Russian pharma producers unlikely to be able to start exports to EU

The Russian pharmaceutical industry risks running into a crisis in the coming years, due to the failure of a planned transition of local drug production to Good Manufacturing Practice (GMP) standards, with the aim of starting exports of Russian pharmaceutical products, including to the European Union.

A new draft of legislation regulating the production of drugs in Russia was recently presented by the Russian government and has caused a significant frustration among the leading local drug producers. According to them, there is no reason to consider the new rules as international GMP standards. The same opinion is shared by experts at the World Health Organization, according to whom the new rules comply by only 16% with the EU standards of pharmeutical production.

The adoption of such rules may result in the fact that Russia will not able to implement one of its most ambitious goals , that of starting to export its pharmaceutical products to the EU from 2014. At present, of 500 Russian pharmaceutical producers, only 25-30 enterprises comply with the EU standards.