INTERVIEW – The Medicines Agency has suspended the authorizations of 11 generic drugs. Certain tests were not carried out according to the rules of the art.
11 drugs are withdrawn from the market as a precaution. The National Medicines Safety Agency (ANSM) has chosen to suspend the authorizations (AMM) allowing their marketing. In question, the lack of respect for good clinical practices during the trials carried out on these generic drugs.
The specialties concerned are listed on the site of the ANSM. 8 brands of hydroxyzine – an antihistamine – and 3 of the perindopril / indapamide combination – an antihypertensive agent – will have to be recalled by batches. All used the same company for bioequivalence tests, intended to show that the generic is as effective as the originator.
But Micro Therapeutic Research (MTR), based in Chennai and Coimbatore (India), did not follow good clinical practice. These irregularities, reported after on-site inspections by Austria and the Netherlands, call into question the bioequivalence of medicines. As long as the Indian company does not provide more solid evidence, the MAs will remain suspended.
However, these recalls do not present a risk to the health of patients. According to the ANSM, contacted by Why actor, no side effects related to these drugs have been reported. This alert does not call into question the safety of generics, believes Professor Jean-François Bergmann, head of the Department of Internal Medicine at Lariboisière Hospital (Paris).
Do these suspensions indicate a potential risk of generics?
Prof. Jean-François Bergmann : It is precisely because these studies are necessary that they are selective. Some drugs fail to show bioequivalence and are not marketed. The suspensions are linked to inspections at the manufacturing sites. If they are not up to standard, all production is suspended. They can also cause withdrawal from batches due to a change in manufacturing where bioequivalence no longer exists in a new batch.
Prof. Jean-François Bergmann, head of the internal medicine department at Lariboisière
Can this information affect the level of trust?
Prof. Jean-François Bergmann : Prize withdrawals are daily. We keep realizing that a production batch is not totally in the nails. These nails are very narrow and demanding. The lot is then withdrawn. If it affects a brand-name drug, no one pays attention. When it’s a generic, everyone gets agitated. If we communicate by saying that we withdraw the generic drug, it is deleterious. People are extrapolating to all generics. The real message is that there are no more side effects, ineffectiveness, failures compared to the originator.
Should we control more generic manufacturers?
Prof. Jean-François Bergmann : We can say that an inspection on one plant at one time does not guarantee its quality on other batches. But bioequivalence is made for other drugs. If the factory has not radically changed its organization, there is no reason for them to deteriorate. Should we do more checks? We can suggest it. But in fact, we have not seen a generic scandal at the level of the controls carried out today. We suspended batches, as for originator, we closed factories, we suspended bioequivalences not demonstrated, but without scandal. No official generic coming out of an official factory with an MA has caused a scandal.
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