3-5a
Quality Control of Medicines and
Organization of Market Surveillance in Kenya
Dr. H. K. Chepkwony, PhD
Director, National Quality Control Laboratory (NQCL); Kenya
Interregional Seminar for Quality Control Laboratories involved in WHO Prequalification Programme and/or participating in
respective sampling and testing projects, Nairobi, Kenya, 23-25 September 2009
Outline
Quality Control of Medicines in Kenya
Pharmacy and Poisons Board (PPB)
National Quality Control Laboratory (NQCL)
Organization of Market Surveillance in Kenya
Conclusion
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Sampling and testing for Quality Control Laboratories, Nairobi, September 2009
Definition of Quality Control (QC)
Component of Quality Assurance concerned with:
 Sampling
 Specifications
 Testing
 Organization
 Documentation
 Release procedures
QC ensures that tests are performed before materials or products
are released for use. QC is not confined to laboratory
operations only.
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Why QC?
QC is crucial at every stage of the drug supply chain, including:
 Manufacturing
 Packaging
 Distribution
 Sale: Wholesale & Retail
 Drug use
(NB: Drug Supply Chain can either be legal or illegal!)
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Quality Control of Medicines in Kenya
Policy Formulation:
KNPP 1994,
MoMS
KNPP 2009 (Draft)
Dept. of Pharmacy
Drug Registration
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Quality Assurance
Procurement
Quality Control/
Testing
PPB
KEMSA
NQCL
Inspectorate
Pharmacovigilance
Sampling and testing for Quality Control Laboratories, Nairobi, September 2009
Quality Control of Medicines in Kenya (Cont’d)
 QA component of the new KNPP outlines four (4) primary
objectives, which include strengthening of national
institutions for:
 Medicines procurement,
 Supply,
 Regulation and
 Quality control
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Pharmacy and Poisons Board (PPB)

National Drug Regulatory Authority in Kenya. Established in
1957 Through an Act of Parliament; CAP. 244 Laws of Kenya

The PPB’s overall mandate is to regulate and control the
pharmaceutical sector.

Initially relied on services of other Govt. agencies (KEBS,
Govt Chemist) in evaluation of drug quality.
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PPB (Cont’d)

Drug registration department set up in 1982.

This Department contracted Drug Analysis & Research Unit
(DARU); School of Pharmacy; University of Nairobi to carry
out quality control of medicines.
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PPB (Cont’d)
Quality control of medicines overseen through the activities of:
1.Drug Registration Department
 Committee for Drug Registration (Human)
 Committee for Drug Registration (Vet.)
2.Inspectorate Department
 Drug Manufacturers: GMP/QA Inspections
 Retail & Wholesale Premises Inspections
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PPB (Cont’d)
3.Pharmacovigilance Department
 Focal Point for Complaints on Poor Quality of
Medicinal Products
 Investigates Complaints and Collects Medicinal
Products through Post-market Surveillance (PMS)
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National Quality Control Laboratory (NQCL): History
 1978:
Originally conceived and temporarily set up as Drug
Analysis & Research Unit (DARU), housed at the
then University of Nairobi, Faculty of Pharmacy
through facilitation of the Ministry of Health.
 1985:
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MoH decided to incorporate a specific quality
control laboratory as part of theNational Drug Policy.
Sampling and testing for Quality Control Laboratories, Nairobi, September 2009
NQCL History (Cont’d)
 1986:
A project study was carried out by the German
Government through GTZ on the establishment of
NQCL.
 1990:
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German Government agreed to assist in the
establishment of the NQCL.
Sampling and testing for Quality Control Laboratories, Nairobi, September 2009
NQCL History (Cont’d)
 1992:
The Government of Kenya through an Act of
Parliament; CAP 244 Section 35D (Pharmacy &
Poisons (Amendment) Act, 1992); established the
Laboratory as a legal entity.
 1993-1994:GTZ reached an agreement with the Kenyan
Government to renovate the facility and equip the
laboratory at its present location.
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NQCL History (Cont’d)
 1994-1999:
NQCL run jointly by GTZ and the Kenyan
Government.
 1999:
Full operation of the laboratory handed over
to the Kenyan Government.
 Mar 2005:
Initiated participation in newly established
WHO laboratory pre-qualification program.
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NQCL History (Cont’d)
 July 2008:
Attained WHO Pre-qualification status.
in the 8th Edition of the official WHO List of Prequalified Quality Control Laboratories.
 Listed
 Became
the first public institution in East, West and
Central Africa to be thus recognized.
 Currently pursuing ISO 17025 accreditation
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NQCL Mandate
1. Check quality of drugs & medicinal substances by
performing physical, chemical, biological and other
pharmaceutical evaluation of drugs and
substances in circulation within the country.
medicinal
2. Inform Government through the PPB of the results of such
tests so that appropriate action can be taken if products do
not comply with set specifications
effectiveness.
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for safety and
NQCL Mandate (cont’d)
3. To contribute to the overall Ministry of Medical Services’
mandate of “delivery of quality healthcare services to all
Kenyans”.
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NQCL Management
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
Administered by Board of Management (BoM) appointed
by Registrar, Pharmacy and Poisons Board.

Director, who is appointed by the BoM, is responsible for
overall day-to-day operations and performance of the
institution.
Sampling and testing for Quality Control Laboratories, Nairobi, September 2009
NQCL Work Force
Civil Servants (15):



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Contracted Staff (14):

Analytical Technicians (7)

Executive Secretary (1)
Pharmaceutical Technologists
(3)

Accounts Assistants (3)

Laboratory Assistants (2)
Driver (1).

Messenger (1).
Pharmacists (11)
Sampling and testing for Quality Control Laboratories, Nairobi, September 2009
NQCL Clients
Pharmacy and
Poisons Board
Government
Hospitals
NQCL
Private
Sector
Collaborations:
PQ Labs/ ISO cert.
Institutions
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Govt Agencies:
KEMSA,DOMC,
NLTP, NASCOP
NonGovernment
Agencies
NQCL Product Analysis: 2002 - 2009
Samples Received
Samples Received & Analysed : 2002 - 2009
Samples Analyzed
1000
870
779 765
Samples
750
500
250
544 523 546
490
413
625
580
565 561
486 462
379
212
0
2002
2003
2004
2005
2006
Year
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2007
2008
2009 (todate)
Detected Counterfeits in Kenya (cont’d)
Drug Analysis & Research Unit (DARU) Findings:
 Panadol Jnr tablets that contained Aspirin instead of
Paracetamol.
 Salbutamol tablets that contained no active ingredient.
 Metakelfin tablets containing Sulfamethoxypyridazine in place
of Sulfamethoxypyrazine
 Hydrocortisone ointment that contained a different ester of
Hydrocortisone than claimed on the label
 Andrew’s Liver Salt which contained NaHCO3 only.
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Sampling and testing for Quality Control Laboratories, Nairobi, September 2009
Detected Counterfeits in Kenya
(cont’d)
NQCL Findings:
 2003:
Zidovudine/ Lamivudine tablets that did not
contain Lamivudine
 2004:
Amoxicillin-Clavulanate tablets that did not contain
Clavulanate Potassium as claimed on the label.
Sulfamethoxypyrazine/Pyrimethamine tablets that
did not have Sulfamethoxypyrazine as labelled.
Bulk raw materials of Amoxicillin Trihydrate and
Ampicillin Trihydrate found to contain no active
ingredients.
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Detected Counterfeits in Kenya (cont’d)
NQCL Findings:
 2005:
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Paracetamol tablets whose packaging was
found to be fake. Tablets presented in a
container labeled ‘Panadol’. The label was
discovered to be a poor quality coloured copy
of the original. The tablets were found to be
circular instead of the normal caplet shape.
They were embossed other letters instead of
‘panadol’ as is the case with the original.
Sampling and testing for Quality Control Laboratories, Nairobi, September 2009
Detected Counterfeits in Kenya (cont’d)
NQCL Findings:
 2006:
Raw material of Caffeine was tested and found
not to contain any of the active ingredient.
Amoxicillin Trihydrate 500mg Capsules (‘Amoxil
500
capsule’) presented by multinational
manufacturer found to contain low levels of
Amoxicillin Trihydrate compared with the
genuine one. The package was not the genuine
one of the manufacturer, it contained
NAFDAC (Nigeria) registration number.04 -2481.
Source of sample: India.
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Detected Counterfeits in Kenya (cont’d)
NQCL Findings:
 2007:
against
the
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Dissolution profile for amoxicillin trihydrate
500 mg capsules for a local manufacturer
a market leader brand. It was found that
market leader brand contained low levels of
Amoxicillin Trihydrate. Its source was
questionable.
Sampling and testing for Quality Control Laboratories, Nairobi, September 2009
Detected Counterfeit in 2008
(Paracetamol & Caffeine Tablets) (Cont’d)
Genuine
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Counterfeit
Detected Counterfeit in 2008
(Paracetamol & Caffeine Tablets) (Cont’d)
Genuine
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Counterfeit
Sampling and testing for Quality Control Laboratories, Nairobi, September 2009
Detected Counterfeit in 2008
(Paracetamol & Caffeine Tablets) (Cont’d)
?
Genuine
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Counterfeit
Substandard Products

Poorly packaged and labeled products;

Products with poor physical characteristics e.g. Caking
suspensions, friable tablets, spilling capsule contents;

Products having inadequate quantity of active ingredients;

Products exhibiting poor dissolution/ bioavailability profiles.
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Impact of Counterfeit & Substandard Products

Therapeutic failure

Harmful ingredients

Erosion of public confidence in healthcare providers

Tarnishing of the reputation and financial standing of
manufacturer whose name is being fraudulently used
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Why Post-Market Surveillance (PMS) of Medicines?
 For drug registration purposes, comprehensive evaluation
of application samples is not always indicative of the
expected quality of the products once they’ve been granted
marketing authorization

Kenya’s Challenges: Illegal chemists, illegal importation of
medicines and hawking of medicines from chemist to
chemist by quacks.
 Quality of Medicines in the supply chain or market?
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Why Post-Market Surveillance (PMS) of
Medicines? (Cont’d)
 PMS ensures that, even after registration, drugs continue to
meet the required standards whilst in the market.
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Kenya’s Current Situation on PMS
 Surveys of medicines to evaluate:
 Range and availability,
 Registration status with PPB and
 Quality analysis
 Post distribution surveillance of KEMSA procured drugs
(2004)
 Antimalarials (baseline pre-ACT, QAMSA), ARV, Anti-TB
(2004-2009)
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Kenya’s Strategy on PMS in Future
 A National Pharmaceutical Quality Assurance Surveillance
Framework (NPQASF).
 Overall goal: To ensure quality medicines, medical supplies
and services are provided to the various stakeholders
according to legal requirements and professional standards,
through a system of monitoring and evaluation directed and
implemented the office of the PS, MoMS.
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NPQASF Specific Objectives
 To provide strategic direction for pharmaceutical quality
assurance in the Kenyan market.
 To co-ordinate, monitor and evaluate the implementation of
pharmaceutical quality assurance activities.
 To ensure that the institutions involved in pharmaceutical
quality assurance provide the outputs of their activities for
dissemination to relevant institutions and stakeholders.
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Elements of the NPQASF
ELEMENTS OF THE
FRAMEWORK
KEY FOCUS AREAS
LEGAL FOUNDATION
Relevant/related Acts of Parliament, policies,
guidelines, enforcement, licensing
PHARMACEUTICAL
PRODUCTS
Manufacture, importation, registration and reregistration, procurement, distribution, storage, market
surveillance, disposal, clinical trials, dispensing (OTC
& POM)
PHARMACEUTICAL
SERVICES
Licensing, professional practice and ethics,
consumption, dispensing (OTC & POM)
OVERSIGHT
Measurement, QA system, monitoring and evaluation,
feedback.
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Conclusion
 The Drug Regulatory Body (i.e., PPB) and Procuring Entity (KEMSA)
collaborates well with the NQCL on Quality Control of Medicines.
 Intensifying Public Awareness on the role of NQCL, taking profit of the
WHO Pre-qualification status.
 The NPQASF will form a strong foundation upon which to launch a
sustainable post market surveillance program that would give an indication
of quality of pharmaceutical products available to the public.
 Enhance Collaboration between Pre-qualified QCLs and National Drug
Regulatory Authorities.
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