06 April 2012

Falsified medicines: a drop in the sea is a fly in the ointment

The turnover of counterfeit medicines is about 0.1% of the total number of batches entering the Russian pharmaceutical market annually

Elena Mekshun, Farmvestnik

Speaking on April 5 at the IV conference "State Regulation and the Russian Pharmaceutical Industry 2012: continuation of the dialogue", Valentina Kosenko, Head of the Organization of State Quality Control of Medical Products of Roszdravnadzor, noted that during 2010-2011, Russian legislation created a favorable environment for pharmaceutical business, eliminated unnecessary barriers. However, these measures were designed for bona fide market participants.

In 2011, 145 items of 313 series of substandard drugs of foreign production were withdrawn from circulation. According to Valentina Kosenko, the statistics of falsified medicines of domestic production are not decreasing. According to the representative of the department, 15 trade names of counterfeit drugs were withdrawn from circulation in 2011. The grounds for withdrawal were the cancellation of the state registration of the drug and its exclusion from the state register of medicines, non-confirmation by the manufacturer of the release of the drug into civil circulation, the sale of the drug according to a quality document, the identification of which is not confirmed by the manufacturer.

The turnover of counterfeit medicines is approximately 0.1% of the total number of batches entering the pharmaceutical market annually, Valentina Kosenko said. Roszdravnadzor is particularly concerned, according to her, with the falsification of pharmaceutical substances. As a way out of the situation, the agency offers a mandatory audit of suppliers and manufacturers of substances.

In 2011, about 2 million packages of counterfeit drugs worth 445.5 million rubles were withdrawn from circulation, a representative of Roszdravnadzor said.

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