Substances and Evidence: How a Tula plant produced an antibiotic without documents
The Tula plant of Interpharma produced the popular antibiotic Biapenem from substances that did not have safety documents. They were supplied from India and China. In addition, the enterprise, which produces other popular drugs - "Cilaspen", "Pantoprazole", "Metformin", found numerous violations in the production and storage of drugs. All this follows from the application to the court, which was filed against "Interpharma" by the Ministry of Industry and Trade. The press service of the enterprise assured Izvestia that a plan to eliminate violations has already been drawn up. What threatens the plant, whether there is a risk to consumers of medicines and how large the problem with substandard drugs in Russia - in our material.
What violations revealed at the pharmaceutical plant in Tula
The Ministry of Industry and Trade filed a petition in the Arbitration Court of the Tula region with the requirement to bring to administrative responsibility company "Interpharma", found out "Izvestia". It follows from the document (Izvestia has it) that representatives of the ministry conducted an unscheduled inspection at the company's plant near Tula and issued an order to eliminate numerous violations.
Thus, violations were found in the production of the antibiotic "Biapenem" in the form of powder for the preparation of solution for infusions 300 and 600 mg. This drug is included in the list of vital and essential drugs approved by the Ministry of Health. Interpharma had no documents on the safety of raw materials supplied for the production of this drug from India and China, it follows from the statement of the Ministry of Industry and Trade.
In addition, the plant revealed violations in the production and storage of drugs.
"The design features, as well as the operation of production and storage facilities does not exclude the risks of contamination (contamination. - Ed.)," the document says. - As a result, the use of this drug may pose a threat of harm to the life and health of patients."
The lack of temperature control on weekends and holidays was named as one of the claims against Interpharma. Another example: leaky suspended ceilings in the production facility and the presence of roughness on the walls.
The Ministry of Industry andTrade confirmed to Izvestia the fact of sending the application to the court and said that "with regard to all licensees, including Interpharma LLC, the Ministry of Industry and Trade carries out assessments within the framework of licensing for the production of medicines."
"Interpharma LLC needs to eliminate the identified violations and notify the Ministry of Industry and Trade of the fulfillment of the order," the agency pointed out.
The company's press service told Izvestia that the company has drawn up "a plan to eliminate the identified violations, work is underway to eliminate them."
"Interpharma", in addition to "Biapenem", produces the antibiotic "Cilaspin", anti-ulcer drug "Pantoprazole", sugar-lowering drug "Metformin" and a number of other drugs.
How many substandard medicines there are in Russia
If a pharmaceutical company fails to eliminate violations, the court may impose a penalty in the form of administrative suspension of activities for up to 90 days, said Vadim Tkachenko, a lawyer, founder and CEO of the vvCube consulting group. In addition, the court may impose fines of Br100-200 thousand on legal entities, added Ilya Vasilchuk, a trial lawyer and expert on the security of electronic transactions.
In practice, the courts most often limit themselves to administrative fines, said Maxim Vaskin, senior lawyer at MAGENTA Legal.
- However, we also know of cases in which licensees have had their activities suspended, although such cases are much more rare," he said. - But given that the term of such suspension can be up to 90 days, the manufacturer can expect very significant consequences: production will stop, obligations under contracts may be fulfilled with serious delays, which may lead to fines and other losses.
In Russia in 2023, more than 2.4 million packages of substandard and falsified drugs were withdrawn from circulation, according to the report of the Ministry of Health on the results of work for that year. At the same time, Roszdravnadzor conducted 3,185 inspections of drug circulation and issued 157 prescriptions and 9,600 warnings. In 2024, the agency blocked about 230 series of substandard drugs.
In 2024, Roszdravnadzor conducted more than 300 joint actions with the Ministry of Internal Affairs, which resulted in the detection of about 8.4 million pieces of substandard, falsified and counterfeit medical devices.
In May 2024, Roszdravnadzor identified batches of the drug Fulvestrant (used for breast cancer) in circulation, the quality of which did not meet the established requirements. It was manufactured by JODAS Expoim, a Russian legal entity of the Indian pharmaceutical company JODAS Expoim Pvt. Ltd. Ltd. The violation was found under the criterion "Quantitative determination. Ethanol."
In June 2024, a batch of prescription antibiotic cefepime + sulbactam for the treatment of bacterial infections produced by the same Indian company was blocked at the Russian border. Neurotoxicity was detected in most of the drugs.
How the antibiotic was produced under false documents
Interestingly, Jodas Expoim was also involved in the launch of Biapenem, produced by Interpharma, on the Russian market. Moreover, this drug was registered under false documents, Izvestia wrote earlier. This decision was made by the Ninth Arbitration Court of Appeal of Moscow, accusing the Ministry of Health of attempting to bring an illegal Indian antibiotic to the Russian market.
In February 2024, the Indian company Copran Research Laboratories Limited, which produces pharmaceutical ingredients and finished dosage forms, filed a lawsuit against the Russian Ministry of Health in the Moscow Arbitration Court. In it, it claimed that the drug was illegally registered in the Ministry of Health's register and that its patent rights to use its substance for the drug Biapenem were infringed. In the lawsuit, the company demanded to cancel the registration of the drug in the Russian Federation.
The holder of the registration certificate turned out to be Jodas Expoim. "Copran Research noted in the lawsuit that Jodas representatives had forged their written consent to the use of their active ingredient, which should have been contained in Biapenem (the document is available to the editorial board).
"Copran appealed to the Ministry of Health (Izvestia also has the letter), assuring that it had not provided any substances or documents for the production of Biapenem. In its reply, the ministry said that it had received documents from Jodas confirming the company's consent to use the substance - they met all the requirements.
The Ministry of Health did not execute the decision of the Ninth Arbitration Court of Appeal, which came into legal force in November, but filed a cassation appeal and a motion to suspend the execution of the appeal decisionon January 14, 2025 . Such an application was also filed by Jodas.
"In support of the motion to suspend the execution of the judicial act, the society refers to the fact that this will entail the cancellation of the registration of Biapenem, the society will lose the authorization for its medical use, the said drug will lose the legal status necessary for targeted circulation, and its circulation will become formally inadmissible. The company will also suffer damage related to the expenses incurred for the production and preparation for the introduction of Biapenem into civil turnover," the company's cassation appeal says (Izvestia has it).
The Ministry of Health and Jodas refused to suspend the decision of the court of appeal, but the complaint was accepted. The hearing is scheduled for February 11, 2025.
