New policy poses challenges for foreign drug companies in Russia
A new policy by the Russian Federation’s Ministry of Industry and Trade will pose challenges for foreign pharmaceutical manufacturers this year. New rules will make it necessary to receive a Russian variant of a certificate of conformity of quality if they wish to do business in the country.
The chief representative of Pfizer in Russia told Business FM that there isn’t enough time or resources to check drugs under the new policy while still working within budget and schedule constraints. This may mean that Russia will be left without modern pharmaceuticals this year. The cost of medicine has already risen by nearly 25%—twice as much as the inflation rate. This year, literally thousands of modern and quality drugs could vanish from the shelves.
Modern pharmacologists use international GMP or Good Manufacturing Practice standards. It is a well-known set of standards used by major pharmaceutical companies. Russian officials decided to issue their own GMP certificates for foreign manufacturers. The Russian standard will be enforced on all new drugs this year and the next, without exception. In 2017, Russian inspectors will have to check several thousand drugs—an impossible task without an increase in the number of inspectors.