All-Russian State Center for Quality and Standardization of Medicines for Animals and Feed

1931-1944

The State All-Union Institute for the Control of Veterinary Medicines (subsequently - VGNKI) was created in 1931 in accordance with the Resolution of the Board of the People's Commissariat for Agriculture of the USSR . The main goal of the Institute was to create an effective system of state quality control of biological products intended for use in veterinary medicine and animal husbandry. One of the founders of VGNKI was the famous Soviet scientist-microbiologist Fanny Ilyinichna Kagan .

The Institute has repeatedly changed its names: see paragraph 1.5.

At the beginning of the XX century in the Russian Empire there was no mass industrial production of biological products for animals. After the October Revolution, the state, which was in a difficult economic situation, needed the development of animal husbandry. Since 1930, construction began on large biofactories and biocombineries for the production of vaccines, serums and diagnostic preparations. A new industry in veterinary medicine has been created - bioproductory, to ensure which qualified specialists were required. In addition, the creation of a new industry in the veterinary and biological industry required the development of unified methods for the manufacture and control of biological products for veterinary use. ^[3]

These prerequisites served as the basis for the emergence of a new institute, in 1933 renamed the State Scientific and Control Institute of Veterinary Medicines (SOCI). The institute was supposed to ensure control of all vaccination products coming into veterinary practice; the maintenance, verification and distribution of strains of microorganisms and matrices to industrial enterprises, which serve as the main seed, as well as the development of common standards for the manufacture, control and use of biological products. In addition, one of the duties of the Institute staff was the creation of new drugs and the improvement of existing ones.

Initially, the Institute included seven structural divisions: departments for the control of vaccines, serums, diagnostic preparations, preparations against filtering viruses, anaerobic and anthrax drugs, as well as a department for culture media and reagents. Most of the Institute’s researchers were young scientists, many of whom had worked in the institution for many years.

The staff of the Institute was gradually increasing. In 1934, the Institute building was located on the territory of Kuzminki. In that year, a paratyphoid-leptospirosis biological product laboratory and a biochemical laboratory were created, and in 1937 a laboratory for the control of chemotherapeutic drugs was created. At all biofactories, control laboratories of SOCI were created. According to the decree of the Council of People's Commissars of the USSR of 1936, all organizations producing bacterial preparations for farm animals in the country had to register with the SOCI, and their products undergo a systematic control check at the Institute. The control system allowed in a short time to improve the quality of products. If in the first year the institute existed, marriage reached 42%, then in 1934 it was reduced to 16.7%, and in 1940 it averaged 1.5-3.0%.

In 1938, Fanny Ilinichna Kagan was repressed on charges of spreading equine anemia. In 1939, she was rehabilitated and returned to the Institute as deputy director.

Years of World War II

During the war, Institute staff were sent to different regions of the USSR to monitor the operation of biofactories that supply biological products for the veterinary service of the Red Army.

During the Great Patriotic War, more than half of the country's biofactories, which produced 65% of biological products for animals, were destroyed. Despite this, animal husbandry was provided with biological products without interruption, and by the beginning of 1952 the production capacity of enterprises was mainly restored.

E.K. Volik during the war organized a new biofactory in Kazan, and then led it; S. G. Kolesov supervised the work of the Omsk Biofactory. F.I. Kagan at the Volga Biofactory organized the production of tetanus biologics for horses, preparations against gas gangrene and serum against emphysematous carbuncle for the needs of the Red Army. A. G. Malyavin was sent to the Sangino Biocomplex to Mongolia, and M. A. Babich to Alma-Ata. many employees of the STCU received orders and medals, including “For Valiant Labor in the Great Patriotic War”.

1945-1990

In 1946, the Institute celebrated its anniversary - the 15th anniversary. The first results of the work of the STCU were summed up. By that time, employees of the Institute had completed more than 200 scientific papers and published 115 articles in medical, veterinary and biological journals. 10 scientific employees of the STCI defended the dissertations of candidates of veterinary sciences and one employee became a doctor of veterinary sciences. Over 15 years, 2 collections of works and a guide to the production and control of veterinary drugs have been published.

In the postwar years, employees of the institute actively participated in the restoration of destroyed biological enterprises, the training of new personnel of microbiologists. The post-war staff made a significant contribution to the creation of the biological industry and the veterinary control system in the post-war period: N. V. Likhachev, Y. R. Kovalenko, F. I. Kagan, A. Kh. Sarkisov, S. G. Kolesov, M. A Babich, M. M. Ivanov, E. K. Volik, A. G. Malyavin, N. M. Nikiforova, P. M. Bazylev, G. D. Glukhovtsev.

In 50 - 60 years. XX century, the Institute organized antiepizootic expeditions to combat foot and mouth disease (head Rostovtseva I.A.) [3] and to study bird diseases (head A.S. Mitropolsky).

During the anti-FMD expedition, the Institute’s scientists tested more than 1700 FMD virus strains, of which more than 800 were classified as type O, more than 600 were classified as type A. According to I. A. Rostovtseva in a scientific article on the results of the expedition published in 1962, FMD virus of types O and A in the indicated period was found in the USSR mixed in the same zones, mainly in the Asian part of the country and in Kazakhstan. ^[four]

L.V. Kirillov, under the guidance of M.M. Ivanov, developed a method for the manufacture of a single tuberculin for cattle and birds. The development and implementation of dry brucellosis vaccine from strain 19 was carried out.

S. G. Kolesov, N. A. Mikhailov, and Yu. F. Borisovich developed the GOA vaccine of VGNKI against anthrax.

A. G. Malyavin proposed and introduced methods for obtaining serum against paratyphoid piglets using formol-alum antigen and obtaining bivalent serum against paratyphoid and calf colibacillosis.

In 1959, the Institute for the first time in veterinary practice in the country created a tissue culture laboratory. The method of tissue cultivation and the cultivation of the viruses of foot and mouth disease, swine fever, smallpox of sheep and birds (V.P. Nazarov, G.F. Shemanova, S.D. Orlov, N.I. Trotsenko) was mastered.

In 1964, a postgraduate study was opened at the Institute to prepare scientists in six specialties: biochemistry (03.00.04), virology (03.00.06), veterinary microbiology, epizootology, mycology with mycotoxicology and immunology (16.00.03), veterinary pharmacology with toxicology (16.00.04), veterinary obstetrics and biotechnology of animal reproduction (16.00.07).

In March 1971, a scientific and production conference was held dedicated to the 40th anniversary of the State Veterinary Administration of the USSR Ministry of Agriculture.

In 1973, the State Prize was awarded to the group of authors for creating a vaccine against cattle trichophytosis (TF-130 vaccine).

In 1976, in order to increase the effectiveness of control work and bring controllers closer to production enterprises, 8 zonal scientific control laboratories were organized at the Institute: Vostochnosibirskaya (Krasnoyarsk); Caucasian (Baku city); North-Western (Kaunas), Siberian (Kurgan), Central Asian (Frunze), Ukrainian (Kiev), Central (Tambov) - headed by Z. K. Augutavichus, candidates of sciences A. V Zinchenko, R.K. Safarov, B.M. Aristov, I.V. Mengel, E.M. Dudin, A.U. Ubashev.

In 1977, VGNKI already had more than 35 departments with a total number of 465 people, of which 254 were scientists, including 1 academician of the V.I. Lenin All-Union Academy of Agricultural Sciences (VASKHNIL, N.V. Likhachev), 14 doctors sciences and 124 candidates of sciences. Scientific work was directed by the deputy. Director - A.V. Selivanov, control work - N.F. Chuklov.

In 1988, a specialized dissertation council was formed at the institute for the defense of doctoral and candidate dissertations. In the same year, the Ukrainian branch of VGNKI was organized - the West Ukrainian Zonal Scientific Control Laboratory in Lviv. Kosenko M.V. was appointed to the position of the acting head of the indicated laboratory ^[5]

1991 - 2000

After the collapse of the USSR, many Russian biofactories went bankrupt. Of the 14 productions in the Russian Federation, 5 remained. Veterinary bacteriological institutes and laboratories joined the production. Many small businesses appeared that produced drugs without proper documentation. Sometimes, imported and domestic preparations were delivered directly to the buyer, bypassing the control authorities. The control system organized in past years has not been effective enough. In this regard, a new system was created, including a company license, registration and certification of products manufactured and sold on the territory of the Russian Federation.

In 1991, the director of the Institute became Panin Alexander Nikolaevich .

Since 1993, in accordance with the order of the State Standard and the Ministry of Agriculture and Food of Russia, VGNKI has a new area of ​​activity: certification of veterinary drugs. In 1994, the Institute was accredited by the State Standard of the Russian Federation as a certification body and an independent Testing Center. There was a post of deputy. Director of the Institute for Certification and Standardization, which was introduced by A. D. Tretyakov.

Since 1995, all drugs for veterinary use entering the territory of the Russian Federation, as well as feed and feed additives, had to be registered at the VGNKI.

In 1996, the All-Russian Collection of Microorganism Strains Used in Veterinary and Animal Husbandry was created at the Institute. About 3,000 strains of bacteria, chlamydia, viruses, and fungi were stored in the collection in the year of creation, of which 800 are industrial.

By the 70th anniversary of 2001), 14 large departments and laboratories functioned as part of VGNKI. The Institute worked: 1 corresponding member of the Russian Academy of Agricultural Sciences - director A. N. Panin, 22 doctors and 108 candidates of sciences, 10 honored scientists and 14 honored veterinarians of the Russian Federation.

In the early 2000s, the institute was given new tasks, including monitoring the safety of food products (identifying residual quantities of drugs, prohibited and harmful substances, GMOs in feed and food). To solve these problems, two additional deputy directors for science were appointed - A. A. Komarov and I. L. Obukhov. The Institute underwent a major structural restructuring, new departments and laboratories were organized.

In 2003, VGNKI was renamed the Federal State Institution “All-Russian State Center for Quality and Standardization of Medicines for Animals and Feed” (FGU “VGNKI”) of the Federal Service for Veterinary and Phytosanitary Surveillance. On the basis of the Institute, a Technical Committee for Standardization (TC 454) "Protection of animal life and health and veterinary and sanitary safety of animal products and feeds" was organized.

In 2005, VGNKI became part of the Federal Service for Veterinary and Phytosanitary Surveillance (Rosselkhoznadzor) of the Ministry of Agriculture of the Russian Federation.

Examination of drugs is still the prerogative of FSBI “VGNKI”. In 2010, a commission of experts was created to conduct expert research and analysis of drug samples. A department for the examination of normative documentation was established, which ensured the established procedure for state registration (head of the candidate of sciences N. N. Lagunina).

During its existence, the department conducted an examination of more than 10,000 products.

FSBI “VGNKI” has become a large research and production institution that manages the quality of medicines for animals, monitors and ensures the safety of livestock products, and leads the system of certification of veterinary drugs in the country. This is the basic institution for the operation of the All-Russian collection of microorganism strains, including more than 800 production strains of bacteria, chlamydia, viruses and fungi.

A new direction of the Institute's activity has been the control and monitoring of food and feed safety. The Department of Feed and Feed Additives was transformed into the Department of Feed and Food Safety (Head, Doctor of Biological Sciences, Professor A. A. Komarov), which includes laboratories for food safety, safety of feed and feed additives.

In 2006, a department of biotechnology was formed at VGNKI, which later became a department. The department is equipped with modern equipment and consumables: a set of devices for real-time PCR and PCR, sequencers, genetic analyzers, etc.

Currently, the Institute is the largest certification center for veterinary medicines, feed and feed additives in Europe.

FSBI “VGNKI” is the center of the World Organization of Animal Health (OIE) for food safety, diagnosis and animal disease control for countries of Eastern Europe, Central Asia and the Caucasus.

The methods developed by FSBI VGNKI cover safety indicators included in the regulatory documents of the Customs Union. Thanks to this, a methodological basis for arbitration control of food safety has appeared. In addition, in recent years, the institution has developed and certified the country's only methods based on HPLC and inductively coupled plasma mass spectrometry (ICP MS).

For the first time in Russia (since 2005), VGNKI Federal State Budgetary Institution in the European Union has received and annually confirms international accreditation for the determination of rabies antibodies in the blood serum of animals (dogs, cats, domestic ferrets) to monitor the effectiveness of rabies vaccination in accordance with international requirements established in EU Regulation No. 998/2003.

Names of institution at different times

Throughout its history, the institute has been renamed several times. In different years he bore the following names:

1933-1934 - The State All-Union Institute for the Control of Veterinary Medicines of the NKZ USSR;

1934-1935 - Central Control Laboratory for Veterinary Drugs;

1935-1936 - Central control laboratory for veterinary biological products;

1938-1976 - State Scientific and Control Institute of Veterinary Medicines - STCI;

1976-1992 - All-Union State Scientific and Control Institute of Veterinary Medicines of the USSR Ministry of Agriculture - VGNKI;

1992-1999 - All-Russian State Research Institute for Control, Standardization and Certification of Veterinary Medicines - VGNKI;

2000-2002 - FGU "All-Russian State Research Institute for Control, Standardization and Certification of Veterinary Medicines" - Center for the Quality of Veterinary Medicines and Feed - FGU "VGNKI".

2003 - By order of the Ministry of Agriculture of the Russian Federation, the institute was renamed to the Federal State Institution “All-Russian State Center for the Quality and Standardization of Medicines for Animals and Feed”.

Guide

1931-1932 - Boldov Efim Ivanovich;

Zhigin Grigory Stepanovich;

Borisov Evgeny Mikhailovich;

Makarov Nikolai Ivanovich;

1932-1933 - Dobrokhotov Alexey Mikhailovich;

1933-1934 - Cheap Victor Ivanovich;

1934-1938 - Kagan Fanny Ilyinichna;

1938-1939 - Skorikov I.G .;

Laktionov Adrian Mitrofanovich;

1939-1944 - Lipin Konstantin Mikhailovich;

1944-1955 - Kovalenko Yakov Romanovich;

1955-1958 - Syurin Vasily Ivanovich;

1958-1971 - Kolesov Semen Georgievich;

1971-1976 - Boyko Arkady Arkadievich;

1976-1990 - Osidze Dmitry Fedorovich

1990—2015 - Panin Alexander Nikolaevich;

2015-2017 - Kramarenko Igor Vasilievich;

2017—2018 - Nikulin Vyacheslav Vyacheslavovich;

May 2018 - p.t. - Kish Leonid Karolevich.

FSBI “All-Russian State Center for Quality and Standardization of Medicines for Animals and Feed” (FSBI “VGNKI”) is a scientific, methodological and expert center of the Federal Service for Veterinary and Phytosanitary Surveillance (Rosselkhoznadzor).

It is the center of the World Organization for Animal Health (OIE) for food safety, diagnostics and the fight against animal diseases in Eastern Europe, Central Asia and the Caucasus.

The FSBI VGNKI has developed the vast majority of confirmatory methods (over 70) used in Russia to detect chemical contaminants in food and feed. These methods cover all groups of chemical pollutants, including persistent organic substances and heavy metals. ^[6]

Among the modern activities of VGNKI (at the end of 2018):

• Monitoring the safety and quality of food raw materials of animal origin, feed and feed additives;
• State control and monitoring of raw materials, feed and food products for GMOs, ruminant DNA and other over-the-counter components;
• State registration of medicines for veterinary use and monitoring the quality of medicines;
• Examination of feed additives for the purpose of their state registration;
• Inspection of pharmaceutical industries for compliance with the requirements of the Rules of Good Manufacturing Practice;
• Confirmation of conformity in the form of mandatory and voluntary certification, as well as registration of declarations of conformity of medicines for veterinary use;
• Preclinical trials of drugs for veterinary use (including the study of carcinogenicity, embryotoxicity and teratogenicity of drugs);
• Diagnostic tests for the detection and identification of pathogens of infectious diseases of animals and birds by molecular genetic methods;
• Educational services: training events for different categories of specialists in the field of veterinary medicine.