Yearbook

2012
Federation of East African
Pharmaceutical Manufacturers (FEAPM)
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 Yearbook
2012
Federation of East African
Pharmaceutical Manufacturers (FEAPM)
 Table of Contents

Acknowledgements 5

Message from the Board of Directors 6

FEAPM Annual Report  7

WTO-TRIPS Public Health Related Flexibilities:

Opportunities for Pharmaceutical Manufacturers in the East African Community 13

FEAPM Position Paper 16

The East African Community Regional Pharmaceutical Manufacturing

Plan of Action: Strengthening Local Production of Medicines 18

The East African Community Medicines Regulatory Harmonisation Project  20

The Role of Medicines Regulatory Authorities in Promoting Local

Pharmaceutical Manufacturing in East Africa 23

Overview of the World Health Organisation Prequalification of Medicines Program 28

German Development Cooperation to Foster Local Pharmaceutical

Production by Utilising WTO-TRIPS-Flexibilities  32

Quality Infrastructure for the Pharmaceutical Sector in the East African Community 33

A Regional Bioequivalence Center in Eastern Africa 38

Education and Training for the East African Pharmaceutical Sector  42

Investment Promotion Centres in the East African Community  59

The Pharmaceutical Distribution Landscape in the East Africa Community 66

4
Acknowledgements

We extend our gratitude to BMZ/GIZ for sponsoring the production of this FEAPM Yearbook 2012. We
thank the EAC/GIZ TRIPS and Pharmaceutical Sector Promotion project and look forward to working
with the EAC/GIZ program Support to the EAC Integration Process in its next phase (2013-2016).

We are grateful to all other cooperation partners of the EAC Secretariat and the EAC Partner States
who have been involved in various projects in support of the regions pharmaceutical industry: UNI-
DO, UNCTAD, WTO, WHO, WB, BMGF, GCC, NEPAD, GOPA, London School of Hygiene and Trop-
ical Medicine, ANDI, South Centre, EANNASO, EACSOF, SEATINI, HAI Africa, EAC, EAHF, Action
Medeor.

Our thanks go out to all authors who have contributed to this yearbook:
Wesley Ronoh, Michelle Maunga, Mboi Evans Misati, Rainer Engels, Frank Schmiedchen, Moses Mu-
lumba, Kathryn Boateng, Nazeem Mohamed, Dhirendra Shah, Sillo Hiiti, Dominik Berger, Kiumbura
Githinji, Lynda Waka, Tobias Diergardt, Thomas Walter, Kay Weyer, Roland Kaestner, Kaale Elian-
girira and special thanks to Max Walter for his contribution to various sections of this Yearbook and
for his persistence and professional editing of the entire document.

We thank journalists Zephania Ubwani, Moses Walugembe Tusubira, Fiona Mbabazi, Havyarimana
Musa for their input and especially George Omondi for his contribution on Kenya and his editing
work of all the journalists contributions.

Last but not least, we are grateful to MEDIA DESIGN for their creative layout design and coordination
of the printing.

Federation of East African Pharmaceutical Manufacturers (FEAPM) | Yearbook 2012 5

 Message from the Board of Directors
It gives us great pleasure to introduce to you
our first Federation of East African Pharmaceu-
tical Manufacturers (FEAPM) Yearbook. We are
pleased to report a number of milestones the
federation has achieved since its formal launch
in December 2011. The first accomplishment of
the Board of Directors was the setting up of a
secretariat at the East African Business Council
(EABC). The federation now has a dedicated
member of staff with other critical support ser-
vices being provided through the EABC.
FEAPM has since worked closely with its part-
ners to increase visibility and provide value-
adding services to the membership. An inter-
active website, www.feapm.com, was set up in
order to strengthen the Federations online pres-
ence and to provide an effective platform for in-
formation exchange with all stakeholders. The
website is currently being improved to better
deliver the online services. To complement this,
the Federation collaborated with GIZ, UNC-
TAD and UNIDO to establish a virtual platform,
www.local-pharma-production.net, an informa-
tion and communication hub on local pharma-
ceutical production in Africa.
In the area of service provision to members, a
number of successes were achieved during the
year. The Federation held its inaugural Annual
General Meeting (AGM), in which the Board of
Directors was appointed. The meeting also iden-
tified priority intervention areas for the regional
pharmaceutical manufacturing sector for ad-
vocacy and lobby efforts. A number of FEAPM
position papers have since been developed. We
are pleased to note that one such paper, which
proposes the adoption of proven interventions
from Ghana to strengthen self-reliant, sustain-
able local production of essential medicines in
East Africa, is reproduced in this yearbook.
At the Federations third Stakeholder Meeting in
December 2011, the EAC Regional Pharmaceu-
tical Manufacturing Plan of Action (RPMPOA)
2012-16 was launched after it had been drafted
and validated by various stakeholders. An EAC-
RPMPOA Steering Committee was established
6
to take responsibility for the implementation of
the plan, which shall guide the EAC in fostering
an effective and internationally competitive re-
gional pharmaceutical manufacturing industry.
Beyond this, the Federation has been a contrib-
uting participant in relevant regional, pan-Afri-
can and international meetings as well as being
actively involved in the establishment of the
Federation of African Pharmaceutical Manufac-
turers Associations (FAPMA) and the Pharma-
ceutical Manufacturing Plan of Africa. Finally,
FEAPM members are benefiting from training
on Good Manufacturing Practices (GMP) in
collaboration with GIZ, such as a workshop on
GMP audit and self-inspection carried out by
Action Medeor in Arusha in October 2012.
We therefore note with satisfaction that the fed-
eration is growing in vibrancy and delivering
on its mission to provide valuable member-
ship services and become a key stakeholder in
the pharmaceutical sector in Africa and globally.
Looking ahead, we are confident that FEAPM
will continue to play its rightful role in influ-
encing regional and national policies towards
creating an enabling and globally competitive
environment for local pharmaceutical manu-
facturers, with the ultimate goal of increasing
access to quality and affordable medicines for
the people of our region. At a broader level, the
Federation will continue working with other
stakeholders in the region to promote a fully
functional customs union and common market
for the benefit of all.
As we conclude, we particularly wish to thank
members for making their contributions through
the subscription fee, and urge them to maintain
this cooperation so that the Federation may sus-
tainably deliver on its mandate. We also express
our sincerest gratitude to the EAC-GIZ Pharma-
ceutical Sector Promotion Project, UNIDO and
EABC for their continued support.
Chairman: Ramadhan R. Madabida
Director: Dr. Dhirendra Shah
Director: Nazeem Mohamed
 FEAPM Annual Report

About the Federation

The Federation of East African Pharmaceutical Burundi:

Manufacturers (FEAPM) was established and 1. Siphar S.A.
incorporated as a Company Limited by Guaran- Kenya:
tee in Arusha, Tanzania on 11th November 2011. 2. Aesthetics Limited
This move was necessitated by the need for local 3. Biodeal Laboratory Ltd
pharmaceutical manufacturers within the region 4. Beta Healthcare International Limited
to have their interests represented at the 5. Cosmos Limited
East African Community 6. Dawa Limited
(EAC) level. During 7. Elys Chemical Industries Limited
FEAPM VISION this first year in op- 8. GlaxoSmithKline
To develop the East African eration, FEAPM has 9. Laboratory & Allied Ltd
region as the principal made great strides 10. Medivet Products Limited
towards achieving its 11. Nerix Pharma Limited
manufacturing source of
mandate as the voice 12. Norbrook Kenya
world-class medicines for of local pharmaceuti- 13. Novelty Manufacturing Limited
Africa cal manufacturers in 14. Oss-Chemie (K) Ltd
the EAC region. From 15. Pharmaceutical Manufacturing
providing advocacy and Company Ltd
training to resource mo- 16. PharmQ Limited
bili- sation, FEAPM continues 17. Regal Pharmaceuticals Ltd
to actively promote the interests of its members. 18. Skylight Chemicals Limited
FEAPMs mission is to strengthen local produc- 19. Universal Corporation Ltd
tion capacity to meet at least 50% of the EACs Rwanda:
demand for affordable, quality medicines by the 20. Rwanda Biomedical Center, Medical Pro-
year 2020 through: duction Unit (former LBOPHAR)
Tanzania:
n World-class production facilities 21. Keko Pharmaceutical Industries (1997) Ltd
n Utilisation of WTO-TRIPS flexibilities 22. Mansoor Daya Chemicals Ltd
n Technical personnel training and skills 23. Tanzania Pharmaceutical Industries (TPI)
enhancement Limited
n An enabling operating environment 24. Zenufa Laboratories (T) Limited
n Incentivising of domestic pharmaceutical Uganda:
production 25. Abacus Parental Drugs Limited
n Promotion of local research and develop- 26. Kampala Pharmaceutical Industries (1996)
ment Ltd
n Facilitation of information sharing and 27. Kwality Afro Asia Limited
transparency 28. Medipharm Industries (E.A.) Limited
29. Quality Chemical Industries Ltd
Membership 30. Rene Industries Limited

The founding members of FEAPM are: the Fed-

eration of Kenya Pharmaceutical Manufacturers
(FKPM), the Tanzania Pharmaceutical Manu- MISSION
facturers Association (TPMA) and the Uganda To be a vibrant and self-sustaining
Pharmaceutical Manufacturers Association pharmaceutical manufacturing
(UPMA). These federations represent a total of industry in Africa by providing
30 manufacturers in the three countries. In to-
tal, FEAPM now has 18 members from Kenya,
quality and affordable medicines
6 from Uganda, 4 from Tanzania and one each so as to contribute to the
from Burundi and Rwanda. reduction of disease burden and
promote economic development
of the continent

Federation of East African Pharmaceutical Manufacturers (FEAPM) | Yearbook 2012 7

 Overview of 2012
Having established an active company by the
end of 2011, FEAPM was ready to take up its
mandate. The following are the major activities
that the Federation undertook in 2012:
Development of FEAPM communication and
networking tools
In order to facilitate fast and effective communi-
cation between the Federation Secretariat, mem-
bers and the outside world, it was necessary to
develop some formal tools of communication.
The Federation thus came up with an official
website which provides members with informa-
tion regarding its activities. An informative bro-
chure highlighting FEAPMs mandate and scope
of operation was also designed, printed and dis-
seminated.
Advocacy
From the outset, FEAPM has endeavoured to
raise awareness of the issues affecting its mem-
bers and lobby for plausible and opportune in-
terventions to address their challenges. To this
end, FEAPM sought representation in various
forums in which pharmaceutical industry chal-
lenges were discussed. One of FEAPMs direc-
tors, Mr. Nazeem Mohammed, attended the
European Generic Medicines Association 2012
Conference in Malta. He was able to project the
challenges of local pharmaceutical manufactur-
ers in East Africa as well as lobbying for inves-
tors within the European Union to support local
manufacturing activities in the East Africa.
Additionally, FEAPM participated in the EAC
Secretary General Forum with Private Sector
and EAC Civil Society Organisations held in De-
cember 2012 in Dar es Salaam. This platform was
used by FEAPM under the auspices of the East
Africa Health Forum to raise the following four
key issues affecting local pharmaceutical manu-
facturers:
1. Fast-tracking implementation of EAC Com-
mon Market Protocol to facilitate cross bor-
der establishment of East African pharma-
ceutical industries
2. Fast-tracking of regional harmonisation of
drug registration and regulation procedures
and guidelines
3. Provision of enabling environment for lo-
cal manufacturers by governments of EAC
member countries, e.g. zero-rating of phar-
maceutical manufacturing inputs and spare
parts
8
4. The Forum also advocated for the imple-
mentation and utilisation of TRIPS within
the region
FEAPM was also involved in the constitution
drafting process and launch of FAPMA (Federa-
tion of African Pharmaceutical Manufacturers
Associations). This was a huge milestone for the
Federation with regard to future networking
and advocacy opportunities considering the fact
that FAPMA is now the Pan-African pharmaceu-
ticals manufacturers body.
Through its members and directors, the Federa-
tion has produced its first major position paper.
The paper draws inspiration from the policies
adopted by Ghana to deal with counterfeit phar-
maceutical products and foster growth for the
local pharmaceutical manufacturing companies
in the country. Referred to as Learning from
the Ghana Model, this paper provides specific
legislation on import control, procurement and
taxation implemented in Ghana to curb sub-
standard pharmaceutical products and support
local manufacturers. Such legislations included
tax abolitions on raw materials and quotas on
certain imports. The paper further ties these leg-
islative and policy changes to the tremendous
expansion of Ghanas pharmaceutical indus-
try and provides statistical evidence. Using the
Ghana experience, the Federation has developed
the East African Model for supporting local
pharmaceutical manufacturers, addressing price
preferences, tax incentives and import classifica-
tions among other issues affecting local manu-
facturers within EAC Partner States.
FAPMA VISION
To facilitate collaboration
between regional pharmaceutical
manufacturing associations to address
the common challenges faced by the
industry and enhance opportunities
towards self-sufficiency. This will
be achieved through advocacy and
partnership with other stakeholders in
promoting the production of quality,
affordable medicines
 FEAPM plans to develop more papers in the
coming year to ensure that the issues affecting
the industry are well articulated and commu-
nicated to the policy makers within the region.
FEAPM also intends to carry out more advocacy
activities in 2013.
Establishment of the
East African Health Forum
The East African Business Council (EABC) and
the East Africa Civil Society Organisations Fo-
rum (EACSOF), the regional apex associations
for the private sector and civil society, initiated
the establishment of the EAC Regional Health
Forum in order to promote and facilitate the
management of health delivery systems and bet-
ter planning mechanisms that will enhance the
efficiency of healthcare services within the EAC
Partner States. FEAPM and the East African
Health Federation were the constituents under
EABC that helped to establish this forum on 27th
March 2013. It is expected to provide an instru-
mental platform for advocacy and policy influ-
encing in the overall EAC health sector, pharma-
ceuticals included.
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FEAPM AGM
The FEAPM Secretariats activities have been
closely guided and monitored by the directors,
members and sponsors. On 20th April 2012, the
Federation successfully held its first Annual
General Meeting (AGM). During this forum,
members elected into office the new Chairper-
son of the Federation, Mr. Ramadhan Madabida,
and other officials. Moreover, they were present-
ed with the FEAPM business plan, activities and
budget. Finally, directors and auditors were ap-
pointed and reporting guidelines for the Federa-
tion were agreed upon.
In addition, the Federation held an extraordi-
nary AGM on 1st November 2012. During this
meeting, the members discussed the financial
status of the Federation, including the remit-
tance of membership subscription fees. Mem-
bers also adopted the position paper The East
African Model.
Participation in Conferences
In 2012, FEAPM sponsored one of its directors,
Mr. Nazeem Mohammed, to attend the Europe-
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 an Generic Medicines Association Conference.
The Federation also participated in the Nairobi
Pharma Expo to create awareness of its activi-
ties.
In addition, the Federation was represented in
the Federation of African Pharmaceutical Manu-
facturers Associations (FAPMA) meeting held in
First, a scoping study was administered within
the five EAC Partner States between March and
April. The surveys main objectives were:
n  o identify key pharmaceutical sector stake-
T
holders (existing and potential) in each EAC
Partner State;
n To identify key issues of concern to the vari-

Ghana, at which the FAPMA constitution was
critiqued, reviewed and redrafted.
In 2013, the Federation is set to offer extensive
training programs to promote competence
among members on Good Manufacturing Prac-
tices (GMP) and other critical elements of phar-
maceutical manufacturing. The first of these,
the WHO-GMP Prequalification training, has
already been successfully completed in three
phases in January, February and March 2013 re-
spectively.
ous stakeholder categories, especially manu-
facturers, distributors and importers; and
n To generate recommendations on the strate-
gic and operational orientation of the EAC
Pharmaceutical Platform.
A report from this scoping study was presented
to stakeholders within the pharmaceutical in-
dustry in May 2012, which eventually led to the
formation of the Pharmaceutical Platform that
later evolved into the East African Health Plat-
form.

During the first half of 2013, FEAPM also in- www.local-pharma-production.net

tends to carry out training on Public Health
Trade Related Aspects of Intellectual Property
Rights (TRIPS) with a particular focus on how
the local industry could use these to promote
joint ventures and technology transfer. Support
for this training has already been secured with
the assistance of GIZ.

Resource mobilisation
FEAPM would not have been able to undertake
all of its 2012 activities without the support of its
partners. In particular, GIZs TRIPS and Phar-
maceutical Sector Promotion project sponsored
all FEAPM meetings, supported the acquisition
of office space and financed EABCs administra-
tive intern. The trainings as well as the FEAPM
Yearbook have also been supported by the GIZ
project. During the AGM, it was decided that
FEAPM would carry out lobbying and advocacy
activities to obtain more funds from diversified
sources. FEAPM already succeeded to secure
additional funding from UNIDO for the next
two years, mainly for capacity building activi-
ties. The process of resource mobilisation is nev-
ertheless on-going and the Federation hopes to
partner with more donors as well as engaging
in innovative fundraising activities in the com-
ing year, including the development of valuable
fees based services in order to generate income
beyond membership fees.

Industry Surveys

FEAPM has been able to collect, collate and dis-

seminate valuable information to its members.
Two major surveys were carried out in 2012.

10
The pharmaceutical sectors of East Africa are
characterised by a wide range of different actors
operating in different environments and under
varying circumstances in regulation, infrastruc-
ture and market determinants. This diversity
demonstrates the liveliness of the industry and
the determination of the private sector in the re-
gion. At the same time, however, it poses a chal-
lenge for companies or organisations not yet en-
gaged in the sector, as a comprehensive overview
is not easily obtained.
This problem was identified at the International
Conference on Local Pharmaceutical Manufac-
turing in Cape Town, South Africa, in early 2011.
To overcome this inefficiency, it was decided by
a broad range of stakeholders, including the re-
gional associations, representatives of the private
sector, supporting organisations and government
representatives, to create a central information
hub serving as a marketing and information tool.
Federation of East African Pharmaceutical Manufacturers (FEAPM) | Yearbook 2012
This was to include a section in which companies
and organisations can present themselves.
The German Government, in partnership with
UNIDO and UNCTAD, developed an internet
platform which offers a wide variety of informa-
tion, especially on Intellectual Property Rights
(IPR) and the flexibilities for Least Developed
Countries (LDCs) granted in the Trade Related
Aspects of Intellectual Property Rights Agree-
ment (TRIPS) of the World Trade Organisation
(WTO). It was developed in close cooperation
with NGOs, the regional associations and other
stakeholders, incorporating their ideas and sug-
gestions. The website has been online since De-
cember 2011.
One of the main aims of the platform is to create a
knowledge hub for all stakeholders in the region-
al production of pharmaceuticals. Companies are
given the opportunity to present themselves on
the website, so that interested investors, buyers
and supporting organisations can quickly attain
an overview of the sector and its actors, obtain a
basic impression of the economic activities and
use the provided contact information to liaise di-
rectly with the companies.
Presently, the platform is being administered and
further developed by the Deutsche Gesellschaft
fr Internationale Zusammenarbeit (GIZ) GmbH.
The ownership and responsibility, which cur-
rently lies with the BMZ, UNIDO and UNCTAD,
will be transferred to the regional associations in
the medium-term and to the Federation of Afri-
can Pharmaceutical Manufacturers Associations
in the long-term.
Due to the outstanding determination of the pri-
vate sector in East Africa as well as important re-
gional achievements such as the approval of the
East African Community Regional Pharmaceu-
tical Manufacturing Plan of Action (EAC-RPM-
POA), it was jointly decided to select FEAPM as
the major cooperation partner in this project. To
involve the individual companies, the Federation
assigned them the mission to create awareness of
the platform and its potential benefits, evaluate
its value for the industry and collect suggestions
for its further development.
Following this, the representatives of these com-
panies further emphasised the need for a joint
information and representation platform con-
necting the different actors in the industry. Sug-
gestions to improve the website were collected
and have either been applied or are currently in
the process of being implemented.
11
 In August 2012, FEAPM visited all member companies and trained them on using and maintaining
this portal. Members were supported to upload company profiles with information such as company
investments, product lines, capacity and sales. This has created a hub of easily accessible information
on the regional sector. So far 17 FEAPM members have uploaded their profiles.

Challenges

Funding is the major impediment to FEAPM activities and only one donor, GIZ, has been actively in-
volved in supporting FEAPM start-up and operational activities. Additionally, not all members have
remitted their annual subscriptions. Without adequate funding, the Federations future is at stake. It is
imperative that FEAPM finds supplementary funding to implement its activities and grow to greater
heights.

The FEAPM Secretariat is currently understaffed as it lacks the financial capacity to hire more work-
ers. To date, the Federation has employed only one person who facilitates all of its activities. The Fed-
eration shall need to expand well beyond the current funding and staffing levels in order to deliver
optimal services to members.

Although the Federation aspires to be the leading voice of pharmaceutical manufacturers in the East
African region, effective formal engagement with the EAC Secretariat and national governments is a
challenge. This is mainly due to existing mistrust between the public and private sector organisations
in the region. However, this is likely to change for the better as the regional and national governments
embrace public-private partnerships in the promotion of socio-economic development. It is hoped that
the recently approved EAC institutionalised dialogue framework for the private sector and civil soci-
ety organisations in the regional integration process, as well as the SG Forums, will provide the neces-
sary platforms for FEAPM to advance its advocacy agenda. Finally, shortcomings in the implementa-
tion of EAC Council decisions and agreed regional strategies continue to hamper the full exploitation
of the EAC Common Market opportunities for the benefit of all.

Financial Report 2012

FEAPM Fund Accountability Statement

January December 2012

Income US$
a) Membership Subsciptions (FKPM) 5.965,00
Membership Subsciptions (UPMA) 2.997,00
b) GIZ Support 36.456,42
Total Income 45.418,42

Expenditure
a) Salary and Allowances 10.750,00
b) Operating Costs
Retainer Fee 1.000,00
Office Renting 6.000,00
Traveling Costs 12.868,81
Postal 45,00
Capacity Building FEAPM Staff 1.080,00
Membership at EABC 1.000,00
Promotional Material 2.500,00
Annual General Meetings 5.950,00
Web Transfer and Hosting 118,00
Bank Charges 40,00
Total Expenditure 41.351,81
Fund Surplus for the Period 4.066,61

12
WTO-TRIPS Public Health Related Flexibilities: Opportunities for
Pharmaceutical Manufacturers in the East African Community
With over 40 pharmaceutical manufacturers
(PMs) operating in the East African Community
(EAC) Partner States (PSs), it is evident that the
EAC has sufficient local pharmaceutical manu-
facturing capacity. The EAC and PSs have put
in place strategic interventions to support this
capacity with the overall aim of pursuing their
economic and social policies, including availing
efficacious and affordable essential medicines
to their populations. The EAC Regional Phar-
maceutical Manufacturing Plan of Action: 2012-
2016 (RPMPOA) is one such intervention. With
the objective of developing a regional roadmap
to guide the EAC towards evolving an efficient
and effective regional pharmaceutical manu-
facturing industry that can supply national, re-
gional and international markets with quality
medicines, the RPMPOA envisages six specific
objectives, including the utilisation of public
health-related flexibilities in the World Trade
Organization Agreement on Trade Related as-
pects of Intellectual Property Rights (WTO-
TRIPS).
Three strategic action plans are foreseen under
the said specific objective: sensitisation at both
EAC regional and PS levels; adoption of the re-
gional policy framework and guidelines; and
domestication by PSs. All of these action plans
are currently being implemented. The EAC Re-
gional Intellectual Property Policy on the Uti-
lisation of Public Health-Related WTO-TRIPS
Flexibilities and the Approximation of National
Intellectual Property Legislation (EAC TRIPS
Policy) is in place. The EAC TRIPS Policy guides
Partner States on how their national intellectual
property legislation must be adjusted in order
to enable them to fully utilise the Public Health-
related Flexibilities of WTO-TRIPS (herein after
the PHF).
This article highlights some opportunities pre-
sented by the PHF in the facilitation of pharma-
ceutical research and development, technology
transfer and local production. It is not exhaus-
tive but hopes to encourage EAC PMs that oper-
ate in PSs availing themselves of the PHF to take
advantage of these opportunities to advance the
EAC agenda.
Federation of East African Pharmaceutical Manufacturers (FEAPM) | Yearbook 2012
WTO-TRIPS Public Health
Related Flexibilities (PHF)
In safeguarding its objectives and principles,
WTO-TRIPS, on one part, contains special pro-
visions obligating WTO-Members to observe
the set minimum standards for the protection of
intellectual property rights (IPRs). On the sec-
ond part, it also contains provisions that allow
Members to deviate from observing the set mini-
mum standards. On the third part, it does not
expressly address some well-known principles
of IPRs, thereby giving Members the freedom to
deal with these as they deem appropriate. The
second and third category provisions accord
Members flexibilities in the implementation of
WTO-TRIPS. The PHF are those flexibilities that
allow Members to address their national public
health concerns. The PHF have been reiterated
in various instruments relating to the WTO-
TRIPS including the Doha Declaration.
The PHF are mainly associated with the patent
regime, since they happen to have more impact
on access to public health products than on any
other aspect of IPRs. They include flexibilities
related to transitional periods; patentability cri-
teria; exclusion from patentability; marketing
approval; test data protection; patent disclosure;
administrative patent opposition procedures;
parallel importation; compulsory licensing; and
anti-competitive practices and patents abuse.
Domestication into National Patent Laws
A WTO-Member that wishes to benefit from the
PHF must domesticate them into its national
law. Virtually all EAC PSs had patent regimes
long before WTO-TRIPS. Some of the PSs have
since reviewed their patent laws to accommo-
date changes in the national and international
scenes, including WTO-TRIPS. Consequently,
the availability of PHF varies amongst the PSs
see e.g. table below. The EAC-TRIPS thus aims
to ensure that every PS fully domesticates the
WTO-TRIPS PHF so as to maximise their impact.
13
 Table 1: Summary of the domestication of some PHF in patent laws of PSs as of 2009.
(Tanzania is separated into Mainland and Zanzibar since both have their own separate patent laws.)

Burundi Kenya Rwanda Tanzania- Tanzania- Uganda

Mainland Zanzibar
2016 Window Yes N/A Yes No Yes Yes
+Mailbox + Mailbox
Disclosure Yes Yes Yes Yes Yes Yes
(One Mode) (One Mode) (Best Mode) (Best Mode) (Best Mode) (One Mode)
Research Yes Not clear Yes Not clear Yes Yes
Exception
Bolar Yes Not clear Yes Not clear Yes Yes
Exception
Compulsory Yes Yes Yes Yes Yes Yes
Licensing (Not Fully) (Not Fully) (Not Fully) (Not Fully) (Not Fully) (Not Fully)
Data Yes No No No Yes No
Protection (Not Fully) (Not Fully)

The sections that follow highlight some PHF and
the opportunities they present under the area of
the pharmaceutical sector that they have the most
impact on.
Facilitating Research & Development
the PSs. The generic manufacturer therefore
does not have to undertake separate clinical
trials (and other market approval preparato-
ry activities), present its own dossier, or pay
any compensation to the innovator manu-
facturer.

(a) D
 isclosure Requirements: Pharmaceutical
patents contain information fully disclosing
new pharmaceutical technologies (processes
and products). It is estimated that 30% of all
expenditure incurred in developing new
technical processes and products could be
saved if information contained in patent
documents was utilised. The PMs have an
opportunity to readily access, preferably via
their PSs patent offices, information from
countless pharmaceutical patents available
in patent offices worldwide, and use them
for further R&D, avoiding research dupli-
cation and thereby saving money. This will
enhance local innovation and production in
the pharmaceutical sector.
(b) R
 esearch Exemption: Accords Members
the flexibility of using patented inventions
for purposes of research. PMs thus have the
opportunity to use patented pharmaceuti-
cal technologies to advance R&D activities
without infringing on any patent rights.
(c) T
 est Data Protection: This also applies
where innovator drugs already have market
approval in a PS. The PMs have an oppor-
tunity to manufacture generics and rely on
test data of innovator drugs for the market-
ing approval of the respective generics in
(d) Marketing Approval (Bolar Exception): Al-
lows PMs who wish to manufacture gener-
ics after the expiry of patented pharmaceu-
ticals to embark on R&D activities related
to marketing approval without infringing
on patent rights. This is to facilitate earlier
entry of the generics into the market imme-
diately upon patent expiry.
Encouraging Technology Transfer
(a) Transitional Periods: PMs may access pat-
ented pharmaceutical technologies in any
part of the world, preferably via patent of-
fices, and utilise them to manufacture gener-
ics without infringing on the patents and/or
without paying any loyalties to the patent
right holder, since patents are not enforce-
able in the respective LDC PSs.
(b) Voluntary Licensing: Avails an opportunity
for the PMs to freely approach owners of
patented pharmaceutical technologies for
appropriate voluntary licenses to manufac-
ture generics under terms and conditions
stipulated in the license, as agreed by both
parties.

14
 (c) C
 ompulsory licensing: Allows PMs who fail
to acquire a voluntary license at reasonable
terms and conditions to access the patented
pharmaceutical technologies in any part of
the world and subsequently utilise them to
manufacture generics under terms and con-
ditions determined by the PSs authorities
issuing the compulsory license.
Enabling Local Pharmaceutical
Manufacturing Capacity
Virtually all the PHF discussed in sections 4 and 5
above present opportunities for EAC PMs to en-
hance their local manufacturing capacities in PSs
that avail themselves of those flexibilities. In addi-
tion, the utilisation of non-patented pharmaceuti-
cal technologies and products also facilitates local
manufacturing capacity. There are many drugs
and other pharmaceutical products that are off
patent in PSs. This is because either the patent
protection was not sought in a PS, or a patent has
expired. For either case, it means that the respec-
tive technology can be utilised in the PS without
infringing upon the right of any patent holder
anywhere in the world. Thus, no royalties or li-
Federation of East African Pharmaceutical Manufacturers (FEAPM) | Yearbook 2012
censing is involved since un-patented technolo-
gies are free-for-all technologies. Pharmaceutical
products manufactured in the PS through this
method may be exported to other PSs or countries
where the respective product is also off patent, or
that allows an appropriate parallel importation.
Information regarding such technologies or prod-
ucts may be obtained from the PSs patent offices.
Conclusion
There is sufficient local pharmaceutical manu-
facturing capacity, supported by strategic inter-
ventions, to provide accessible, efficacious and
affordable essential medicines to the populations
of the EAC region as well as achieving regional
industrial and economic policy objectives for the
pharmaceutical sector. The onus is on the regions
pharmaceutical manufacturers to take advantage
of the opportunities presented by such interven-
tions, in particular the WTO-TRIPS public health
related flexibilities, to advance their own produc-
tion and competiveness and thereby contribute
to the realisation of the EAC development objec-
tives.
15
 FEAPM Position Paper

FEAPM Position Paper

Proposed Model for the Growth of the East African Pharmaceutical Manufacturing Sector

Support for Local Pharmaceutical Manufacturing

Proposed Model for the Growth of the East African Pharmaceutical Manufacturing Sector

Background
This Model is based on the Government of
Ghanas interventions in supporting its local
pharmaceutical manufacturers. The Ghana
Model has proven to be successful in
developing a very healthy local industry
which has reduced the reliance on imports
and the prevalence of counterfeit products in
the market.
In the mid 1980s the Ministry of Health in
Ghana was very concerned about the
proliferation of counterfeit and sub-standard
medicines in the country. Their research
indicated that these types of medicines were
mostly imported into the country. Concurrent-
ly, there was pressure on the Government to
support local production of essential drugs
which was in a nascent stage at that time.
The Government set about developing a
policy to address the above issues.
1. Eliminate or reduce the high level of sub-
standard and counterfeit medicines on the
market in Ghana;
2. Grow the local pharmaceutical manu-
facturing industry and thus reduce the
reliance on imports.
Key Features of the Policy
Price Preference
A preferencial margin of 20% for all locally
produced medicines and medical devices in
national tenders
Tax Incentives
No duties on imports of raw and packing
material, pharmaceutical manufacturing related
equipment as well as spare parts for this
equipment

The Policy Import Classification

In 1989, the Government introduced a policy,
the so called Ghana Model, in order to
achieve the following:
Classification of medicines according to the
table which shows different approaches to
banning and/or taxing the import of medicines

Import Classification Ghana Model

Category Feature

Finished product imports List of finished products that are NOT allowed to be imported, initial list included 14
banned products. These were products manufactured by more than one local company with the
right quality and in quantities necessary.

Finished product imports A large list of finished products which could be imported but the following taxes need to be
allowed but taxed paid:
Import duty 10%
VAT 12.5%
NHI tax 2.5%
Others 5.0%
Total 30% (VAT not re-claimable)

Finished product imports A list of products that can be imported without any tax. These were mostly specialized
allowed with no tax products that local companies could not produce and had no immediate plans of producing.

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16
 FEAPM Position Paper
Proposed Model for the Growth of the East African Pharmaceutical Manufacturing Sector

The Policy Impact
The policy has been implemented for over 20
years in which time positive effects have been
achieved in the following areas (related to the
local pharmaceutical sector):
Counterfeit/Sub-standard Products
Since the implementation of this policy there
has been a significant reduction in the
prevalence of sub-standard and counterfeit
products. The share of local products has
increased to around 30% of the total
medicines used in Ghana. These facts
suggest that sub-standard products were
primarily coming from outside of Ghana as
imports.
Growth in Local Pharmaceutical
Production
In 1989 there were only 9 manufacturing
companies, today there are 35;
The pharmaceutical industry currently
employs approx. 3800 persons directly;
Three companies are listed on the Ghana
stock exchange;
Three companies are in the process of
attaining WHO approval;
Several of the companies export their
products within the West African Region;
One Company manufactures active phar-
maceutical ingredients (APIs);
Several companies have partnered with
multi-nationals to manufacture products;
One Company manufactures ARVs.
Most of these companies have at least one major
brand that is on the banned for imports list of
products and this has served as the main source
of income for further development of the industry.
As local companies have become stronger they
are better able to compete with importers, e.g.
despite the Affordable Medicines Facility for
malaria (AMFm) programme of subsidies, several
company brands of ACTs have managed to
remain competitive. For the future, the Ministry of
Health in Ghana plans to increase the products on
the banned list with the aim of local products
contributing around 50% of all products consumed
in the country.
Conclusion
The Ghana Model has achieved its combined
goal of reducing sub-standard products in the
market and also supporting the growth of local
manufacturers. The model accepts the need for
imports but also recognizes the importance of
developing a home industry in the very strategic
sector of Health.
Most importantly, the EAC has already adopted
the EAC Regional Pharmaceutical Manufacturing
Plan of Action (RPMPOA) and the EAC TRIPS
Policy in a bid to strengthen and promote local
pharmaceutical production. The implementation of
these policies will synergize and harness existing
national, regional and international initiatives
towards strengthening local production of
pharmaceuticals.

FEAPMs Position
The EAC should use the Ghana Model as tactical evidence for the strategic EAC
Regional Pharmaceutical Manufacturing Plan of Action (RPMPOA). The EAC and its
Partner States can promote local pharmaceutical manufacturing through a balanced mix
of similar policy measures regarding procurement, taxation and import control:
Specifically;
20% price preference should be awarded to local manufacturers within the region
All raw materials used in pharmaceutical manufacturing should be zero rated for
tax purposes
Partner States should restrict importation of key finished products that can be
produced locally in the right quality and quantities.
In the context of the EAC Common Market, these measures need to be developed and
enforced in a harmonized and coordinated manner.

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Federation of East African Pharmaceutical Manufacturers (FEAPM) | Yearbook 2012 17

 The East African Community Regional Pharmaceutical Manufacturing
Plan of Action: Strengthening Local Production of Medicines
Background
The East African Community (EAC) is commit-
ted to promoting access to affordable, quality es-
sential medicines, including those for the treat-
ment of various priority communicable diseases
such as HIV/AIDS, Malaria, Tuberculosis and
Neglected Tropical Diseases (NTDs) as well as
non-communicable diseases including Diabetes,
Cardiovascular Diseases, Chronic Respiratory
Diseases and Cancers, among others. However,
the provision of safe, efficacious and affordable
essential medicines and other quality health
commodities to the people of the EAC remains
a major challenge due to inadequate local pro-
duction of pharmaceuticals and an overreliance
on the importation of finished pharmaceutical
products and related health supplies from out-
side the region.
Fostering the capabilities of the local pharma-
ceutical industry is not only crucial in address-
ing this gap in access to medicines, but would
also contribute substantially to the achievement
of industrial and economic development objec-
tives in the EAC Partner States.
In this regard, the five-year East African Com-
munity Regional Pharmaceutical Manufactur-
ing Plan of Action (EAC-RPMPOA): 2012-2016
serves as a roadmap to guide the EAC towards
collectively and synergistically evolving an ef-
fective regional pharmaceutical manufacturing
industry that will supply national, regional and
international markets with the requisite medi-
cines. The Plan of Action is closely aligned to the
short-, medium- and long-term goals and poli-
cies of the EAC and individual Partner States
and serves to complement past and present re-
gional as well as pan-African strategies.
The EAC-RPMPOA recommends strategic inter-
ventions to be applied at the firm, institutional,
national and regional levels to improve the busi-
ness environment for pharmaceutical manufac-
turing, strengthen the associated regulatory ca-
pacity and further develop the relevant human
resource capacity through a programmatic ap-
proach. The Plan has set out the following pri-
mary strategic objectives for the region:
18
1. Promotion of competitive and efficient phar-
maceutical production;
2. Facilitation of increased investment in phar-
maceutical production;
3. Strengthening of pharmaceutical regulatory
capacity;
4. Development of skills and knowledge for
pharmaceutical production;
5. Utilisation of TRIPS flexibilities towards im-
proved local production of pharmaceuticals;
and
6. Mainstreaming of innovation, research and
development.
Representatives of the Ministries of Health and
Industrialisation from each of the five Partners
States, along with private sector representation,
constitute the EAC Steering Committee, which
manages the implementation of the EAC-RPM-
POA at the regional level. The EAC Industri-
alisation Policy and Strategy complements the
RPMPOA in that it has prioritised the regional
pharmaceutical industry among sectors to be
promoted through collective efforts by the EAC
Partner States.
The development of a regional plan by the EAC
Partner States is one of several regional and con-
tinental initiatives towards enhancing capacity
utilisation of local pharmaceutical companies,
increasing access to medicines and boosting for-
mal pharmaceuticals export markets over the
past decade. Notable amongst these are the Af-
rican Union Pharmaceutical Manufacturing Plan
for Africa (AU-PMPA), the Economic Commu-
nity of West African States (ECOWAS) Pharma-
ceutical Manufacturers Association (WAPMA)
and the South African Generic Manufacturers
Association (SAGMA). Joining forces with these
regional associations, FEAPM recently became a
founding member of the Federation of African
Pharmaceutical Manufacturers Associations,
which is supported by UNIDO. We are confi-
dent that these national, regional and continen-
tal efforts will ultimately strengthen local phar-
maceutical manufacturing in Africa.
The six pillars of the East African Community
Regional Pharmaceutical Manufacturing Plan of Action
Based on a SWOT analysis of the East African pharmaceutical sector, the EACs Plan of Action identi-
fies priority areas and major activities to be implemented at the micro-, meso- and macro-levels in or-
der to strengthen the local production of medicines. These major activities are clustered into six pillars
designed around the strategic objectives of the plan as detailed in the table below:
Pillar 1:
Promotion of competitive and efficient regional
pharmaceutical production
1. Strengthening of local producers capacity to
meet WHO-GMP and WHO prequalification
standards;
2. Establishment of a regional pharmaceutical
manufacturers association;
3. Promotion of regional and international
collaborations including technology transfer
4. Development and implementation of
marketing campaign to promote domestic
pharmaceutical producers and products;
5. Effective use of collective purchasing preference
schemes by public procurement agencies;
6. Implementation of pooled procurement of raw
materials and other pharmaceutical production
inputs by manufacturers;
7. Regional pharmaceutical demand
quantification study for 2011 to 2016;
8. Baseline survey to determine the regional
pharmaceutical production capacity as well as
firm-level underutilised capacity.
Pillar 3:
Strengthening pharmaceutical regulatory capacity in
the region
1. Strengthening human resource capacity in
regulatory affairs in the region;
2. Development/improvement of infrastructure
of NMRAs;
3. Review of national laws for medicines
regulation;
4. Harmonisation of regulations for drug
registration, licensing of pharmaceutical
manufacturers, Standard Treatment
Guidelines and Essential Medicines List across
the region.
Pillar 5:
Utilisation of WTO-TRIPS flexibilities to improve
local production of pharmaceuticals in East Africa
1. National and regional sensitisation on
intellectual property rights and public health
related WTO-TRIPS flexibilities;
2. Adoption of a regional policy framework and
guidelines to effectively implement public
health related TRIPS flexibilities;
3. Domestication of public health-related TRIPS
flexibilities within national laws.
Federation of East African Pharmaceutical Manufacturers (FEAPM) | Yearbook 2012
Pillar 2:
Facilitation of increased investment in pharmaceutical
production regionally
1. Promotion of a conducive investment
environment in the region;
2. Feasibility study identifying suitable long-term
financing options for pharmaceutical
manufacturing in the EAC region;
3. Sensitising key stakeholders on unique
pharmaceutical industry dynamics;
4. Development of national and regional policy
framework for pharmaceutical industry clusters
and special economic zones;
5. Mapping of existing and potential locations for
pharmaceutical industry clusters and special
economic zones.
Pillar 4:
Development of appropriate skills and knowledge on
pharmaceutical production in the region
1. Identification, equipping and accreditation of
training institutions;
2. Development and implementation of a gender-
based sectoral human resource development
strategy.
Pillar 6:
Mainstreaming innovation, research and development
within the regional pharmaceutical industry
1. Pharmaceutical Research and Development
capacity enhancement in the region;
2. Promotion and enhancement of the use of locally
sourced inputs (including herbal or natural
products) for production of active pharmaceutical
ingredients, excipients and final dosage forms;
3. Structuring and resource mobilisation for a
regional pharmaceutical innovation fund.
19
 Implementation
The anticipated cost of implementation of the
Plan of Action is approximately USD 45 million.
Concerted efforts by the EAC Partner States,
development partners and the regional phar-
maceutical industry are needed to mobilise the
required resources. The ongoing EAC Medicines
Registration Harmonisation project, which is be-
ing supported by a consortium of partners and
is covered in detail elsewhere in this yearbook,
will, upon completion, lead to the attainment
of most of the set activities of the strategic ob-
jective of strengthening pharmaceutical regula-
tory capacity in the region (Pillar 3). Similarly, a
three year (2013 -2016) EAC project in partner-
ship with the Physikalisch-Technische Bunde-
sanstalt (PTB), the German technical authority
for metrology and physical safety engineering,
on strengthening quality infrastructure for the
pharmaceutical sector in the region has been de-
signed and is anchored towards supporting the
successful implementation of the Plan of Action.
The new project phase of the EAC-GIZ project
The East African Community Medicines Regulatory Harmonisation Project
Governance, regulations and accountability in
the pharmaceutical sector are important pillars
of effective health systems. Improved regulatory
policy and harmonisation can lead to more com-
petitive markets, economic growth, improved
access to new medicines, higher quality phar-
maceuticals in circulation and ultimately better
health outcomes.
In 2009, a coalition of partners including the
Pan-African Parliament (PAP), NEPAD Coordi-
nating and Planning Agency, the World Health
Organisation (WHO), the Bill & Melinda Gates
Foundation (BMGF), UK Department for Inter-
national Development (DfID), and the Clinton
Health Access Initiative came together to estab-
lish the African Medicines Regulatory Harmoni-
sation (AMRH) program. Working with African
regional economic communities (RECs), the pro-
grams goal is to increase access to good quality,
safe and efficacious medicines through harmo-
nising medicines regulation and expediting the
registration of essential medicines a central
component of the Pharmaceutical Manufactur-
ing Plan for Africa.
20
on industrialisation and pharmaceutical sector
promotion has allocated resources towards sup-
porting an effective steering structure for the
implementation of the Plan of Action for the pe-
riod 2013 2016. The program will also continue
ongoing efforts to attract and build a consortium
of partners to support this implementation.
The development and launch of the RPMPOA
marked an important early milestone towards
the achievement of universal access to essential
medicines for the people of the region and ulti-
mately for the attainment of the United Nations
Millennium Development Goals and Targets by
2015. With sustained concerted efforts to mobi-
lise resources for, and effectively manage, the
implementation of the Plan of Action, the East
African Community will continue to move de-
cisively towards universal access to safe, effica-
cious and affordable essential medicines in the
region while making progress towards its in-
dustrial and economic development objectives.
With generous support from the BMGF, the
Global Medicines Regulatory Harmonisation
Multi-Donor Trust Fund (GMRH) was set up by
the World Bank in 2011 to implement and scale
up AMRH activities. In 2012, the East African
Community (EAC) became the first REC in Af-
rica to receive GMRH funding. The EAC was se-
lected because of its commitment to medicines
regulatory harmonisation, which is underscored
in the EAC Treaty and has been endorsed by the
EAC Sectoral Committee on Health and the Sec-
toral Council of Ministers.
On March 30, 2012 in Arusha, Tanzania, the East
African Community Medicines Regulatory Har-
monisation (EAC-MRH) Project was officially
launched amid 200 high-level African and EAC
delegates, pharmaceutical manufacturers, bilat-
eral donors, UN agencies, government agencies,
national medicines regulatory authorities (NM-
RAs) and product development partnerships.
The Project

The EAC-MRH project is a five-year project that will be implemented in two phases. GMRH provides
support for Phase I, which covers the first three years (2012-2015) of the project. The project aims to
harmonise medicines registration systems, improve efficiency and enhance transparency in medicines
registration among EAC Partner State NMRAs. To achieve these objectives, the project is implement-
ing a variety of activities focused on strengthening existing capacities, minimising inefficiencies and
increasing transparency in medicines registration for East Africa.

Key Features of the Project

Grant USD 5.5 million

Duration 2012-15 (Phase I)
Countries Burundi, Kenya, Rwanda, Tanzania and Uganda
Two Project I. Component I focuses on regional coordination and capacity
Components building for medicine regulation. Core activities planned include
the development of standardised operating procedures, manuals
and capacity building guidelines. Regional technical working
groups (TWGs), comprised of members from each countrys
NMRA, will develop technical standards relevant for the region in
the following areas: (i) medicines evaluation and registration; (ii)
good manufacturing practices (GMP) inspection; (iii) information
management systems; and (iv) quality management systems.
II. Component II focuses on capacity building activities to empower
NMRAs to enhance their efficiency and transparency in medicines
registration. Specifically, the project supports the hiring of
additional staff for newly established NMRAs and regional and
national project coordinators as well as the training of staff in areas
of project management, assessment of quality and safety of
medicines and GMP inspections. Funding is also available to
support mentoring opportunities between NMRAs, in-country
workshops and consultations, and the procurement of consultants
and ICT equipment/software to improve regulatory capacities.
Roles Implementers Regional Economic Community (NMRAs from Partner States):
develops and implements the harmonised standards
EAC Secretariat, Project Coordination Team: works with NMRAs
to implement the project by providing regional coordination and
routine operational support
Regional Project Steering Committee: provides strategic
operational oversight and approves regional work plans and
activities
Partners NEPAD: Ensures support for regional project development and
continent-wide coordination
WHO: Provides expert technical assistance to the TWGs and
facilitates cross-regional exchanges and study tours for capacity
building
World Bank: Manages overall project implementation and
provides fiduciary oversight
Expected - EAC Partner States have a harmonised medicine registration
Results system
- NMRAs using common integrated Information Management
System
- NMRAs have functioning quality management system in place
- Regulatory capacity building in the region institutionalised
- Government, industry and civil society partnerships improved

Federation of East African Pharmaceutical Manufacturers (FEAPM) | Yearbook 2012 21

 Progress
Since its launch in March 2012, the EAC-MRH
project has advanced considerably. Two key
achievements deserve a special mention. First,
the Regional Project Steering Committee has
been constituted and several meetings were
held in 2012. Second, all four technical working
groups (Medicines Evaluation and Registration,
GMP Inspection, Quality Management System
and Information Management System) have
been formed and a number of draft documents,
manuals and assessments have been completed.
Additionally, the project has led to regular in-
teractions between NMRAs. These interactions
have helped to determine synergies and po-
tential opportunities for collaboration, enabled
mentoring for newer NMRAs within the EAC
region, and engendered trust and a willingness
among NMRAs to share responsibilities in terms
of regulatory functions.
Benefits to Local Pharmaceutical
Manufacturers
The Harmonisation of regulatory environments
supports the development of a regional market,
creating a level playing field for fair competi-
tion leading to consumer benefits. East African
pharmaceutical manufacturers will benefit from
a well-functioning regulatory environment in
two distinct ways. First, the implementation of a
harmonised medicines registration system in the
22
EAC region will reduce barriers for local drug
companies to sell across national borders. This
promotes regional trade and growth - an impor-
tant goal of the EAC Common Market Protocol.
Second, given the projects emphasis on ensur-
ing that technical standards and guidelines be-
ing developed by the region adhere to interna-
tional WHO standards, it can be expected that
East African manufacturers will improve their
competitive position for exports beyond the
EAC to the rest of Africa and eventually to other
parts of the world.
Conclusion
The EAC-MRH project aims to improve access
to priority essential medicines and promote
industry growth through the adoption of har-
monised approaches to medicines registration,
thereby reducing barriers for manufacturers.
Though still at an early stage, the project is al-
ready generating lessons on the importance of
harmonised standards and cooperation among
regulators. As the project moves ahead, continu-
ous dialogue and collaboration with local indus-
try and civil society groups will be instrumental
to developing an effective standards infrastruc-
ture in the EAC.
For more information about the EAC-MRH Pro-
ject and the broader AMRH initiative, please
visit: www.amrh.org
The Role of Medicines Regulatory Authorities in
Promoting Local Pharmaceutical Manufacturing in East Africa
Medicines regulation is a government function
whereby the safety, efficacy and quality of medi-
cines is determined as a prerequisite for market-
ing authorisation, and continuously monitored
and evaluated after authorisation has been
granted. The ultimate goal of medicines regu-
lation is to promote and protect public health.
Effective medicines regulation operates within a
legal framework and demands sound medical,
scientific and technical knowledge and skills.
Key medicines regulatory functions include the
following:
a) Assessing the quality, safety and efficacy of
medicines and issuing marketing authorisa-
tion (also called Product Licensing or Drug
Registration);
b) Post-marketing surveillance - controlling
and monitoring the quality of medicines on
the market;
c) Licensing of the manufacture, import, ex-
port and distribution of medicines;
d) Inspecting and surveillance of manufactur-
ers, importers, wholesalers and retailers;
e) Controlling the promotion and advertising
of medicines;
f) Pharmacovigilance - monitoring the safety
of marketed medicines, including collecting
and analysing adverse drug reactions;
g) Providing independent information on
medicines to professionals and the public;
and
h) Control of clinical trials of medicines and
medical devices.
From these functions, it is clear that in order for
NMRAs to effectively perform their mandates,
they need to work very closely with pharmaceu-
tical manufacturers. Pharmaceutical manufac-
turers are expected to meet regulatory standards
of quality, safety and efficacy through documen-
tation submitted for assessment by NMRAs be-
fore their products are given marketing authori-
sation. One of the prerequisites for marketing
authorisation is the inspection of pharmaceutical
manufacturers for compliance with the require-
ments of current good manufacturing practices
(GMP). GMP ensures that products are consist-
ently produced and controlled to the quality
standards appropriate to their intended use and
Federation of East African Pharmaceutical Manufacturers (FEAPM) | Yearbook 2012
according to the marketing authorisation re-
quirements. Pharmaceutical manufacturers are
also required to monitor the quality and safety
of their products in circulation on the market
and report any quality defects and adverse drug
reactions.
The relationship between regulators and
local manufacturers in the region
Regulators and local manufacturers are key
partners in ensuring the availability of safe and
efficacious medicines of acceptable quality. Un-
fortunately, essential medicines for the treat-
ment of the diseases affecting many people in
the East African region remain out of reach due
to various challenges.
Many regulators, including those in the EAC
region, have resorted to solutions that have in-
vited local manufacturers into the center of the
regulatory process. When developing regula-
tory standards, regulators consult the pharma-
ceutical manufacturers who are later expected to
comply with those standards. Typical examples
are guidelines for submission of documentation
for registration of medicinal products and those
for GMP. The consent of pharmaceutical man-
ufacturers on regulatory standards facilitates
their voluntary compliance to those standards
and therefore facilitates the quick approval of
their products.
The challenges and opportunities of pro-
moting better synergies between the two
stakeholders
One of the central challenges the two stake-
holders are facing is compliance by the local
manufacturers to meet the required regulatory
standards for the registration of medicines and
compliance to GMP. This has either delayed ac-
cess to essential medicines by patients, or led to
rejections of applications for registration of med-
icines, thus denying manufacturers their return
on investment.
23
 A lack of regulatory capacity and ability to en-
sure the quality, safety and efficacy of medi-
cines in some EAC Partner States compounds
this challenge. This poses a risk of substandard
and counterfeit medicines circulating alongside
genuine medicines in the region, posing serious
public health and economic implications to both
the governments and the industry.
The harmonisation of technical requirements
for medicines registration constitutes a major
opportunity for promoting a more synergistic
and successful relationship between the two
stakeholders. This lesson has been learnt from
the International Conference on Harmonisation
of Technical Requirements for Registration of
Pharmaceuticals for Human Use (ICH), which
was launched in 1990. ICH brings together drug
regulatory authorities from Europe, Japan and
the United States along with pharmaceutical
manufacturers associations from these regions,
to discuss issues relating to scientific and tech-
nical requirements for product registration. The
objectives of ICH have been to improve the ef-
ficiency of new drug development and registra-
tion processes, promote public health, prevent
duplication of clinical trials in humans and mini-
mise the use of animal testing without compro-
mising the safety and effectiveness of medicines.
International forums such as the International
Conference of Drug Regulatory Authorities
(ICDRA) offer another opportunity for the in-
dustry to interact with regulators. The ICDRA
meeting normally provides space for preceding
meetings, which bring together industry, civil
society, scientific institutions and non-govern-
mental organisations to discuss and exchange
experiences on all topics related to ensuring ac-
cess to medicines of good quality. These topics
range from clinical trials to supply chain secu-
rity. The conferences have been providing regu-
lators from the EAC Partner States with an excel-
lent platform for information sharing.
Enhanced training provides a further opportu-
nity for effective collaboration between man-
ufacturers and regulators. For example, the
Kilimanjaro School of Pharmacys Industrial
Pharmacy Teaching Unit offers trainings for
pharmaceutical personnel on various aspects of
drug manufacturing. These have helped build
the industrys human resource capacity to meet
quality and safety standards. Further, some spe-
cialised trainings on TRIPS, public health, GMP
and WHO prequalification are aimed at both
manufacturers and regulators, thus fostering a
common understanding of quality drug produc-
24
tion as well as offering a meeting place for inter-
action and networking between the two stake-
holder groups.
Measures being taken by regulatory au-
thorities in the region in order to promote
local pharmaceutical manufacturing
In March 2012 the EAC became the first Region-
al Economic Community in Africa to launch a
regional project under the African Medicines
Registration Harmonisation Initiative (AM-
RHI). The EAC Medicines Registration Harmo-
nisation (EAC-MRH) project aims to harmonise
medicines registration in the EAC Partner States
in order to:
n i ncrease the rapid availability of safe, effica-
cious and good quality essential medicines
in the region; and
n enable the free movement of pharmaceu-
ticals within the region to complement the
implementation of the EAC Customs Union
operational from 2010.
The projects goal is to have a harmonised and
functioning medicines registration system with-
in the EAC in accordance with national and
international policies and standards (WHO &
ICH). The industry, on the other hand, will ben-
efit from harmonised registration documenta-
tion (dossier format and technical requirements)
as well as increased transparency and reduced
delays leading to lower costs in preparing regis-
tration applications for multiple countries. More
predictable registration processes and short-
ened timelines for registration shall mean that
manufacturers can access larger markets faster,
creating an incentive for manufacturers to pro-
duce and register more of their products across
more countries.
Finally, some of the strategic objectives of the
EAC Regional Pharmaceutical Manufacturing
Plan of Action (EAC-RPMPOA) are linked to
those of the EAC-MRH project in that they focus
on strengthening national medicines regulatory
capacity and aim to promote competitive and
efficient regional pharmaceutical production by
strengthening local manufacturers capacity to
meet WHO-GMP and WHO prequalification.
The establishment of the Federation of East Af-
rican Pharmaceutical Manufacturers (FEAPM)
is itself a key milestone of the EAC-RPMPOA.
This organ will facilitate dialogue between reg-
ulators and manufacturers on various matters
related to the manufacture and regulation of
medicines in the region. Regulators are work-
ing closely with the Federation on issues such as
the development and review of legislations and
guidelines that have an impact on pharmaceuti-
cal manufacturing.
Conclusion
The successful implementation of the EAC-
MRH project and the EAC-RPMPOA will con-
tinue to depend on effective coordination and
collaboration mechanisms between regulators
and manufacturers through FEAPM. It is envis-
aged that through such mechanisms, the two
stakeholders will build and strengthen the regu-
lation and local pharmaceutical manufacturing
capacity in the region. This will in turn promote
better synergies between the two stakeholders in
order to complement the overall goals of the two
projects enhancing the manufacture of, and ac-
cess to, affordable, efficacious, high-quality and
safe essential medicines within the region, and
contribute to the simultaneous achievement of
public health and industrial development objec-
tives in all the EAC Partner States.

The Uganda Pharmaceutical

Manufacturers Association (UPMA) is
duly registered as an association with
the registrar of societies, Uganda.
Our membership comprises
companies registered with the
registrar of companies and licensed by
the National Drug Authority, to
operate small or large pharmaceutical
manufacturing business in Uganda.
Below is a list of the names of the
members and their addresses.
Our Aim: is to provide sustainable accessibility, quality and affordable pharmaceutical products
through local manufacturing.
Our Motivation: is that a healthy nation is a strong nation.
Our Vision: A vibrant Industry that will move the country from dependency to self- reliance in the
provision of essential drugs.
Our Mission: Our association aims to build a strong, dedicated and motivated membership that
answers sufficiently to the provision of the basic pharmaceutical needs of our country and beyond.
We will do this through collaboration, association and participation in the Private sector
Government initiatives to build adequate manufacturing capacities in both human and investment
capital.
Achievements to date:
Through participation in the MeTA project, we were able to influence the development of
the Pharmaceutical Manufacturing Plan of Action for MoH, Uganda
Worked closely with CSOs to persuade the Government to amend the Counterfeit Bill, which
was done, otherwise any generic product could have been classified as a counterfeit!!
Worked with PPDA and MoH to include a 15% price preference for locally manufactured
products in Government tenders. This is now in the procurement laws of Ugand

Member Company Contact Person Position Contact Details

Kampala Pharmaceutical Nazeem Mohamed Chairman Tel: +256 752785773
Industries(1996) Ltd E-mail: nazeem@kpi.co.ug
Quality Chemical Emmanuel Katongole Vice Chairman Tel: +256 772727262
Industries Ltd E-mail: ceo@qcil.co.ug
Rene Industries Ltd Rishi Vadodaria Treasurer Tel: +256 712401075
E-mail: Rishi@africaonline.co.ug
Abacus Parental Drugs Ramesh Babu General Secretary Tel: +256 712230121
Ltd E-mail: Ramesh@kiboko.co.ug
Medipharm Industries Emmanuel Ogalo Member Tel: +256 712625199
(E.A) Ltd E-mail: sales@medipharm.co.ug
Kwality Afro Asia Ltd Manoj Patel Member Tel: +256 782133497
E-mail:kwalityafroasia@yahoo.com
Federation of East African Pharmaceutical Manufacturers (FEAPM) | Yearbook 2012 25
 Burundis
pharmaceutical firms
fight to build positive
image for market.

By Moses Havyarimana

The recently formulated National Pharmaceuti-
cal Policy (NPP) is promising to change invest-
ment landscape for manufacturers in Burundi
but players are calling for urgent institutional
reforms to propel the industry to its growth po-
tential.
Last year, the government handed the National
Institute of Public health (INSP) direct control of
all locally manufactured medicines, but its labo-
ratory is yet to be certified. As such it has not
started testing the samples of locally manufac-
tured drugs.

At the moment, weak institutions have cast a
dark shadow on manufacturers and promot-
ers of generic drugs such as Mutuel Life In-
surance Company which have to grapple with
negative perception in the market.
Mr Emmanuel Bamenyekanye, director of the
laboratories at Burundis national regulator for
medicines and pharmaceuticals echoes these
sentiments.

Because of poor pharmaco-vigilance, most con-

sumers in Burundi regard locally produced
medicine as inferior and unsafe, industry play-
ers say.
It is true there is a problem of quality medi-
cine management but as regulators, we try
and make sure that all imported medicines are up to
good quality standards. He said in an interview.
Like its partners in East Africa, Burundi nurses

My customers dont prefer locally manu-

factured medicines with the claims
that they are not of good quality standards, says
Cassien Ntadambanya, a pharmacist and chair-
man of Pharmacists Association in Burundi.
But in the absence of proper national quality
control and surveillance system for drugs, Mr
Ntadambanya himself does not know whether
his customers are right in their perception of lo-
cal medicine or not.
the ambition of boosting domestic pharmaceu-
tical production. So far, the country has put to-
gether an Inter-Ministerial Commission whose
immediate task is to set up the countrys second
pharmaceutical manufacturing enterprise called
SONAPHA, Mr Bamenyekanye said.
The new firm will work closely with Pharma-
ceutical Industrial Society (SIPHAR) so far the
only manufacturing Industry in Burundi - and
the government to internal production of medi-
cine, Mr Bamenyekanye said. But the weak qual-

My family uses locally manufactured

drugs but I am not sure about the
quality. I have faith that at least the product from the
ity control remains an overriding concern that is
set to haunt the industry for years to come.

region is analyzed before it is distributed. It is also

cheaper and affordable for some of us, he said.

26
What we have to do is to make sure all
quality standards are respected,
and strategies are taken to promote the industry,
Burundis centre for essential drugs, medical de-
vices, products and laboratory materials.

says Pierre Claver Niyonizigiye, Director of Ad-

ministration and Legal Affairs at the SIPHAR.
Mr Niyonizigiye believes one way of building
trust in the market is through harmonisation of
regional regulatory frameworks to standardise
pharmaceutical manufacturing in East Africa.
For instance, Mr Niyonizigiye and his family
trust and consume the locally produced medi-
cine but he cannot readily share his experience
of quality improvements with the market since
unlike other EAC partner states, Burundi pro-
hibits advertisement of medicines.
The NPP will open up the market for investors
from the region and boost domestic competi-
tiveness, industry players have said. Industry
players, acknowledging the multifaceted nature
of the problems that pharmaceutical manufac-
turers face in Burundi, say enormous task lies
ahead for the Inter-Ministerial Commission.
It is my first time to hear about FEAPM. The
organisation need to show us what it is do-
ing and also start working with CAMEBU closely,
Mr Rihanda said.
As for Mr Ntadambanya, regional integration is
working for the industry and should therefore
be leveraged to boost access to medicine in Bu-
rundi. He said:
The government should work on the re-
moval of political and trade barriers
in the country for the free movement of medicines. I
import medicines from Uganda (part of EAC com-
mon market) but I still have to pay taxes to do so.
Mr Bamenyekanye shares these sentiments. He
said the EAC Common Market has a great po-
tential but FEAPM has to partner with industry
players in raising capacity, creating awareness
and providing training to enable them tap avail-
able opportunities.

The Government has a very big role to

play in making capital available by
reviewing bank policies that affect interest rates,
Mr Niyonizigiye said, adding that manufactur-
ing of medicines is capital-intensive.

But Burundi also faces acute shortage of skill

manpower since it does not have internal capac-
ity to train personnel for the industry. The last
time the countrys tertiary institutions offered
degree courses in pharmacy was 15 years ago,
players recalled as they urged the government
to reintroduce such courses.

Mr Niyonizigiye also called for transparency in
the registration of saying the current system of
registration through the pharmacists associa-
tion was a tedious non-tariff barrier to industrys
growth.
Some of the Burundian pharmaceutical distribu-
tors are yet to feel the impact of the East Africas
economic integration five years after their gov-
ernment joined the bloc.
Mr. Pierre Claver Niyonizigiye talking about the opportuni-
ties in the pharmaceutical industry during the interview
PIERRE CLAVER NIYONIZIGIYE is the Director of Ad-
ministration and Legal Affairs of the Pharmaceutical Indus-
trial Society (SIPHAR) - the only manufacturing Industry
in Burundi. In this interview, he talks about his experience
on Federation of East African Pharmaceutical Manufacturers
(FEAPM) since its establishment.

Neither are they aware of the role of FEAPM,

a regional lobby group for the pharmaceutical
industry, says Mr Barnabe Rihanda, the direc-
tor general of CAMEBU, a distributing firm and

Federation of East African Pharmaceutical Manufacturers (FEAPM) | Yearbook 2012 27

 Overview of the World Health Organisation
Prequalification of Medicines Program

Objective Strategy

To ensure the quality, safety and efficacy of n  pply unified standards of acceptable qual-
A
medicines procured using international funds ity, safety and efficacy.
and propose a list of prequalified products and n Comprehensively;

manufacturers meeting international norms and n evaluate the quality, safety and efficacy of

standards. The standards against which the as-
sessment teams evaluate both the quality specifi-
cations of medicines and the manufacturing sites
are based on the principles and practices agreed
by the worlds leading regulatory agencies.
medicinal products based on information
submitted by the manufacturers
n  inspect the corresponding manufacturing
and clinical sites
n monitor the product after prequalification

n Help the national medicines regulatory au-

Key facts
n  orld Health Organisation (WHO) prequal-
W national norms and standards
ification of medicines is a service provided
by the WHO to assess the quality, safety and
efficacy of medicinal products
n Originally, in 2001, the focus was on medi-
cines for treating HIV/AIDS, tuberculosis
and malaria
n In 2006, this was extended to cover medi-
cines and products for reproductive health,
and in 2008, to cover prequalification of zinc
for managing acute diarrhoea in children
n At the end of 2012, the WHO List of Prequali-
fied Medicinal Products contained 316 medi-
cines for priority diseases
thorities to build up capacity in assessment,
inspection and quality control meeting inter-
n Develop local possibilities of manufacturing
and clinical studies by offering customised
technical assistance
Why Prequalification of Medicines Pro-
gram? United Nations Perspective
n  any of the UN and other procurement agen-
M
cies lack sufficient means to ensure safety, ef-
ficacy and quality of procured medicines and
other medical items
n Many of the receiving and exporting countries

n Every year, billions of US dollars worth of
medicines are purchased by or through in-
ternational procurement agencies such as
UNICEF, the Global Fund to Fight AIDS,
Tuberculosis and Malaria, and UNITAID for
distribution in resource-limited countries.
do not have/did not have well established reg-
ulatory systems
n Increasing demand for generic medicines be-
ing produced by several players and emer-
gence of substandard products
n Need for common international standard

Prequalification is intended to give these

agencies the choice of a wide range of qual-
ity medicines for bulk purchase
n The WHO Prequalification of Medicines Pro-

gram (PQP) helps ensure that medicines sup-

plied by procurement agencies meet accept-
able standards of quality, safety and efficacy
n WHOs list of prequalified medicinal prod-

ucts is used by international procurement

agencies and increasingly by countries to
guide bulk purchasing of medicines.
n PQP also prequalifies Active Pharmaceutical

Ingredients (APIs) and quality control labo-

ratories

28
Why Prequalification of Medicines Pro-
gram? Local Manufacturers Perspective
i) Advantages
n Participation in tender procedures organ-
ised by international procurers and finan-
cial profit
n Recognition as being WHO listed company
leads to increased confidence in quality,
safety and efficacy of prequalified product
n Offers a level playing field
nAccelerated registration in several recipi-
ent countries
n Reduction of inspections from recipient
countries
n Learning process improving companys
chance to succeed with submissions to SRAs
n Being on the list of WHO-prequalified med-
icines might open door for international co-
operation and markets beyond Africa
nAPI PQ assists in identifying sources of
quality assured Active Pharmaceutical In-
gredients
Federation of East African Pharmaceutical Manufacturers (FEAPM) | Yearbook 2012
ii) Disadvantages
n Significant amount of resources, financial
and otherwise, needed to either upgrade
manufacturers current facilities or con-
struct new ones
n PQP demands stringent documentation
procedures and equipment maintenance,
adding significantly to operations costs
n Prequalification process for manufacturing
facilities and products is considered com-
plicated, tedious and expensive but does
not guarantee market access
nThe increased operational costs associated
with WHO PQ certification has unintended
consequence of raising the cost of produc-
tion of essential medicines that are pro-
duced in the same facility but do not neces-
sarily require WHO PQ
29
 Strict surveillance boosts
confidence in Rwandas
drugs as firms await key
reforms to boost local
production.

By Fiona Mbabazi

Rwandas pharmaceutical industry is banking

on strict national surveillance system to main-
tain steady flow of high quality medicines to
citizens even as it hinges its hopes on pending
reforms to guide future growth.
We trust our pharmacies, he said, add-
ing that his family too preferred lo-
cally produced medicines to international ones
because of belief that Rwanda produces drugs of
high quality and safety standards.

The medicines pro- According to RBC,

duced in the country Rwanda consumes
are of high safety stand- 500, 000 litres of infu-
ards while pharmacists sions annually and
are under strict guide- the government plans
lines to sell drugs of to process about 900
high quality to people, litres per day to meet
says Donatien Ngabo the national demand.
Ntagara, acting head
of medical production Mr Ntagara noted that
division at Rwanda Bio- the country which had
medical Centre (RBC). been importing infu-
sions was now looking

Before
we authorise the sale of
forward to local man-
ufacturing in a bid to
cut the extra expense
A Pharmacy in Rwanda
drugs in any pharmacy in of obtaining them
Rwanda, we first do the tests to ascertain the quality from international market.
of the drugs. We send samples to Europe and we have
confirmed Rwandan manufactured drugs are better
than some the drugs manufactured in Asia and other
countries in the world. He said
We are contributing to the online produc-
tion, especially infusions and this will
cover the national demand and even the international
audience. He said
Drugs consumer Jean Baptiste Habiyaremye, 45,
echoed these sentiments when he said that most
of the drugs sold in Rwanda pharmacies were of
high quality.

30
Rwandas Health Ministry says it plans to put
in place a better pharmaceutical sector after
amending the existing laws and regulations that
govern the importation of medicines and their
usage in Rwanda.
The overall objective of the legal changes is to
harmonise domestic regulations with those of
other EAC states. This way, the ministry hopes
to boost access to safe and quality medicine for
the treatment of neglected and priority diseases.
We are in the process of harmonising regu-
lations in the EAC sectors, and the
health sector is among the priority areas, said Dr
Agnes Binagwaho, the minister of health was
quoted recently as saying.
Mothers at a clinic in Rwanda
In the meantime, the industry is banking on
the Federation of East African Pharmaceutical
Manufacturers (FEAPM) to guide its steps to the
growth potential.
Industry stakeholders expect the lobby - estab-
lished one year ago to address common chal-
lenges facing drug manufacturers in East Africa
- to a chart out a professional path for growth to
other partner states.
The formation of EAC drug manufactur-
ers platform is a great initiative that
will increase the availability of medicines in Rwanda
and other EAC nations. EAC common market is pillar
behind the flow of medicines in the region, said Mr
Habiyaremye.
Federation of East African Pharmaceutical Manufacturers (FEAPM) | Yearbook 2012
He called on EAC countries to support the
growth of local pharmaceutical manufacturers
in terms of financial support and capacity build-
ing skills.
The FEAPM offers a number of key services such
as advocacy, human resource capacity building,
research, conferencing services and technology
transfer to both members and non members.
According to the Rwandas health ministry,
since June 2012 it has been monitoring - on a
weekly basis - the stock levels of vital medicines
and supplies in the 43 District Hospitals and 30
District Pharmacies across the country after an
old procurement process had been stopped for
health and safety reasons.
This constant monitoring system has al-
lowed reduction of drug stock-outs
from 23 per cent at the District Hospitals to two per
cent today and from 13 per cent at the District Phar-
macies to 4.9 per cent as of January 4, 2013, the
ministry says.
The monitoring system was, in December, ex-
tended to National Referral Hospitals. Ministry
of Health reports show a decreasing trend of
stock-out in those hospitals from an average of
12 per cent in December 2012 to seven percent as
of January 4, 2013.
We are committed to reducing these figures
even further to ensure availability of all
key drugs within our health facilities, the ministry
says.
Mr Ntagara also sees light at the end of tunnel. In
the planned reforms, he sees the region adopting
the Ghana national drug industry model which
encourages local production of drugs instead of
imports.
We are studying this Ghana model for pos-
sible adoption by EAC countries. Its
possible to elevate our local production by applying
the Ghana model but we need to strategise to avoid
duplication of manufacturing drugs, he said.
31
 German Development Cooperation to Foster Local
Pharmaceutical Production by Utilising WTO-TRIPS-Flexibilities
Germanys program fostering local pharmaceu-
tical production and utilising WTO-TRIPS-Flex-
ibilities was established to support developing
countries in achieving the Millennium Devel-
opment Goals (MDGs) by improving access to
medicines, developing their local pharmaceuti-
cal industry and fostering private sector devel-
opment and trade capacities.
The German Program is
implemented by:
n  eutsche Gesellschaft fr Internationale
D n Training courses for judges and lawyers at na-
Zusammenarbeit (GIZ) GmbH
n KfW Entwicklungsbank and its subsidiary,
Deutsche Investitions- und Entwicklungsge-
sellschaft (DEG)
n Physikalisch-Technische Bundesanstalt
(PTB)
German Trust Fund Projects are
implemented by:
n  nited Nations Industrial Development
U n Facilitation of public-private dialogue on phar-
Organisation (UNIDO)
n United Nations Conference on Trade and
Development (UNCTAD)
Cooperation partners:
n  orld Health Organization (WHO)
W turers (FEAPM)
n European Union (EU)
Thematic areas
n assistance to local enterprises to produce
high quality essential medicines
n technology and know-how transfer for the
local pharmaceutical industry
n capacity development of national/regional
quality infrastructures and human resources
in the pharmaceutical sector
n strengthening of public institutions and lo-
cal and regional pharmaceutical business or-
ganisations
Activities
Within these thematic areas, German develop-
ment cooperation specifically supports:
n  he African Union in implementing the Phar-
T pects of pharmaceutical manufacturing
maceutical Manufacturing Plan for Africa
32
(PMPA), and the EAC in implementing their
Regional Pharmaceutical Manufacturing Plan
of Action (RPMPOA) (also a priority sector for
the EAC Industrialisation Strategy)
n Capacity building for patent office officials and
other public servants from ministries of indus-
try, trade and health to speed up regional har-
monisation of patent legislation and domesti-
cation of the World Trade Organisation (WTO)
Trade Related Intellectual Property Rights
(TRIPS) flexibilities (using EAC-TRIPS Policy)
and common market promotion
tional/regional levels to familiarise judiciary
with TRIPS flexibilities for public health & lo-
cal production and their application and inter-
pretation under domestic laws
n Blended learning courses on intellectual prop-
erty and public health to raise awareness of im-
plications of TRIPS flexibilities for local generic
production for government officials, pharma-
ceutical manufacturers, civil society, and aca-
demia
maceutical sector development through na-
tional and regional pharmaceutical sector
strategy building processes
n Federation of African Pharmaceutical Manu-
facturers Associations (FAPMA) and Federa-
tion of East African Pharmaceutical Manufac-
n Regulatory authorities in quality control
n Enterprises in certifying (GMP, WHO prequal-
ification) and establishing guidelines for the
fulfilment of quality standards, e.g. through
short trainings
n Industrial Pharmacy Teaching Unit (IPTU), St.
Luke Foundation and Kilimanjaro School of
Pharmacy (KSP) in Tanzania (training of spe-
cialised production personnel)
n Infrastructure and services for applied research
at Pharma R&D Lab at Muhimbili University
of Health and Allied Sciences (MUHAS)
n Regional Bioequivalence-Center for Eastern Af-
rica (Addis Ababa)
n Development of Production Partnership Plat-
form (U4P) to facilitate partnerships (business
and not-for profit)
n Web portal for local pharmaceutical produc-
tion to facilitate information exchange on tech-
nical, financial, legal, market and business as-
Quality Infrastructure for the Pharmaceutical Sector
in the East African Community
A well-developed infrastructure is essential for
economic growth and trade. Apart from the vis-
ible infrastructure of transport and communica-
tion, countries also have what might be called in-
visible infrastructure. This ensures, for example,
that screws fit screw nuts, drugs are correctly ad-
ministered, and food is safe for consumption. The
so-called Quality Infrastructure (QI) lays the basis
for trade on the one hand and for environmental,
health and consumer protection on the other hand.
QI is comprised of standardisation, quality assur-
ance, metrology, and testing. Standards Bodies,
Calibration and Testing Laboratories as well as
Certification and Accreditation Bodies avail the
necessary services. Every manufacturing sector
needs QI-services to be competitive on the market
and to be able to meet the requirements of regulat-
ing authorities. For every sector, specific standards
and certification schemes exist, particular safety
guidelines are in place, individual testing meth-
ods are defined, or special kinds of calibrations are
required. In the case of the pharmaceutical sector,
which directly influences the health of consumers,
it is particularly crucial to have a functioning QI in
place that ensures quality and safety.
QI services enable manufacturers to produce ac-
cording to internationally recognised standards
while allowing regulators to ensure that these qual-
ity standards are really met. The standards that ap-
ply to the pharmaceutical sector are mainly GMP
(Good Manufacturing Practice) and ICH (Interna-
tional Conference on Harmonisation of Technical
Requirements for Registration of Pharmaceuticals
for Human Use) guidelines. ISO Standards such as
ISO/IEC 17025 for testing and calibration labora-
tories are also an issue. Besides quality assurance
during the production process, it is necessary to
have well-equipped and functioning quality con-
trol laboratories and an established market surveil-
lance and inspection system in place.
Quality Infrastructure in the East African
Community
The development of a functioning QI that answers
to the needs of all stakeholders is a challenge for
many countries. The PTB (Physikalisch Technische
Bundesanstalt), the national metrology institute of
Germany, has worked in the area of QI since its
foundation in 1887 and is one of the leading me-
trology institutes in the world. Beside its domestic
responsibilities, the PTB also promotes projects for
Federation of East African Pharmaceutical Manufacturers (FEAPM) | Yearbook 2012
the establishment of QI in many developing coun-
tries and transition economies within the scope of
the German Development Cooperation.
The PTBs cooperation with the East African Com-
munity started in 2004 with the following long-
term goals:
n o contribute to the economic, social and ecologi-
T
cal development of the Partner States and thus to
an improvement in their peoples living condi-
tions
n
To protect people and the environment through
technical regulations and international standards
n
To facilitate regional trade and enable participa-
tion in the international exchange of goods and
services
Over the last 9 years, the PTB has continuously sup-
ported the EAC Directorate of Customs and Trade
in developing a functioning and comprehensive QI
in the EAC based on international best practices.
A major milestone was achieved when the SQMT
(Standards, Quality Assurance, Metrology and Test-
ing) Act came into force in 2007. All principle provi-
sions for a general QI framework in the EAC have
now been made. When the PTB-EAC project came
to an end in 2012, the German Government and the
EAC Secretariat decided to continue their joint sup-
port for a regional QI but to focus the interventions
on the needs of the pharmaceutical sector. As a re-
sult, a new project has started in March 2013 with
the EAC Health Department as the major imple-
menting partner.
The project will contribute to the Regional Pharma-
ceutical Manufacturing Plan of Action (RPMPOA)
and aims to strengthen the capacity of both regu-
latory authorities and local producers to introduce
and meet WHO-GMP standards. The major chal-
lenges identified in this regard are the availability
of qualified laboratory staff and service technicians,
calibration services for laboratory equipment and
cost-effective reference standards. Regional capaci-
ties will be developed by working together with
FEAPM, the National Medicines Regulatory Agen-
cies, the National Standards Bodies, metrology insti-
tutes, other donor organisations and various train-
ing institutions to ensure the quality of medicines
without relying on costly services from abroad. This
will ultimately contribute to improved medical care
for the population and a more competitive local
pharmaceutical manufacturing sector.
33

Establishment of a regional
Quality Infrastructure for
the pharmaceutical sector
in the EAC
34
PTB in brief Project Data
Establishment of a regional Quality Infrastructure for the
A globalized international economy calls for globalized pharmaceutical sector
metrology. This is why the orientation and impact of
PTB, the national metrology institute of Germany, is not Source of finance
restricted to the national borders. Federal Ministry for Economic Cooperation and
Development, Germany
PTB with its 2,000 staff members is rather a global
player in the world of metrology and faces the Commission value
responsibility involved for society, economy and science. 1,500,000 EUR
The international tasks of PTB include cooperation in all Implementing agency
kinds of metrological organizations (the Meter Background O
Physikalisch-Technische Bundesanstalt (PTB)
Convention being the most prominent example) and National Metrology Institute, Germany
During the past few years, a pharmaceutical industry has T
cooperation with national metrology institutes all over the
developed in East Africa which produces generics and its i
world. Furthermore, the PTB International Technical Term
own pharmaceutical products. The pharmaceutical sector i
Cooperation advises and supports the conceptual design March 2013 until February 2016
thus contributes to improve the medical care for the t
and practical implementation in the establishment of
the quality infrastructure in developing and transition population and to reduce imports of pharmaceutical
Contact
countries. products. Most pharmaceutical enterprises are only
EAC Secretariat
allowed to produce for their own domestic market. They
Ms. Jane Mashingia
The clients of the Technical Cooperation projects are are excluded from tendering for the large-scale orders of
Health Department
donors such as the WHO because they cannot prove that C
above all the Federal Ministry for Economic Cooperation Directorate of Productive and Social Services
and Development (BMZ), which finances the majority they will comply with the respective quality standards.
jmashingia@eachq.org T
of projects with PTB participation, but also the European For the approval and market surveillance of pharmaceuti-
www.eachq.org
Union, the World Bank and other organizations. For the cals in the member states of the East African Community
implementation of projects a network of strategic partners (EAC), special regulatory authorities and control
PTB Project Coordinator
is available. laboratories are responsible.
Tobias Diergardt
Phone: +49 531 592 8228
All in all, the global networking of PTB has one major
objective: the international harmonization of quality
Fax: +49 531 592 8225
tobias.diergardt@ptb.de
infrastructure and its mutual acceptance. http://www.ptb.de/q5
updated: 04/2013
The Quality Infrastructure in the region is not well
adapted to the requirements of the pharmaceutical
sector. There are shortcomings as regards the number
Physikalisch-Technische Bundesanstalt
of trained quality managers and service technicians, the
Bundesallee 100
calibration
38116 of laboratory
Braunschweig, Germanyequipment, the capacity to carry
out comparison measurements and the availability of
www.ptb.de
reference materials.
The EAC has an interest in supporting the pharmaceutical
industry. This is reflected by the fact that the health
ministers of the EAC states have approved the EAC
Regional Pharmaceutical Manufacturing Plan of Action
(RPMPOA).
 PTB in brief Project Data
Establishment of a regional Quality Infrastructure for the
A globalized international economy calls for globalized pharmaceutical sector
metrology. This is why the orientation and impact of
PTB, the national metrology institute of Germany, is not Source of finance
restricted to the national borders. Federal Ministry for Economic Cooperation and
Development, Germany
PTB with its 2,000 staff members is rather a global
player in the world of metrology and faces the Commission value
responsibility involved for society, economy and science. 1,500,000 EUR

The international tasks of PTB include cooperation in all Implementing agency

Objectives kinds of metrological organizations (the Meter Physikalisch-Technische Bundesanstalt (PTB)
Convention being the most prominent example) and National Metrology Institute, Germany
The overall objective of the project is to contribute to the
cooperation with national metrology institutes all over the
implementation of the RPMPOA and to improve quality
world. Furthermore, the PTB International Technical Term
infrastructure services (QI) in the region in such a way that
Cooperation advises and supports the conceptual design March 2013 until February 2016
they meet the demand of the pharmaceutical sector.
and practical implementation in the establishment of
the quality infrastructure in developing and transition Contact
countries. EAC Secretariat
Ms. Jane Mashingia
Components of support The clients of the Technical Cooperation projects are Health Department
Objectives above all the Federal Ministry for Economic Cooperation Directorate of Productive and Social Services
The project focuses on the following areas: and Development (BMZ), which finances the majority jmashingia@eachq.org
The overall objective of the project is to contribute to the of projects with PTB participation, but also the European www.eachq.org
implementation
Strengthening of of theproducers
local RPMPOA and to improve
capacity to meetquality
WHO- Union, the World Bank and other organizations. For the
r infrastructure
GMP and WHOservices (QI) in thestandards
prequalification region in(focus
such aon
way that implementation of projects a network of strategic partners PTB Project Coordinator
they meet the demand
calibration and validation)of the pharmaceutical sector. is available. Inspection of a pharmaceutical production site Tobias Diergardt
Phone: +49 531 592 8228
Developing the capacities of pharmaceutical control All in all, the global networking of PTB has one major Fax: +49 531 592 8225
laboratories (through comparison measurements and objective: the international harmonization of quality tobias.diergardt@ptb.de
provision of reference material) infrastructure and its mutual acceptance. http://www.ptb.de/q5
Components of support Project Partners
Supporting market surveillance in partner states in the
The project focuses on the following areas: The project is an integral part of the German develop-
- prevention of inferior quality
ment program Support of the EAC Integration process.
Strengthening of local producers capacity to meet WHO-
GMP and WHO prequalification standards (focus on It is implemented in cooperation with the EAC
Inspection of a pharmaceutical production site
calibration and validation) Secretariat, its Health Department, which is part updated: 04/2013

of the Directorate of Productive and Social Services.

Developing the capacities of pharmaceutical control
laboratories (through comparison measurements and
provision of reference material)
Supporting market surveillance in partner states in the
prevention of inferior quality
HPLC for the analysis of pharmaceutical
substances
Beneficiaries are the National Medicines Regulatory
Agencies and their control laboratories as well as
the local pharmaceutical manufacturers who are
Project Partners
organized in the Federation of East Africa Pharmaceutical
Manufacturers.
The project is an integral part of the German develop-
ment program Support of the EAC Integration process.
Physikalisch-Technische Bundesanstalt
It is implemented in cooperation with the EAC Bundesallee 100
38116 Braunschweig, Germany
Secretariat, its Health Department, which is part www.ptb.de
of the Directorate of Productive and Social Services.
Beneficiaries are the National Medicines Regulatory
Agencies and their control laboratories as well as
the local pharmaceutical manufacturers who are
organized in the Federation of East Africa Pharmaceutical
Manufacturers.

HPLC for the analysis of pharmaceutical

substances
l

Federation of East African Pharmaceutical Manufacturers (FEAPM) | Yearbook 2012 35

 Cheap drugs from
Asia push Tanzanian
Pharmaceutical firms to
think regional, demand
action nationally.
By ZEPHANIA UBWANI
Pharmaceutical manufacturers in Tanzania are push-
ing for friendly regulation to ease their expansion
to other East African states as stiff competition from
Asian firms continue to squeeze their space in the do-
mestic market.
Most of the drugs on shelves are from India, the Asian
nation which produces relatively cheaper drugs and
has successfully taken advantage of Tanzanias open
market policy to grow its market share, industry play-
ers say.
The Tanzania Food and Drug Authority (TFDA) is the
only body that approves importation of pharmaceuti-
cals and also screens locally produced drugs.
Its Director-General Hiiti Sillo says the country im-
ports about 70 per cent of its pharmaceuticals, the
remaining 30 per cent being sourced from four local
plants.
While the regulator maintains it tests all drug sam-
ples to ascertain their safety, efficacy, quality and
conformity to Good Manufacturing Practice (GMP),
manufacturers have taken issue with the countrys
open-trade policy.
We have TFDA as our watchdog to control im-
portation but experience has shown it can-
not stop such pharmaceuticals getting into the country,
says Dr Mansoor Daya, the managing director of
Mansoor Daya Chemicals Limited, one of the oldest
manufacturing chemists in Tanzania.
The TFDA has since built a Sh2.7 billion testing labo-
ratory for food and drugs in its effort to rid domestic
36
market of counterfeits and substandard drugs. Like
other EAC countries, Tanzania has been grappling
with counterfeit and sub-standard drugs, mostly im-
ports.
When he inaugurated the new facility in March this
year, President Jakaya Kikwete said the government
was committed to drive fake goods out of the local
market.
It is highly risky to the health and safety of con-
sumers when products are manufactured without
being inspected by relevant authorities to authenticate their
standards, President Kikwete said. The remarks were
shared by Mr Sillo. He said that the new laboratory
had come at the right time for the fight against fake
products in the country.
Counterfeit goods do not only
infringe the eco-
nomic interests of the individual rights, but they also pose
a threat to economic interests of society, Mr Sillo said.
To promote local production, the government gives a
15 per cent preferential treatment to the local manu-
facturers in every tender floated publicly.
Despite these efforts, the local manufacturers still ex-
pect the Government to lead the way in lowering cost
of production and openly encourage use of locally
produced drugs in public health facilities.
The immediate steps should include restricting im-
port of medicines that can be produced locally and
removing value added tax (VAT) which makes the
domestic products uncompetitive in the region, says
Dr Daya.
At the moment, the government charges VAT on raw
materials mostly the active ingredients for making
pharmaceuticals. These active ingredients not avail-
able in most of the sub Saharan African countries
meaning manufacturers in Tanzania will always have
to import them from abroad.
Similarly, the government also charges VAT on pack-
aging materials for medicines. While Tanzania Rev-
enue Authority allows manufacturers to claim these
charges, the VAT refund procedure is tedious and
takes a long time to accomplish.
Industry players also cite high interest rates of banks
among the factors that drive up their cost of opera-
tions. Banks also take too long to process the loans,
delaying procurement of raw materials from abroad
and consequently the actual production, says Dr
Kishor Athalye, operations manager of Zenufa Labo-
ratories Limited, a Dar es Salaam-based pharmaceuti-
cal plant.
Dr Athalye feels the government is not doing much
at the moment to protect the local pharmaceutical in-
dustry against the giants from Asia, notably India and
China which enjoy economies of scale in their opera-
tions.
And while the 140 million-people EAC market looks
inviting from the outside, Tanzania has to press for
harmonisation of pharmaceutical practices in the re-
gion to create a fair play ground against their coun-
terparts in Kenya.
Tanzania has only four licensed pharmaceutical
plants but these have met numerous administrative
hurdles in their efforts to cross the border and set up
shops in the neighbouring Kenya which has about 40
such firms.
Kenya is a big producer but let the peo-
ple decide on what to buy and
where to get it from, Dr Daya said in an interview, not-
ing that despite having been in the industry in the last
50 years, he still finds registration of Tanzanian-made
pharmaceuticals in Kenya a frustrating exercise due
to long time it takes.
These views were shared by Dr Athalye who insisted
that it was still difficult to export to countries within
the EAC region such as Kenya despite the launch of
Common Market Protocol in July 2010.
Federation of East African Pharmaceutical Manufacturers (FEAPM) | Yearbook 2012
Selling pharmaceutical products from
one country to the other in East
Africa remains only in theory. Registration of products in
another country takes a long time, is cumbersome and has
proved to be another barrier to intra-regional trade, said
Dr Athalye.
The TDFA, however, has a different take on what
manufacturers see as frustrating red tape placed on
the way of investors seeking to expand regional pres-
ence.
Each country - Tanzania, Uganda and Kenya - has dif-
ferent regulatory regimes which have not been har-
monised, he says.
Many times, manufacturers are not able to
comply with the required standards.
When we start acting against such inconsistencies, they
blame us, he said.
The quality, safety and efficacy of medicines
should not be compromised in any way
whether drugs are imports or manufactured locally.
He however expressed optimism that harmonisation
of medicines regulatory systems in East Africa under
the NEPAD-financed project would yield positive re-
sults in the blocs fight against fake and substandard
drugs as well as serve as a model for other African
countries.
The project which started last year, seeks to stand-
ardise quality, standards, regulations and laws in
the broader quest to check movements of counterfeit
drugs in Tanzania.
In all these plans, the local manufacturers see Fed-
eration of East African Pharmaceutical Manufacturers
(FEAMP) as an active partner. The lobby is expected
to work closely with the EAC Secretariat and partner
states in promoting dialogue on health care and phar-
maceutical industry issues and practices.
The federation should find us cheap and sub-
sidised finance. It should also assist us
get the required technical staff. Trained pharmacists in the
region do not want to join manufacturers but want to start
own pharmacy shops to make more profits than in jobs,
Dr Athalye said, adding that Zenufa Laboratories has,
for instance, been forced to recruit experts from India
after failing to get the locals who have opted to work
outside the manufacturing plants.
37
 A Regional Bioequivalence Center in Eastern Africa
The first regional Bioequivalence Center in East-
ern Africa, based in Addis Ababa, was officially
inaugurated on November 14th by His Excellen-
cy Tadesse Haile, State Minister of the Ministry
of Industry of the Federal Republic of Ethiopia.
When GIZ, on behalf of the German Govern-
ment, started its program of support to the lo-
cal production of pharmaceuticals in developing
countries in 2002, there was general scepticism
among experts regarding the possibility of pro-
ducing high quality medicines in Africa. There
were also doubts
about the eco-
nomic feasibil-
ity of producing
medicines local-
ly, as companies
from industri-
alised countries
as well as from
China and India
are able to pro-
vide any drug,
and Indian com-
panies can do so
at a very com-
petitive price
level.
Of course, many companies all over the devel-
oping world have been producing pharmaceu-
ticals for their local markets, but it has not been
possible for them to serve international markets,
as their quality management systems were gen-
erally not accepted internationally. This was
for good reasons in many cases - the quality of
such drugs was lacking and a large amount of
substandard and counterfeit drugs were on the
markets. However, the management and staff
of some African pharmaceutical manufacturers
had internalised the needed quality thinking
and, after some intensive training and several
test audits, were able to guarantee the quality of
their products using up-to-date quality manage-
ment systems. This is now the case for almost a
dozen companies spread across several African
countries, and this figure is growing rapidly.
Nevertheless, compliance with the current WHO
Good Manufacturing Practice standards is only
38
the first step to global market competitiveness.
In order to sell a generic internationally, it is also
necessary to demonstrate that the generic drug
acts in the human body the same way as the
originator does. From an ethical perspective, it
is not acceptable to run through all of the same
clinical trials for registration if the new medicine
has the same active pharmaceutical ingredient
in the same concentration and combination of
ingredients as the originator. If the toxicity of
the substance is low, simple laboratory testing
may suffice. However, in most cases, producers
of generic drugs
must demon-
strate bioequiv-
alence, which
means that the
drugs active
substance pass-
es the intestine/
blood barrier in
the same quan-
tity and speed
as the original
drug and shows
the same char-
acteristics in the
body.
Undertaking a bioequivalence study requires a
clinic and a lab that is able to analyse substances
in blood plasma on a very low concentration and
in a reproducible manner. While this is not par-
ticularly advanced science, currently only labo-
ratories in high- and middle-income countries
are able to provide such studies. To do a bio-
equivalence study in South Africa or India, not
to mention industrialised countries, is expensive
(starting at USD 100,000) and takes considerable
time due to long waiting lists. A bioequivalence
center in sub-Saharan Africa would reduce this
cost by up to 50% as well as speeding up the pro-
cess.
With this in mind, GIZ discussed the possibility
of constructing a bioequivalence center in Africa
with its partners in 2008. Two German experts
on bioequivalence carried out a feasibility study,
interviewing numerous stakeholders through-
out Eastern Africa and several international ex-
perts. The results of the study were discussed in
workshops in Ethiopia and Kenya. The experts
ultimately reached the conclusion that a bio-
equivalence lab in Africa was technically and
economically feasible, and proposed Addis Aba-
ba as the right location for it. With the results of
the feasibility study confirmed, and several Af-
rican firms already interested in investing in the
project, GIZ successfully solicited co-financing
from the German Government.
The German Government worked with a range
of public and private partners to make the Re-
gional Bioequivalence Center in Eastern Africa a
reality. These include pharmaceutical manufac-
turers from Germany, Kenya and Ethiopia, Ad-
dis Ababa University as public partner and host
of the Bioequivalence Center, the Governments
of Ethiopia and Kenya, the World Health Or-
ganisation and several elements of the German
Development Cooperation.
The Regional Bioequivalence Center has been
registered as a shared company under Ethiopian
law. The staff is now in training on the job and in
Germany, and the instruments for the lab have
been installed and qualified. The Centers next
steps are to undertake its first pilot studies and,
after up to two years, to be audited and hopeful-
ly certified by the WHO. The real research work
MPD is the only one drug manufacturing plant in Rwanda | Thirty years of drug manufacturing and Quality
RWANDA BIOMEDICAL CENTER
P.O. Box 340, Butare / Rwanda | Tel.: (+250) 252 530 164/155 | Fax: (+250) 252 530 416
www.rbc.gov.rw | mp@ rbc.gov.rw
Federation of East African Pharmaceutical Manufacturers (FEAPM) | Yearbook 2012
case studies [] demonstrate the
essential value of regulatory systems
to low- and middle-income countries.
When they work, people live; when
they fail, people die. As the challenges
of globalization mount, and efforts to
provide medical products to low- and
middle-income countries scale up,
there is no better time to put regulatory
system strengthening squarely on the
global health and development agenda.
Lets contribute to this effort.
Charles Preston, USFDA
begins after being certified as a WHO-prequali-
fied Contract Research Organisation (CRO).
The importance of a regional, African Bioequiva-
lence Center cannot be underestimated. It will
contribute to the overall development of the
pharmaceutical sector in Africa, and thus to bet-
ter, high quality drugs for Africa, produced in
Africa.
Medical Production Division
The mission of RBC is to promote quality affordable and sustainable health care
services to the population through innovative and evidence based interventions
and practices
The mission of Medical Production Division (MPD )is providing enough quantity
of generic essential drugs with great therapeutic effectiveness at affordable
prices to all layers of the population of Rwanda
Other lines: Tablets, Capsules, Suspensions, Ointments & Supporitories
Production Lines Infusions:
Dextrose 5%; Normal Saline 0,9%; Lactated Ringer
Quality Control Laboratory:
QC tests for starting materials, in-process and finished products
Testing Methods: Physical and physicochemical methods, chemical
methods, biological methods, methods for materials of plant origin, phar-
maceutical technical procedures.
39
 The Ugandan
pharmaceutical industry
places its bet on FEAPM to
lobby for friendly business
environment in East Africa.
By Walugembe Moses Tusubira
Ugandas drug industry is counting on a strong
regional lobby group to mobilise capacity sup-
port as insufficient skilled labour, high opera-
tion costs and conflicting regulation restrict their
growth.
Nazeem Mohammed, CEO of Kampala Pharma-
ceutical Industry (KPI) says last years formation
of Federation of East African Pharmaceutical
Manufacturers (FEAPM) was a significant step
towards consolidating support for the industry.
The KPI, together with Abacus Parenterals
Drugs Limited and Quality Chemical Industries,
form Ugandas manufacturing base. The KPI
produces a range of over 50 registered products,
including paracetamol and drugs used in the
treatment of Malaria, Diabetes and Hyperten-
sion.
Now we have one strong voice for the
industry which can be used to cre-
ate or change policies to build a strong pharmaceuti-
cal sector in East Africa.
My expectation is that FEAPM becomes a powerful
body that is able to influence the legislators in EAC
to increase support for local manufacturing, said
Mr Mohammed.
At the moment, the pharmaceutical industry
is grappling with an unfair competition in the
domestic market, mainly posed by cheap drugs
from China and India.
The conflicting regulations in East Africa as well
as the high cost of running factories, driven by
40
prices of importing raw materials and rising cost
of utilities, have been cited as top industrys con-
cerns.
Industry stakeholders estimate that locally pro-
duced drugs now constitutes between 10 and
25 percent of medicines procured annually in
Uganda.
A report produced by the United Nations Indus-
trial Development Organisation (UNIDO) indi-
cates that by 2010, the country was importing
more than 90 per cent of its essential medicines
and health supplies, mainly from India and Chi-
na.
The pharmaceutical industry in Ugan-
da is still young and has a number
of challenges, says Moses Kamabare, General
Manager, National Medical stores.
We would want to give them the opportu-
nity and are on record as having given
them enough tenders, he said, citing the purchase
of IV fluids from Abacus Parenteral Drugs Lim-
ited in a bid to protect local industries.
Such preferential treatments are extended with
clear understanding that India, the local firms
key competitor, has a mature manufacturing
base that local cannot match.
Pharmaceuticals
in India receive subsidies on utilities such as water
and electricity which are necessary for survival of
local manufacturers to enhance cheap export produc-
tion and this is what Uganda needs to borrow, Mr
Kamabare said. This is because there are other benefits
that accrue and outweigh the 15%
that government and people of Uganda get from buy-
Mr Mohammed agrees: ing in Uganda than buying from India or China,

Indian and Chinese companies can

export finished pharmaceuti-
says Kamabare.

cal products to the East African region at artificially

low prices because these companies get subsidies
from their governments.
Ms Kate Kikule, Chief Inspector, Uganda Na-
tional Drug Authority said numerous factors
dictate the level of support needed to promote
local pharmaceutical production.
These, she said, range from policies that favour
locally manufactured medicines like investment
policies, tax waivers for imported raw materials
and equipment, to health policies that favor lo-
cally manufactured medicines.
There could also be restrictions on imports, in-
troduction of higher verification fees for import-
ed medicines, and provision of incentives for ex-
port of locally manufactured medicines.
We are also of the opinion that if there are
products not manufactured in Ugan-
da but within the East African Community member
states, they should also be given preference above
other foreign products, Mr Kamabare said.
Martin Olowo, Chief pharmacist at the Ministry
of Health commends the local manufacturers for
having provided some relief and security to
the potential challenges related to low availabil-
ity of medicines in Uganda.
Their medicines have significantly in-
creased access to medicines in
the EAC, he said, adding strengthening qual-
ity assurance and management systems of local
manufacturers would help increase their share
the regional market.

Investment in skilled hu-

man resource for
FEAPM should now work as a
catalyst for industry
growth in the region so that they impact on future
pharmaceutical manufacturing and creation of pos- policy development processes both at national and
sibly free trade zones must also be a focus, she said. regional levels, said Mr Olowo.

So far, the local manufacturers enjoy technical
support to develop and register their products.
Such support has been in form of training in cur-
rent Good Manufacturing Practice, Ms Kikule
said, adding the regulator also charges lower
fees for registration of locally produced drugs
and licensing of premises.
For all these plans to materialise, says Nazeem
Mohammed, there has to be the political will to
make the right policies. This way, Uganda could
seize the obtaining opportunity to build a for-
midable pharmaceutical manufacturing base,
eventually reducing reliance on imports and
creating an export-based sector at home.

She wants the FEAPM to advocate and lobby

for policies in all relevant ministries that would
assist in increasing the market share of locally
manufactured medicines.

On its part, the national procurement agency is

already pledging its support to the new body.

For us, we have been engaging them,

having started by giving them mar-
ket. All we want is for them to maintain the flow, if
they can, then why not support them by buying their
bulk of products, Mr Kamabare.

He said the Government had submitted to par-

Mrs Kate Kikule Chief Inspector National Drug Authority-
liament an amendment in the law of procure-
Uganda during her Interview with Moses Tusubira Walubenge
ment in which local companies would be given
a 15 percent margin of preference once passed.

Federation of East African Pharmaceutical Manufacturers (FEAPM) | Yearbook 2012 41

 Education and Training for the East African Pharmaceutical Sector
Various studies have pointed out that there is
a serious shortage of healthcare workers and
pharmaceutical personnel in the East African
Community (EAC). For instance, the Tanzanian
population of over 40 million is served by only
about 1,000 registered pharmacists, 650 phar-
maceutical technicians and 350 pharmaceuti-
cal assistants. With a density of 0.02 pharma-
ceutical personnel per 10,000 people, Tanzania
and Burundi are among the most underserved
countries in sub-Saharan Africa in this regard.
Burundis density (0.10) is also low, Uganda
(0.26) lies near the middle, while Kenya (1.00)
has the ninth highest density in sub-Saharan
Africa. Kenya thus sets an example for the rest
of the region, while countries such as Botswana
and Namibia, with densities of 1.8 and 1.9 per
10,000, set standards for the EAC as a whole to
aspire to. South Africa, with 2.8, and Vietnam,
with 3.2 pharmaceutical personnel per 10,000
people, may represent longer-term targets for
the region.
A total of 34 universities and colleges in the
EAC offer pharmaceutical training at different
levels ranging from certificates to PhDs. Eleven
of these offer bachelors degrees and four offer
postgraduate training. Besides training a low
number of general pharmaceutical staff, most of
these institutions do not specialise on the spe-
cific requirements attached to pharmaceutical
manufacturing. Indeed, training targeting phar-
maceutical engineers is missing altogether in the
region. Most institutions lack teaching person-
nel with industry experience, well-equipped
and well-maintained laboratories and libraries,
industrial hands-on training facilities and prop-
er internship agreements with the manufactur-
ing industry.
As a result, most pharmaceutical manufacturers
still have to recruit highly professional staff such
as operations managers or quality assurance
officers from abroad. In addition, companies
complain that those professionals hired after
graduating from one of the regions institutions
normally lack practical know-how and require
extensive in-house training as well as external
professional training courses.
In the eyes of East African manufacturers, de-
42
velopment partners and educational institutions
alike, a critical gap thus exists in training for
industrial pharmacists and technical pharma-
ceutical staff. Addressing this human resource
gap should constitute a central part of the EACs
efforts to help pharmaceutical manufacturers
achieve World Health Organisation (WHO) pre-
qualification and assist the sector as a whole in
enhancing access to safe, efficacious and afforda-
ble medicines in the region. This can be done by
improving and expanding university courses to
produce a higher number of well-trained gradu-
ates for the pharmaceutical industry on the one
hand, and providing focused short-term profes-
sional trainings for pharmaceutical manufactur-
ing personnel on the other hand.
University Courses
The general shortage of locally trained pharma-
ceutical staff can be addressed by expanding
the capacity of university courses to educate a
greater volume of students. In terms of qual-
ity enhancement and regional integration, an
important initiative is currently underway to
standardise pharmaceutical education in the re-
gion at the EAC Secretariat in the form of cur-
ricula harmonisation. However, further work is
needed in several areas.
Based on experience and exchange with local
manufacturers, the GIZ-EAC Program experts
specifically point to a need for more professors
who have practical experience in pharmaceutical
manufacturing and better-equipped laboratories
to enable hands-on training with up-to-date in-
dustry standard equipment as well as practical
laboratory research training. Training institu-
tions, public and private funders, and pharma-
ceutical manufacturers should also collaborate
to expand internship programs in order to bring
students of pharmacy closer to the industry.
Enhancing university courses
n I ncreased admissions volumes
n L abs with industry standard equipment
n P  rofessors with industry experience
n I  ndustry internships
Federation of East African Pharmaceutical Manufacturers (FEAPM) | Yearbook 2012 43
 Post-university trainings

Short professional training courses on spe-
cific aspects of quality drug manufacture can
likewise empower pharmaceutical personnel
to help their firms produce medicines to inter-
national quality standards. The success of any
such course depends on the companies ability
to give their employees leave of absence in or-
der to attend. A survey of East African pharma-
ceutical manufacturers showed that a combina-
tion of weekdays and weekend days would be
best suited. This would mean that employees
miss fewer working days and that the costs are
shared between the company and the trainee -
the company pays for travel expenses and fees
while the employee sacrifices her weekend. The
majority of companies surveyed favoured train-
ings lasting between three days and one week,
depending on the amount of practical training
involved.
Model Institutions
Future efforts to enhance training provision
for pharmaceutical manufacturing may draw
inspiration from the St. Luke Foundations In-
dustrial Pharmacy Training Unit (IPTU), its host
institution, the Kilimanjaro School of Pharmacy
(KSP), in Moshi, and the Pharm R&D Lab at the
Muhimbili University of Health and Allied Sci-
ences (MUHAS) School of Pharmacy in Dar es
Salaam, Tanzania.
KSP, the only pharmaceutical training institu-
tion in Tanzania that is accredited by the Nation-
al Council for Technical Education (NACTE),
offers a three-year training program for phar-
maceutical technicians (level 6) and a four-year
program for pharmaceutical assistants (level 5).
In addition, KSP collaborates with Purdue and
Howard Universities to offer the Industrial
Pharmacy Advanced Training Program (IPAT).
This consists of short courses for pharmaceuti-
cal producers in drug research and develop-
ment, manufacturing and quality compliance.
The IPAT also offers courses for regulatory au-
thorities. The high demand among manufactur-
ers for the IPAT shows that knowledge transfer
from abroad to this region is highly needed and
appreciated by the regional pharmaceutical in-
dustry.
The IPTU is available for teaching, trainings and
pharmaceutical development studies (e.g. scale-
up batches up to 50kg). It is a model factory
where students and professionals can be trained
in a fully functional Good Manufacturing Prac-
tices (GMP) compliant production environment
with a variety of older (e.g. mixers) and state-of-
the-art (e.g. tablet coating) machines that reflect
the industry standards in place.
With support from the Deutsche Gesellschaft
fuer Internationale Zusammenarbeit (GIZ)
GmbH and Action Medeor, The Pharm R&D
Lab at MUHAS also offers short courses for
pharmaceutical professionals in a state-of-the-
art laboratory used by regional manufacturers
for pharmaceutical research and development.
Similar to the IPAT at Kilimanjaro School of
Pharmacy, a range of specialised courses on
aspects of drug development, production and
quality assurance are on offer.

Main subject areas in need of additional training provision

n Theory and practice of tablet production, esp. granulation,
coating and compression
n Advanced sterile production of i.v. medicines.

n Calibration/validation and QA systems

n Advanced Good Manufacturing Practices (GMP)

n Advanced engineering/tool setting

n Water analysis/water systems and other analytical questions

44
The Way Forward
The success of the EAC regions pharmaceutical
manufacturing industry depends on the ability
of all involved stakeholders to close the current
human resource gaps. The opportunities for
progress in this area are clear and multi-facet-
ed targeted investment in the regions higher
education infrastructure will not only enable
manufacturers to more effectively provide qual-
ity, safe affordable drugs to East Africas pop-
ulation, but also build lasting local capacity in
a crucial sector moving towards international
competitiveness.
Pharmaceutical manufacturers have already
identified the key areas in which more and
better training is needed, as well as the sort of
Federation of East African Pharmaceutical Manufacturers (FEAPM) | Yearbook 2012
post-university trainings they would be willing
to invest in. Likewise, experts have laid out the
necessary interventions needed to help univer-
sities empower their students to be true assets
to the regional pharmaceutical industry. Finally,
any future initiatives may draw inspiration and
information from two outstanding training in-
stitution already providing targeted enhanced
training for the East African pharmaceutical sec-
tor. The door is thus wide open for more collabo-
ration between manufacturers, training institu-
tions, governments and development partners
to bolster the pharmaceutical sectors local hu-
man resource base by investing in pharmaceuti-
cal education in the region.
45
 Saint Luke Foundation
Our History:
In 1977 Georg Kamm s
Infusion Units Program osmosis - an energy sav
Kilimanjaro Tanzania. S
Kilimanjaro School of Pharmacy of intravenous fluids,
Zacharias Nkya, his fi
A Trust of the Evangelical Lutheran Church of Tanzania install similar units in oth
Training and Support Services Units Project was born.
for Pharmaceutical and Health Systems
From the beginning tra
equipment, profession
retraining, preventive m
spare parts and consu
project.
The program for hosp
supported by the Evang
and Mission OneWorld (
long term cooperation wi
started with regular
technology and standa
German Institute for Med

OUR MISSION:
WE ENHANCE HEALTH
IN DEVELOPING COUNTRIES THROUGH
APPROPRIATE INNOVATIVE SERVICES,
TRAINING & RESEARCH,
BASED ON CHRISTIAN VALUES
OUR VISION:
TO ACHIEVE
SELF PRODUCTION, OWNERSHIP,
SELF RESPONSIBILITY & IDENTITY
LEADING TO
QUALITY HEALTH CARE FOR ALL
www.saintlukefoundation.co.tz
Founder Georg Kamm
In 1991 the base of the p
location near KCMC in
activities. In 2004, in the
ELCT Infusion Project wa
a Trust of the Evangelic
Main Objectives and Va
For the patients in ne
production should guara
infusions and other bas
compounds at affordable
Decentralised productio
Production according to e
by a self controlled unit, i
by continuous staff trainin
create the feeling of own
key values leading to loc

46
ndation The Organisation
Our History:
In 1977 Georg Kamm started the first infusion unit using reverse
am osmosis - an energy saving new technology- in Machame Hospital Pharmaceutical S
Kilimanjaro Tanzania. Seeing the success, continuous availability
armacy of intravenous fluids, neighboring hospitals asked him and
Zacharias Nkya, his first technician, for help. They started to
urch of Tanzania install similar units in other hospitals: the Decentralized Infusion
vices Units Project was born.
Systems
From the beginning training of the needed staff, standardized
equipment, professional installation, regular supervision and
retraining, preventive maintenance and supplies with quality
spare parts and consumables were essential elements of the
project.
The program for hospital based sterile production has been
supported by the Evangelical Lutheran Church in Germany (EED)
and Mission OneWorld (Bavarian Lutheran Church). In 1986 the
long term cooperation with the Medical Mission Institute Wuerzburg The Pharmacist Mr. Mu
started with regular consultancies focusing on appropriate teaching unit for hospit
technology and standards, followed by cooperation with the used also for practical
German Institute for Medical Mission in Tuebingen. School of Pharmacy
preparations in hospital
In this unit the 3 months
gram and refresher cou
training on eye drop
procurement of raw ma
here.

Technical Departm
Specialised technician
procurement of equipm
In the department the R
LTH Founder Georg Kamm Infusion Unit South TZ locally.
S THROUGH
In 1991 the base of the project moved from Machame to its present
SERVICES, location near KCMC in Moshi with sufficient space for additional
CH, activities. In 2004, in the course of the 25 years celebration, the
VALUES ELCT Infusion Project was transferred into Saint Luke Foundation,
a Trust of the Evangelical Lutheran Church of Tanzania.

Main Objectives and Values:

For the patients in need, the support of local, hospital based
production should guarantee the continuous access to life saving
NERSHIP, infusions and other basic pharmaceuticals like eye drops or other
DENTITY compounds at affordable prices.
Decentralised production opens elements of flexibility:
FOR ALL Production according to expressed demand, quality assurance The department perform
by a self controlled unit, improvement of knowledge and skills with an infusion produc
by continuous staff training, and independence from imports macist specialized in s
create the feeling of ownership and self reliance. These are them. If needed addition
on.co.tz key values leading to local capacity building.

Federation of East African Pharmaceutical Manufacturers (FEAPM) | Yearbook 2012 47

 The Organisation of SLF and activities
sion unit using reverse
- in Machame Hospital Pharmaceutical Services Department
continuous availability
tals asked him and
help. They started to
ecentralized Infusion

d staff, standardized
ular supervision and
supplies with quality
ential elements of the

production has been

rch in Germany (EED)
Church). In 1986 the
on Institute Wuerzburg The Pharmacist Mr. Muro and his team are responsible for the
sing on appropriate teaching unit for hospital based sterile production. This unit is
cooperation with the used also for practical training of students of the Kilimanjaro
ingen. School of Pharmacy including compounding courses of
preparations in hospital pharmacies.
In this unit the 3 months basic training courses for infusion pro-
gram and refresher courses are performed as well as practical
training on eye drop production. Also the professional
procurement of raw materials for the hospitals is coordinated
here.

Technical Department
Specialised technicians at the base are responsible for the
procurement of equipment and spare parts for each hospital unit.
In the department the Reverse Osmosis machines are assembled
Unit South TZ locally.
Machame to its present
nt space for additional
years celebration, the Technical
aint Luke Foundation, Department:
h of Tanzania. Assembling
and testing of
a new
local, hospital based RO- machine
access to life saving
ike eye drops or other

of flexibility:
quality assurance The department performs regular service visits to all hospitals
wledge and skills with an infusion production unit. At least once a year a phar-
ce from imports macist specialized in supervision and quality assurance joins
iance. These are them. If needed additional visits are organised.
ng.

48
Our Aim FEDERATION OF KENYA
To advocate for the strengthening of local pharmaceutical manufacturing of medicines so as to enhance PHARMACEUTICAL
sustain and expand the market share in Kenya, East African region and beyond medicines. MANUFACTURERS
Our Objectives
a) To promote and advocate for policy change that is friendly and providing higher incentive for domestic
pharmaceutical production.
b) To provide a platform for promotion of Local research and development in pharmaceutical sciences.
c) To engage stakeholders, and in particular regulatory agencies in the formulation of laws, regulations and
guidelines that inform and impact on good manufacturing practices.
d) To initiate, facilitate and establish contacts with similar associations worldwide.
e) To promote and represent the Kenya Pharmaceutical manufacturing Industry regionally and
internationally.
f) To keep member firms fully informed of all relevant developments affecting the pharmaceutical markets
in East Africa and beyond.
g) To conduct and liaise with training institutions whether public or private in order to enhance industrial
pharmacy awareness and emerging trends
h) To prepare main position papers for onward engagement with other stakeholders and in particular public officials upon request or own
motion on any matter that would affect and enhance the practice in the pharmaceutical manufacturing industry.

Membership to the Federation

Enterprise Road Mogadishu Road, off Lunga Lunga Rd. Lunga Lunga Rd Ind Area
Box 18171 Nairobi Industrial area Box 32040-00600 Nairobi
aesthetics@iconnect.co.ke Box 42569-00100 Nairobi info@biodeal.co.ke

Baba Dogo Rd, Ruaraka

Rangwe Road off Lunga Lung Road Road 'B' Off Enterprise Road
Box 16633-00620
Box 414333-00100 Nairobi Box 40411-00100 Nairobi
info@dawalimited.com
info@cosmos-pharm.com elys@africaonline.co.ke

Likoni Road Mombasa Road

Kikuyu Town Past Post Office, Box 1748-00902 Kikuyu Box 78392-00507 Nairobi Box 42875-00100 Nairobi
reception@ucl.co.ke william.mwatu@gsk.com info@laballied.com

MEDIVET PRODUCTS LTD Regal Pharmaceuticals Limited

P.O.BOX 47951 - 00100 Alpha Centre Off Mombasa Rd
Off Baba Dogo Road Ruaraka
NAIROBI Box 25453-00603 Nairobi
Box 44421-00100 Nairobi
info@medivetpl.com info@nerixpharma.com
info@regalpharmaceuticals.com
FACTORY - RUIRU TOWN

Junction of Dakar/Enterprise Road Old

North Airport Road; Box 68502-00622 Nairobi
info@osschemie.co.ke Box 47211-00100 Nairobi Limuru Road, P.O. Box 1287-Sarit
Centre, Nairobi Kenya.
pmc@africaonline.co.ke

Industrial Area
Box 56739-00200
Nairobi
info@skylightchemicals.co.ke

Federation of East African Pharmaceutical Manufacturers (FEAPM) | Yearbook 2012 49

 Quality Assurance Department In addition KSP offers f
Saharan pharmaceutica
The philosophy of SLF is to build quality into hospital produced
universities new advanc
drugs.
In cooperation with Purd
USA), supported by UN
Training Program (IPA
offered: Drug Developm
Manufacturing Process
Drug Approval Submissi
Industrial Pharmacy in
under preparation.

The team ensures compliance with professional specifications

for appropriate production equipment, production procedures
and in-process-control, for selection of quality raw materials &
re-analysis, and batch-release control of finished products.
Applying all these processes assures permanent quality.

Kilimanjaro School of Pharmacy (KSP)

The recognized need of
KSP was officially granted permission to engage in training the plan of the Industr
of pharmaceutical personnel by the Government of Tanzania building fully equipped f
through the Ministry of Health and Social Welfare in the year (GMP) under real produ
2000 and started enrolling first students in September 2002. It equipment. IPTU is also
is established as an institute under Saint Luke Foundation. collaboration with MUHA
KSP was granted Full Registration by the National Council for scale up of batches, sh
Technical Education (NACTE) after meeting the set criteria in BASF coating course.
2007 and Full Accreditation in September 2009 at National
Technical Award (NTA) Level 6.

Students of
the certificate
and diploma
course in
front of the
new
KSP building

Currently KSP offers training in Basic Technician Certificate for

Pharmaceutical Assistants (NTA Level 5) and Ordinary Diploma for
Pharmaceutical Technicians (NTA Level 6).

50
 In addition KSP offers for training of professionals from Sub-
Saharan pharmaceutical industries, regulatory authorities and
o hospital produced
universities new advanced training programs.

In cooperation with Purdue University and Howard University (both

USA), supported by UNIDO, the Industrial Pharmacy Advanced
Training Program (IPAT) consisting of 4 two-week courses is
offered: Drug Development, Regulatory Quality Compliance, Drug
Manufacturing Process (GMP), Regulatory Documents, Generic
Drug Approval Submissions and Drug Discovery. A MSc course for
Industrial Pharmacy in collaboration with the two universities is
under preparation.
Administration an
This unit deals with the a
base, financial managem
procurement, storage an
spare parts and the com
ional specifications
duction procedures
ity raw materials &
finished products.
nent quality.

(KSP)
The recognized need of a teaching unit for practical training led to
age in training the plan of the Industrial Pharmacy Teaching Unit (IPTU), a
ment of Tanzania building fully equipped for teaching Good Manufacturing Practices
lfare in the year (GMP) under real production conditions with a 50 kg batch size
eptember 2002. It equipment. IPTU is also used for pharmaceutical development in
e Foundation. collaboration with MUHAS for local pharmaceutical industries e.g.
tional Council for scale up of batches, short training courses e.g. FDA training or
the set criteria in BASF coating course.
09 at National

Students of
the certificate
and diploma
course in
front of the
new
KSP building
SLF, P.O.Box 481, Mos
Tel./ Fax: 00255-27-27
Cooperation partners: TFD
Mission EineWelt, MMI, G
Mary, Rotary Club Wuerzb
Bonn Germany, Mr. G. Ko
chnician Certificate for Pharmacist, Prof. Steve By
d Ordinary Diploma for Fortunak, Howard Univers
Pharmacists without Borde

Federation of East African Pharmaceutical Manufacturers (FEAPM) | Yearbook 2012 51

nals from Sub- KSP is
authorities and recognized by
ANDI as
Centre of
ard University (both Excellence in
armacy Advanced Drug
o-week courses is Manufacturing
y Compliance, Drug and Regulatory
ocuments, Generic Training to
y. A MSc course for serve the Sub
two universities is Saharan Africa.

Administration and Finance Department

This unit deals with the administrative activities of the
base, financial management of the organisation, logistics in
procurement, storage and distribution of raw materials,
spare parts and the communication with the partners.

ctical training led to

ng Unit (IPTU), a
ufacturing Practices
a 50 kg batch size
cal development in
tical industries e.g.
g. FDA training or

Planning for the

future:
Executive
Director SLF
Dr. B. Koehler,
Principal KSP
Mr. Wilson Mlaki

SLF, P.O.Box 481, Moshi, Tanzania,

Tel./ Fax: 00255-27-2752303 e-mail: infusion@kilinet.co.tz
Cooperation partners: TFDA, NACTE, MUHAS, DIFAEM, EED,
Mission EineWelt, MMI, GIZ, CIM, UNIDO, Medical Missionaries of
Mary, Rotary Club Wuerzburg Germany, Prof. Dr. K. Steffens, Univ.
Bonn Germany, Mr. G. Koerblein, Engineer, Dr. F. v. Massow,
Pharmacist, Prof. Steve Byrn, Purdue University USA, Prof. Joseph M.
Fortunak, Howard University USA, FDA, BEGECA, Falk, KSG, TTM,
Pharmacists without Borders Denmark

52
 MUHAS School of Pharmacy MU
Dar Es Salaam

Who we are: Our Expertise

A high tech teaching, research and development Tablet F

lab at the School of pharmacy, MUHAS Process
Various
Our Vision: Blister P

To become a Regional Centre of Excellence for Stability

practical training of pharmaceutical processionals Analytic
and offering Formulation Development,
Manufacturing Procedures, Scale-up Processes, Analytic
Stability Testing, Analytical testing and Equipme
Qualification and Validation services

What we offer:

Development of Solid Dosage Forms

Optimizing your Existing Formulations
Analytical and Stability testing services
Continued Education for pharmaceutical
Professionals
Practical Training for Technicians and
Students (B.Pharm., MSc., PhD)

Federation of East African Pharmaceutical Manufacturers (FEAPM) | Yearbook 2012 53

 acy MUHAS School of Pharmacy M
Dar Es Salaam

Our Expertise: Our Training

development Tablet Formulations, using Granulation Quality

AS Process or Direct Compression
Qualific
Various Granulation processes Manufa
Blister Packaging for Stability Trials Analytic

cellence for Stability Testing Develo

processionals Analytical method development and validation formula
nt, Fluid be
p Processes, Analytical Testing services
Tablett
nd Equipment qualification
Upcoming sh

Basic m
industry
rms Quality
Pharma
tions
vices
Tailor mad
eutical request.

and

54
acy MUHAS School of Pharmacy
Dar Es Salaam

Our Training Courses:

ation Quality assurance and quality control

Qualification and validation in Pharmaceutical
Manufacturing
s Analytical method development and Validation
Development and optimization of generic drug
d validation formulations
Fluid bed drying, granulating, coating and
Tabletting.

Upcoming short courses:

Basic machines Operator Course for Pharma

industry - May /June 2013
Quality Control and Quality Assurance of
Pharmaceuticals - November 2013.

Tailor made courses can be offered on special

request.

Federation of East African Pharmaceutical Manufacturers (FEAPM) | Yearbook 2012 55

 MUHAS School of Pharmacy MU
Dar Es Salaam
MUHAS School of Pharmacy M
Dar Es Salaam
Our Staff: Our Equipme

Dr. Eliangiringa Kaale, Senior Lecturer 2 Tablet

Equipme
Our Staff: Our
Tablet P
Dr. Vicky Manyanga, Lecturer
Dr. Eliangiringa Kaale, Senior Lecturer Fluid Be
2 Table
Mr. Prosper Tibalinda, Pharmaceutical
Tablet P
Formulation Scientist. Lecturer
Dr. Vicky Manyanga, Semi-au
Fluid Be
Ms
Mr.Ruth Ngwananogu,
Prosper Senior Pharmaceutical
Tibalinda, Pharmaceutical Various
Technician
Formulation Scientist. Semi-au
Blistering
Mr.
Ms Mhando Maro, SeniorSenior
Ruth Ngwananogu, Analytical
Pharmaceutical for Stabi
Various
Laboratory
TechnicianTechnician
Basic An
Blisterin
Mr.
Mr.Edson
MhandoLutta,
Maro,Analytical Laboratory
Senior Analytical Testing,
for Stab
Technician
Laboratory Technician
Laborato
Basic A
Ms
Mr.Bertha
EdsonFrancis, Senior Equipment
Lutta, Analytical Laboratory tablets
Testing
Maintenance
Technician Engineer
Laborat
Ms Bertha Francis, Senior Equipment tablets
Maintenance Engineer

56
cy MUHAS School of Pharmacy MU
Dar Es Salaam
acy MUHAS School of Pharmacy MU
Dar Es Salaam
Our Equipment: Please contact

rer 2 Tabletting Presses with various sets of

Equipment: Dr. Eliangiring
Our Please contac
Tablet Punches
School of Pha
urer 2 Tabletting
Fluid PressesDryer
Bed Granulator with various sets of
and Coater Dr. Eliangirin
cal Muhimbili Univ
Tablet Punches P.O. Box 6501
Semi-automatic Capsule Filling Machine School of Ph
Fluid Bed Granulator Dryer and Coater Dar Es Salaam
tical
rmaceutical Muhimbili Un
Various Equipment for In-process Controls Tanzania
Semi-automatic Capsule Filling Machine P.O. Box 650
Blistering Machine for Packaging of Samples Dar Es Salaa
armaceutical Various
for Equipment for In-process Controls Tel +255 22 2
Stability Trials Tanzania
Fax +255 22 2
Blistering
Basic Machine
Analytical for Packaging
equipment of Stability
including Samples elia.kaale@m
al Tel +255 22
ory for Stability
Testing, Trials
HPLCs, Dissolution apparatus Fax +255 22
Basic Analytical
Laboratory equipment
mini-coater including
for film coating Stability
of
http://www.m
elia.kaale@m
tory
nt Testing,
tablets HPLCs, Dissolution apparatus
The lab was e
http://www
Laboratory mini-coater for film coating of technical supp
ent tablets
The lab was
technical sup

Federation of East African Pharmaceutical Manufacturers (FEAPM) | Yearbook 2012 57

 acy MUHAS School of Pharmacy
Dar Es Salaam

of Pharmacy MUHAS School of Pharmacy

alaam Please contact us:Dar Es Salaam

sets of Dr. Eliangiringa Kaale

Please contact us:
School of Pharmacy
oater
th various sets of Dr. Eliangiringa
Muhimbili Kaaleof Health and Allied Sciences
University
achine P.O.School
Box 65013
of Pharmacy
ryer and Coater Dar Muhimbili
Es Salaam, University of Health and Allied Sciences
eControls
Filling Machine Tanzania
P.O. Box 65013
Dar Es Salaam,
of Samples
n-process Controls Tanzania
Tel +255 22 2151244
Packaging of Samples Fax Tel
+255 22222150465
+255 2151244
ng Stability elia.kaale@muhas.ac.tz
Fax +255 22 2150465
ment including Stability elia.kaale@muhas.ac.tz
ratus
ution apparatus
ating
http://www.muhas.ac.tz/pharmrd/
http://www.muhas.ac.tz/pharmrd/
for filmofcoating of
TheThe
lablab
waswasestablished with
established with financial
financial and and
technical support
technical support fromfrom

58
Investment Promotion Centres in the East African Community

Burundi - www.investburundi.com

Burundi is characterised by a high dependence on pharmaceutical imports (approximately 95%). Con-

sumers still have a relative negative perception towards locally manufactured medicines. However,
the government has recognised these challenges and endeavoured to attract investors into Burundis
pharmaceutical sector by passing the National Pharmaceutical Policy, which gives the National In-
stitute of Public Health the mandate to regulate all locally produced medicines. This is aimed at en-
hancing quality and restoring consumer confidence in locally manufactured pharmaceutical products.
Burundi is of course also part of the mentioned regional pharmaceutical sector promotion projects.

The Burundi Investment Promotion Agency (API - Agence de Promotion des Investissements) pro-
vides assistance to investors though information on the pharmaceutical sector as well as the acqui-
sition of documents needed to conduct business in Burundi. Potential investors are encouraged to
explore the more or less untapped pharmaceutical sector in Burundi and at the same time enjoy the
advantages of regional economic integration in the EAC.

Federation of East African Pharmaceutical Manufacturers (FEAPM) | Yearbook 2012 59

 Kenya - www.investmentkenya.com

As a Developing Country (DC), Kenya is currently the only non-LDC (Least Developed Country) in
the EAC. Kenya is not only the largest producer of pharmaceutical products in the EAC but also in the
Common Market for Eastern and Southern Africa (COMESA). Kenya is also active in medical and in-
dustrial research through key research bodies such as the Kenya Medical Research Institute (KEMRI),
Kenya Industrial Research and Development Institute (KIRDI) and medical faculties of various public
and private universities.

Kenyas policy offers patent protection for pharmaceuticals based on the African Regional Intellectual
Property Organisation (ARIPO) patent system. The Kenya Industrial Property Bill passed in 2001 also
allows for the importation and production of more affordable medicines. Besides manufacturing phar-
maceuticals for both local and international markets, Kenyas pharmaceutical sector is also involved in
making disposable syringes and surgical gauzes as well as in assembling capsules.

Membership in regional bodies like COMESA and the East African Community (EAC) provides Ken-
ya with preferential access to regional markets and reduced tariffs for its pharmaceutical products.
Kenya exports its medicinal and pharmaceutical products to Uganda, Burundi, Tanzania, Rwanda, the
Comoros, DRC, Ethiopia and Malawi among other countries.

Taking this into consideration, the Kenya Investment Authority has endeavoured to support the phar-
maceutical sector through investment promotion targeting both domestic and foreign investors. There
is high potential in the pharmaceutical sector and KenInvest encourages investors to take up opportu-
nities in the following key pharmaceutical areas:

n  rocessing traditional medicines for commercial purposes using the diverse flora in Kenya
P
n Plants to manufacture antibiotic rifampicin, anti-leprosy and anti-tuberculosis drugs
from the penultimate state
n Manufacture of latex gloves, disposable surgical gloves and condoms

n Manufacture of medical supplies eg. Catheters, gauzes, syringes and other medical equipment

n Manufacture of Quinine through extraction from Cinchona bark

n Pharmaceutical processing of locally available salt (sodium chloride), sugars and ethanol for

pharmaceutical industry use

60
Rwanda - www.rdb.rw

Rwanda also relies heavily on imports for its pharmaceuticals supply (approximately 95%). Rwanda
encourages investors to take advantage of the huge gap in the local pharmaceutical supply. The gov-
ernment offers a number of generous incentives aligned with its Vision 2020 healthcare promotion
program to attract investors to the pharmaceutical manufacturing sector in Rwanda. Among the key
policy aspects that favour potential manufacturers in the pharmaceutical sector are:

n  ccessibility of quality medicines

A
n The subsidy of some medicines
n Support for the vaccination program through universal coverage

n The supply of treated nets at accessible prices to the poorest

n Prevention and treatment of HIV/AIDS, reproductive health, reducing child and maternal mortal-

ity and the decrease in births attended.

The Rwanda Development Board (RDB) offers comprehensive support to investors and the Rwanda
Biomedical Center (RBC) can provide additional information on the pharmaceutical sector.

Federation of East African Pharmaceutical Manufacturers (FEAPM) | Yearbook 2012 61

 Tanzania - www.tic.co.tz

Around 80% of Tanzanias pharmaceuticals and healthcare products are imported. Due to high de-
pendence on imports, there are shortages of drugs and other pharmaceuticals within the country.

There have been a series of major economic and social changes in Tanzania and the Government has
adopted a stronger approach towards encouraging private investments. New policies have been de-
veloped that favour the private sector and the Tanzania Investment Centre informs investors on how
to take advantage of the improved business climate.

62
Uganda - www.ugandainvest.go.ug

Since Uganda produces only 5-10% of its demand for pharmaceutical and health products it is highly
dependent on imports. The Uganda Investment Authority estimates that pharmaceutical and health
products account for more than 10% of the countrys total imports.

There are still very few pharmaceutical manufacturers operating in Uganda despite high consumption
of drugs. This creates high market potential for investors to tap into Ugandas pharmaceutical sector.
According to the Uganda Investment Authority, investors can set up manufacturing plants for phar-
maceutical products and take advantage of the incentives provided for local pharmaceutical manu-
facturing. There is a shortage not just in the production of drugs but other health products as well.
For instance, given the high prevalence of HIV/AIDS in Uganda and the relatively widespread use of
condoms, a manufacturing plant for latex products and condoms would meet the high demand and
generate profits. Uganda also has one plant that specialises in the production of disposable syringes,
but this meets only 20% of the demand and the remaining 80% is satisfied through imports.

The Uganda Investment Authority encourages potential investors to exploit Ugandas favourable cli-
mate, macroeconomic conditions and political stability.

Federation of East African Pharmaceutical Manufacturers (FEAPM) | Yearbook 2012 63


mIssIon stAtement
to improve the health and Welfare of mankind by
providing Quality pharmaceutical medicines at cost-effective
prices with an emphasis on timely and Accurate deliveries
Founded in 1981 by dr. mahendra K.v. shah
east African based
one of east and central Africas leading
manufacturers of Quality essential pharmaceuticals
IntroductIon
Regal Pharmaceuticals Limited is a
Kenyan based company founded in 1981
and has grown to become one of the
leading manufacturers of quality essential
pharmaceutical products in Eastern and
Central Africa.
In 1986, the company moved into a custom
built factory which led to a significant increase
in production capacity. In 2002, the company
transferred all manufacturing activities to
a new state of the art facility designed to
produce a wide range of formulations in an
efficient and hygienic environment.
64
reGAl phArm
Manufacturers of Quali
Investments
Regal Pharmaceuticals has expanded ra
investing in order to maintain its stron
Some of the recent installations include:
1. Investment In A New Capsule Prod
Enhancing product quality attributes a
the new capsule filling and polishing
doubt enhance customer satisfactio
sought after Penicillin products.
2. Commissioning of a New Bliste
As part of our facility modernizatio
just installed and commissioned a ne
packing machine. The new entrant
operator MMI control panel features t
blisters that match the product qualit
machine constructed with SS316 in al
and SS304 in non-contact areas has
with acrylic guard as a key operator s
ActIvItIes
Regal Pharmaceuticals continues to
fraternity during various conferences a
include:
1. Kenya Paediatric Association annual
held in Mombasa on 18th -21st April
2. Kenya Association of Dermatologists B
conference held at Enashapai Resort
27th-29th April 2012.
3. Kenya Pharmaceutical Associations A
Conference held on 26th July 2012 to
Bontana Hotel in Nakuru.
plot no. 7879/18, off bab
p.o. box 44421 - 00100, nairobi w
mAceutIcAls ltd.
ity Pharmaceutical Products

4. The Uganda Pediatric Associations 8th Annual Scientific

apidly and is cautiously Conference held at Hotel Africana on 30th & 31st of August.
ng marketing position.
: contInuous medIcAl educAtIon
The Company also takes pride in support of the health fraternity
duction Line by providing the latest medical news and updates by holding
and our output capacity, CMEs where we engage eminent medical personnel to share
g assembly line will no medical updates to participants.
on for Regals highly
dIstrIbutors Get toGethers
er Packing Machine Regal Pharmaceuticals values its customers and hence organises
on program, we have periodic get-togethers for them in the countries we operate in.
ew double track blister A get together was held for Uganda local customers in
comes with superior conjunction with Abacus Pharmaceuticals Uganda who is the
thus producing elegant main distributor in Uganda.
ty. The GMP compliant
ll product contact areas A get together was held in Dar es Salaam for local customers.
s its front side covered This was done in conjunction with Abacus Pharmaceuticals
safety attribute. Tanzania and Jilichem T Limited who are our main distributors
in Uganda.

support the medical corporAte socIAl responsIbIlIty

and exhibitions. They
As our corporate social responsibility, Regal Pharmaceuticals has
continuously supported various medical camps with donations
scientific conference and participation through various organisations.
2012.
Bi-annual scientific reGAl tImes
Spa in Naivasha on
Continuous updates on the activities and the various changes at
Regal Pharmaceuticals is done through a quarterly publication
Annual Scientific
of the Regal Times which is distributed to our customers both
o 28th July 2012 at
internal and external.

ba dogo road, ruaraka

www.regalpharmaceuticals.com

Federation of East African Pharmaceutical Manufacturers (FEAPM) | Yearbook 2012 65

 The Pharmaceutical Distribution Landscape
in the East Africa Community
Currently home to about 140 million people, the
East African Community presents a significant
market for pharmaceutical manufacturers and
their networks of distributors. The region has
enjoyed a stable political climate with steady
but moderate economic growth. The plan by
the Southern African Development Community
(SADC), the East African Community (EAC) and
the Common Market for Eastern and Southern
Africa (COMESA) to ultimately form a free trade
area (FTA) has also enhanced the regions appeal
to manufacturers and distributors of medical
commodities. This FTA would cover more than
530 million people with a combined GDP of over
USD 600 billion.
Further, the disease burden has remained high
in the region. Malaria, HIV, TB and other non-
communicable diseases are a cause for high
morbidity among the citizens of East Africa. De-
mand for healthcare services and commodities is
growing, buoyed by a growing population with
an emerging middle class, increased healthcare
funding and increasing citizen awareness of the
right to health.
This article gives an overview of medicine im-
porters/distributors in the EAC Partner States.
Burundi
Burundi has a population of 11 million people
growing at a high rate of 3.5 % per annum. As in
Rwanda, the disease burden remains high and
the healthcare sector under-resourced to meet
the resulting high demand. The Pharmaceutical
industry revenue is estimated at USD 50 million,
of which 95% is spent on a limited range of im-
ported generics and some brands from East Af-
rica, India, China and Europe. Burundi has one
local pharmaceutical manufacturer (SIPHAR),
producing about 5% of the total needs. The main
public actor, Centrale dAchat de Medicaments
Essentiels au Burundi (CAMEBU), distributes
about 85% of total consumption. Some of the
private distributors include: Uni Pharma, Life
Pharma, Alchem, ABACUS Pharma and Mul-
tiphar Ltd.
66
Kenya
Kenya has a population of 40 million people
growing at a rate of 2.5% per annum and has one
of the fastest growing pharmaceuticals sectors in
the region. In 2010 there were about 13,000 reg-
istered pharmaceutical products in Kenya, from
over 400 different companies around the world.
The size of the pharmaceutical industry in 2011
was estimated to be USD 450 million. Imported
branded generics account for 40% and imported
generics account for 32% of the overall pharma-
ceuticals market.
Imported medicines are managed by distribu-
torships and appointed agents. In an ideal dis-
tribution system, pharmaceutical goods flow
from importers (also known as distributors) to
wholesalers and then to retailers, who dispense
the goods to end-users. In reality, the distinction
between importers and wholesalers is superfi-
cial, determined mainly by agency agreements/
import capabilities. Some pharmaceutical out-
lets operate at all distribution levels, from im-
portation to retail. On the side of demand, be-
cause of their immense bargaining power, large
hospitals and retail stores tend to deal directly
with importers, bypassing wholesalers.
According to Pharma Finder report Volume 3.1
(February 2007), the sector is highly fragmented,
with over 180 private pharmaceutical wholesal-
ers and distributors in Kenya alone, which pro-
cess the bulk of the USD 208 million volume of
pharmaceuticals. Since there is little sharing of
information, it is difficult to determine the rela-
tive market shares of distributors, but based on
the number and size of agencies held, the top
five distributors in Kenya are: (1) Eurapharma
Laborex, (2) Philips Pharmaceuticals, (3) Sur-
gipharm Pharmaceuticals, (4) Harleys, and (5)
Sunpar Pharmaceuticals. The first three distrib-
utors deal mainly in branded original prod-
ucts while the latter two deal in generics. The
not-for-profit and public distributors operating
in Kenya include: the Kenya Medical Supplies
Agency (KEMSA), Mission for Essential Medi-
cines and Medical Supplies (MEDS), The Inter-
national Committee of the Red Cross (ICRC) and
Mdecins Sans Frontires (MSF). KEMSA and
MEDS are briefly described below due to their
central role in supplying the public sector.
Kenya Medical Supplies Authority
The Kenya Medical Supplies Authority (KEM-
SA) is a parastatal with the mandate to procure,
warehouse, and distribute medical commodi-
ties to public health facilities. In 2012, KEMSAs
pharmaceutical distribution volumes were esti-
mated to be valued at about USD 253 million.
KEMSA does not carry out any importation ac-
tivities. Rather, it sources its products through
competitive tenders, supplied by private sector
importers and distributors. KEMSA purchases
about 50% of all prescription drugs in Kenya. It
distributes health commodities to over 5000 pub-
lic facilities including pharmaceuticals procured
for agencies such as the United States Agency
for International Development (USAID), United
Nations Childrens Fund (UNICEF), United Na-
tions Population Fund (UNFPA), World Bank,
Global Fund and DANIDA.
KEMSA has undergone a tremendous transfor-
mation in the last four years. Shifting from an
Agency to an Authority, most parallel supply
chains have been integrated under KEMSA,
which has become the leading supply chain or-
ganisation for pharmaceuticals in the country.
Further, KEMSA has been capitalised and com-
mercialised with assistance from the World Bank
and the new commercial window for KEMSA is
already trading with public facilities at competi-
tive terms. USAID has provided additional fund-
ing for an Enterprise Resource Planning System
(ERP), an integrated end-to-end ICT platform
to improve business processing. They have also
provided long-term technical advisors and in-
vested in various supply chain processes, which
has increased KEMSAs capacity to throughput
its current high volumes with greater efficiency.
Mission for Essential Medicines and Medical
Supplies
The Mission for Essential Medicines and Medi-
cal Supplies (MEDS) plays a similar role as
KEMSA for Christian faith-based health insti-
tutions primarily in Kenya. MEDS is a not-for-
profit healthcare provider established in 1986 as
a joint service of the Kenya Episcopal Confer-
ence (KEC) and the Christian Health Association
of Kenya (CHAK). Its client base is estimated at
about 1,800, which includes church health facili-
ties in Kenya, NGOs in Kenya and neighbour-
Federation of East African Pharmaceutical Manufacturers (FEAPM) | Yearbook 2012
ing countries, donor funded healthcare projects,
government health facilities, community based
healthcare initiatives and other faith-based
health facilities. In 2011, MEDSs turnover was
estimated at USD 14 million.
Retail Pharmacies
All of the 1,000 licensed retail pharmacies in
Kenya are privately owned. Because of gaps in
law enforcement, an estimated 3,000 - 4,000 un-
licensed retail pharmacies operate in Kenya. Re-
tail pharmacies make a significant contribution
to health service delivery. Besides being the first
point of call for outpatient services, retail phar-
macies also dispense prescriptions from both
private and public health institutions.
Rwanda
Rwandas population of 11 million is growing
by 2.8% per annum. The disease burden for com-
municable and non-communicable diseases has
remained high, translating into high demand for
healthcare services.
The countrys under-resourced health systems
and supply chain networks have struggled to
keep pace with increasing demand for essential
health commodities. To meet the need for scale-
up, the Government of Rwanda introduced a
national coordinated procurement and distribu-
tion system for health commodities. The Rwanda
Biomedical Centre / Medical Procurement and
Distribution Division (RBC/MPDD), the Rwan-
dan national essential medicines procurement
organisation, operates the public medical stores
and has sole responsibility for quantifying, pro-
curing, storing, and distributing public health
commodities. MPDDs mission is to avail quality
and cost effective medical equipment, drugs and
medical supplies to the Rwandan people. This is
achieved through three major objectives:
n  o procure world class quality pharmaceuti-
T
cal products;
n 
To continually improve storage and distri-
bution through a computerize management
system;
n 
To insure the quality of stored health com-
modities through good storage practices and
regular quality control in WHO accredited
Laboratories.
67
 Tanzania
The most populous country in East Africa with
a population of 44 million, Tanzania imports
about 80% of its total pharmaceutical require-
ments. Kenyan manufacturers supply approxi-
mately 8% of the total demand. The Tanzanian
pharmaceutical market has distinct public and
private sectors.
The public sector is comprised of the govern-
ment and its international donors. The Medical
Stores Department (MSD) operates the public
supply chain for essential medicines and medical
supplies, procuring commodities valued at USD
86.5 million (2011/12), nearly 60% of all govern-
ment and donor-funded medicines in the coun-
try. The medicines are sold to over 5,000 public
healthcare facilities, which include Government,
faith-based organisation (FBO) and NGO facili-
ties. MSD has been decentralising distribution to
facilities through a network of ten zonal stores.
The Ministry of Health and Social Welfare As-
sessment of Pharmaceutical Human Resource
Report of 2009 recorded that pharmaceuticals
are supplied to the Tanzanian market through a
network of 4,185 public, 659 private, 155 NGO
and 853 FBO facilities as well as 375 wholesalers
and 661 private retailers. In addition to this there
are over 6,000 Duka la Dawas, which are only
authorised to sell non-prescription, or Over The
Counter (OTC), medicines.
The main players in the private sector include:
Salama Pharmaceuticals, Philips Distributors,
JD Pharmacy, Laborex Tanzania Ltd, Samiro
Pharmaceuticals, Astra Pharma Tanzania Ltd,
ABACUS Pharma Ltd, Moraf Pharmaceuticals,
ACB Pharmaceuticals, Pharmed ltd, Heko Phar-
macy, Bahari Pharmacy, Jiichem Tanzania Ltd
among others.
These companies import pharmaceuticals (both
brands and generics), surgical and medical dis-
posables from the United Kingdom, Southeast
Asia, Kenya, India and China, and distribute
them in Tanzania to private as well as public fa-
cilities. Their individual market shares are not
in the public domain and thus difficult to accu-
rately profile.
Uganda
Uganda is an open market economy with a pop-
ulation of 33 million people growing at a rate of
3.6% per annum and is seen as a growing local
and regional market for medical supplies. In
68
2012 Ugandas total pharmaceuticals business
was USD 317 million. This is growing at a rate of
18.5%. Uganda imports 95% of its total pharma-
ceuticals. The public supply chain of medicines
is dominated by The National Medical Stores
and the private sector is layered with wholesal-
ers, retailers, chemist shops and private clinics.
There are over 500 registered pharmacies, over
4,500 chemist shops and 115 hospitals that form
a network of outlets for medical commodi-
ties. Nearly 80% of all private pharmacies are
in Kampala, Jinja and Mbarara, meaning some
marginal areas are grossly underserved.
The National Medical Stores (NMS)
NMS is an autonomous government corporation
mandated to procure, warehouse and distribute
health commodities to public health facilities in
Uganda. Joint Medical Store (JMS) is the main
distributor targeting faith-based organisations
(FBOs) in Uganda. NMS supplies 55%, JMS pro-
vides 35%, and private distributors supply 10%
of the public sector value.
NMS serves 2,850 public health facilities (at all
levels including National Referral Hospitals
and Institutes) with over 2,400 essential medical
commodities. NMS does not operate regional
warehouses but rather directly distributes to the
2,850 facilities through a Hub & Spoke mecha-
nism with the countrys 112 districts forming the
hubs/distribution points.
Private Distributors
Ugandas private distributors include: Abacus
pharma, Surgipharm Uganda Ltd , Laborex
Uganda Ltd , Tittoes Pharmacy, Super Medic
Pharmaceuticals, Venus Pharmaceuticals, Ugan-
da Pharmaceuticals, Rene Industries Ltd, Bap
Pharma Suppliers Uganda ltd, A&A Medicor
Pharmacy and Vine Pharmaceuticals.
These firms import a wide variety of gener-
ics and brands from manufacturers in Europe,
India, Kenya, the Middle East and China and
distribute to government facilities, NGOs and
retailers.
Challenges Facing Pharmaceuticals
Distribution in East Africa Conclusion
n  oor roads and road networks contribute to
P It is imperative that all stakeholders work to-
increased cost of delivery to the client. Hard gether to streamline pharmaceuticals distribu-
to reach areas are poorly supplied translat- tion in the region to support the growth of the
ing to lengthy order turnaround of up to sev- manufacturing enterprises, distributors and re-
eral weeks; tailers for the benefit of healthcare delivery in
n 
Gaps in sector regulation and surveillance East Africa. All such actions should aim to re-
has led to growing incidence of counterfeits, duce the cost of drugs, increase access to essen-
diverted medicines and unregulated parallel tial medicines for improved health outcomes.
pharmaceutical trade; The EAC is expected to play the critical roles of
n 
Lack of timely and accurate consumption coordinating, aligning, harmonising and inte-
data make it difficult to forecast and plan for grating individual member country efforts with-
future demand; in the broader EAC strategy.
n 
Poor distribution infrastructure including
warehouses and limited hospital storage
delay distribution and in many cases nega-
tively affect the quality of the product before
it reaches the end user;
n 
Poor supply chain management, in most
cases manual, create room for stock pilferage
and expiries;
n 
Fragmented supply chains serve small mar-
kets with limited consumer purchasing
power and load unnecessary costs to the end
product;
n 
Extensive border controls are a major obsta-
cle to intra-regional distribution.

Recommendations
n  armonise policies of different line minis-
H
tries nationally and between countries to
arrive at a comprehensive policy and regu-
latory framework to support the regional
production and distribution of medical com-
modities;
n 
Promote regional and international collabo-
ration on medicines regulation and purchas-
ing in line with EAC and other initiatives;
n 
Build capacity in technical disciplines by
committing more resources to teaching insti-
tutions targeting health commodities supply
chain;
n 
Promote pooled procurement of essential
Medicines and medical Supplies to exploit
economies of scale;
n 
Integrated approach towards Pharmacovigi-
lance in order to ensure medicines in the
block are safe and produced and traded on a
level playing field;
n 
Merger of small distributor enterprises to
build greater capacity as well as increase ef-
ficiency and effectiveness.

Federation of East African Pharmaceutical Manufacturers (FEAPM) | Yearbook 2012 69

 Kenyas pharmaceutical
firms turn heat on the
restrictive national
regulations in fresh push
for share of EAC Common
Market.

By George Omondi

The push by Kenyas pharmaceutical firms to claw
back more share of regional market from the tight
grip of cheap Asian drugs is waning amid multiple
charges, conflicting regulations and high costs of run-
ning factories.
While the government does not charge duty on
drugs, the two per cent on F.O.B that Kenya Revenue
Authority levies as import declaration fee remains a
burden, says Dr Kamamia Wa Murichu, chairman of
Kenya Drug Manufacturers and Distributors Associa-
tion (KDMDA).
In addition, says Dr Murichu, the Kenya Pharmacies
and Poisons Board (PPB) has introduced quite a num-
ber of levies, among them, 0.75 per cent on F.O.B. as
retention charges.
To local firms which have limited control on most of
their operation costs, these regulatory levies only pile
more pressure on retail prices of drugs they produce.
The firms have to import equipment and active ingre-
dients, something that limits their ability to compete
with Asian counterparts on the fronts of speed and
cost.
Beset by high costs, industry players are now root-
ing for increased uptake of their products by public
health facilities. Unlike imports, it is easier for regula-
tors to inspect conditions under which local medicine
is produced and guarantee the public of its quality
and safety, KDMDA maintains.
sal Corporation which has WHO prequalification for
production of ARVs.
The local manufacturers, he said, understand envi-
ronmental conditions of various sale points and there-
fore provide appropriate packaging for each area of
the region to ensure medicine remains in good condi-
tions on shelves.
Generally, I prefer local medi-
cines not only be-
cause they are working but also due to their pocket-friend-
liness, Dr Murichu who also serves as Secretary of
East African Health Platform said.
Mr Kiumbura Githinji, Supply Chain Advisor at Ken-
ya Medical Supplies Agency (Kemsa) agrees:
To the best of my knowledge, the quality of lo-
cally produced medicine is largely good ex-
cept in cases where retailers fail to handle them according
to manufacturers specifications.
But even in this new campaign, manufacturers in
Kenya still face a hostile public procumbent and dis-
posal Act 2005 in their bid to get more of the locally
produced medicine to the domestic market.
Part of the Act gives preference margin to local firms,
allowing them to win tenders even if they quote pric-
es which are up to 15 per cent higher than those of

Compared to most of products

that we import from
countries such as India and China, I can say very strongly
foreign bidders. However, the same Act blindly re-
serves 10 per cent of publicly floated drug tenders to
any companies where Kenyans hold at least 51 per
that drugs produced here in Kenya are far, far ahead in cent stake.
terms of better quality, Dr Murichu said, citing Univer-

70
This is what is killing local industry because
even a firm which imports everything is
still considered in the 10 percent threshold as long as it has
the prescribed local shareholding, said Mr Palu Dha-
nani, CEO of Universal Corporation.
At the moment, locals supply 30 per cent of all medi-
cines consumed in Kenya while 70 per cent is im-
ported. For Kemsas stores which procure largely
for government and development partners, the local
manufacturers supply 70 per cent of annual orders
while foreign manufacturers, mainly imports from
Asian firms, ship in the remaining 30 per cent.
Kemsa also procures non pharmaceuticals like band-
ages, syringes, etc where the ratio is 30 per cent local
and 70 per cent foreign.
The agency has been pushing for increased health
budget, which is currently hovering around five per
cent of the GDP, to at least 15 per cent of GDP in order
to raise threefold the portion that trickles down for
public procurement of drugs.
However, whenever time comes for making a pro-
curement decision, the agency will always go for
good quality that can be obtained at cheapest price,
says Mr Githinji.
Ours is an open tendering system
which means the locals must de-
velop capacity to compete with foreign firms in terms
of ability to produce more and supply at short no-
tice, he said.
On its part, the PPB maintains that addressing manu-
facturers cost of production requires a concerted ef-
fort of regulators, procurement agencies, finance min-
istries and the manufacturers themselves. The joint
effort should focus on lowering cost of production,
especially energy where Asian firms have obvious ad-
vantage, says Dr Fred Sioyi, the PPB registrar.
We are already doing our part as PPB by giv-
ing local firms preference in registration
(fast track registration). Here in Kenya, we charge local
manufacturers $500 for registration instead of the $1000
for foreigners, he said.
While battling stringent regulation at home, indus-
try investors, including Mr Dhanani are also casting
their nets wide to the regional market. The firms have
since been rooting for a specific preference margin for
regional firms to be applied by all the five member
states. Mr Dhanani says a good volume of business
will translate to lower unit cost for regions pharma-
ceuticals.
Federation of East African Pharmaceutical Manufacturers (FEAPM) | Yearbook 2012
Kenyan drug manufacturers have so far led the way
in making cross-border investments but players gen-
erally cite conflicting regulatory regimes for slowing
down their expansion drive.
The EAC Common market neither has a harmonised
drug registration system nor uniform manufacturing
practice with end result being that a firm has to take
between six months and three years to get products
registered in a member state, says Dr Murichu.
Multiple registrations come with extra cost burden
and also mean regulatory agencies waste a lot of time
re-inspecting products that bear clearance certificates
from other member states.
FEAPM should lead the way in push-
ing for harmonisation of
production standards to ensure quality medicine within
East Africa. It should also lobby governments to support
development of pharmaceutical market in this region,
said Mr Dhanani.
Despite the entry hurdles, the very presence of EAC
Common market has increased interaction and in-
spired confidence that is set to drive cross-border in-
vestments in the industry in future, players say.
Unlike a few years go when only Kenyan firms were
keen on moving their investment across the borders,
companies such as Quality Chemical Industries of
Uganda and Aspen of Tanzania are now showing in-
terest in other member states.
Improving access to quality
medicine is also one
area where regional integration has recorded tremendous
success, says Dr Murichu.
Due to regional integration, a number of
Kenyan firms have set up units in mem-
ber states, taking with them quality medicine, expertise and
equipment that used to cause patients to travel long dis-
tances for treatment in Nairobi.
Still, Dr Murichu laments that governments in the re-
gion have failed to make legislations that could en-
courage pharmaceutical industry to boost access to
essential medicine through the flexibilities of WTO
TRIPS such as parallel importation, duty exemption
and compulsory licensing. Mr Dhanani agrees:
Only a few of manufacturers have taken ad-
vantage of WTO TRIPS flexibilities.
The main reason for this has been unawareness and lack
of training.
71
 Q&A
By George Omondi
with Dr Kamamia Wa Murichu, Chairman; Kenya Pharmaceutical Manufacturers and
Distributors Association; Secretary of East African Health Platform

The FEAPM has been in existence in the last one year. What is your experience with it so far?

I have been part of it from inception. It has given the region a single voice, providing a platform for
pharmaceutical manufacturers from Uganda, Tanzania, Zanzibar, Rwanda, Burundi and Kenya to
share experiences. Through it, GIZ has been able to organise training sessions to industry players in
areas such as good practices in pharmaceutical manufacturing and emerging technology that could
help them cut costs and improve efficiency in production.

What capacity support do you expect from FEAPM?

Through FEAPM, I see pharmaceutical firms in the region sourcing for raw material together to gain
economies of scale in future. We will also be able to push for market access together. This federation
was meant to provide linkage among manufacturers in the region. This way, a manufacturer who
gets a tender that it cannot service by internal capacity is able to join hands with other members.
Remember that manufacturers only produce a limited number of drugs. Through this Federation, it
will now be possible to join hands in supplying all drugs specified in a tender. By working together,
the industry hopes to end this habit where everybody tries to be jack of all trade and master of none.
Through this Federation, we hope to understand the dynamics of regional integration better to even-
tually conquer the 140million-people EAC market.

I bet you are conversant with World Trade Organisations trade related intellectual property rights
(WTO TRIPS). How flexible do you find them?

Generally, a manufacturer is supposed to pay for use of someone elses intellectual property for
commercial purposes. But in order to boost access to medicine and also encourage them to develop
internal capacity, the least developed countries (LDCs) such as Uganda, Burundi, Rwanda and Tan-
zania have a leeway in producing or importing generic form of essential drugs without compensat-
ing patent owners. The LDCs can achieve these through various ways including parallel importation,
duty exemption and compulsory licensing.

The truth is that WTO does not force any country to take advantage of this flexibility. Instead, it is
the LDCs which have the responsibility of coming up with national laws that capture the spirit of
WTO TRIPS. What we have seen so far, however, are national legislations that are too stringent to
allow manufacturers to take advantage of this flexibility.

72
What impact has the more than one decade of regional integration had on
pharmaceutical industry?

To say the truth, the industry does not have much to show for being part of EAC Common Market.
The process of registering drugs has not been harmonised in the region and this means we still have
to take between six months and three years to get our products registered in each member state.
Multiple registrations come with extra cost burden because a manufacturer has to pay fees in each
member state. This is not to say we are closing our eyes on increased interaction and confidence that
is driving cross-border investments in the industry. Unlike a few years go when only Kenyan firms
were keen on moving their investment across the border, we are now see potential for cross-border
investments with a company such as Aspen of Tanzania already establishing operations in Kenya.

And what would you say has been the impact of regional integration on access to medicine in
Kenya or East Africa as a whole?

Improving access to quality medicine is one area where regional integration has recorded tremen-
dous success. Previously, patients from other EAC countries used to travel all the way to Kenyas
health facilities. With many European firms established here, Kenya has been way ahead in produc-
ing latest molecules of essential drugs for cancer, HIV, etc. As a result of regional integration, a num-
ber of these firms have set up units in member states, taking with them quality medicine, expertise
and equipment that used to cause patients to travel long distances.

What specific support do you think governments aught to give manufacturers to encourage them
to raise the level of local pharmaceutical production?

In Kenya, government does not charge duty on drugs but Kenya Revenue Authority charges 2 per
cent on F.O.B as import declaration fee. In addition PPB has introduced quite a number of charges,
one of them being the 0.75 per cent on F.O.B. as retention charges. We feel these levies, together with
duty on packaging material should be removed. Within EAC as a whole, governments need to stop
levying duty on medical equipment and also remove VAT currently charged on multivitamins and
other essential drugs. They also need to appreciate that we face unfair competition from Asian firms
due to high cost of doing business here and therefore give local manufacturers preferential treatment
in procurement. The governments could go the Ghana way of banning importation of any drug that
can be produced locally.

How do you rate the quality of medicine produced locally?

Compared to most of products that we import from countries such as India and China, I can say
drugs produced here in Kenya are far ahead in terms of better quality. Today, in this country, we
already have a company, Universal Corporation, which has WHO Prequalification for ARV produc-
tion. In any case, unlike imports, regulators can easily inspect conditions under which local medicine
is produced.

Do you and your family take medicines produced in the local market?

Yes we do. Not only do I find them working but they are also pocket-friendly. One advantage of lo-
cally produced medicine is that the manufacturer understands environmental conditions of various
markets and therefore provides appropriate packaging for each area of the region to ensure drugs
stay longer on the shelves.

Federation of East African Pharmaceutical Manufacturers (FEAPM) | Yearbook 2012 73

 Q&A by George Omondi
with Palu Dhanani, CEO of Universal Corporation Ltd, Kenya- manufacturer of generic drugs

FEAPM has been in existence for one year now. What experience have you had with it so far?

I dont have much experience with FEAPM at the moment. I can say it is a good lobby group that is
just starting and a lot of programmes aught to be put in place.

With FEAPM in place, what areas of pharmaceutical production do you hope to see improvement?

The lobby should lead the way in pushing for harmonisation of production standards to ensure
theres quality medicine within East Africa. We have several companies in this region, about 52, but
just a few of them are operating. The standards of operation are very different from each other. The
FEAPM also needs to lead the way in lobbying the governments to support development of pharma-
ceutical market in the region.

What capacity support do you expect from FEAPM?

First, it has to push for harmonisation of regulatory environment and ensure national regulatory
agencies respect verdict of each other. We waste a lot of time re-inspecting products that bear clear-
ance certificates from other member states. The federation should also push for government support
for regional manufacturers to reduce export of jobs.

I bet you are conversant with World Trade Organisations TRIPS. How flexible do you find them?

Unfortunately, and to the best of my knowledge, very few companies in this part of the world have
utilised WTO TRIPS. Only a few of manufacturers have taken advantage of WTO TRIPS flexibilities.
The main reason for this has been unawareness and lack of training. Lately, there have been some
awareness campaigns and training but the success has been limited.

What impact has the regional integration had on your business?

As a pharmaceutical manufacturer, I can say absolutely nothing.

But the border rules have been relaxed for manufacturers in the region like you to set up units or sell
drugs in any part of EAC?

We still have to register our products in each of these member states. The guidelines for pharmaceuti-
cal industry are not similar in these countries. The uniform guidelines are currently being developed
but stakeholders are not involved. I think this is one area that FEAPM needs to take up seriously.

Do you think regional integration has had any noticeable impact on availability of medicine in
the region?

Not to the extent that it is supposed to. Thats why the region is still importing almost 72 per cent of
medicine and produces only 28 per cent of its requirement.

What specific support do you think the government(s) should extend to local manufacturers to
encourage them to raise their level of production?

Kenya needs to review the public Procurement and Disposal Act 2005 because it is killing the lo-
cal pharmaceutical industry. We appreciate the part of the Act which gives 15 per cent preference
margin to local firms but at the same time the Act gives 10 per cent preference to companies where
Kenyans have 51 per cent stake. This means that even if a firm imports everything, it is still consid-
ered in the 10 percent threshold as long as it has the prescribed local shareholding. For East Africa,
we need a specific preference margin for regional firms. A good volume will ensure lower unit cost
for regions pharmaceuticals.

74
In what specific areas would you wish to see improvements if manufacturers were to gain greater
access to regional pharmaceutical market?

Inspection requires serious thought. Secondly, regulation in this part of the world has not been as
strong as it is supposed to be.

How do you rate the quality of medicine that you supply to the market?

A pharmaceutical product is not good simply because it has passed quality test or bad because it
has failed one. Medicine is manufactured under very strict and unique control system. If the whole
process is not clear, then the laboratory test of quality is useless. Let me illustrate. If you manufacture
paracetamol in a facility that also has component handling penicillin, the manufactured medicine
will pass laboratory test for paracetamol but will never reveal particles of penicillin which came in
due to poor air control. The drug cleared gets to market as paracetamol but will still cause allergy in
patients who react to penicillin.

Do you and your family take the generic drugs that come out of your facility?

Yes, all the time. Even relatives and friends prefer locally manufactured drugs.

Q&A by George Omondi

with Kimbura Githinji, Supply Chain Advisor, KEMSA

What proportion of medicine procured for public facilities in Kenya does Kemsa obtain from
pharmaceutical manufacturers in the region?

Let me start by saying that the locals supply 30 per cent of all medicines consumed in Kenya while 70
per cent is imported. For Kemsa which procures largely for government and development partners,
the local manufacturers supply 70 per cent of what we buy while foreign manufacturers, mainly im-
ports from Asian firms ship in the remaining 30 per cent. Kemsa also procures non pharmaceuticals
like bandages, syringes, etc where the ratio is 30 per cent local and 70 per cent foreign.

What do you think needs to be done to encourage Kemsa to raise these ratios further in favour of
regional manufacturers?

Basically, increasing the funding made available to Kemsa will lead to increase in volumes of drugs
bought from regional market. The health budget currently hovers around five per cent of the GDP
and we have been pushing for 15 per cent to increase the portion of funds available to Kemsa three-
fold.

However, ours is an open tendering system. This means the locals must develop capacity to compete
with foreign firms in terms of ability to produce more and be able to supply at short notice. Remem-
ber local firms have to import equipment and active ingredients that they use meaning they have
limited room to compete on the fronts of speed and cost.

You dont sound worried at all about the issue of quality?

We have a quality control unit at Kemsa and also a national body (PPB) that handles that. To the best
of my knowledge, the quality of locally produced medicine is largely good except in cases where
drugs have not been transported and stored according to manufacturers specifications.

Is there anything that regulators can do to encourage the use of locally produced medicine in East
Africa?

The manufacturers need to be encouraged, and possibly assisted, to adopt good manufacturing
practices (GMP). We need to engage more with them to help them appreciate our quality control
expectation. We have been using our open forums to impress upon them that we are operating under
an environment that requires strict adherence to quality.

Federation of East African Pharmaceutical Manufacturers (FEAPM) | Yearbook 2012 75

 We already have 15 per cent preferential procurement clause but to fully benefit local manufacturers,
this needs to have a clear implementation guideline. Otherwise, it simply states that local bidders
should be awarded supply tenders if they quote prices that are not more than 15 per cent higher than
foreign bidders.

Do you and your family use locally manufactured drugs?

Yes, I have no problem using local drugs because the country has a quality surveillance system that
works. I know majority of Kenyans dont even check the label to find out where medicine on the
shelves came from because they trust the screening process by authorities.

Do you think EAC integration has improved market access for regional pharmaceutical firms?

It has created a greater potential for robustness in terms of capacity to procure, cross border supply
of raw materials and labour. Some of trade barriers and other hurdles that restrict business have been
removed. But we still have some gaps in the pace at which we are aligning and standardising poli-
cies, and also coordinating them between agencies and even among EAC member states.

What specific support do you think governments need to give manufacturers to increase their pie
of the regional market?

The governments need to provide enabling environment for doing business. Efforts to provide
cheaper electricity, clean water, and good roads will go a long way in boosting competitiveness. The
government regularly needs to identify skill gaps and organise tailored training in partnership with
key training institutions. Most importantly, the government needs to shield manufacturers from
counterfeits as well as create affordable source of capital to finance Research and Development and
also buy equipment.

Q&A by George Omondi

Dr Fred Sioyi, Registrar, Kenya Pharmacies and Poisons Board (PPB)
What proportion of drugs used in Kenya is procured from pharmaceutical manufacturers in East
Africa?

It keeps varying, between 30 and 40 per cent. But almost all of this is manufactured in Kenya. To be
honest, I have never seen drugs from any of the four other EAC countries being sold here.

Does this mean regulators have locked out manufacturers from other EAC states?

No. Its a question of competition. Kenya happens to have the biggest manufacturing base in the
region. There have been some attempts by Ugandan manufacturers to penetrate the local market,
notably Quality Chemical Industries, but this has not been very successful.

So what is it that should be done to have more of locally produced medicine and those of other
firms from East Africa gaining bigger chunk of this market?

The local manufacturers are mainly out-competed by Asian firms. We need to address the issue of
competitiveness. Lets address the cost of production which has direct impact on retail prices of
drugs. Anyone who has to make a procurement decision will always go for good quality obtained at
a cheaper price. Of particular interest is the cost of energy where Asian firms appear to have advan-
tage at the moment.

76
Obviously these disparities will take time to address. What specific interventions are regulators
like PPB implementing in the meantime to promote local pharmaceutical production?

We are currently giving local firms preference in registration, what we call fast track registration.
Here in Kenya, we charge local manufacturers $500 for registration instead of the $1000 on foreign-
ers. Local manufacturers also enjoy 15 per cent preference in the public procurement and disposal
Act.

Generally, I think addressing manufacturers plight requires concerted effort of regulators, procure-
ment agencies, finance ministries and the manufacturers themselves.

There is a general feeling that being the gateway to East Africa, Kenya lets in a lot of counterfeit
drugs that have squeezed the market space for regions firms. Is this your observation as well?

I think people, especially multinationals, in a bid to preserve market share, tend to brand most of
the locally manufactured drugs, including generics, as counterfeits. Counterfeiting is a trade issue
that should only refer to infringement of proprietary rights. We have the Kenya Anti-counterfeit
Authority to deal with that. For us at PPB, we handle quality, safety and efficacy. We are concerned
with whether drugs are substandard or spurious, or falsely labelled. Most of the time, genuine drugs
become substandard because they are stored or transported in poor conditions.

So what specific steps do you think the governments and regulators should take to promote local
production of drugs?

Like I said before, this requires a holistic approach by industry lobbies, regulators and finance min-
istries to come up with the agreeable solution. The regulars have reformed registration requirement
but I think the industry could thrive with a raft of incentives such as 30-year tax holiday for those
that set up in rural areas.

Do you and your family take locally produced drugs

Yes, all the time.

Federation of East African Pharmaceutical Manufacturers (FEAPM) | Yearbook 2012 77

The voice of the Private Sector in East Africa
The East African Health Platform (EAHP) is an
advocacy forum for Private Sectors Organizations,
Civil Society Organizations, Faith Based
Organizations and other interest groups working on
health in East Africa. It was founded in 2012
subsequent to the approval of the dialogue framework
between PSOs, CSOs and the East African
Community (EAC) Secretariat. Its mandate is derived
from article 118, 127,128 and 129 of the Treaty for
the Establishment of the EAC: to provide the space,
be the voice and representative of PSOs, CSOs,
FBOs and other Interest Groups in East Africa so as
to effectively drive sustainable health, development
and growth in the region.
Our Mandate
To provide the space, be the voice and representative
of PSOs, CSOs, FBOs and other Interest Groups of
East Africa to effectively drive sustainable health,
development and growth in the region.
Our Vision
A healthy and productive population which enjoys
quality and affordable health care within the EAC
region
Our Mission
To coordinate and facilitate CSOs, PSOs, FBOs and
other Interest Groups in improving the regions
health through promoting pro-growth policies and
appropriate legislation.
Objectives
a) To advocate for the development and or
reform of effective pro-growth policies and
appropriate legislation for the promotion of
sustainable health growth and development
in East Africa;
b) To represent and voice its members
position in the EAC health policy and
legislation processes;
Fostering Stronger Ties for Better Health in East Africa
c) To monitor the implementation of regional
health policies, legislation, practices and
international commitments to ensure that
PSOs, CSOs, FBOs effectively drive and
shape sustainable development and growth
in the region;
d) To increase and facilitate its members
engagement with the EAC Secretariat, its
organs, institutions and other RECs on
health matters;
e) To provide networking opportunities for its
members on health policies and legislation
regionally and internationally.
Membership to the East African Health Platform
Membership of the East African Health Platform is
open to Private Sector Organizations (PSOs),
Pharmaceutical & Manufacturing Organizations,
Civil Society Organizations (CSOs), Faith Based
Organizations (FBOs) and Other Interest Groups
working on health and subscribe to the mission and
vision of EAHP and those that may qualify to be
members as per the provision of EAHP membership
and guideline and constitution.
For more information regarding the Platform
Contact:
Joyce Kevin Abalo
Coordinator
East African Health Platform
East African Business Council Building
Olorien House; along perfect Printers Street
C/o P.O. Box 2617
Phone: +255 27254 3047
Cell: +255 752224570
Fax: +255 27 2509997
Arusha, Tanzania
E-mail: eahp.coordinator@gmail.com
Website: www.eahp.or.tz
Imprint
Published by
Federation of East African Pharmaceutical Manufacturers (FEAPM)
www.feapm.com

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Publishing date
June 2013

Contact
Federation of East African Pharmaceutical Manufacturers (FEAPM)
c/o East African Business Council (EABC)
Olorian House, Perfect Printers Street
P.O. BOX 2617
Arusha
United Republic of Tanzania
Tel.: +255 758 124 317 | +255 27 254 3047
Email: michellemaungu@yahoo.com