The French Medicines Agency has decided to suspend the marketing authorization for nine generic drugs. In question: the fraud of a private control body.
A drug says “princess” and his General medicine must not only contain the same dose of active ingredient, but they must also “behave” in the same way and induce the same reactions in the body. It is essential, for example, that the two drugs diffuse at the same speed in the body.
This is called the “bioequivalence”And this is a condition sine qua non for a generic drug to receive its marketing authorization (MA).
Manipulation of results
By inspecting a laboratory of a private company carrying out bioequivalence tests in Bangalore (India), the American Food and Drug Administration (FDA) and the World Health Organization (WHO), revealed manipulation of results. Samples were replaced by others to obtain consistent results. This fraud “characterizes a lack of respect for Good Clinical Practices concerning these bioequivalence studies and calls into question the reliability of the results of all the bioequivalence tests conducted by this company ”, wrote the ANSM, the French drug agency, in a press release.
Nine drugs (antimalarials and antihistamines) are affected. The list is available on the ANSM website.
Like other EU countries, France has decided to suspend the marketing of the drugs pointed out, in compliance with European regulations.
These suspension measures are taken “As a precaution”, specifies the agency, nothing has led to “to establish a proven risk for human health or a lack of efficacy of these drugs ”.
Moreover, this decision only concerns drugs which are available under other brands. No risk, therefore, of breakage or interruption of treatment.
This decision is not the first of its kind. In 2014, for example, 25 generic references were temporarily withdrawn from the market for similar reasons, again in India.