The pharmaceutical industry in the country is actively gaining momentum and is considered one of the most promising among other industries. A radical substitution of imported drugs is being carried out in their own domestic market, and a significant proportion of drugs relates to high-tech products.
Current situation in the country
Last year alone, Russia began to produce 84% of the total number of vital funds for the population. The state invests heavily in the development of this sector of industry. For several years now, the production of medicines has been a particular priority and is one of the most important factors that can have an impact on stability in the country and increase its independence from the rest of the world.
Since 2014, a special state program called “Development of the pharmaceutical and medical industries” has been responsible for improving the situation. It is planned that this campaign will last until 2020. It is worth noting that on December 26, 2018, the government also allowed the cultivation of drug-containing plants in the country in order to independently produce various medicines and psychotropic substances purely for solving medical problems.
Domestic market growth
Statistics say that in Russia this industry is one of the fastest growing in comparison with all countries of the world. The profit from pharmaceuticals in industrial production alone amounted to about 594 billion rubles in 2008, and in 2014 grew to 1,152 billion rubles. This growth rate is provided by many factors. Moreover, among them, both positive and relatively negative are mentioned. The first include a large number of people in the country and an increase in life expectancy after various government reforms and innovations.
If we mention the negative points, then it is worth highlighting an almost total unhealthy lifestyle: drinking, smoking and lack of daily activity lead to poor health. Also, many Russians still prefer to engage in self-treatment, and the names of suitable drugs to learn more from relatives and acquaintances than from qualified doctors. However, such negative factors also contribute to the growth of the pharmaceutical market. Thus, the volumes of production of drugs are naturally increasing.
Sources of raw materials
The initial process begins at this stage. In total, there are five main sources for any drugs that are planned to be released at the industrial level:
- Mineral compounds. Sodium sulfate and magnesium sulfate are produced.
- Plants. On their basis create reserpine, morphine and glycosides.
- Organs and tissues of animals. They are quite widely used in the production of drugs. They are based on the production of insulin, enzyme preparations, as well as means for regulating digestion and thyroid hormones.
- Microorganisms. They serve as the basis for antibiotics like penicillins, macrolides and cephalosporins. For the first time, the method began to be used back in the 1940s, when the extract was extracted from soil mushrooms. After about 40 years, technology has enabled the production of drugs through genetic engineering.
- Chemical synthesis. Paracetamol, valproic and acetylsalicylic acids, novocaine and sulfanilamides are created.
The latter method, by the way, is the oldest, because it was used as early as the middle of the 19th century. To date, the situation has changed little, and chemical synthesis still dominates among other methods.
Description of the creation process
In general terms, it can be said that pharmacologists, pharmacists and chemists are jointly involved in organizing the production of drugs. Russian products must comply with three world standards, including:
- Quality laboratory practice. It is designated GLP.
- Quality manufacturing practice. It is designated GMP.
- Good clinical practice. Designated by GCP.
Usually, a natural compound is usually taken as the basis for a new drug. Then experiments are conducted, during which the structure of the main molecule changes slightly, due to which a new drug is obtained. After that, the finished formulas and the structure of the substance are displayed. However, before the start of industrial production, the medicine will certainly be subjected to multiple checks, excluding its toxic or harmful effects on potential consumers.
The main stages of development and testing
It is customary to distinguish three main processes. The production of medicines cannot be started until all of these steps have been successfully completed. These sequential steps include the following:
- empirical path;
- directed synthesis;
- targeted synthesis.
The first is the process of searching for a specific biological compound that could positively affect the body. In history, there were both random discoveries, such as the creation of a purgen based on phenolphthalein, and obtained by the method of sifting, that is, active enumeration.
Directed and targeted synthesis
After the completion of empirical tests, the already tested substance undergoes a process of modernization and improvement by various specialists in the laboratory. Then the medicine awaits a series of animal tests. The activity of a substance is easily amenable to change even with a slight adjustment. For example, codeine as a cough suppressant is obtained by replacing just one molecule in morphine. Thus, the analgesic effect is reduced by 10 times.
The final step before admitting drugs to production is targeted synthesis. In the process of this step, a pre-designed substance with certain properties is manufactured. It is usually necessary to synthesize new structures with supposed activity in the same class of chemical compounds in which the directional mechanisms of action of the future drug were established at the previous stages.
What are substances
By this term, in this context, is meant a biologically active substance that has been manufactured exactly according to specified quality standards. The procedure is carried out in order to create raw materials for a predetermined medication. In the process of production of drug substances, the most advanced technologies are used, including cellular, genetic and biological.
The state cooperates with various private firms and issues them orders for any necessary substances. Each substance has a generic name, usually consisting of one long and unpronounceable word, for example, beclamethasone dipropionate. All such substances are entered into a specific state register and undergo rigorous quality control.
What are the production
In addition to the large-scale pharmaceutical industry, there are also small factories, usually related to certain pharmacy departments. Their main product is various tinctures and extracts, that is, galenic preparations. The manufacture of such tools does not require particularly complex and expensive equipment, and therefore can be considered one of the sectors of small or medium-sized businesses.
Types of production of drugs can be strictly divided by the form of the final product or by the workshop in which the main process takes place. These include galenic, tablet and ampoule substances. There is also a packaging workshop, but its role is limited only to the packaging of finished products. In such plants, the so-called technological control department is invariably present. If the staff of OTK do not give permission for the release of products from the factory, then such a medicine will not be able to get to the drugstore in the future.
Problems of domestic pharmaceuticals
According to many experts, the main difficulty lies in the imperfect legislative regulation of the industry. One in four drug manufacturers agrees with this statement. In addition, significant unrest caused the recent economic crisis and the collapse of the national currency. Nevertheless, the production of drugs in Russia has many prospects for improving the current situation and strengthening its position both in the domestic and international markets.