On veterinary medicine manufacturing in Russia
“Russian manufacturers, supported by the government, increase the production of vaccines and therapeutic agents for farm animals and pets on a yearly basis,” the Rosselkhoznadzor said in a statement.
According to the service, in 2022 the production of Russian vaccines for animals and pharmaceuticals increased by 2 and 6 times, respectively, compared to 2021.
“Only domestically produced vaccines are used against animal diseases that bear the most significant economic burden,” said the service. According to Dmitry Patrushev, the head of the Ministry of Agriculture, as he said at the final board of the Rosselkhoznadzor, Russia had reached 100% self-sufficiency in vaccines against the most dangerous animal diseases.
Representatives of the Rosselkhoznadzor also noted that the commercial release of veterinary medicines is closely controlled by the service, and manufacturers’ compliance with GMP (Good Manufacturing Practice) requirements is confirmed.
The volume of live vaccine production for the agricultural sector in Russia reached 12.74 billion doses in 2022, which is 88% more than in 2021 (6.76 billion doses). The Rosselkhoznadzor noted that SPE AVIVAC and the Federal Center for Animal Health of the Rosselkhoznadzor (FSBI ARRIAH of the Rosselkhoznadzor) have many-fold increased the production of live vaccines.
Besides that, Russian production of vaccines for dogs and cats increased by 18% to 14.98 million doses.
The Rosselkhoznadzor emphasized that Russian manufacturers have the capabilities to replace the entire list of essential veterinary medicines.
On veterinary vaccine imports
Representatives of the Russian service underlined the lack of a ban on the imports of foreign-made vaccines.
Rosselkhoznadzor records an increase in animal vaccine imports. About 5.2 billion doses of vaccines for all kinds of animals were supplied to Russia in the first quarter of 2023, which is 26% more than in the same period last year (4.1 billion doses). The experts note that this is enough for intensive trade and stockpiling.
“However, there is a deficit for certain pharmaceuticals, which has been intentionally created by some foreign companies that ceased supplies to Russia on their own accord and are now exploiting this circumstance in order to adjust Russian legislation to their advantage,” the Rosselkhoznadzor noted.
The officials specified that this mostly refers to the members of the Association of Veterinary Pharmaceutical Manufacturers (AVPHARM), which joins four global animal health companies: MSD Animal Health, Elanco, Zoetis, and Boehringer Ingelheim.
“They support and distribute at all levels, including through mass media, the misrepresenting version of the animal health products shortages and excessive control,” the Rosselkhoznadzor emphasized. “The reality is that GMP inspection requirements are not new, redundant, unfeasible, or trade-disrupting”.
GMP inspections are obligatory for everyone
According to the service, all Russian manufacturers have already passed GMP inspections within the time limits set by law.
The new law unifying requirements for Russian and foreign manufacturers (Law No. 317-FZ of July 2, 2021) will come into force on September 1, 2023. Foreign animal health companies that supply their products to the Russian market will have to confirm the compliance of their production facilities with GMP requirements.
“Rosselkhoznadzor has created all the conditions necessary for inspection activities, including online inspections for the companies that are willing to supply their products to the Russian market in compliance with Russian legislation,” the representatives of the service said.
According to the service, such inspections were successfully carried out at 32 foreign manufacturing facilities in France, China, Portugal, Romania, Spain, the Czech Republic, Israel, Slovenia, Hungary, Croatia, Italy, Brazil, India, Vietnam, and New Zealand. The conclusions for another 23 productions are currently being worked on.
“However, a number of foreign companies are sabotaging the requirements of Russian legislation and refusing to have inspections of their facilities, which is used to weaken state control and conduct trade manipulations. For instance, foreign animal health companies (AVPHARM members) withdrew their applications from inspections of 14 production sites, which they had previously submitted. Another refusal was received today, from the Zoetis site in Italy this time,” said the Rosselkhoznadzor.
The service explained that the production of veterinary medicines, especially live vaccines for animals, is connected with biological risks. At the same time, GMP inspections represent a standard measure applied worldwide. “For instance, veterinary products can’t be supplied to the member countries of the European Union and the United States without such inspections. However, some companies located in these countries want to supply their vaccines to Russia without undergoing any inspections, which could be possible only if changes are made to the regulatory documents. We believe that Russian legislation doesn’t need any assessments, comments, or changes made by foreign businesses,” summarized the Rosselkhoznadzor.