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Seven generic drugs are being withdrawn from sale in France as of today. The efficacy test carried out by an Indian company does not meet European requirements, the drug agency announced in its press release. What are they?
In a press release dated July 3, 2024, the French National Agency for Medicines (ANSM) announced the immediate suspension of marketing authorizations (MAs) for seven common generic drugs. A decision that follows a European inspection of the Indian company Synapse Labs.
Bioequivalence analyses carried out in India deemed insufficient
The Indian company’s specialty is indeed testing generic drugs before they are sent to Europe. But an inspection by the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) in late 2023 at Synapse Labs revealed “irregularities” And “raised serious concerns regarding the data from the bioequivalence studies conducted.”
As a reminder, bioequivalence is what guarantees the identical efficacy and safety of use of a generic drug to that of the original drug.
In short, the efficacy controls of generic drugs did not comply with the rules imposed by the European Union. At the end of May, the European Commission then imposed the suspension of the marketing authorisations of the drugs controlled by Synapse Labs, setting them a deadline of one month.
Diabetes or pain medications affected
In France, 72 drugs were initially affected by this decision. Around twenty then successfully passed new tests, but seven were withdrawn from the market yesterday due to lack of guarantees.
These are drugs used in the treatment of diabetes, HIV, certain forms of schizophrenia or even as painkillers.
- Olanzapine Arrow 5 mg tablet (Arrow Generics) – antipsychotic (schizophrenia, bipolar)
- Olanzapine Arrow 7.5 mg tablet (Arrow Generics)
- Olanzapine Arrow 10 mg tablet (Arrow Generics)
- Nevirapine Arrow LP 400 mg prolonged-release tablet (Arrow Generics) – antiretroviral (HIV)
- Metformin Almus 500 mg, film-coated tablet (Almus France) – antidiabetic
- Tramadol Almus 50 mg, capsule (Almus France) – painkiller
- Ibuprofen Liderlens 400 mg, soft capsule (Nutra Essential OTC SL) – anti-inflammatory suspended but no batch recall
Equivalents remain available in pharmacies
No worries though if you recognize and consume these references.
As the ANSM specifies: “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.”.
This is not the case for 41 other generics involved in this affair. These latter, used against cancer, diabetes or heart diseases, are essential for certain patients, but have no equivalent on the market.We are granting a postponement of the suspension of marketing authorization, because the cessation of marketing would create a critical situation for the continuity of patient care” justifies authority.
The ANSM is therefore granting them an additional two years to conduct new studies. However, the Agency would like to reassure patients: to date, no reports of safety or loss of efficacy have been reported for any of the drugs mentioned.