E-MED:(2)Contrefa�on d'antir�troviraux en C�te d'Ivoire
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Il semble d'apr�s les autorit�s du minist�re de la sant� de Namibie qu'aucun
laboratoire Selchi Pharmaceuticals ne soit autoris� en Namibie. [mod�rateur:
cf le messag e-drug ci-dessous]
Ce type de probl�me d�montre une fois de plus l'importance du travail de
pr�qualification du couple produit/fabricant qui est fait par l'�quipe du
service QSM de l'OMS, pr�qualification des produits utilis�s par les
patients touch�s par le SIDA, la tuberculose et le paludisme.
En dehors de ces produits reconnus et pour lesquels l'acheteur doit v�rifier
la coh�rence du produit achet� et les specificit�s du dossier de
pr�qualification (m�me site de fabrication et m�me origine du principe
actif) tout g�n�rique doit �tre suspect� et rejet�.
Jean-Yves Videau
CHMP
E-DRUG: Fake AIDS drugs linked to unlicensed Namibians?
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[Counterfeit medicines continue to worry. Here a press report about the MOH
Namibia's follow-up of a WHO counterfeit alert (see
http://www.who.int/medicines/library/qsm/drugalert/alert110.pdf) on a fake
3-in-1 ARV being sold in Ivory Coast, apparently through a Namibian company.
WHO and drug regulators are meeting in madrid 13-14 February to discuss
counterfeits. Interested parties can attend, see
http://195.53.79.19/ICDRA/pre_icdra.htm
Here is the press coverage of the Namibian MOH investigation, copied as fair
use. WB]
http://www.namibian.com.na/2004/january/national/04193B5260.html
TANGENI AMUPADHI
A NAMIBIAN company accused of selling fake AIDS medicines in West Africa has
no licence to make the anti-retroviral drugs.
The Ministry of Health and Social Services said yesterday that preliminary
investigations had disclosed that Selchi Pharmaceuticals was not even
registered as a drug manufacturer in Namibia.
The Ministry's probe followed a World Health Organisation (WHO) warning last
year that Selchi Pharmaceuticals had exported a "counterfeit triple
anti-retroviral combination" drug known as Ginovir 3D to Cote d'Ivoire
(Ivory Coast).
A spokesperson for Selchi Garments - the only Selchi business firm listed in
the Windhoek telephone directory - yesterday denied that her company had
sold anti-retrovirals to the West African nation or anywhere else, but did
say it had sought registration as a drugs manufacturer.
The WHO said a French laboratory had analysed Ginovir 3D and found no
definite trace of any of the three elements listed on the label.
On the website of a Singaporean company that makes the drug, it states that
a Ginovir 3D capsule contains 200 mg of zidovudine, 150 mg of lamivudine and
40mg of indinavir.
But laboratory tests did not find any lamivudine or indinavir.
Instead, each capsule contained stavudine "in addition to a non-identified
substance".
In a special alert posted on the internet, the WHO said that Selchi
Pharmaceuticals, which it described as a company with a Windhoek mailbox,
manufactured Ginovir 3D.
But one of Selchi's business partners, a woman who identified herself only
as Selma, said a plan last year to make and distribute the anti-retrovirals
never got off the ground after the Ministry of Health refused Selchi a
licence because there was no pharmacist in the company.
Permanent Secretary Kalumbi Shangula said on Monday: "We identified the
place but it's so strange that the name is linked to fishing, not
pharmaceuticals".
(This is thought to be an allusion to another member of the Selchi group of
companies.) Selma said the only drugs Selchi had possessed were the samples
sent to the Health Ministry and the WHO.
"When they said it was counterfeit and refused to register us we dropped it
altogether.
We just got samples, but not for distribution.
Why would we distribute to other countries while we have people who need
that tablet?" said Selma.
Ginovir is legally manufactured by GB King-Repa Trading, part of the K&K
group of companies operating in the People's Republic of China, Singapore
and Taiwan.
They sell other anti-AIDS drugs under the brand names Stavir, Laxivir,
Lamivir and Indivir.
Selma said Selchi had responded to a request by GB King-Repa's Singapore
office for a Namibian distributor.
Selma said she did not know how AIDS drugs with labels identifying her
company as the manufacturer ended up in Ivory Coast.
It is unclear whether Ginovir is still being sold in West Africa.
Shangula said the AIDS medicine had not been brought into Namibia, but he
was awaiting the final report of an investigation of the whole matter.
"What we want is the person dealing with pharmaceuticals, not the fishing
business," said Shangula.
A WHO representative in Windhoek, Dr Desta Tiruneh, said the UN agency was
still waiting to hear from the Health Ministry. "As the WHO, we have no
authority.
We just pass information to Government to investigate" and take steps, he
said.
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