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USP teams with Russian regulators to fight substandard drugs and raise quality standards

By Gareth MacDonald+

11-Oct-2011

The United States Pharmacopeial Convention (USP) has forged closer ties with Russian regulators to help tackle substandard pharmaceuticals and harmonize quality standards.

The deal, signed late last month, establishes a formal mechanism that enables the USP and Russia’s Ministry of Healthcare and Social Development (MoH) to share data in cases where drugs or their ingredients are found to be contaminated or deliberately adulterated.

USP spokesman Mat Heyman told in-Pharmatechnologist.com that: “The quality of drugs remains an issue in Russia, as it is in a number of countries around the world.

According to the Roszdravnadzor, a separate MoH agency that USP also works with, in 2010 1179 lots of 422 trade names of substandard drugs were identified and removed from circulation. Low quality of active pharmaceutical ingredients is of special concern to Russian regulatory authorities.

This was echoed by Russian deputy minister of Healthcare Veronika Skvortsova who said: “Partnerships and strong alliances between nations are critical as pharmaceuticals become an increasingly globalized industry,” adding that “In particular as we all collectively grapple with the risks posed by substandard and counterfeit medicines.

Collaboration

The USP-MoH accord also proposes staff exchange and scientific workshops designed to promote the adoption of internationally accepted laboratory standards in Russia.

The impact of these efforts will be reflected in the level of debate and interaction they create according to Heyman.

Are we able to identify areas of mutual interest in technical meetings? Do our scientists share useful information in these meetings and in personnel exchanges? Then, we will look toward specific achievements in the utilization of that information by each organization, with an eye toward improved public health via quality medicines.”

The organisations have sought to forge closer ties since 2009 when they co-hosted a number of quality-focused training courses for pharmaceutical manufacturing professionals.

Pharma 2020

The new agreement is one of several the USP has signed with international regulators over the last year . It also fits with an increased focus on the Russian drug manufacturing sector that was prompted by the launch of the Government’s Pharma 2020 policy last year.

However, while the 2020 plan – designed to foster drug production in Russia and reduce reliance on imports – was a motivation for the agreement, the accord is part of the Moh'swider effort to improve the quality of drugs sold in Russia regardless of where they are made according to Heyman.

The MoH has been very direct in asking that we work with them to address quality of medicines issues – just as we do in the US and elsewhere around the globe and regardless as to whether they are imported or produced domestically. Their commitment is straightforward, and we look forward to a cooperative relationship to improve medicines quality for all.”

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