The human medicines committee (CHMP) of the European Medicines Agency (EMA) has recommended the suspension of marketing authorisations for generic medicines tested in India.
The recommendation comes after Austrian and German inspectors found irregularities in how the company, Panexcell Clinical Laboratories Pvt. Ltd, carried out bioequivalence studies. 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. The EMA said 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 recommended that all medicines authorised in the EU on the basis of bioequivalence studies conducted by Panexcell be suspended from the market.
Medicines currently being evaluated for authorisation on the basis of data from Panexcell will not be granted authorisation in the EU.
The CHMP's recommendation is being sent to the European Commission for a legally binding decision.