Authorities are reducing support for the development of drug standards

The Ministry of Industry and Trade will support the development of standard samples used to control the quality of drugs only for 442 drugs from the list of vital drugs, despite the fact that there are more than 800 such drugs in total. The Ministry, which previously promised pharmaceutical companies to provide them with samples in full, explains its decision by the complexity of the process, for example, in the case of with biological products. But manufacturers are in no hurry to use reference substances already made within Russia, preferring to import such products from the EU and the USA through third countries.

As Kommersant was told in the Ministry of Industry and Trade, they have so far decided not to support the development of standard samples – reference substances required for drug quality control – for biological products. These include, for example, drugs based on monoclonal antibodies, widely used in the treatment of cancer or autoimmune diseases, insulins, and blood products. The ministry explains its decision by saying that the process of developing and certifying samples is “difficult due to the complexity of the source materials.”

Biocad, which produces biological products, confirms the complexity and resource-intensive nature of this process. There are not many reference substances for drugs based on monoclonal antibodies in the world, the company says: the first one appeared in 2017, and since then there have been four more.

In total, from the summer of 2022 to the summer of 2023, Russian developers received grants to create 472 types of standard samples, the Ministry of Industry and Trade specified. The government has allocated 800 million rubles for this. They will be needed to produce 442 drugs from the list of vitally important drugs (VED), according to data from the Agency for Technological Development, presented at the beginning of October this year at the Biotechmed forum. The developers previously made samples for another 100 drugs using their own funds, the agency adds. They clarified that by the fall of 2024, samples of 542 drugs will be on sale. The full list of vital and essential drugs consists of 816 drugs.

General Director of the Agency for Technological Development Vladimir Pastukhov told Kommersant that in addition to biological samples, it was decided not to support the development of reference substances for vital and essential drugs, which have not recently been introduced into circulation in Russia and for quality control of which analysis methods based on standard samples are not necessary. The development of samples for radiopharmaceuticals will not receive support either, he added.

However, even in a truncated format, the authorities are ready to facilitate the development of only samples of the main substances contained in drugs. There are no plans to support the creation of reference substances for impurities contained in drugs, the Ministry of Industry and Trade explained to Kommersant. They added that it is impossible to “reflect the entire range of impurities used by manufacturers.” But the ministry promises to continue supporting the development of active substances for vital and essential drugs in 2024. The Ministry of Health did not respond to Kommersant’s request.

At the Scientific Center for Expertise of Medicinal Products (NCESMP) of the Ministry of Health and the Federal State Unitary Enterprise “Moscow Endocrine Plant” (“Endopharm”), they make samples of some impurities at their own expense, their representatives reported. The third developer, the National Center for Reference Materials, did not respond to Kommersant’s request. At the same time, NTSESMP and Endopharm note an increase in demand for their samples from pharmaceutical companies. Thus, NTSESMP sold more than 1.25 thousand standard substances in January-September 2023, while for the whole of 2022 it was half as much.

The need for urgent development of such substances in the Russian Federation could be adjusted, since alternative channels for their supply from abroad have been established, says Nikolai Bespalov, development director at RNC Pharma. Nevertheless, he emphasizes, in the long term the need for Russian samples, at least for key products, will remain.

Biocad told Kommersant that they use biological samples from a British manufacturer, having established stable purchases. Binnopharm Group, according to its CEO Rustem Muratov, does not use Russian samples, since their list is currently small, and there are no local samples for the drugs that the company produces. The group has reconfigured logistics, although delivery times have increased, adds Mr. Muratov. Peak Pharma Development Director Sergei Morozov says that the company would like to use Russian samples, but there are not enough of them yet.

Polina Gritsenko