IHS Global Insight Perspective | |
Significance | Local drug makers Sotex and Flower of the Caucasus have topped a blacklist of producers selling substandard medicines in Russia, which also includes foreign firms such as Zdorovie, and a unit of Novartis. |
Implications | Federal drug watchdog Roszdravnadzor has increased its quality-control sampling of drugs by 45% in the past year, and will launch a new monitoring system within the next two years, in an effort to bring Russia's pharmaceutical supply chain in line with international standards. |
Outlook | With the implementation of mandatory GMP compliance still not fully carried out across Russia, and with minimal legal repercussions for offenders, substandard medicines will continue to make their way into the pharmaceutical supply chain with regularity. |
New Warning on Drug Quality
Russia's Federal Service for Surveillance in Healthcare and Social Development (Roszdravnadzor) has published a blacklist of companies known to be producing sub-standard medicines. The list was unveiled at a meeting chaired by Roszdravnadzor this week, during which the agency discussed its drug-safety monitoring activities of 2008 and the first quarter of 2009. Representatives of over 120 pharmaceutical companies with an active presence on the Russian market attended the meeting.
Roszdravnadzor says its random sampling of medicines in the Russian supply chain increased by 45% in 2008 compared with 2007, and that it ordered the withdrawal of 3.5% of the drugs that it tested. In the first quarter of 2009, the leading Russian offenders in terms of the volume of substandard drugs seized were Sotex, Flower of the Caucasus and Iodine Technology and Marketing. Sotex's dubious distinction of topping the list follows its pursual by Roszdravnadzor in court, after a labelling error on one of its most popular drugs led to the death of two patients and the serious illness of many more (see Russia: 15 April 2009: Roszdravnadzor Vows to Appeal as Arbitration Court Refuses to Remove Sotex's Operating Licence). Both Sotex and Flower of the Caucasus also appeared on the agency's 2008 blacklist (see Russia: 4 February 2009: Roszdravnadzor Names and Shames as 406 Low-Quality Drugs are Withdrawn from Russian Supply Chain in 2008).
Among foreign drug companies that have their medicines imported into Russia, named offenders for the first quarter include Zdorovie (Ukraine) and a German subsidiary of Novartis (Switzerland), as well as companies originating from Estonia, France, India, Poland, Slovenia, and the United States.
According to the Gazeta newspaper, the agency is hoping to launch a new and improved system for the quality-control monitoring of pharmaceuticals within two years, and intends to boost its level of communication with counterpart agencies in other countries, in order to harmonise its methods with international norms. Efforts in this area have already begun, with Roszdravnadzor having signed a memorandum of understanding on the subject with the U.S. Pharmacopeial Convention earlier this month (see Russia: 9 April 2009: Roszdravnadzor Signs MoU with U.S. Pharmacopeial Convention on Fighting Counterfeit Drugs).
Outlook and Implications
Roszdravnadzor has become much more vocal and strident in its criticism of companies that fall short of state rules on quality control in drug production, labelling, and distribution compared with even a year ago. In theory, increased vigilance by the agency should prompt drug makers to adhere more tightly to Good Manufacturing Practice (GMP) standards and invest in maintaining safety levels at all stages of the production and distribution processes. However, as demonstrated recently with Sotex, there is a discrepancy in thought between Roszdravnadzor and Russia's courts over how severely companies that breach rules on drug quality should be punished. In the case of Sotex, Roszdravnadzor is pushing strongly for the firm's operating licence to be removed while a full investigation is carried out, but the Moscow Court of Arbitration has ruled that this is unnecessary. The presence of international drug-monitoring agencies working together with Roszdravnadzor may be sufficient to spur companies into action if they want to maintain their reputation for producing quality treatments in other markets. However, with the implementation of mandatory GMP compliance still not fully carried out across Russia, and with minimal legal repercussions for offenders, medicines of substandard quality will continue to make their way into Russia's pharmaceutical supply chain with regularity (see Russia: 18 December 2008: Pharma Industry Warns Up to 70% of Production Plants Could Close Under Russia's GMP Compliance Plan).