Title: COUNTERFEITING OF DRUGS AND THE NECESSITY OF QC SYSTEMS IN DEVELOPING COUNTRIES: THE KENYAN EXPERIEN
1COUNTERFEITING OF DRUGS AND THE NECESSITY OF QC
SYSTEMS IN DEVELOPING COUNTRIES THE KENYAN
EXPERIENCE
By Isaac O. Kibwage
2- Authors
- G.N. Thoithi1, K.O. Abuga1, H.K. Chepkwony2 and
I. O. Kibwage - 1Department of Pharmaceutical Chemistry,
University of Nairobi, Kenya. - 2National Quality Control Laboratory (NQCL),
Nairobi, Kenya
3Quality 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
4Daily Nation, Monday May 2, 1988
PSK Symposium1988 Debate on quality of locally
produced medicines stopped by PSK chairman
5Kenya Times, Tuesday May 3, 1988
6Africa Health Market Letter, Vol. 6 No. 4, April
1992
VLIR, KUL UON Project for QC of drugs
7Sunday 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
8Sunday 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
9Specialties authorized for the Kenyan
market1982-2007
10Historical 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
11Sources of Drugs
- Central Medical Stores
- Government and Private Hospitals
- Pharmaceutical industry
- Pharmacy and Poisons Board
- Community Pharmacies
- Doctors, Dentists and patients
12Sources of Drugs
- Local Manufacturers
- Imported
- India
- China
- Israel
- Far East
- Western/ Eastern Europe
-
13Results for DARUPeriod 1980 - 2007
14Results for DARUPeriod 1980 - 2007
15Results for DARUPeriod 1980 - 2007
Therapeutic categories ( Failure)
16Results for DARUPeriod 1980 - 2007
17Failure Rate for Analgesics ()
18Failure Rate for Antibiotics ()
19Failure Rate for Antimalarial Drugs ()
20Failure Rate for Antitubercular Drugs ()
21Failure Rate for Skin Preparations ()
22Observations
- 2001-2007 Quality of drugs has improved
- Failure rate slightly higher in locally
manufactured drugs - Drugs of greatest concern
- 1980 1990 skin preps (?50 failure)
- nutritional preps (25-38)
- antibiotics (about 30).
- 1996-2007 antimalarials, especially S/P
(30)
23Possible Reasons for Improved Quality
- Improved technology globally
- Professional advice given to local industry
following failure of their products. - Investment in QC Labs
- More pharmacists in the industry
- Greater vigilance by the regulatory authority.
24Results for NQCLPeriod 1996 - 2007
25Results for NQCLPeriod 1996 - 2007
26Failure Rate for Analgesics ()
27Failure Rate for Antibiotics ()
28Failure Rate for Antimalarials ()
29Failure Rate for Antitubercular Drugs
30Observations
- 2001-2007 Quality of drugs has improved
- Failure rate slightly higher in imported
drugs - Drugs of greatest concern by end 2007
- antibiotics (17.3)
- anthelmintics (10)
- antituberculars. (17.4)
- antimalarials, (13.8)
31Counterfeit Medicines
32Counterfeit Medicines
33Counterfeit Medicines
34PREDINSOLONE TABLETS COUNTERFEIT (NQCL)
TWO PACKS WITH THE SAME BATCH TABLETS LOOK
DIFFERENT
35METAKELFIN? TABLETS COUNTERFEIT (NQCL)
Counter feit
Genuine product
36METAKELFIN? TABLETS COUNTERFEIT (NQCL)
Genuine product
Counter feit
37DUO-COTECXIN? TABLETS COUNTERFEIT (DARU)
Counterfeit product
Genuine product
38DUO-COTECXIN? TABLETS COUNTERFEIT (DARU)
New product bears the hologram FACT
39DUO-COTECXIN? TABLETS COUNTERFEIT (DARU)
Counterfeit
Genuine product
New genuine pack
40DOU-COTECXIN? TABLETS COUNTERFEIT (DARU)
Counterfeit
Genuine product
New pack
41DUO-COTECXIN? TABLETS COUNTERFEIT (DARU)
Counterfeit
Genuine product
New pack
42The Financial Standard, Tuesday April 20,1999
43The People Daily, Friday August 6, 2004
44The Financial Standard May 18,1999
45Market Surveillance
46Market Surveillance Reports
47Market Surveillance
- Market surveillance is weak in Kenya
- Concern for quality
- Availability of substandard products in the
market - Regulatory authority needs to be more stringent
48Conclusions
- Counterfeits harm health, results in economic
loss - Meaningful surveillance
- Strong DRA
- Well equipped QC facilities
- Comprehensive policies on handling and
distribution of drugs
49ACKNOWLEDGEMENTS
VLIR Equipment Human resource
development Technology transfer DARU
Staff NQCL Staff GoK, PPB Donors GTZ, DANIDA,
WHO
50ACKNOWLEDGEMENTS
NATIONAL QUALITY CONTROL LABORATORY (NQCL) STAFF
51ACKNOWLEDGEMENTS
DRUG ANALYSIS AND RESEARCH UNIT (DARU) STAFF