In Russia there can be a shortage of vaccines. About it the Ministry of health warned the company “national immunobiological company” (“national immunobiological company”), a subsidiary of state Corporation rostec, told TASS. From mid-2015, “national immunobiological company” acts as a single supplier of domestic vaccines under the immunization calendar.
The reason because of which the country may be a shortage of vaccines, “national immunobiological company” indicates the new law developed by the Ministry of health, according to CEO Mary Hubiev in his letter to the Minister of health Veronika Skvortsova. A copy of the letter is available .
We are talking about the project, offering batch state control for vaccines. According to information on the website disclosure of legal information regulation.gov.ru it was designed to improve the procedure of the admission of pharmaceuticals to the market.
Now in Russia the vaccine manufacturers conduct independent examination of the quality of the individual series and receive a special certificate for all products that lasts for some time, says in the letter Hubiev. Such expertise takes time: for example, at least 21 days for vaccines against influenza, “Savegrp” and 28 days for the other influenza vaccines “, Ultrex”. In addition, these flu drugs have a limited period of production — from March (after the announcement of who the actual strains of the disease) until the end of September, highlights Hubiev. If you enter the test vaccines, not selectively, but each series, the production period will be reduced, and hence the number of preparations will decrease, concludes it.
Impact batch control at the factory and the cost of drugs, stressed the representative of “national immunobiological company”. Given the fact that today, many domestic vaccine purchased by the government at a price below cost, this will negatively affect the Russian pharmaceutical manufacturers, I’m sure Hubiev.
“As the sole supplier and main producer of vaccines for the national vaccination calendar, we cannot articulate the risks facing the market in the case of the bill and to warn about the negative consequences of its adoption”, — said the press service of “national immunobiological company”. The company stresses that the quality of vaccines, of course, need to control, but if the company works according to GMP (international quality standards for pharmaceutical manufacturing), is licensed to manufacture, then additional checking of each series will create unnecessary difficulties and risks.
This letter, reported in “national immunobiological company”, the company expressed the General opinion of both domestic and foreign manufacturers to localize their production in Russia, as well as the opinion of professional associations, including the Association of Russian pharmaceutical manufacturers (ARPM). To quickly get through to the General Director of ARPM Victor Dmitriev failed.
“We stress that the adoption of this law can result in serious consequences for the country’s vaccines against dangerous infectious diseases to the extent necessary”, — concluded the press-service of “national immunobiological company”.
The project is under discussion, and a letter “national immunobiological company” will be taken into account when preparing the final version of the document, told in the press service of the Ministry of health. Additionally, the Department noted that when drafting the law the Ministry took into account the production time and the volume of supply of influenza vaccine. According to the Ministry of health, the adoption of the document will not lead to a shortage of drugs.