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[e-med] Rapport d'inspection OMS sur une industrie pharmaceutique ougandaise

[E-drug nous informe que le rapport d'inspection de l'industrie 
pharmaceutique  "Quality Chemical Industries Ltd" de Kampala (Ouganda) est 
disponible sur le site web de l'OMS. Cette industrie respecte les Bonne 
Pratiques de fabrication.

Mais elle ne fait pas encore partie des laboratoires préqualifiés par l'OMS
voir également la clarification posté le 12 Mars 2010 sur le site web de WHO 
Prequalification of Medicines Programme concernant ce laboratoire
"As indicated by the posting1 of the WHO Public Inspection Report relating 
to the manufacture of finished pharmaceutical products by Quality Chemical 
Industries Ltd (QCIL) of Luzira, Uganda, QCIL was inspected in January 2010 
and found to comply with WHO good manufacturing practice (GMP). This does 
not constitute prequalification by WHO of the products manufactured by QCIL.
The inspection followed the receipt of a variation application from Cipla 
Ltd, to include QCIL's site at Luzira as an additional manufacturing site 
for one of its antiretroviral products. This particular product, currently 
manufactured in India, has already been prequalified by WHO.
Prequalification of a product has two major components: evaluation of a 
dossier containing product-related information and inspection of the 
manufacturer for compliance with GMP. The variation application to add 
QCIL's site at Luzira is currently under assessment by WHO.
A variation is a change to the prequalified product dossier. Any such 
changes (variations) may involve administrative and/or more substantial 
changes (that may impact on safety, quality and efficacy) that are subject o 
approval by WHO."


----- Original Message ----- 
From: "E-Drug" <e-drug@healthnet.org>
To: "E-drug" <e-drug@healthnet.org>
Sent: Saturday, March 13, 2010 2:09 PM
Subject: [e-drug] First plant in a Least Developed Country prequalified 

E-DRUG: First plant in a Least Developed Country prequalified by WHO

The WHO website has listed a new WHO Public Inspection Report (WHOPIR)
on its website that it has prequalified Quality Chemical Industries Ltd
in Kampala, Uganda as being compliant to WHO Good Manufacturing
Practices (GMP). See

Although QCIL is the 48th manufacturing plant that received WHO
prequalification for finished products, and the 3rd in Africa, this
prequalification is the 1st in a Least Developing Country (LDC). (for a
list see http://apps.who.int/prequal/WHOPIR/pq_whopir.htm)

This is important as LDC countries (and thus QCIL) can benefit from the
exemption of TRIPS and patents until 2016, and is thus theoretically
able to make generic copies of products that are elsewhere patented. If
QCIL is able to source the raw materials from another LDC (Bangladesh?),
then it can supply other LDCs with generic copies like India did since
1995, but which became more difficult for newly patented products in
2005, when India had to become fully TRIPS compliant.
If QCIL also gets its generic products prequalified by WHO, it will then
be able to supply all Global Fund recipients, and put pressure on the
prices of originator products.

QCIL will therefore be looked at with critical eyes by big farma, as can
be demonstrated by a critical review of QCIL last year by the American
Enterprise Institute:

Wilbert Bannenberg, E-drug (co-)moderator
Email: wjb@wxs.nl
Website: http://www.essentialdrugs.org/edrug/about.php
E-drug archives: http://www.essentialdrugs.org/edrug/archives.php
(Un-)Subscribe: http://list.healthnet.org/mailman/listinfo/e-drug


E-DRUG: First plant in a Least Developed Country prequalified by WHO (3)

I would like to draw your attention to the clarification posted on 12 March 
2010 on the website of the WHO Prequalification of Medicines Programme 
regarding this company:


Jacqueline Sawyer
Liaison Officer
WHO Prequalification of Medicines Programme

Tel: +41 22 791 36 54
Mobile: +41 79 509 06 58
Fax:+41 22 791 47 30
e-mail: sawyerj@who.int

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