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Support of Local Production in Africa

– The Tanzanian Experience

International Conference on Local Pharmaceutical Production in Africa

Cape Town, April 4-6, 2011

German Medical Aid Organisation

action medeor

� action medeor e.V. founded 1964

� non-profit distribution of high quality – low cost essential

medicines and equipment

� headquarter and warehouse in Tönisvorst / Germany

� 45 employees

� 2 - 3.000 customers (NGO hospitals) in approx. 130 countries

� comprehensive QA system

=> compliance with GMP

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Pharmaceutical-medical projects

� Local production of ARV´s and Malaria medicines• TPI ARV project in Tanzania (EU funded)

• Artemisia annua cultivation and extraction in Kenya

� Capacity building for local manufacturers• GMP / QC workshops in East Africa (Tanzania) since 2005

& West Africa (Ghana) since 2008

� Training for pharmacy students & generic product development • R&D lab at the Muhimbili University / Dar es Salaam

(pharmaceutical technology & analytics)

action medeor activities

in the pharmaceutical sector in Tanzania

Ministries

Authorities/ institutions

Manufacturers

Wholesalers

Health facilities

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action medeor

International Healthcare Tanzania Ltd.

� Non-profit drug supply organization located in Dar es Salaam • 1st local branch of action medeor Germany

• Operating since 2005

� Suppliers• 2/3 of products from Tanzanian and

Kenyan manufacturers

• other suppliers from Europe, India, South Africa

� Assured quality• GMP complicance of suppliers

=> on-site audits

• random testing of products by certified laboratories

Quality Assurance

and Quality Control

Manufacturer

GMP,

Registration

Drug Regulatory Authority

Registration and Control of

the Products and the

Manufacturing Facility

Hospital,

Patient

Additional Quality Control:

Audits, Product Analysis

Qualified

Personnel

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Production of ARVs in Tanzania –

the TPI EU Project

Overall objective: HIV/AIDS related socio-economic decline in

Tanzania slowed down

Specific objective: The demand of 100,000 HIV and AIDS

patients for first-line antiretroviral treatment can be met by

locally produced high-quality ARVs

Result 1: Factory compliant with WHO GMP established

Result 2: Sufficient production capacity of high-quality first-line

ARVs according to the need installed and output achieved

Result 3: Knowledge generation and capacity building

programmes on GMP and TRIPS supported and/or conducted

Technology transfer

and local ARV production

� Financial Volume: 6.2 Million Euro

� Main Sponsor: European Union• ca. 5 Million Euro – Programme: „Aid for poverty-related diseases (HIV/AIDS,

Tuberculosis and Malaria) in developing countries”

� European Partner: action medeor e.V.

TanzaniaTanzania PharmaceuticalPharmaceutical Industries limitedIndustries limited

- Manufacturer of essential medicines

- Production site: Arusha

- Current staff: 92

- Former governmental Organization , privatized since 1997 (40%

GRN)

- Since 2005 ARV manufacturer of fixed dose combination

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Main activities

and target groups

� Main activities:• Set up of a modern WHO GMP compliant pharmaceutical production

facility in Arusha / Tanzania

• Planned production capacity: 100 million tablets/year for AIDS treatment => initiation of WHO prequalification

• Capacity building for personnel and strengthening of local structures

� Target groups:• AIDS patients in Tanzania: ART for 100.000 people in need

• Personnel of local pharmaceutical manufacturers and key personsfrom governmental institutions and non-governmental organizations

=> international workshops on GMP and TRIPS

Project structure

Project:Local Production of ARV

action medeor EC EC Delegation Tanzania

Tanzania Pharmaceutical

Industries

Local Partner

Stakeholders

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Stakeholders and clients

� Stakeholders• Ministry of Health - support of local manufacturers (15% advantage in

national tenders)

• TFDA (Tanzania Food and Drugs Authority)

• Ministry of Finance

• TACAIDS (Tanzania Commission for AIDS)

• NGOs TZ

� Potential clients• Tanzanian Government

• Non-governmental organizations

• Church institutions

Project Implementation

Plant construction

Installation of modular

plant/equipment

Implementation of

production

External training for

governmental

institutions/pharmaceuti-

cal personnel and

manufacturers

Internal training for

local staff

Preparing dossiers for

initiation of WHO-

prequalification process TRIPS/International

regulations, ToT on ARV

pharmacology/ Procure-

ment/Store management

Processing, QA, QC,

GMP-Standards

Carry out bioequivalence

study for x products

Tendering/contracting

Pre-construction on site

Procurement of

equipment, vehicle, other

supplies

Production of needed

1st/2nd line ARV

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Aimed ARV range

� Efavirenz 600 mg, film-coated tablets (Pharm R&D Lab)

� Saquinavir 500 mg film-coated tablets (Pharm R&D Lab / Roche TTI)

Fixed-dose combinations:

� Lamivudine 150 mg / Tenofovir 150 mg / Efavirenz 300 mg, film-coated tablets (Pharm R&D Lab)

� Lamivudine 150 mg / Zidovudine 300 mg, film-coated tablets

Current status

� Production Building and accessory buildings are ready built

� Cleanroom and Engineering company contracted

� Factory Acceptance Test of major production equipment performed

� The first 5 containers of the total of 40 have arrived in Dar and are subject toclearing

� Final acceptance of production rooms, equipment and utilities: September 2011

� Drug Development according to new WHO treatment guidelines has started in collaboration with international senior experts and Muhimbily University Dar es Salaam

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Project progress –

construction of the outer shell

Inauguration ceremony (June 2010)

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Next steps

� Procurement of QC lab equipment

� Training of further personnel

� Establishment of a Quality Assurance System

� Start of Qualification and Validation

� Start of pilot batches: October 2011

� Start of commercial batches: April 2012

� Registering of product with Drug Regulatory Authority: August 2012

� Submission of Drug Dossier to WHO: November 2012

Sources of technology

and access to know-how

� International team of (senior) experts• Detailed URS (design qualification) for production plant and

equipment

• Implementation of QA system incl qualification and validation processes

• Training of local personnel

• Assistance with product development at Pharm R&D Lab

� Experienced contractor from India• construction of the clean-room system acc to URS

� Stringent supervision on-site by TPI / action medeor project management team• Compliance with agreed international standards

• FAT, Qualification (IQ, OQ)

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Challenges

During project implementation:

� Infrastructure / utilities on-site

� Qualification of local personnel / recruitment (cost containment!)

� Intercultural interaction (European – Asian – African): different approaches and

expectations, e.g. compliance of contractor with URS

� Stringent tendering requirements

� Product development for WHO prequalification (change of first-line recomm.)

� Budget limitations

⇒ Project extension of 32 months was necessary

Long-term:

� Maintaining the implemented standards

� Locational challenges (infrastructure/ utilities, skilled personnel, supply of materials, lack of support structures - like calibration, maintenance, repair - etc.)

⇒ International competitiveness ?!

� Training for DRAs and regional

pharmaceutical manufacturers on GMP,

QC and product developmement

� Workshop on TRIPS

� Implementation of a teaching and

development laboratory „Pharm R&D Lab“ in

cooperation with Muhimbili University in Dar

es Salaam (PPP GIZ – action medeor –

MUHAS)

=> Good Manufacturing Practice Standard

=> WHO Prequalification

Capacity building

and quality approach

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Final remarks

� Local Production is not automatically improving access to medicines:

quality and affordability are pre-requisites

� Quality in East Africa is strongly improving due to investments in

production, quality management and human ressources

� Key for quality are ongoing capacity building, strong regulatory authorities and a vivid competition between the manufacturers

� R&D capacities have to be strengthened (e.g. Pharm R&D Lab at MUHAS in Dar es Salaam)

� For improved access an effective distribution is essential

Thank you for your attention !

Christine Häfele-Abah

Pharmacist / MScIH

Head of Quality Assurance

action medeor e.V.

St. Töniser Str. 21

47918 Tönisvorst / Germany

Christine.haefele@medeor.org

www.medeor.org

Tel. 0049-2156-9788-192