26 June 2013

Insulin in Russia sits on the import needle

Russia does not produce insulin
Diabetic Russians are guaranteed high-quality insulin
they can only get it from abroadAlexandra Borisova, "Newspaper.

Ru"Correspondent of "Gazeta.

Ru" found out whether Russia has its own insulin, where insulin comes from on the Russian market, how many diabetics there are in the country and how the number of diabetics in the world will change.

The first production cycle of insulin syringe pens in Russia has been launched at the plant in the Orel region. This form of insulin intake is most convenient for diabetics. Such devices appeared on the world market about 20 years ago and attracted patients with ease of use. The syringe pen is a bottle with a drug, a metered feeding mechanism and a replaceable needle, with its help it is easier to inject and dose insulin, it creates a minimum of pain, and such a device is much easier to carry than a real syringe with ampoules.

The project was launched on behalf of Vladimir Putin, who was prime minister at the time, and the governor of the Orel region, Alexander Kozlov, tirelessly emphasized the role of politicians and partners from Rostechnologies in the fact that the project was carried out at all (it was implemented by the French firm Sanofi, the third largest supplier of insulin to the Russian market, and other Western companies that came to the Russian market with similar offers were unable to implement their plans).

The management of the plant says that its opening solves two tasks at once – providing Russians with high-quality drugs and reducing dependence on the supply of foreign medicines. But the second goal of this plant will obviously not be achieved, at least in the near future: the substances themselves in dry form come to the Orel plant from Germany.

The products of the Orel plant are well–known insulin preparations and insulin analogues of both long- and short-acting. The quality is identical to the quality of the head factory in Frankfurt. Thus, Russians are offered German insulin in Russian packaging.

The plant's technologists admit that not all Russian drugs are bad, but most of the production is not certified according to GMP standards ("Good Manufacturing Practice", Good Manufacturing Practice), so it is not clear how to distinguish a high-quality drug from a mediocre one. One way or another, insulin-dependent patients will still be waiting for a high-quality drug from abroad.

Human insulins and their analogues are produced by genetically modified bacteria, that is, they are real GMO products. However, diabetic patients are not afraid of GMOs: substances synthesized by bacteria are of much higher quality and less allergenic to humans. The full cycle of insulin production in Russia is implemented only at the level of low-power production on the basis of the Institute of Bioorganic Chemistry of the Russian Academy of Sciences in Moscow and JSC "National Biotechnologies" in Obolensk (the website of the latter enterprise reports that it is certified according to GMP standards), however, they pack insulin in inconvenient containers, suitable mainly only for use in hospitals. In addition, they do not offer prolonged insulin.

Installation of own equipment for the production of syringe pens is very expensive and is not yet within the power of manufacturers. The state also supports foreign companies.

Medsintez in Novouralsk and Pharmstandard in Ufa pack imported insulin, but due to small production volumes, its prices differ little from fully imported. The largest players in the Russian and world markets remain foreign Novo Nordisk, Sanofi-Aventis and Eli Lilly. According to 2011 data, Novo Nordisk accounts for 43.4% of the market, Eli Lilly – 27.6%, Sanofi-Aventis – 17.8%. Only in fourth place is Pharmstandard with 6%. Other manufacturers do not cover even 3% of the market.

The needs of Russian patients for insulin are great and continue to grow. According to official statistics, more than 3.3 million people have diabetes in Russia, and about 285 million in the world. However, experts of the Endocrinological Research Center believe that the real number of diabetics in Russia is three times more – more than 10 million people. However, not all patients require insulin: both in our country and in the world, 90% of patients are patients with type II diabetes, non–insulin-dependent at the initial stage. Type I diabetes is most often hereditary. Various infections, such as enteroviruses, act as a "trigger", the susceptibility to which, in turn, is determined by the work of leukocyte antigens.

Type I diabetes most often develops at a relatively early age and is not associated with lifestyle. Type 2 diabetes, on the contrary, occurs during life under the influence of a number of external factors, the main of which is improper nutrition.

Scientists agree that the incidence of diabetes will increase significantly in the next ten years. Although the incidence of type I diabetes among children has increased markedly during the 20th century (scientists are still arguing about the causes of this phenomenon), the main increase is still brought by type II diabetes. The main reason for this is poor nutrition and stress. Biologically, in such a situation, any nutrients are deposited in adipose tissue, so stress is to blame not only for the increase in the incidence of diabetes, but also for cardiovascular and oncological diseases. Particularly strong growth will be observed in Asian and African countries, which are switching to a "Western diet" and an appropriate lifestyle.

Since any disease is easier to prevent than to cure, people at risk of developing diabetes can be advised to avoid stress, exercise, not overeat and not smoke.

Portal "Eternal youth" http://vechnayamolodost.ru26.06.2013

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