Insulin production: get off the import needle
Russian diabetics need high-quality insulin, and it is already produced in RussiaIzvestia of the Udmurt Republic, 25.03.2010
Insulin–dependent diabetes is a disease that requires lifelong therapy. The patient's life literally depends on the presence or absence of insulin. And the quality of the patient's life directly depends on the quality of insulin. When using low-quality insulin or a lack of it, a person develops blindness, kidney failure, disorders of the circulatory system and nervous system very quickly.
Diabetes is officially recognized as a non-communicable epidemic and, according to the World Health Organization (WHO), ranks third in terms of the rate of spread after cardiovascular and oncological diseases. There are 200 million diabetic patients in the world, more than 2.7 million of them live in our country. More than 750 thousand Russians need daily insulin intake. The pace of development of the epidemic is frighteningly high. According to WHO forecasts, by 2030 the number of diabetics will exceed 360 million people. Unfortunately, Russia is not lagging behind in terms of the spread of the disease. But it is lagging behind in the pace of production of vital medicines, in fact, having turned into an insulin-dependent country dependent on supplies from abroad.
A few Russian manufacturers occupy only 4-5% of the market, while they produce medicine again on the basis of a substance purchased abroad. The only exception is one Russian enterprise – National Biotechnologies, which has a full–cycle industrial production – from the creation of the primary substance of genetically engineered human insulin to the production of commercially available dosage forms from it.
The National Technologies company started developing the technology for the production of Russian insulin back in 1998. At that time, the production of domestic insulin based on animal raw materials in the country had been completely absent for almost 10 years. And the production of a new, safer for patients genetically engineered human insulin has not been established. In 2003, National Biotechnologies commissioned Russia's first industrial line capable of producing 30 kg of human genetically engineered insulin identical to natural insulin (which is 1 million vials of ready-made short- and medium-acting dosage forms).
Three independent certified laboratories in Germany highly appreciated the quality of the substance "National Biotechnologies". It is not inferior to the European and American pharmacopoeia. Moreover, today, for testing all insulin preparations imported into the country, a state standard sample is used, produced by the National Biotechnologies enterprise on the basis of the National Biotechnologies substance.
The preparations manufactured by "National Biotechnologies" have passed all the required clinical trials and have proven full compliance of the clinical effect with foreign insulins of the world's leading manufacturers. At the same time, domestic insulin is more affordable, which also does not depend on exchange rates. It should be noted that in 2009 alone, Russia spent over $ 250 million on the purchase of insulin.
So far, "National Biotechnologies" can provide about 8% of Russia's insulin needs. To rid the country of "insulin dependence", it is necessary to increase the volume of production. The technology can also be scaled on the basis of the National Biotechnologies enterprise. Already now it is possible to produce several times more than today's volumes here. There are all possibilities for this. And then Russia will be able to fully provide a growing number of diabetics with high-quality and modern domestic insulin.
Portal "Eternal youth" http://vechnayamolodost.ru05.04.2010