The State Duma will consider a bill to cancel the GMP certificate for imported veterinary drugs in May

This  bill  was sent to the State Duma by a group of deputies of the lower house. The authors propose to amend the law on the circulation of medicines and suspend until January 1, 2026 the mandatory requirement for foreign manufacturers of veterinary medicines to comply with the Russian GMP standard.

GMP (from the English Good Manufacturing Practice) is a set of rules and requirements to ensure the high-quality production of veterinary products, their testing and storage.

According to the law, domestic as well as imported manufacturers of veterinary drugs must comply with Russian GMP requirements if they supply their products to the Russian market.

The authors of the bill are convinced that such concessions for foreign companies are necessary for the biological security of the country. “Since September 2023, supplies of critical drugs from abroad have practically ceased, but there is no domestic import substitution program in the industry even in project status,” the authors present their arguments. “Moreover, leading domestic developers and manufacturers recognize their inability to meet the market needs in the required volumes and range in the coming years without government support.”

However, Russian manufacturers express fears that this will open the way to Russia for low-quality imported veterinary drugs.

“To allow the sale of imported veterinary drugs without certification means to oppose the development of the domestic veterinary pharmaceuticals industry and open the way to low-quality imports,” Oleg Zhukov, director of the NITA-PHARM enterprise, Candidate of Chemical Sciences, commented on the bill to Veterinary and Life.

In his opinion, such a measure will put domestic producers of veterinary drugs and importers in an unequal position and, as a result, will only worsen the situation with dependence on imported drugs.

“The procedure for confirming production compliance with the requirements of the international GMP standard is not redundant, but on the contrary, it is generally accepted throughout the world,” noted Oleg Zhukov.

Representatives of another Russian manufacturer of veterinary medicines, the VIK group of companies (VIK Group), agree that the abolition of GMP certification for foreign manufacturers will hit domestic companies. “The repeal of this law or the postponement of its deadlines will lead to a multiple increase in the financial burden and will set veterinary pharmaceuticals back 10 years. All veterinary manufacturers are in an active investment phase for new production facilities and research projects,” the press service of the VIK Group commented to ViZh.