There are multiple challenges to meeting GMP in Russia including bureaucracy and past pharmaceutical practices.

The state of GMP compliance in Russia is not yet up to Western standards. Currently only 50 of Russia’s 528 drug factories meet international GMP standards. Only 1 of the top 20 producers of drugs sold in Russia is not foreign owned and only one out of every five drugs purchased in Russia is produced domestically. The most concerning statistic is that 90% of pharmaceutical materials sold in Russia are from unknown origins.

The history of GMP compliance in Russia is very different than in the West. Until 1991 the Russian economic systems and principles were completely communistic. All property belonged to the state. All plants received plans and orders for manufacturing of products from the state. Supply of all materials was centralized and controlled by the state. Thus the plant managers were not concerned about meeting standards as much as meeting their duty to fulfill state plans. Under this system, the state consumed 100% of manufacturing capacities and the state created the mandatory standards.

So the state had several roles in pharmaceutical manufacturing:

– it was the only customer,

– it was the only supplier,

– it was owner of plants,

– and it was the authority that created standards and controlled compliance to them.

All this was controlled by a huge bureaucratic system with many institutions that were not concerned about meeting production and quality standards as in the rest of the world. The people who set the standards did so only on basis of their own understanding of how best to serve the interests of the bureaucracy. This changed dramatically in the early 90s when the USSR started to break up. In 1991 and 1998 two nationally oriented standards were approved in Russia. In fact they were compilations of GMP EC text with some withdrawals and changes. They added some new unnecessary requirements that were even more rigid then in GMP EC Guide. It wasn’t until 2004 that the EU GMP Guideline was approved as Russian national standard GOST R 52249-2004