Russia Moves To Improve Drug Product Controls

Two major changes are taking place in the Russian drugs market. Under the first, quality monitoring of immunologicals has been assigned to the Tarasevich state research institute for standards, making it a national control body reporting both to the Health Ministry and the state epidemiological committee, says its director Nikolai Medunitsyn.

Farmatsevtichevsky Vestnik reports that this follows the arrival of growing numbers of products of doubtful quality that could be dangerous or damaging to health. They are delivered mainly by small firms operating inside Russia or abroad, often unregistered. Major Russian firms are also known to have failed to meet Good Manufacturing Practice standards for the production of immunologicals relating to high-standard store and specific transportation temperatures. From now on, all deliveries of Russian-made vaccines and all imported batches for human use must be approved by the institute.

The volume checked is to be raised to "no less than 80%," from 5%-10% at present of all vaccines produced and 20%-40% of products assigned to vaccination and diagnostic test systems for hepatitis B and C and HIV. Quality will also be monitored on a larger scale. The institute is inspecting production in the immunological sector, with manufacturing licenses said to be issued only to companies meeting GMP requirements. So far, 46 producers have qualified, for the production of 534 items. There are 49 firms in the sector in Russia, accounting for 819 immunobiologicals, of which 179 are for parenteral use.