The European Medicines Agency has banned the sale of medicines

The Committee of the European Medicines Agency /European Medicines Agency, EMA/ has announced that it imposes a ban on the sale in the territory of the European Union of about 4 dozen generic drugs produced in India and intended for the treatment of such diseases as diabetes mellitus, depression and arterial hypertension.

The basis for such a measure is the results of an inspection carried out by EMA experts in India, in which gross methodological violations in the conduct of clinical studies were found, which cast doubt on the results of these studies and the safety of medicinal preparations.

Among other things, the list of prohibited drugs includes such preparations as donepezil, escitalopram, esomeprazole and metmorphine. The complete list of medicines manufactured in India takes up more than 120 pages, as these preparations have different trade names in different EU countries and are also available in different forms and doses.

Earlier, some of the medicines manufactured in India were already banned for sale in France, Germany, Belgium and Luxembourg, now EMA is expanding this list and announcing a ban on the sale of these medicines in the entire territory of the European Union.

Clinical trials of these medicinal preparations were conducted in India and have not been subjected to new research in other countries. Therefore, a team of French inspectors was sent to India to visit the factories and clinical centers of the GVK Biosciences company.

During the inspection of the correct way of observing the protocols for the conduct of the research, gross violations were found, in particular “manipulation of the data from the electrocardiograms during the conduct of some clinical trials of some generic medicinal preparations”, which, as seems to have been systematic and lasted no less than 5 years.

The systematic nature and duration of these violations, as well as the number of staff involved in their commission, cast doubt on these clinical trials, EMA said in a statement.

However, experts from the European Medicines Agency emphasize that there is no evidence of direct harm or lack of effectiveness when using these medications.

In a counter statement published on the website of the company GVK Biosciences, the EMA decision was called “unprecedented and grossly disproportionate”.

Representatives of the Indian company believe that the European Medicines Agency extrapolated the suspicious electrocardiograms found in only 9 of all the studies conducted by the company’s scientists.

From the management of GVK Biosciences, they quote the conclusion of the French inspectors, in which only the bioequivalence of these preparations is questioned, and they emphasize that this is not a reason to doubt the bioanalytical studies, pharmacokinetics and statistical aspects of the scientific studies carried out by the company’s scientists research.

By the way, the American analogue of the EMA – the FDA has so far not withdrawn from the market any medicinal products produced by the Indian GVK Biosciences.

Representatives of the US Food and Drug Administration said that about 40 generics manufactured by the Indian company are currently available in the pharmacy network in the US, however, their trade names have not been disclosed so far in order not to provoke a wave of anti-advertising.

The FDA will soon consider the results obtained from the French inspection in India and, if it deems necessary, will follow the example of the EMA and ban their sale on the territory of the United States.