[e-med] (4)Hetero Drugs vient de retirer tous ses ARV de la listedel'OMS

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

[et en plus clair!CB]

Les produits Hetero retirés de la liste sont: Stavudine 40 mg capsule;
Stavudine 30 mg capsule; Lamivudine 150 mg plus Zidovudine 300 mg cp;
Indinavir 400 mg capsule; Lamivudine 150 mg cp; Zidovudine 300 mg cp.

Les produits Ranbaxy retirés de la liste sont: Indinavir 400 mg capsule,
blister (60, 100); Lamivudine 150 mg tablet, blister (60, 100);
Lamivudine/Stavudine 150 mg/40 mg tablet, Al strip (10), 60 in box;
Lamivudine/Stavudine 150 mg/30 mg tablet, Al strip (10), 60 in box;
Nevirapine 200 mg tablet, blister (60, 100); Stavudine 30 mg capsule, Al
strip (10), 60 in box; Zidovudine 300 mg tablet, blister (60, 100).

***************
19 nov 2004
Note for the press N°24

 http://mednet3.who.int/prequal/

HETERO DRUGS LTD WITHDRAWS ANTIRETROVIRALS FROM WHO PREQUALIFICATION LIST
FOR FURTHER REVIEW

Geneva - Following an inspection by the World Health Organization (WHO),
generic manufacturer Hetero Drugs Limited, in Hyderbad, India, is
withdrawing six antiretrovirals* from the WHO prequalification list in order
to review data on their bioequivalence. The company has told WHO it
recognized that the "centres" it had used for studies of bioequivalence
"were incompatible with the current standards" and that there were
"deficiencies in the data submitted ? for the studies done at these
centres."

As in the case of Ranbaxy last week, the company evaluated the contract
research organizations (CROs) it had used after receiving a warning letter
sent by WHO to all manufacturers earlier this year, and found them
non-compliant with international standards of Good Clinical Practice and
Good Laboratory Practice. Hetero Drugs has committed to contract different
CROs and submit new test results for the bioequivalence of the six medicines
as soon as possible.

"Our findings, and the companies' admission of responsibility by withdrawing
their products, show that CRO inspections are necessary," said Dr Lembit
Rago, Coordinator of Quality, Safety and Efficacy of Medicines at WHO.
"Current WHO procedures are ultimately improving medicines monitoring
mechanisms which will, in the long term, ensure better quality treatment for
patients."

Ongoing WHO inspections of CROs conducting tests on antiretrovirals are part
of the continuing monitoring process and an integral component of the
prequalification work. That work reflects WHO's responsibility to assist
countries in promoting quality medicines and improving their quality
assurance mechanisms.

The irregularities found during the CRO inspections do not undermine the
proven pharmaceutical quality of the medicines ? including their purity and
stability ? but show that not all CROs can be relied upon as a source of
evidence on the medicines' bioequivalence with their originator products.
Bioequivalence tests are conducted in volunteers whose blood is tested after
receiving treatment with the medicine, to determine whether the blood
concentration of the generic drug is similar to that of the originator
product.

The current WHO list of prequalified medicines contains 48 antiretrovirals,
including a triple fixed dose combination (a three-in-one pill) manufactured
by Cipla.

WHO's advice to countries is that, in principle, patients should suspend the
use of de-listed medicines and switch to other prequalified products.
However, if it is difficult to obtain alternative prequalified products
immediately, it is recommended that patients continue the use of de-listed
products. The risk of withholding treatment is higher than that of providing
medicines whose bioequivalence is not proven but which have demonstrated
quality and safety. A switch to non-prequalified products is not
recommended, as their quality has not been documented by WHO.