[india-drug] WHO statement on removal of two AIDS medicines

[Leela McCullough <leela@healthnet.org>]

WHO statement on removal of two AIDS medicines
-------------------------------------------------


>From Kenji Tamura, 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/>www.who.int/mediacentre/statements/2004/statement_aidsprequal/en/

WHO statement on removal of two AIDS medicines from list of 
prequalified products

17 JUNE 2004 | GENEVA -- The World Health Organization (WHO) removed 
two antiretroviral products from the WHO List of prequalified 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 
prequalification 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 Research 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 removed the 2 products

from the list.

The products are still compliant with quality standards (specifications

for Active Pharmaceutical Ingredients, impurity profile, formulation, 
manufacturing in compliance with Good Manufacturing Practices). What is

missing is proof of bioequivalence.

WHO will consider the products for listing again once bioequivalence 
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 standards.

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 regulatory 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 Nations 
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)
20 Avenue Appia, CH-1211 
Geneva 27 Switzerland




__________________________________________________


Leela McCullough, Ed.D.
Director of Information Services

SATELLIFE
30 California Street, Watertown, MA 02472, USA
Tel: +617-926-9400    Fax: +617-926-1212
Email: leela@usa.healthnet.org


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