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.
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