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Pharma Industry Fails in Quest to Scrap Registration Requirements for Drug Ingredients in Russia
19 May 08
Russia's healthcare watchdog says the law needs tightening to crack down on counterfeit medicines.
Global Insight Perspective | | Significance | Russia's pharma industry association has failed to convince Roszdravnadzor to relax laws on registering all chemical ingredients of new drugs prior to registering and seeking approval for the drugs themselves. | Implications | This initial phase of Russia's cumbersome process of drug approval is here to stay, and drug companies can expect the same delays and fees applicable to registering drug ingredients to remain firmly in place. | Outlook | The Russian pharmaceutical market is expected to keep growing in value, but international pharma players will maintain their arm's-length approach to the market as long as administrative barriers to local production and drug registration remain so unaligned with international norms. |
Russia's pharmaceutical industry association, the AIPM, has failed to persuade the country's Federal Service for Surveillance in Healthcare and Social Development (Roszdravnadzor) to relax a law that requires all chemical ingredients of medicines to be registered with the government. Representatives from the AIPM participated in a session of the State Duma last week, presenting their case, that in markets such as the United States or the European Union (EU) such stringent registration requirements are not in place, and that they present an additional layer of time-consuming administrative red tape that hinders the rapid marketing of new treatments. However, in an interview with pro-government newspaper Vremya Novostei, Roszdravnadzor's Director Nikolai Yurgel said that not only had the agency refused to grant the AIPM's request, but that it planned on tightening its surveillance of new drugs to an even greater extent. This is understandable to a certain extent, given Russia's continuing difficulty in ridding its medicine supply-chain of counterfeit drugs. In 2006, it was estimated that 10% of all drugs on the market were fakes, although some observers say that this is a conservative estimate. Yurgel said that despite the fact that fine chemicals—destined for use in pharmaceuticals—were submitted to Roszdravnadzor for approval and registration, there continued to be cases where producers used other, non-approved imported supplies of the same chemicals to pad out their stocks. Foreign drug-makers, meanwhile, also present risks in that all of their products are made overseas, and are therefore beyond the reach of Roszdravnadzor's chemical-registration process. According to Yurgel, this is justification enough for Roszdravnadzor to increase its practice of conducting random inspections of companies' drug supplies once they have entered Russian territory. Yurgel said that the agency initially planned to focus its efforts most intensely on drugs produced by companies from Asia, particularly from China and India, which are both known to have thriving counterfeit drug markets. The RIA Novosti news agency cites Yurgel as saying that Roszdravnadzor needs to carry out checks on at least 10% of drugs that go on sale in Russia, but at present the agency only has the capacity to inspect about 1.5-2% of all stocks. Outlook and Implications While registering fine chemicals with Roszdravnadzor looks set to remain the norm for drug companies in Russia, the agency has made concessions for both domestic and multinational pharma companies in other areas of drug pre-marketing. In March, the agency proposed several new measures aimed at clarifying the registration process for finished pharmaceuticals; the final administrative step prior to seeking marketing approval (see Russia: 4 March 2008: New Legislation Proposed for Facilitating Registration of New Drugs in Russia). At present, the Russian health authorities aim to complete registration of new drugs produced overseas within a 90-day timeframe, although this is adhered to more strictly for companies from countries with which Russia has signed a memorandum of understanding on pharmaceutical trade. As this time period comes on top of the required registration of chemical and active ingredients for local companies, as well as possible border checks for foreign firms, Russia's drug-approval process is often both cumbersome and lengthy. In spite of this, Russia's pharmaceutical market—which gained 16% year-on-year in value terms to US$14.3 billion in 2007—is expected to keep growing in value, fuelled by growing demand and the increasing subsidisation of innovative medicines for certain sectors of the population. Nevertheless, international pharma players will maintain their arm's-length approach to the market as long as administrative barriers to local production and drug registration remain so unaligned with international norms.
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