The Problems of Russian Pharmaceutical Industry
90% medicines used in Russia are unknown by its origin.
One year ago Russia has buried its pharmaceutical industry, after having finished producing its own antibiotics. Now they are being produced only from imported raw pharmaceutical materials (like 90% of ALL medicines being produced in Russia).
The responsible organizations control the quality of imported medicines and promise to toughen this control. But in words, not in practice. A journalist of Russian newspaper MK (Moskovsky Komsomolets) got shocking documents showing the real situation in this sphere. These documents witness that Russian Sanitary Inspection gives easily the permissions for importing semis to produce pills and globules.
This is a national shame! The share of national medicines produced from national semi-products in Russia is negligibly small. If within the Soviet period we were producing 70% of all necessary medicines, today, according to the statistics of the Russian Academy of Science’ Institute of Pharmacology we are at the level of 1914 (when we were producing next to nothing). Why? It is not advantageous to produce semis for medicines. In this sphere Russia can not compete even with India and China, providing cheaper substances. But it is not a secret that the quality of Indian and Chinese made medicines are poor. To say nothing of the fact that these countries export dozens of tons of counterfeit medicines top Russia.
The official statistics say there are 7-12% of counterfeited medicines consumed in Russia (the expert evaluation is about 60%). If before the major part of counterfeit was so called simple medicines, now we witness an enormous number of expensive strong medicine: immuno-modulators, antibiotics, cardiologic, antifungal, hormone containing and gastroenterological medicines. Taking into account, that 90% of medicines are being produced from foreign semis, may we ask a question: what semis are being imported? The specialists say that the lion’s share of the falsified and counterfeited medicines is being produced from imported semi-products.
The law says: one has right to export to Russia only registered medicines (the pharmaceutical substance is a ready medicine – you have just to press pills, to pack it and sell. If a medicine didn’t pass through registration, that means that it didn’t pass through clinical trial. And in this case its safeness (and its effectiveness, too) is not proved by anything or anyone. At that, a foreign medicine has to be registered at the Russian territory.
But there is still a loophole: the lion’s share of pharmacological semi-products is being imported as simple chemical compounds. It is more profitable to register it at the Russian market and the customs duty, are half the ordinary price. The producers and selling companies “forget” about these medicines’ danger for the consumers’ health.
One more problem – within the framework of our customs system it is very difficult to find out who is the real producer of the pharmaceutical semi-product.
The Russian Minister of Health Mikhail Zurabov admitted, that some semi-products pass through the Russian birders and when we ask the producer did he export them to Russia he says “No”. It is a very seldom practice when we buy the semis from the producer directly. More often it passes through the semi-legal schema of import transactions through the intermediary companies. Sometimes these semis are being gathered at storehouses and it is impossible to control their use-by-date.
Last years the Russian Sanitary Inspection and Federal Customs Service signed an agreement on the exchange of information, that according to the parties, had to relieve consumers from counterfeits. The Chief Sanitary Inspector Ramil Khabriev promised then to complicate the import of pharmaceutical substances which the quality of Russian medicines depends on. He also said this would end the import of unregistered pharmaceutical substances to Russia.
But the practice witnessed that would be quite possible.
According to the law, even the most high-ranked official has no right to permit with a stroke of the pen the import of unregistered medicines. But the law is not a wall – you can push it aside. You want proves? Here you are.
A Russian company from Kemerovo region signed a contract with a Swiss company for delivering pharmaceutical substance phenobarbital. After the contract was signed it turned out that this Chinese substance is not registered in Russia. And it is impossible to bring it in to Russia legally.
What is the next step of this Kemerovo company? In March 12, 2004 it asks the Russian Health Ministry for the permission to import 5 tons of phenobarbital to produce benzonal. April 8, the Department of Medicines Control refuse to give the permission referring to the law regulating medicines production and import. The Kemerovo company officials ask the Russian Ministry for accepting them in Moscow. The Ministry refuses. Kemerovo informs the Federal Service of Health Control and complains that there is the deficit of benzonal in Russia. 3 days later the Federal Service allows the import of 5 tons of unregistered substance to use it “as a chemical semi-product for producing benzonal”. I.e. allows to import the unregistered semi-product as a chemical compound. At the same time the Russian Ministry of Health also allows the import. This is a pardon for customs. As a result, the unregistered substance, which quality is not controlled by anyone are imported to Russia, pills are produced - not benzonal, but andipal and phenobarbital. Let’s hope for the best that no one damaged of these pills.
This is not an exception.
For example, February 4, 2005 the Russian Health Inspection in its letter allowed a Moscow region company to use a Chinese pharmaceutical semi trimetoprim (unregistered in Russia) in producing duaseptol. The schema is just the same – there is a permission to import it as a chemical compound (and after that to produce medicines for consumers). Besides, the company doesn’t pay taxes.
We are sure that it is possible to find many more examples. But the above-mentioned examples are enough to take a conclusion: the practice of importing unregistered pharmaceutical semi-products to Russia by authority of high officials exists.
According to an official of Russian law-enforcement bodies, “… these facts can be considered as smuggling under the cover of high officials’ permission. They in fact allow the import of unknown products that will be afterwards used for producing medicines for our people. I can not exclude the possibility that the schema is widely used by drug dealers, because many pharmaceutical substances are included into a list of strong substances”.
The unregistered pharmaceutical substances used for producing medicines are fraught with the serious threat. And the most dangerous threat is that from the unregistered semis they produce medicines registered in Russia, so in this situation it is impossible to distinguish the original from the counterfeit.