EMA recommends suspension of Panexcell-tested meds

The European Medicines Agency’s human medicines committee, the CHMP, has recommended the suspension of the marketing authorizations of generic medicines tested by Indian firm Panexcell Clinical Laboratories at its site in Mumbai.

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 drug produces the same amount of active substances 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.