Ministry of Industry and Trade of the Russian Federation plans to hold the manufacturing enterprise Interpharma in Tula administratively liable and suspend its activities
Maksim Vaskin, a senior lawyer with MAGENTA Legal, commented for Izvestia on an important dispute in the field of pharmaceutical production – the attempt by the Ministry of Industry and Trade of the Russian Federation to place the Tula manufacturing enterprise under administrative responsibility and suspend its activities. The very fact of the unannounced inspection, the severity of the penalty demanded (suspension of operations, not a fine) and the possible consequences (possible suspension of production, possible delay in the fulfilment of contractual obligations, which may lead to fines and other losses) make this dispute very important for all pharmaceutical manufacturers.
According to Izvestia, the company was found to have committed violations in the production of the antibiotic biapenem in powder form for the preparation of a 300 and 600 mg solution for infusion. This medicine is included in the list of vital and essential medicines approved by the Ministry of Health. It is alleged that the company did not have documentation on the safety of the raw materials supplied from India and China for the manufacture of this medicine.
It is worth noting that substandard medicines remain a fairly serious problem – in 2024, Roszdravnadzor carried out more than 300 joint activities with the Ministry of Internal Affairs, which led to the detection of about 8.4 million substandard, counterfeit and falsified medicines. Roszdravnadzor also blocked about 230 batches of substandard medicines.
MAGENTA Legal lawyers have extensive experience in legal consulting in the pharmaceutical and healthcare sectors, including for such well-known companies as Galderma and Pentax Russia. Our clients also include drug manufacturers and pharmaceutical distributors from Russia, Belarus and Latvia. Our lawyers have successfully assisted clients in international level projects on disputes with such companies as AstraZeneka, Merck and many others, including in proceedings in international commercial arbitration and foreign courts.
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