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The production of medicines in Russia has become even more dependent on imported components

There are fewer low-quality drugs in Russia, but the share of domestic products among them is growing. One of the reasons is the growth in imports of components (not always of the proper quality) for the production of medicines. The dependence of the Russian pharmaceutical industry on imports is increasing.

Domestic Defective Products 

According to Roszdravnadzor, over the past five years, the number of identified low-quality drugs on the Russian market has decreased significantly. So, in 2018, the agency during the inspections identified 439 series and 311 trade names of such drugs, and in 2022 only 247 series and 117 names.

The number of low-quality drugs withdrawn from circulation over the same period decreased by more than 1.85 times: from 752 to 406 batches.

However, at the same time, the share of Russian-made drugs in this stream is growing: if in 2018 only 61.5% of all substandard drugs were domestic, then in 2022 - already 75.3%. 

However, judging by the documents of Roszdravnadzor, there are fewer complaints about foreign drugs, and among them the main ones concern not the drug itself, but the packaging and description. For example, on the packaging of Nurofen Forte tablets (Great Britain) "the letters are not readable or missing," appears in the claim of Roszdravnadzor. 

According to  MASHNEWS :

The volume of the pharmaceutical market in Russia in 2022 amounted to 2,573 billion rubles (data from DSM Group). This is 11.9% more than in 2021.

The volume of sales of medicines in physical terms fell by 6% and amounted to 5.2 billion packs.

According to experts, part of the decrease in the number of claims by government agencies for medicines is due to an increase in the share of domestically produced drugs. According to DSM Group analysts, in 2022 imported medicines accounted for 55.5% of the Russian market in rubles and 32.3% in packages. In 2018, these figures were estimated at 70.2% and 39.4%, respectively. 

"In Russia, they take very seriously the quality control of production, the effectiveness and safety of drugs, both manufactured in Russia and exported from abroad. All production sites are checked by the Ministry of Industry and Trade for compliance with GMP rules (good manufacturing practice) even before the production stage In addition, there is a special procedure for putting manufactured products into circulation, as well as selective and serial control,” commented MASHNEWS in the National Association of Manufacturers of Pharmaceutical Products and Medical Devices “APF”.

According to representatives of the association, Russian pharmaceutical enterprises are often equipped with more modern and high-quality equipment than European ones, since the pharmaceutical industry in our country has been called one of the priorities for the last 10–15 years. With the support of the state, many large enterprises were opened, and the existing production facilities were modernized.

On the other hand, the state control over industry participants has been tightened, which also contributes to improving the quality of products. 

However, in most cases, Russian drugs can only be called domestic with a stretch.

“Most of the drugs are not fully produced in the Russian Federation. They are made from ready-made pharmaceutical substances that are imported from abroad,” says Olga Makhova, head of the Department for organizing the work of pharmaceutical institutions and enterprises of the St. Petersburg Health Committee.

The Ministry of Industry and Trade estimates the share of domestic ingredients at less than 20%. 

According to Alexander Semyonov, president of the Active Component company (produces pharmaceutical substances in the Russian Federation), a maximum of 6% of substances for strategically important medicines are produced in Russia.

Such a high dependence led to the fact that after the introduction of anti-Russian sanctions in 2022, domestic enterprises had problems with components. Although foreign manufacturers did not officially refuse to supply substances to Russia, many intermediary companies disappeared, Russian manufacturers had to look for new suppliers and change logistics, DSM Group says. 

However, despite these problems, imports of active pharmaceutical ingredients (APIs) to Russia in 2022 grew by almost 19% and turned out to be a record for the entire history of RNC Pharma, which has been keeping statistics since 2013.

According to her, 20.8 thousand tons of active pharmaceutical ingredients were imported into Russia against 17.5 thousand tons in 2021. The main deliveries came from China and India, and the PRC increased its volumes both in money (+8%) and in kind (+33%). And India reduced supplies: by 13% in rubles and by 14% in tons.

The range of imported substances has also expanded by 42 items (up to 717 items).

The increase in imports of substances, in particular, was facilitated by government policy: the authorities took measures to simplify the production and use of active pharmaceutical ingredients. For example, if manufacturers need to change the suppliers of the substance or excipients specified in the documents, then this can be done without conducting a quality examination, which was previously mandatory in such cases.

As a result of all these changes in the market, the volume of substances of insufficient quality has increased, which also affected the characteristics of final medicinal products, experts say. 

In December 2022, the Ministry of Industry and Trade promised, together with VEB.RF, to launch a program to support the production of pharmaceutical substances from 2023. The main measure of support is preferential loans. According to the Ministry of Industry and Trade, at that time he already had 12 investment projects from six leaders in the production of APIs. Active component, Polisintez, Promomed claimed participation in the program, the ministry reported. It is assumed that if the program works, by the beginning of 2025, 100 substances for the production of vital drugs will be produced in Russia, and by 2027 - 145 APIs.

Source: https://mashnews.ru/proizvodstvo-lekarstv-v-rossii-stalo-zaviset-ot-importnyix-komponentov-eshhyo-bolshe.html