KYIV. July 19 (Interfax-Ukraine) – The leadership of the State Medicines Service is forcing the laboratory of the Marzeev Institute for Public Health out of the drug quality control market, according to the head of the laboratory, Natalia Ostanina.

"They are trying to accuse us of incompetence, falsifying data, and being unable to be an authorized laboratory in our Ukrainian market. We see that our laboratory is gradually being pushed out of the market. We are not receiving any directions, although for 28 years we worked with the State Service of Ukraine for Medicinal Products and Drug Control, authorized bodies, the Ministry of Health, the Security Service of Ukraine, the police, and other competent authorities," she said at a press conference at Interfax-Ukraine on Friday.

Ostanina noted that the laboratory has been working in the drug quality control market for over 27 years. It is accredited to international ISO standards, including the WHO, conducts scientific activities, is equipped with modern equipment, and has an animal testing facility in its structure, which allows for accurate research in line with international standards.

Ostanina also said that the laboratory, part of the state institution of the National Academy of Medical Sciences of Ukraine, employs more than 40 people but receives funding for only 15 employees; the others are financed through economic contracts. Recently, however, it has not received orders for such tests.

Meanwhile, according to Ostanina, a completely new laboratory appeared on the market in August last year, which received authorization literally two weeks after its appearance.

"Since our laboratory stopped receiving quality control orders from the State Service for Medicinal Products and Drug Control, we have been getting feedback. Everyone redirected to this new laboratory returned to us asking for help with tests – the newly created laboratory had neither standards nor chemical reagents," she said.

Ostanina pointed out that because logistics in the country are disrupted, procuring many standard substances today is very difficult and takes a long time (more than 30-60 days for delivery).

"We have been understandingly passing on standards from our institute's archive and some chemicals, realizing that without this, it is impossible to conduct quality control of drugs in our country, and our citizens would be deprived of many medicines on our market," the expert said.

According to her, "all heads of departments related to drug quality control are seemingly interested in ensuring that directions do not go to our laboratory."

Ostanina did not specify the list of drugs in question but clarified that it concerns Dobrobut Likilab LLC.

The head of the laboratory also reported that an investigation had been initiated against the laboratory. A court ruling exists, stating that during an investigation, it was allegedly found that the laboratory of the Marzeev Institute for Public Health abuses its official position and, together with authorized persons from several business entities, implemented a scheme to sell substandard drugs for profit, contrary to the interests of the public institution.

"We are being accused of falsifying drug research that the laboratory never conducted... As for the drugs that underwent our control, all documents and originals of the chemists-analysts' journals, all primary analysis data, copies of job descriptions for working personnel, etc. have been seized. I believe that law enforcement will investigate and prove who is right and who is wrong," she said.

Ostanina reported that "the leadership of the State Service for Medicinal Products and Drug Control, upon learning about the plans to hold a press conference, is threatening to remove us from the list of authorized laboratories."

"The State Service for Medicinal Products and Drug Control believes that by law, only they have the right to decide where to direct drugs for quality control, without considering the capabilities of authorized laboratories. I would not trust new private, newly created laboratories that have not proven their competence beyond receiving authorization from the State Service for Medicinal Products and Drug Control. This is still state control over drug quality. We will be addressing an open letter to the President's Office, the President of Ukraine, the Cabinet of Ministers, and the Ministry of Health," she said.

The head of the laboratory said that the current situation in the drug quality control laboratory services market could lead to the disappearance of several drugs from the market.

"There are far fewer drugs on our market now than there were several years ago or even two years ago. Of course, the war, difficult logistics, and the bans imposed by our State Service for Medicinal Products and Drug Control are to blame. If the implementers could not figure out how to conduct the research, they simply write that the drug does not meet the stated quality, and the State Service for Medicinal Products and Drug Control imposes a ban throughout the country," she said.

Ostanina said that drugs used during the ARVI season for fever, to improve well-being during autumn colds, were initially banned. "In the autumn, they were not available, and only in January, after arbitration control, it suddenly turned out that everything was fine, and they were released to the market," she said.

According to her, the subjective approach to organizing drug quality control and involving inadequately qualified specialists could lead to the drug being removed from the market.

The State Scientific Research Laboratory for Drug Quality Control of the Marzeev Institute for Public Health of the National Academy of Medical Sciences of Ukraine was established in 1996. It employs four doctors of science, ten candidates of science, and 30 scientific staff.

It is accredited by the National Accreditation Agency of Ukraine in line with the requirements of EN ISO/IEC 17025:2019 (EN ISO/IEC 17025:2017, IDT; ISO/IEC 17025:2017 IDT) standard and certified by the State Service for Medicinal Products and Drug Control. The quality management system is certified by the Ukrainian Medical Certification Center for compliance with EN ISO 9001:2018 standard requirements.

The laboratory is the only one among state scientific institutions to be prequalified by the WHO to conduct drug quality control.