EMA’s human medicines committee (CHMP) has recommended the suspension of the marketing authorisations of generic medicines tested by Panexcell Clinical Laboratories Priv. Ltd at its site in Mumbai, India.
The recommendation comes after Austrian and German inspectors found irregularities in how the company carried out bioequivalence studies. These are studies used to show that a generic medicine produces the same amount of active substance in the body as the reference medicine.
The inspectors found samples from different patients that were exceptionally similar and an instance of personnel documenting the wrong room temperature for the area where samples were being processed. These findings raise serious concerns about the company’s quality management system and the reliability of data from that site.
The CHMP looked at all medicines tested by Panexcell on behalf of EU companies and found none for which adequate data were available from other sources.
The Committee therefore recommended that all medicines authorised in the EU on the basis of bioequivalence studies conducted by Panexcell be suspended from the market. To lift the suspension, companies in the EU relying on data from Panexcell must provide alternative data demonstrating bioequivalence.
Medicines currently being evaluated for authorisation on the basis of data from Panexcell will not be granted authorisation in the EU.
EMA and national authorities will continue working closely together to ensure that studies on EU medicines are carried out to the highest standards and that companies comply with all aspects of Good Clinical Practice (GCP). If companies do not meet required standards, authorities will take whatever measures necessary to ensure the integrity of data used to approve EU medicines.
The CHMP‘s recommendation is being sent to the European Commission for a legally binding decision.