WHO removes two AIDS medicines from prequalified products list

The World Health Organization (WHO) has removed two antiretroviral products from its list of prequalified products: Lamivudine 150mg tablet from Cipla, of Kurkumbh, India, in blisterpack of 10; and Lamivudine 150mg plus Zidovudine 300mg tablet from Cipla, of Vikhroli in India, in a blisterpack of 10.

The WHO says 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. However, as part of the ongoing monitoring and verification process, an inspection was later performed at the Contract Research Organisation (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. The CRO was found not to be compliant with GCP and GLP and the raw data failed to prove bioequivalence, resulting in the removal of the two 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.