First Deputy Chairman of the SF Committee on Agrarian and Food Policy Sergei Mitin said that the adoption of the amendment could have a negative impact on the quality and effectiveness of veterinary drugs and their harmlessness to animals. In addition, the amendments may entail a threat to the biological security of the country.

 

"I should note that compliance by manufacturers of veterinary drugs with the requirements of the rules is a standard global practice, one of the main guarantors of the production and release of high-quality and safe drugs," the senator said.

 

Sergey Kasparyants, Executive Director of VIK Group of Companies, spoke on behalf of the business community. He noted that the shift in the timing of the law will lead to a multiple increase in the financial burden for domestic companies. "VIK" from 2020 to 2026 will invest 10 billion rubles in the development of domestic veterinary drugs. During this time, the company's R&D center will develop and prepare for release more than 200 new products. Earlier, in the spring of 2023, the representative of "VIC" has already cited at the parliamentary hearings calculations that import substitution in the industry will stretch to the 2100s.

 

As a result of the working group meeting, senators made a collective decision not to support the bill, which suspends the requirement for foreign production facilities to comply with the Russian GMP standard until January 1, 2026. They said at the meeting that the bill could have a negative impact on the quality and effectiveness of veterinary drugs and their harmlessness to animals.

According to Maria Litvinova, executive director of the Association of pharmacy institutions "SoyuzPharma", which includes veterinary pharmacies, they have already faced the consequences of the cessation of imports of veterinary drugs - the average check for the last six months has fallen by 10%, despite inflation.

 

"The fact is that the most popular products, now unavailable officially, consumers order directly from foreign buyers. The growth of such a "gray" channel, in my opinion, is much more dangerous for both consumers and the state - we do not control the quality of drugs, we can not confirm compliance with transportation conditions, and pharmacies and distributors are deprived of revenue," said Litvinova.

 

Bill No. 555529-8 "On Suspension of Part 3 of Article 52-2 of the Federal Law "On Circulation of Medicines" was submitted to the State Duma on February 19. If it is adopted, the requirement to have an opinion on the compliance of the manufacturer of medicines with the requirements of GMP rules will be suspended until January 1, 2026. The changes concern the entry into civil turnover of medicines for veterinary use, which are imported into Russia. The State Duma will consider the bill in May.

 

Source: Pharmaceutical Bulletin