Results for DARU Period: 1980 - 2007 Jan 1980- Jun-81 Jul 1981- Dec-82 1983 -86 1987- 90 1991 -95 1996- 2000 2001 -05 2006 -07 Analgesics20.031.39.1009.7-6.9 Antibiotics14.931.530.026.218.410.73.255.4 Anthel-minthics--14.3025.037.510.03.0 Antimalarial drugs -14.36.702327.726.910.9 Therapeutic categories (% Failure)

16. Results for DARU Period: 1980 - 2007 Jan 1980- Jun-81 Jul 1981- Dec-82 1983 -86 1987 -90 1991 -95 1996- 2000 2001 -05 2006 -07 Anti-TB20.020.2--40.000- Electro- lytes 30.845.537.840.014.323.101 Vitamins /minerals -040.0-83.333.30- Skin33.058.056.367.741.725.033.3-

17. Failure Rate for Analgesics (%)

18. Failure Rate for Antibiotics (%)

19. Failure Rate for Antimalarial Drugs (%)

20. Failure Rate for Antitubercular Drugs (%)

21. Failure Rate for Skin Preparations (%)

22. Observations 2001-2007: Quality of drugs has improved 2001-2007: Quality of drugs has improved Failure rate slightly higher in locally manufactured drugs Failure rate slightly higher in locally manufactured drugs Drugs of greatest concern Drugs of greatest concern 1980 – 1990: skin preps (  50% failure) nutritional preps (25-38%) antibiotics (about 30%). antibiotics (about 30%). 1996-2007: antimalarials, especially S/P (30%) 1996-2007: antimalarials, especially S/P (30%)

23. Possible Reasons for Improved Quality Improved technology globally Improved technology globally Professional advice given to local industry following failure of their products. Professional advice given to local industry following failure of their products. Investment in QC Labs Investment in QC Labs More pharmacists in the industry More pharmacists in the industry Greater vigilance by the regulatory authority. Greater vigilance by the regulatory authority.

24. Results for NQCL Period: 1996 - 2007 1996-20012002-20032004-20052006-2007 Number of drugs analyzed 1014421139955 Local drugs (%) 414027.228.2 Imported drugs (%) 596072.871.8 Overall failed drugs 30.827.112.615 Local drugs failure (%) 22.73218.723.8 Imported drugs failure (%) 34.923.910.411.5

25. Results for NQCL Period: 1996 - 2007 Therapeutic categories (% failure) 1996-20012002-20032004-20052006-2007 Analgesics5016.712.317.5 Antibiotics24.319.99.417.3 Anthihelmithics033.317.910 Antimalarials14.338.820.613.8 Anti-TB3038.946.517.4 Electrolytes16.70250 Vitamins/Minerals-036.725

26. Failure Rate for Analgesics (%)

27. Failure Rate for Antibiotics (%)

28. Failure Rate for Antimalarials (%)

29. Failure Rate for Antitubercular Drugs

30. Observations 2001-2007: Quality of drugs has improved 2001-2007: Quality of drugs has improved Failure rate slightly higher in imported drugs Failure rate slightly higher in imported drugs Drugs of greatest concern by end 2007 Drugs of greatest concern by end 2007 antibiotics (17.3%) anthelmintics (10%) antituberculars. (17.4%) antimalarials, (13.8%)

31. Counterfeit Medicines Year Labeled API Found API OtherParameterComments2003 Zidovidine / LamivudineZidovidine-- 2004 Amoxycillin trihydrate (RM) None-- 2006 Amoxil  500 mg capsules (Amoxycillin)AmoxycillinPackagingcounterfeited Product failed dissolution and assay

32. Counterfeit Medicines Year Labeled API Found API OtherParameterComments2004CaffeineNone-- 2005 Panadol  tablets (Paracetamol)ParacetamolPackagingcounterfeited- 2007 Prednisolone tablets NonePackagingCounterfeited-

33. Counterfeit Medicines Year Labeled API Found API OtherParameterComments2004 Sulphametho- xypyrazine/ Pyrimethamine Pyrimethamine only -- 2007 Duo-Cotecxin  tablets (Dihydroarte- misinin/ Piperaquine) Dihydroarte- misinin only Packagingcounterfeited- 2007 Metakelfin  tablets (Sulphametho- xypyrazine/ Pyrimethamine Pyrimethamine only Packagingcounterfeited Failed assay and dissolution

34. PREDINSOLONE TABLETS COUNTERFEIT (NQCL) TWO PACKS WITH THE SAME BATCH TABLETS LOOK DIFFERENT

35. METAKELFIN  TABLETS COUNTERFEIT (NQCL) Counter feit Genuine product

36. METAKELFIN  TABLETS COUNTERFEIT (NQCL) Genuine product Counter feit

37. DUO-COTECXIN  TABLETS COUNTERFEIT (DARU) Counterfeit product Genuine product

38. DUO-COTECXIN  TABLETS COUNTERFEIT (DARU) New product bears the hologram ‘FACT’

39. DUO-COTECXIN  TABLETS COUNTERFEIT (DARU) Counterfeit Genuine product New genuine pack

40. DOU-COTECXIN  TABLETS COUNTERFEIT (DARU) Counterfeit Genuine product New pack

41. DUO-COTECXIN  TABLETS COUNTERFEIT (DARU) Counterfeit Genuine product New pack

42. The Financial Standard, Tuesday April 20,1999

43. The People Daily, Friday August 6, 2004

44. The Financial Standard May 18,1999

45. Market Surveillance

46. Market Surveillance Reports YEARLAB CLASS OF DRUGS AREA COVERED FAILURE RATE 2000DARU SP products Nairobi City 70% 1992- 2000 DARU Ampicillin products Nairobi20% 2002NQCLAntimalarialsCountrywide29% 2006NQCLAntimalarialsCountrywide12%

47. Market Surveillance  Market surveillance is weak in Kenya  Concern for quality  Availability of substandard products in the market  Regulatory authority needs to be more stringent

48. Conclusions Counterfeits harm health, results in economic loss Counterfeits harm health, results in economic loss Meaningful surveillance Meaningful surveillance –Strong DRA –Well equipped QC facilities –Comprehensive policies on handling and distribution of drugs

49. ACKNOWLEDGEMENTS VLIR: Equipment Human resource development Technology transfer DARU: Staff NQCL: Staff GoK, PPB Donors: GTZ, DANIDA, WHO

50. ACKNOWLEDGEMENTS NATIONAL QUALITY CONTROL LABORATORY (NQCL) STAFF

51. ACKNOWLEDGEMENTS DRUG ANALYSIS AND RESEARCH UNIT (DARU) STAFF