PHA-Exchange> WHO statement on removal of two AIDS medicines

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WHO statement on removal of two AIDS medicines
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 From Kenji Tamura, MD at WHO

Dear Colleagues,

Please visit the following WHO web site for the WHO statement.

http://www.who.int/mediacentre/statements/2004/statement_aidsprequal/en/

WHO statement on removal of two AIDS medicines from list of pre-
qualified products

17 JUNE 2004 | GENEVA -- The World Health Organization (WHO) re-
moved two antiretroviral products from the WHO List of prequali-
fied products: Lamivudine 150mg tablet from Cipla Ltd, Kurkumbh,
India. Blister pack of 10. And Lamivudine 150mg plus Zidovudine
300mg tablet. Cipla Ltd, Vikhroli, India. Blister pack of 10.

The data and information Cipla had originally submitted for pre-
qualification in the product dossiers were considered acceptable
and meeting international norms and standards for quality as
well as bioequivalence. Hence, the medicines were considered
eligible for prequalification and were placed on the list.

However, as part of the ongoing monitoring and verification
process, an inspection was later performed at the Contract Re-
search Organization (CRO) that was used by Cipla to carry out
the bioequivalence studies. During the inspection, compliance
with Good Clinical Practices (GCP) and Good Laboratory Practices
(GLP) was assessed. The data and information submitted in the
product dossiers were also verified against the raw data from
CRO.

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 patented version.

The CRO was found not to be compliant with GCP and GLP and the
raw data failed to prove bioequivalence. As a result, WHO re-
moved the 2 products from the list.

The products are still compliant with quality standards (speci-
fications for Active Pharmaceutical Ingredients, impurity pro-
file, formulation, manufacturing in compliance with Good Manu-
facturing Practices). What is missing is proof of bioequiva-
lence.

WHO will consider the products for listing again once bioequiva-
lence has been demonstrated by Cipla - that is, once the data
have been submitted by Cipla, evaluated by WHO assessors and
found to be reliable and meeting international norms and stan-
dards.

Bioequivalence (in vivo study) is required by WHO for products
indicated for serious conditions requiring assured therapeutic
response. In some countries, contrary to WHO recommendations,
bioequivalence is not necessarily a requirement for generic
products. National authorities must therefore review their own
situation and take action in accordance with their own regula-
tory requirements and practices.

The prequalification process includes rigorous assessment of
data and information in product dossiers for safety and efficacy
(bioequivalence for generic products) and quality. Each product
dossier is assessed by a team of assessors. Manufacturing sites
are inspected by a team of inspectors to assess compliance with
Good Manufacturing Practices (GMP) as recommended by WHO.

WHO manages the prequalification project on behalf of United Na-
tions partners (WHO, UNICEF, UNFPA, UNAIDS) and with support
from the World Bank.
Thanks

Kenji Tamura MD PhD
WHO
HIV TB and Malaria cluster/HIV department (HTM/HIV)
AIDS Medicines and Diagnostics Services (AMDS)


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