Production of medicines in Russia

2024 Author: Howard Calhoun | [email protected]. Last modified: 2023-12-17 10:16

The pharmaceutical industry in the country is actively gaining momentum and is considered one of the most promising among other industries. There is a radical substitution of imported drugs in our own domestic market, and a significant proportion of drugs are high-tech products.

Current state of affairs in the country

Only last year, 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. The production of medicines has been a special priority for several years and is one of the most important factors that can have an impact on the stability of the country and increase its independence from the rest of the world.

Since 2014, a special state government has been responsible for improving the state of affairs.program called "Development of the Pharmaceutical and Medical Industry". The campaign is planned to run until 2020. It is worth noting that on December 26, 2018, the government also allowed the cultivation of narcotic plants in the country in order to independently produce various drugs and psychotropic substances purely for solving medical problems.

Growth of the domestic market

Statistics says that in Russia this industry is one of the fastest growing in comparison with all countries of the world. In 2008 alone, profit from industrially produced drugs amounted to about 594 billion rubles, and in 2014 it increased to 1,152 billion rubles. Such a growth rate is provided by many factors. At the same time, both positive and relatively negative ones are mentioned among them. The former 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 aspects, then it is worth highlighting the almost rampant unhe althy lifestyle: drinking, smoking and lack of daily activity lead to poor he alth. Also, many Russians still prefer to engage in self-treatment, and the names of suitable drugs are more likely to be found out from relatives and friends than from qualified doctors. However, such negative factors also contribute to the growth of the pharmaceutical industry.market. Thus, the volume of production of medicines naturally increases.

Sources of raw materials

The initial process begins at this stage. In total, there are five main sources for any medicines that are planned to be produced at the industrial level:

1. Mineral compounds. Sodium sulfate and magnesium sulfate are produced.
2. Plants. Based on them, reserpine, morphine and glycosides are created.
3. Organs and tissues of animals. They are widely used in the production of pharmaceuticals. They are based on the production of insulin, enzyme preparations, as well as agents for regulating digestion and thyroid hormones.
4. Microorganisms. They serve as the basis for antibiotics such as penicillins, macrolides and cephalosporins. The method was first used in the 1940s, when the extract was extracted from soil fungi. Approximately 40 years later, technology has made it possible to extract drugs through the use of genetic engineering.
5. Chemical synthesis. Paracetamol, valproic and acetylsalicylic acids, novocaine and sulfonamides are created.

The last method, by the way, is the oldest, because it was used in 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

BIn general terms, we can say that pharmacologists, pharmacists and chemists are jointly engaged in the organization of the production of drugs. Russian products must comply with three international standards, including:

1. Quality laboratory practice. Designated GLP.
2. Quality manufacturing practice. Designated GMP.
3. Good Clinical Practice. Designated GCP.

Usually, it is customary to take some natural compound as the basis of a new drug. Then experiments are carried out, 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 drug will certainly be subjected to multiple checks, excluding its poisonous or harmful effects on potential consumers.

Main stages of development and testing

It is customary to single out three main processes. The production of medicinal products cannot be started until all of the above steps have been successfully completed. These successive steps include the following:

• empirical path;
• directed synthesis;
• purposeful synthesis.

At the first stage, there is a process of searching for a certain biological compound that could have a positive effect on the body. In history, there have been both accidental discoveries, such as the creation of purgen based on phenolphthalein, and those obtained by the sifting method, that is, activebusting.

Directed and targeted synthesis

After the completion of the empirical tests, the already tested substance undergoes a process of modernization and improvement by various specialists in the laboratory. The drug then awaits animal testing. The activity of a substance can be easily changed even with minor adjustments. 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 drug approval for production is targeted synthesis. During this step, a pre-designed substance with certain properties is made. It is usually necessary to synthesize new structures with a proposed activity in the same class of chemical compounds in which the targeted mechanisms of action of the future drug were established at the previous stages.

What are substances

This term in this context refers to a biologically active substance that has been manufactured exactly to specified quality standards. The procedure is carried out in order to create raw materials for a predetermined drug. The most advanced technologies, including cellular, genetic and biological technologies, are used in the production of drug substances.

The state cooperates with various privatefirms and gives them orders for any necessary substances. Each substance has a generic name, usually consisting of one long and hard-to-pronounce word, such as beclamethasone dipropionate. All such substances are entered into a certain state registry and are subject to strict quality checks.

What are the productions

In addition to the large-scale pharmaceutical industry, there are also small factories, usually associated with certain pharmacy departments. Their main product is various tinctures and extracts, that is, herbal preparations. The manufacture of such products 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 drug production can be strictly divided according to the form of the final product or the workshop in which the main process takes place. These include galenic, tablet and ampoule substances. There is also a packing shop, but its role is limited only to the packaging of finished products. At such plants, there is invariably a so-called process control department. If the OTC employees do not give permission to release products from the factory, then such a medicine will not be able to get on pharmacy shelves in the future.

Problems of domestic pharmaceuticals

According to many experts, the main difficulty lies in imperfect legislative regulationindustries. Every fourth drug manufacturer agrees with such a statement. In addition, significant unrest caused the last economic crisis and the collapse of the national currency. Nevertheless, the production of medicines in Russia has many prospects for improving the current situation and strengthening its positions both in the domestic and international markets.