[e-med] Hetero Drugs vient de retirer tous ses ARV de la liste de l'OMS.

["Carinne Bruneton" <remed@remed.org>]

[modération: Hetero Drugs (génériqueur indien) vient de retirer tous ses
antirétroviraux (6) de la liste de l'OMS.
Hetero Drug a pris cette décision d'office, à la suite de la lettre de l'OMS
de septembre dernier demandant à tous les génériqueurs d'ARV de vérifier
leurs essais de bio-équivalence.
Désormais, il ne reste sur la liste ARV de l'OMS que quelques génériques CIPLA (et 1 espagnol), tout le reste sont des produits princeps, ce qui est dramatique pour le programe de pré - qualification et pour les programmes... Pas encore de communiqué sur le site de l'OMS.]

http://www.reuters.com/newsArticle.jhtml?type=healthNews&storyID=6868524&src
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India's Hetero Takes AIDS Drugs Off WHO List
Fri Nov 19, 2004 08:54 AM ET
http://www.reuters.com/newsArticle.jhtml?type=healthNews&storyID=6868524&src
=rss/healthNews
By Stephanie Nebehay

GENEVA (Reuters) - Hetero Drugs has withdrawn all six of its antiretroviral
drugs from the WHO's list of approved drugs following concerns about their
laboratory tests, the World Health Organization (WHO) said on Friday.

It was the third time since June that an Indian company has removed
anti-AIDS drugs following WHO inspections which revealed faulty
bioequivalence tests meant to show the drugs have the same effect as name
brands.

There are still some 48 antiretrovirals on WHO's list of so-called
"prequalified" life-extending generic drugs, a key weapon in the
international fight against the global epidemic.

"All six drugs on WHO's prequalified list have been withdrawn by them
(Hetero)," WHO spokesman Iain Simpson said.

"There are certainly major concerns about the lab testing, about the quality
of it, about the situation that has been found by these (WHO) inspections,"
he added.

Hetero, which is based in Hyderabad, will redo the studies and hoped to
resubmit the results for consideration early next year, according to the WHO
spokesman.

In a statement, the WHO said that Hetero had acknowledged that there were
"deficiencies in the data submitted" and had pledged to hire different
contract research organizations (CROs) to carry out fresh testing.

The pharmaceutical companies contract independent laboratories to do the
bioequivalence testing, the last stage of the lengthy process of approving a
product, according to WHO.

"The irregularities found during the CRO inspections do not undermine the
proven pharmaceutical quality of the medicines -- including their purity and
stability ...," the WHO said.

However, it showed that not all CROs can be relied upon for evidence on the
medicines' bioequivalence with their originating products, according to the
United Nations agency.

The WHO also reiterated its advice that countries should suspend the use of
de-listed medicines and switch to other prequalified products. But if
alternative prequalified products were difficult to obtain immediately, it
was recommended that patients continued the use of de-listed products.
Continued ...

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