Pharmacies sell hundreds of names of dangerous drugs

Black label for pharmacistsIrina Vlasova, GZT.RU

The head of the federal service, Nikolai Yurgel, harshly criticized the situation in the field of drug quality. "Quality control remains at a very low level, and the information received by Roszdravnadzor does not cause optimism," Yurgel said. "The consequence of this situation was an egregious case involving gross violations of the organization of the production of the drug mildronate, a solution for injection at CJSC PharmFirma Sotex, which led to the development of serious negative reactions in 23 patients, including two deaths."

The quarterly rating of manufacturers of low–quality medicines compiled by Roszdravnadzor was headed by CJSC PharmFirma Sotex, in second place – the company Flora of the Caucasus, in third - Iodine Technologies and Marketing.

Among the importers, the Ukrainian pharmaceutical company Zdorovye, the German Novartis Pharma AG, as well as Polish, American, French, Slovenian, Indian and Estonian manufacturers supplied substandard drugs more often than others.

Of particular concern to the Department is a significant number of substandard and falsified pharmaceutical substances from which medicines were produced. Over the past year and the first quarter of 2009, Roszdravnadzor identified and withdrew from circulation a total of 37 trade names of 81 series of falsified medicines, 6 names of 187 series of falsified pharmaceutical substances and 1190 series of finished drugs produced from these materials.

According to the service, today up to 3.5% of medicines submitted by manufacturing organizations and importers for preliminary state control are rejected. Therefore, the agency has increased the volume of selective control by an average of 45% compared to the level of 2007.

"In 70% of the cases of inspections carried out, protocols on administrative offenses were drawn up for gross violations of licensing requirements and conditions," said Valentina Kosenko, head of the State Control Organization for the circulation of medical products and Rehabilitation of disabled people of Roszdravnadzor.

Taking into account, frankly, the alarming situation in the pharmaceutical market, Roszdravnadzor plans to create a more effective quality control system of drugs within two years, which will be able to successfully interact with similar international institutions. In the meantime, it has been decided that Roszdravnadzor will partially conduct subsequent inspections jointly with the Accounts Chamber of the Russian Federation, about which a corresponding agreement was signed on April 10.

Portal "Eternal youth" www.vechnayamolodost.ru13.04.2009