The federal agency of medications and health products (Agence fédérale des medicaments et des produits de santé (AFMPS) have been preventively taken four generic medication off the market. This is after “major non-conformities” with directives on good clinical practices at the Indian company GVK Biosciences came to light. The AFMPS announced it was stopping the sale of the medications on its internet site. A generic medication can be an alternative choice to a well-known medication. However, producers of generic medications must show that their product is as effective and safe as the usual medication through bioequivalence studies.
An inspection done by the French agency in charge of medication (ANSM) revealed infringements at GVK Biosciences, which raised doubts “about the acceptability of data provided with the request for authorization to put the medications on the market”, says the AFMPS.
A reevaluation procedure was undertaken in September at the request of the European Commission. While waiting for the decision, the AFMPS has asked for additional data on the 4 medications sold in Belgium. “Following analysis of the data provided, it has been decided to preventively suspend the authorization for the medications to be on the market”, said the agency.
The medications pulled from the market are Candesartan Mylan for high blood pressure, antihistamines Desloratine Teva and Desloratine Apotex and well as the gastric antisecretory treatment Esoprazole Mylan.
The AFMPS reminds people that alternative therapies are available, and insists that “no adverse effects due to the medications have been reported at this moment, in Belgium or in Europe”.
Jason Bennett (Source: Belga)