FRANCE’S medicines watchdog Agence Nationale de Sécurité du Médicament is suspending the sales of several generic pharmaceuticals made by Indian laboratory GVK Bio – including some versions of everyday drugs – because of doubts over their quality.
In all, 25 pharmaceutical generics will no longer be for sale after December 18, including versions of painkillers ibuprofen and tramadol, antihistamines desloratadine and ebastine, anti-depressant escitalopram, high blood pressure treatment candesartan, dementia treatment donepezil, migraine treatment rizatriptan and anti angina drug rimetazidine.
The versions of the drugs are marketed by companies such as Abbott, Mylan, Biogaran (Servier subsidiary), Teva, Cristers, Gerda, Medipha Santé and Zydus.
Generic pharmaceutical manufacturers are responsible for testing the quality of their drugs but the ANSM said its own tests had uncovered faults in GVK Bio’s cardiograph testing equipment.
It said there was no indication that there was any problem with the effectiveness of the drugs, but the balance of risk meant that it was safer to ban the sale of these ones made by GVK Bio. It added that patients using the drugs could easily get different makes of generic.
Only the versions of medicines contained on the ANSM list are banned – other versions marketed by other companies are still available.
The list of drugs is:
Escitalopram Abbott 10 mg, comprimé pelliculé
Escitalopram Abbott 15 mg, comprimé pelliculé
Escitalopram Abbott 20 mg, comprimé pelliculé
Escitalopram Abbott 5 mg, comprimé pelliculé
Ebastine Biogaran 10 mg, comprimé orodispersible
Desloratadine Cristers 5 mg, comprimé pelliculé
Ibuprofene Cristers 400 mg, comprimé pelliculé
Desloratadine Arrow 5 mg, comprimé pelliculé
Desloratadine GNR 5 mg, comprimé pelliculé
Candesartan Mylan 32 mg, comprimé
Donepezil Mylan 10 mg, comprimé orodispersible
Donepezil Mylan 5 mg, comprimé orodispersible
Ebastine Mylan 10 mg, comprimé orodispersible
Rizatriptan Mylan 10 mg, comprimé orodispersible
Trimetazidine Mylan 35 mg, comprimé à libération modifiée
Desloratadine Teva Sante 5 mg, comprimé pelliculé
Desloratadine Zydus 5 mg, comprimé pelliculé
Escitalopram Zydus 10 mg, comprimé pelliculé
Escitalopram Zydus 15 mg, comprimé pelliculé
Escitalopram Zydus 20 mg, comprimé pelliculé
Escitalopram Zydus 5 mg, comprimé pelliculé
Ibuprofene ZF 400 mg, comprimé pelliculé
Ibuprofene Zydus France 200 mg, comprimé pelliculé
Ibuprofene Zydus France 400 mg, comprimé pelliculé
Tramadol paracetamol Zydus France 37,5 mg/325 mg comprimé pelliculé