India is furious. The European Union, through the European Medicines Agency, has just put it under a snub by banning in its member countries the sale of 700 generic medicinestested and manufactured on Indian soil. The decision will be effective from August 21.
Why this withdrawal from the sale?
This decision follows the discovery in May 2014 by the French Medicines Safety Agency (ANSM) of deficiencies in clinical trial procedures. These dysfunctions were observed during a routine check on a site of the GVK BIO group, a company specializing in clinical trials in southern India.
The European Union has found breaches in clinical practices for 700 drugs tested by GVK over the past five years, continues Le Monde, which has posted a document on the scientific assessment of the European Commission online. “Electrocardiogram (ECG) data manipulations were detected in each of the 9 trials inspected by the ANSM. These data manipulations raise doubts as to the authenticity of all other clinical records of these nine clinical trials, points out report. Consequently, they were considered by the ANSM as non-compliant with Good Clinical Practices (GCP) and as unreliable in supporting marketing authorization applications. “
Which drugs are affected?
The drugs affected by this withdrawal from sale are drugs known as Advil (painkiller), Aerius, an antihistamine or Seroplex, an antidepressant.
France has already started to withdraw the incriminated molecules, according to the Ministry of Health contacted by Le Monde, while specifying that alternatives exist to treatments withdrawn from the market.
>> To read also:Generic drugs: effective or not?
