The range of imported medicines for pets may be reduced
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New rules for the introduction of veterinary medicines into circulation from September 1 could reduce the number of available imported medicines for pets from about 130 to 20 items, suppliers warn. Foreign players see the problem of the need to pass the test for compliance with the requirements of good manufacturing practice (GMP) for all drugs. Russian market participants support the requirements, assuring the ability of local manufacturers of veterinary drugs to fill gaps in the assortment.
The Association of Veterinary Pharmaceutical Manufacturers (AVPHARM; includes MSD Animal Health, Elanco, Boehringer Ingelheim, Zoentis) says that the tightening of rules for introducing veterinary drugs into circulation from September 1 threatens to reduce the number of available imported medicines for pets: as of July 10, new conditions corresponds to only 19 positions out of 127 drugs supplied to the Russian Federation in 2022.
The list does not include cardiological and dental drugs, antibacterial sprays, vaccines, there are almost no original drugs developed in the last 3-7 years, AVPHARM emphasizes.
From September 1, in order to put veterinary drugs into circulation, it is necessary to submit a quality document to the Rosselkhoznadzor, confirmation of compliance with GMP requirements, and the introduction of vaccines is possible only based on the results of tests in an accredited laboratory, the Veterinary and Life publication explains.
AVPHARM says that earlier GMP inspections were carried out only for registration of new drugs on the Russian market, and now the procedure will be mandatory for previously supplying companies. AVPHARM members, they say, are denied certification in most cases.
RNC Pharma Development Director Nikolay Bespalov says that in the first five months, 8.2 million packages of pet medicines worth 3.9 billion rubles were imported to Russia. Year-on-year indicators increased by 4.8% and 13.5%, respectively. The number of suppliers, adds Mr. Bespalov, has decreased from 35 to 22 companies, and the number of supplied trademarks has decreased by 16 items, to 88 pieces. The expert estimates the share of imports in the market of drugs for the treatment of pets at about 50% in physical terms.
Sergei Sereda, president of the Russian Association of Veterinary Practitioners, says that rapid import substitution in an industry occupied by foreign companies for 30 years cannot be achieved.
In the register of drugs for veterinary use, there are so few drugs for pets, adds Diana Nasyrova, director of the National Veterinary Chamber.
But Kirill Dmitriev, president of the National Association of the Pet Industry, believes that the changes equalize the rules for working in the market for Western and Russian producers, who already have to obtain GMP certificates. The practice, he believes, is also fair from the point of view of the international approach: “Russian manufacturers of veterinary drugs cannot enter Western markets without inspections established by national regulators.” As the expert notes, the new rules at the moment may lead to a reduction in the range, but the retired positions will gradually replace analogues of manufacturers from Russia and “friendly countries”.
The Rosselkhoznadzor believes that AVPHARM “is lobbying for changes in legislation to suit its interests,” and since 2022, many foreign manufacturers have reduced the supply of veterinary drugs to Russia on their own initiative. They added that the market for Russian drugs is actively developing and an accelerated procedure for registering drugs is provided for local companies. The Ministry of Agriculture clarified that of all registered drugs for pets, imports account for 27%.
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