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COUNTERFEITING OF COUNTERFEITING OF DRUGS AND THE DRUGS AND THE NECESSITY OF QC NECESSITY OF QC
SYSTEMS IN DEVELOPING SYSTEMS IN DEVELOPING COUNTRIES:COUNTRIES:
THE KENYAN EXPERIENCE THE KENYAN EXPERIENCE
ByBy
Isaac O. KibwageIsaac O. Kibwage
Authors:Authors:
G.N. ThoithiG.N. Thoithi11, K.O. Abuga, K.O. Abuga11, H.K. , H.K. ChepkwonyChepkwony2 2 andand I. O. Kibwage*I. O. Kibwage*
11Department of Pharmaceutical Department of Pharmaceutical Chemistry, Chemistry, University of University of Nairobi,Nairobi, Kenya.Kenya.
22National Quality Control Laboratory National Quality Control Laboratory (NQCL), (NQCL), Nairobi, KenyaNairobi, Kenya
Quality of MedicinesQuality of Medicines
Quality of medicinesQuality of medicinesImpact of quality on consumersImpact of quality on consumersKenyan mass media reports – Kenyan mass media reports –
drug quality concernsdrug quality concernsPoor quality Poor quality Expired products Expired products CounterfeitsCounterfeits
Lack of adequate policyLack of adequate policyLimited market surveillanceLimited market surveillance
Daily Nation, Monday May 2, Daily Nation, Monday May 2, 19881988
PSK Symposium1988:
Debate on quality of locally produced medicines stopped by PSK chairman
Kenya Times, Tuesday May 3, Kenya Times, Tuesday May 3, 19881988
Africa Health Market Letter, Vol. 6 Africa Health Market Letter, Vol. 6 No. 4, April 1992No. 4, April 1992
VLIR, KUL – UON Project for QC of drugs
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, 1997Sunday Standard, Nov. 9, 1997
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, 1997Sunday Standard, Nov. 9, 1997
Specialties authorized for the Specialties authorized for the Kenyan market:1982-2007Kenyan market:1982-2007
CategoryCategory Number of Number of SpecialtiesSpecialties
Total RegisteredTotal Registered 1957019570
Newly Newly Registered Registered
Drugs in 2007Drugs in 2007643643
Re-registered in Re-registered in 20072007 11261126
Historical Background Historical Background
DARU:DARU: Established in 1977Established in 1977
Work started in1980Work started in1980
VLIR funded KUL-UoN project was VLIR funded KUL-UoN project was a a major boostmajor boost
NQCL:NQCL: Established in 1993Established in 1993
Takeoff slow - inadequate facilitiesTakeoff slow - inadequate facilities
2004 – Enhanced budgetary 2004 – Enhanced budgetary allocation allocation + donor funding+ donor funding
WHO certification in the processWHO certification in the process
Central Medical StoresCentral Medical StoresGovernment and Private HospitalsGovernment and Private HospitalsPharmaceutical industryPharmaceutical industryPharmacy and Poisons BoardPharmacy and Poisons BoardCommunity PharmaciesCommunity PharmaciesDoctors, Dentists and patientsDoctors, Dentists and patients
Sources of DrugsSources of Drugs
Sources of DrugsSources of Drugs
1.1. Local ManufacturersLocal Manufacturers2.2. ImportedImported
IndiaIndia ChinaChina IsraelIsrael Far EastFar East Western/ Eastern EuropeWestern/ Eastern Europe
Results for DARUResults for DARUPeriod: 1980 - 2007Period: 1980 - 2007
Jan Jan 1980-1980-Jun Jun 19811981
Jul Jul 1981-1981-Dec Dec 19821982
1981983-863-86
1981987-907-90
1991991-951-95
19961996--20002000
2002001-051-05
2002006-076-07
Number Number of drugs of drugs analyzedanalyzed
182182 191191 379379 127127 262262 261261 379379 101101
Local Local drugs drugs (%)(%)
6565 6565 7171 5454 5959 6060 3737 2424
Imported Imported drugs (%)drugs (%) 3535 3535 2929 4646 4141 4040 6363 7676
Overall Overall failed failed drugsdrugs
23.123.1 26.726.7 31.431.4 21.621.6 17.617.6 21.121.1 6.16.1 8.98.9
Results for DARUResults for DARUPeriod: 1980 - 2007Period: 1980 - 2007
Jan Jan 1980-1980-Jun-81Jun-81
Jul Jul 1981-1981-Dec-Dec-8282
1981983-3-8686
1981987-7-9090
1991991-1-9595
1991996-6-20020000
2002001-1-0505
2002006-6-0707
Local Local drugs drugs failure (%)failure (%)
-- 5151 4646 2424 2020 2525 99 00
Imported Imported drugs drugs failure (%)failure (%)
-- 1515 3131 2020 1414 1616 55 16.716.7
Results for DARUResults for DARUPeriod: 1980 - 2007Period: 1980 - 2007
Jan Jan 1980-1980-Jun-81Jun-81
Jul Jul 1981-1981-Dec-Dec-8282
1981983-863-86
19871987-90-90
1991991-951-95
19961996--20002000
2002001-051-05
2002006-076-07
AnalgesicAnalgesicss
20.020.0 31.331.3 9.19.1 00 00 9.79.7 -- 6.96.9
AntibioticAntibioticss
14.914.9 31.531.5 30.030.0 26.226.2 18.418.4 10.710.7 3.23.2 55.455.4
Anthel-Anthel-
minthicsminthics-- -- 14.314.3 00 25.025.0 37.537.5 10.010.0 3.03.0
AntimalariAntimalarial drugsal drugs -- 14.314.3 6.76.7 00 2323 27.727.7 26.926.9 10.910.9
Therapeutic categories (% Therapeutic categories (% Failure)Failure)
Results for DARUResults for DARUPeriod: 1980 - 2007Period: 1980 - 2007
Jan Jan 1980-1980-Jun-81Jun-81
Jul Jul 1981-1981-Dec-Dec-8282
1981983-863-86
1981987-907-90
1991991-951-95
1996-1996-20002000
2002001-051-05
2002006-076-07
Anti-TBAnti-TB 20.020.0 20.220.2 -- -- 40.040.0 00 00 --
Electro-Electro-lyteslytes 30.830.8 45.545.5 37.837.8 40.040.0 14.314.3 23.123.1 00 11
VitaminVitamins/s/mineralmineralss
-- 00 40.040.0 -- 83.383.3 33.333.3 00 --
SkinSkin 33.033.0 58.058.0 56.356.3 67.767.7 41.741.7 25.025.0 33.333.3 --
Failure Rate for Analgesics (%)Failure Rate for Analgesics (%)
0
5
10
15
20
25
30
35
1980-1981
1981-1982
1983-1986
1987-1990
1991-1995
1996-2000
2001-2005
2006-2007
Failure Rate for Antibiotics (%)Failure Rate for Antibiotics (%)
0
5
10
15
20
25
30
35
1980-1981
1982 1983-1986
1987-1990
1991-1995
1996-2000
2001-2005
2006-2007
Failure Rate for Antimalarial Failure Rate for Antimalarial Drugs (%)Drugs (%)
0
5
10
15
20
25
30
1980-1981
1982 1983-1986
1987-1990
1991-1995
1996-2000
2001-2005
2006-2007
Failure Rate for Antitubercular Failure Rate for Antitubercular Drugs (%)Drugs (%)
0
5
10
15
20
25
30
35
40
1980-1981
1982 1983-1986
1987-1990
1991-1995
1996-2000
2001-2005
2006-2007
Failure Rate for Skin Preparations Failure Rate for Skin Preparations (%)(%)
0
10
20
30
40
50
60
70
1980-1981
1981-1982
1983-1986
1987-1990
1991-1995
1996-2000
2006-2007
ObservationsObservations
•2001-2007: Quality of drugs has improved 2001-2007: Quality of drugs has improved •Failure rate slightly higher in locally Failure rate slightly higher in locally manufactured drugs manufactured drugs•Drugs of greatest concern Drugs of greatest concern
1980 – 1990: skin preps (1980 – 1990: skin preps (50% failure)50% failure)nutritional preps (25-38%) nutritional preps (25-38%)
antibiotics (about 30%).antibiotics (about 30%).
1996-2007: antimalarials, especially S/P 1996-2007: antimalarials, especially S/P (30%)(30%)
Possible Reasons for Improved Possible Reasons for Improved QualityQuality
• Improved technology globallyImproved technology globally
• Professional advice given to local Professional advice given to local industry following failure of their products.industry following failure of their products.
•Investment in QC LabsInvestment in QC Labs
• More pharmacists in the industry More pharmacists in the industry
• Greater vigilance by the regulatory Greater vigilance by the regulatory authority.authority.
Results for NQCLResults for NQCLPeriod: 1996 - 2007Period: 1996 - 20071996-1996-20012001
2002-2002-20032003
2004-2004-20052005
2006-2006-20072007
Number of Number of drugs analyzeddrugs analyzed 101101 442442 11391139 955955
Local drugs (%)Local drugs (%) 4141 4040 27.227.2 28.228.2
Imported drugs Imported drugs (%)(%) 5959 6060 72.872.8 71.871.8
Overall failed Overall failed drugsdrugs 30.830.8 27.127.1 12.612.6 1515
Local drugs Local drugs failure (%)failure (%) 22.722.7 3232 18.718.7 23.823.8
Imported drugs Imported drugs failure (%)failure (%) 34.934.9 23.923.9 10.410.4 11.511.5
Results for NQCLResults for NQCLPeriod: 1996 - 2007Period: 1996 - 2007
Therapeutic categories (% failure)Therapeutic categories (% failure)
1996-20011996-2001 2002-2002-20032003
2004-2004-20052005
2006-2006-20072007
AnalgesicsAnalgesics 5050 16.716.7 12.312.3 17.517.5
AntibioticsAntibiotics 24.324.3 19.919.9 9.49.4 17.317.3
AnthihelmithicsAnthihelmithics 00 33.333.3 17.917.9 1010
AntimalarialsAntimalarials 14.314.3 38.838.8 20.620.6 13.813.8
Anti-TBAnti-TB 3030 38.938.9 46.546.5 17.417.4
ElectrolytesElectrolytes 16.716.7 00 2525 00
Vitamins/MineralsVitamins/Minerals -- 00 36.736.7 2525
Failure Rate for Analgesics (%)Failure Rate for Analgesics (%)
0
10
20
30
40
50
60
70
80
1996-2001 2002-2003 2004-2005 2006-2007
Failure Rate for Antibiotics (%)Failure Rate for Antibiotics (%)
1996-2001 2002-2003 2004-2005 2006-2007
Failure Rate for Antimalarials (%)Failure Rate for Antimalarials (%)
0
5
10
15
20
25
30
35
40
45
50
1996-2001 2002-2003 2004-2005 2006-2007
Failure Rate for Antitubercular Failure Rate for Antitubercular DrugsDrugs
0
5
10
15
20
25
30
35
40
45
50
1996-2001 2002-2003 2004-2005 2006-2007
ObservationsObservations
•2001-2007: Quality of drugs has improved 2001-2007: Quality of drugs has improved •Failure rate slightly higher in imported Failure rate slightly higher in imported drugs drugs•Drugs of greatest concern by end 2007Drugs of greatest concern by end 2007
antibiotics (17.3%)antibiotics (17.3%)anthelmintics (10%)anthelmintics (10%)antituberculars. (17.4%)antituberculars. (17.4%)antimalarials, (13.8%)antimalarials, (13.8%)
Counterfeit MedicinesCounterfeit Medicines
YearYear Labeled APILabeled API Found Found APIAPI
OtherOther
ParameterParameterCommentsComments
20032003Zidovidine /Zidovidine /
Lamivudine Lamivudine Zidovidine Zidovidine --
--
20042004 Amoxycillin Amoxycillin trihydrate (RM) trihydrate (RM) NoneNone -- --
20062006AmoxilAmoxil 500 500 mg capsulesmg capsules
(Amoxycillin) (Amoxycillin)
AmoxycilliAmoxycillin n
PackagingPackaging
counterfeitecounterfeitedd
Product Product failed failed dissolution dissolution and assayand assay
Counterfeit MedicinesCounterfeit Medicines
YearYear Labeled APILabeled API Found Found APIAPI
OtherOther
ParameterParameterCommentsComments
2004 2004 Caffeine Caffeine None None -- --
20052005
PanadolPanadol tabletstablets
(Paracetamol)(Paracetamol)ParacetamParacetamolol
PackagingPackaging
counterfeitecounterfeitedd
--
2007 2007 Prednisolone Prednisolone tablets tablets None None
PackagingPackaging
CounterfeiteCounterfeited d
--
Counterfeit MedicinesCounterfeit Medicines
YearYear Labeled Labeled APIAPI Found APIFound API
OtherOther
ParameterParameterCommentsComments
2004 2004
SulphamethSulphametho-o-xypyrazine/xypyrazine/
PyrimethamiPyrimethamine ne
PyrimethamiPyrimethamine only ne only -- --
2007 2007
Duo-Duo-CotecxinCotecxin tabletstablets
(Dihydroarte(Dihydroarte-misinin/-misinin/
Piperaquine) Piperaquine)
Dihydroarte-Dihydroarte-misinin onlymisinin only
PackagingPackaging
counterfeitcounterfeiteded
--
2007 2007
MetakelfinMetakelfin tabletstablets
(Sulphameth(Sulphametho-o-xypyrazine/xypyrazine/
PyrimethamiPyrimethamine ne
PyrimethamiPyrimethamine only ne only
PackagingPackaging
counterfeitcounterfeiteded
Failed assay Failed assay and and dissolutiondissolution
PREDINSOLONE TABLETS PREDINSOLONE TABLETS COUNTERFEIT (NQCL)COUNTERFEIT (NQCL)
TWO PACKS WITH THE SAME BATCH TABLETS LOOK DIFFERENT
METAKELFINMETAKELFIN TABLETS TABLETS COUNTERFEIT (NQCL)COUNTERFEIT (NQCL)
Counterfeit
Genuine product
METAKELFINMETAKELFIN TABLETS TABLETS COUNTERFEIT (NQCL)COUNTERFEIT (NQCL)
Genuine product
Counterfeit
DUO-COTECXINDUO-COTECXIN TABLETS TABLETS COUNTERFEIT (DARU)COUNTERFEIT (DARU)
Counterfeit
product
Genuineproduct
DUO-COTECXINDUO-COTECXIN TABLETS TABLETS COUNTERFEIT (DARU)COUNTERFEIT (DARU)
New product bears the hologram ‘FACT’
DUO-COTECXINDUO-COTECXIN TABLETS TABLETS COUNTERFEIT (DARU)COUNTERFEIT (DARU)
Counterfeit
Genuine product
New genuine
pack
DOU-COTECXINDOU-COTECXIN TABLETS TABLETS COUNTERFEIT (DARU)COUNTERFEIT (DARU)
Counterfeit
Genuine product
New pack
DUO-COTECXINDUO-COTECXIN TABLETS TABLETS COUNTERFEIT (DARU)COUNTERFEIT (DARU)
Counterfeit
Genuine product
New pack
The Financial Standard, Tuesday The Financial Standard, Tuesday April 20,1999April 20,1999
The People Daily, Friday August The People Daily, Friday August 6, 20046, 2004
The Financial Standard The Financial Standard May 18,1999May 18,1999
Market SurveillanceMarket Surveillance
Market Surveillance ReportsMarket Surveillance Reports
YEARYEAR LABLAB CLASS OF CLASS OF DRUGSDRUGS
AREA AREA COVERECOVERE
DD
FAILURFAILURE RATEE RATE
20002000 DARUDARU SP productsSP products Nairobi Nairobi CityCity 70%70%
1992-1992-20002000 DARUDARU Ampicillin Ampicillin
productsproducts NairobiNairobi 20%20%
20022002 NQCLNQCL AntimalarialAntimalarialss
CountryCountry
widewide29%29%
20062006 NQCLNQCL AntimalarialAntimalarialss
CountryCountry
widewide12%12%
Market SurveillanceMarket Surveillance
Market surveillance is weak in KenyaMarket surveillance is weak in KenyaConcern for qualityConcern for qualityAvailability of substandard products Availability of substandard products in the in the marketmarketRegulatory authority needs to be Regulatory authority needs to be more more stringentstringent
ConclusionsConclusions
• Counterfeits harm health, results in Counterfeits harm health, results in economic losseconomic loss
• Meaningful surveillanceMeaningful surveillance– Strong DRA Strong DRA – Well equipped QC facilitiesWell equipped QC facilities– Comprehensive policies on handling and Comprehensive policies on handling and
distribution of drugsdistribution of drugs
ACKNOWLEDGEMENTSACKNOWLEDGEMENTS
VLIR: VLIR: EquipmentEquipment
Human resource developmentHuman resource development
Technology transferTechnology transfer
DARU: StaffDARU: Staff
NQCL: StaffNQCL: Staff
GoK, PPBGoK, PPB
Donors: GTZ, DANIDA, WHODonors: GTZ, DANIDA, WHO
ACKNOWLEDGEMENTSACKNOWLEDGEMENTS
NATIONAL QUALITY CONTROL LABORATORY (NQCL) STAFF
ACKNOWLEDGEMENTSACKNOWLEDGEMENTS
DRUG ANALYSIS AND RESEARCH UNIT (DARU) STAFF