ANSM withdraws seven drugs from the market, whose efficacy tests are deemed to have been poorly carried out

The French National Agency for the Safety of Medicines is withdrawing seven drugs from the market, whose efficacy tests were not properly carried out, franceinfo learned from the ANSM. These are drugs used in the treatment of diabetes, HIV, certain forms of schizophrenia or even as painkillers. “These recalls are not expected to impact patient care as several comparable medicines can be used as alternatives and are available in sufficient quantities to treat patients.”specifies the ANSM.

The decision follows a European inspection of Synapse Labs. The authorities discovered that the Indian company did not meet European requirements. The efficacy controls of generic drugs did not comply with the rules imposed by the European Union. The European Commission then imposed the suspension of marketing authorisations for drugs controlled by Synapse Labs at the end of May, setting them a one-month deadline.

In France, 72 drugs were affected by this decision. About twenty have then successfully passed new tests, but seven must still be withdrawn from the market, starting Wednesday. These seven generics all have equivalents on the market, which is not the case for the 41 other generics targeted in this case. These drugs against cancer, diabetes or heart disease are essential for certain patients, but they have no equivalent on the market. The ANSM therefore gives them a period of two years to carry out new studies. The Agency assures franceinfo that no reports of safety or loss of effectiveness have been reported for these drugs.