[e-drug] First ARV prequalified from Varichem, Zimbabwe

e-drug
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E-DRUG: First ARV prequalified from Varichem, Zimbabwe
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The WHO Prequalification of Medicines Programme (WHO/PQP) prequalified
lamivudine + zidovudine tablets (150mg + 300mg) produced by Varichem
Pharmaceuticals (Pvt) Ltd of Harare, Zimbabwe.

HA402: Lamivudine/Zidovudine - 150mg/300mg - Tablets - Varichem
Pharmaceuticals (Pvt) Ltd - ZIMBABWE

For the complete list of prequalified medicinal products, please go to:
http://www.who.int/prequal/query/ProductRegistry.aspx or
http://apps.who.int/prequal/default.htm

Comments:

This represents a first for Varichem (http://www.varichem.co.zw) and for
Zimbabwe. Congratulations!

Although suffering from a long and severe economic crisis, Zimbabwe is
officially not a "Least Developed Country" as defined by UNDP. Therefore
Zimbabwe, being a WTO member, is subject to full TRIPS compliance.
However, the Zimbabwean Government has granted compulsory licenses for
ARVs in the past, which enabled Zimbabwean companies like Varichem to
manufacture generic copies of patented products.

Varichem is the fourth company in sub-Saharan Africa to have achieved
WHO prequalification for a pharmaceutical product; Aspen Pharmacare and
Sandoz in South Africa, and Quality Chemical Industries in Uganda had
already prequalified products.

Until now, Uganda remains the only LDC country with a WHO prequalified
approved manufacturing plant. This means it theoretically can make
generic copies of products that are patented in most developed and
developing countries.

More African prequalifications are expected: additional products
submitted by companies in Kenya and Tanzania, and Varichem in Zimbabwe,
are currently being evaluated by WHO/PQP.

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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

2

E-DRUG: First ARV prequalified from Varichem, Zimbabwe (3)
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This is very good. Let us see how many donors and African governments
commit to supporting local production and ensuring that both scale of
operations and scope of production is not only supported but
increased... If one looks at how many lock in arrangements there with
donor support, these companies face a tough battle... and leaves one
wondering why after so many years after BigPharma vs Mandela, these
options only come to the fore now... it is certainly an indictment on
North -South relations...

Riaz K Tayob
South Africa
riaz.tayob@gmail.com