The management of the State Service for Medicinal Products is forcing the laboratory of the Marzeyev Institute out of the market of quality control of medicinal products, the head of the laboratory, Natalia Ostanina, believes.
“They are trying to accuse us of being incompetent, of falsifying data, of not being an authorized laboratory in our market in Ukraine. We see that our laboratory is gradually being pushed out of our market. We do not receive any referrals, although for 28 years in a row we have been working both with the State Service of Ukraine, and with authorized bodies, with the Ministry of Health, SBU, police and other competent authorities,” she said at a press conference at the Interfax-Ukraine agency on Friday.
Ostanina noted that the laboratory has been working on the drug quality control market for more than 27 years, is accredited according to international ISO standards, including the WHO, conducts scientific activities, is equipped with modern equipment, and also has a vivarium in its structure, which allows to guarantee accurate research in accordance with international standards.
At the same time, Ostanina noted that the laboratory, which is part of the state institution of the National Academy of Medical Sciences of Ukraine and employs more than 40 people, receives funding only for 15 employees, the rest are funded by host contracts. At the same time, it has not recently received orders for such research.
At the same time, according to Ostanina, a brand new laboratory appeared on the market last August and was authorized just two weeks after its appearance.
“From the moment our laboratory stopped receiving referrals for quality control from Gosleksluzhba, we started receiving feedback. Everyone who was redirected to this new laboratory came back to us with a request to assist in conducting research – the newly created laboratory had neither standards nor chemical reagents,” she said.
At the same time, Ostanina noted that since logistics in the country are broken, it is very difficult and time-consuming to purchase many standard substances today (more than 30-60 days delivery).
“We with understanding transferred standards from our archive of the institute and some chemical substances, realizing that without this in our country it is impossible to conduct quality control of medicines, and our citizens will be deprived of many drugs on our market,” the expert pointed out.
According to her, “all heads of departments that are associated with quality control of medicines, apparently, are interested in the fact that the referrals went not to our laboratory.”
Ostanina did not name the list of drugs in question. She only specified that it was Dobrobut Likilab LLC.
The head also said that an investigation was launched against the laboratory. And there is a court ruling, which states that allegedly during the investigation it was established that the laboratory of the State Institution of IOH named after Marzeyev NAMS of Ukraine abuses its official position and together with authorized persons of a number of economic entities implemented a scheme for the sale of substandard medicines in order to make a profit for themselves contrary to the interests of the state institution.
“We are attributed to falsification of studies of medicines, which the laboratory has never conducted (…) As for the medicines, which were under control at us, absolutely all documents and original journals of analytical chemists, all primary data on the analysis, copies of job descriptions for the working staff, etc. were seized. I think that law enforcement agencies will sort out and prove who is right and who is guilty,” she said.
Ostanina said that “the leadership of the State Service of Ukraine, having learned about the plans to hold a press conference, scares us that they are ready to turn us off the list of authorized laboratories.”
“Goslexluzhba believes that according to the law only they have the right to decide where to send a medicinal product for quality control, without taking into account the capabilities of authorized laboratories. I would not trust new private, newly established laboratories, which have not confirmed their competence by anything other than receiving authorization from the State Service for Medicinal Products. After all, this is the state quality control of medicines. We will address an open letter to the Presidential Administration, the President of Ukraine, the Cabinet of Ministers and the Ministry of Health,” she said.
The head noted that the situation on the market of laboratory quality control services for medicines may lead to the disappearance of a number of drugs from the market.
“We have much less medicines on the market than it was a few years ago, or even two years ago. Of course, the war, complicated logistics are to blame for this, but also the bans applied by our State Administration of Medicines. If the executors could not figure out how to conduct a study, they simply write that the drug does not meet the declared quality and the State Service of Ukraine imposes a ban throughout the country,” she said.
Ostanina specified, in particular, that the drugs that are used in the season of ARVI from temperature, to improve well-being during the fall colds, were first banned. “They were not available in the fall, and only in January after arbitration control, suddenly it turned out that everything was good there, correctly, and they were released on the market,” she noted.
According to her, that subjective approach to the organization of quality control of medicines and involvement of insufficiently qualified specialists in the control can lead to the fact that the drug will actually be removed from our market.
The State Research Laboratory for Quality Control of Medicines of Marzeyev IOH of NAMNU was established in 1996, it employs four doctors of sciences, 10 candidates of sciences and 30 researchers.
It is accredited by the National Accreditation Agency of Ukraine in accordance with the requirements of GOST EN ISO/IEC 17025:2019 (EN ISO/IEC 17025:2017, IDT; ISO/IEC 17025:2017 IDT), certified by Gosleksluzhba,
The quality management system is certified by the Ukrainian Medical Certification Center for compliance with the requirements of GOST EN ISO 9001:2018.
The laboratory is the only one among scientific state institutions authorized by WHO to conduct quality control of medicines.
