The State Service of Ukraine on Medicines and Drugs Control has suspended the license of the Public Health Laboratory of Marzieiev Institute.

According to the official website, it was done "due to the systematic nature of the identified violations, the laboratory's certification has been suspended until the issues are resolved."

The suspension follows an assessment conducted on July 18-19, which evaluated the laboratory's compliance with industry standards for the organization of drug quality control. The inspection revealed discrepancies related to the quality management system, equipment, and the testing of medicines.

Key findings from the inspection suggest that numerous data integrity violations cast doubt on the quality control results of the tested medicines. The laboratory was found to be conducting studies using methods not reflected in the approved quality control methods in Ukraine.

Furthermore, the State Service said that the laboratory failed to inform them about the lack of resources for conducting studies and did not coordinate subcontracted work. There were also issues regarding the handling of medicine samples.

The State Service reported that, in addition to the Marzieiev Institute Laboratory, there are two other WHO-prequalified laboratories in Ukraine: the Central Laboratory of the State Service of Ukraine on Medicines and the Pharma Analysis Laboratory at the State Expert Center of the Ministry of Health. Additionally, the Central Laboratory for Drug and Medical Product Quality Analysis is accredited by the European Directorate for the Quality of Medicines (EDQM) and is part of the European network of OMCL laboratories.

In turn, during a meeting of the parliamentary committee on public health, medical care and medical insurance on Friday, Head of the laboratory Natalia Ostanina said that "a twist and forgery were found in the report of the State Service on Medicines and Drugs Control."

"In a day and a half of work, it is impossible to collect more than 668 pages of the report [by the State Medicines Service]. Of the 668 pages, we looked through 57 and have already found a twist and forgery," she said.

Ostanina said that the suspension of the industry certificate will lead to the fact that "long-term contracts with factories will be suspended, other laboratories will have to be included in the licenses, and audits will have to be conducted."

"There was not a single comment from the factories on our work, there was not a single ban on drugs that our laboratory controlled," she said.

Ostanina said that "the actions of the State Medicines Service made it possible to remove two laboratories from the market in a year."

Previously, the Marzieiev Institute Laboratory appealed to President Volodymyr Zelenskyy and other high-ranking officials to prevent the transfer of the drug quality control market to private hands. The laboratory claimed that "state drug quality control is being handed over to private business, with the State Service using a private authorized laboratory, Dobrobut-Likilab LLC, established for its own interests."