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

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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.

For more information contact:

Ms a Bagozzi

Telephone: +41 22 791 4544

Mobile phone: +41 79 475 5490 Email: bagozzid@...

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

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