According to the explanatory note to the bill on the suspension of the GMP requirement, “since September 2023, supplies of critically important drugs from abroad have almost ceased, but there is no domestic import substitution program in the industry even in the project status.” Leading domestic developers and manufacturers of veterinary drugs admit their inability to meet the market’s needs in the necessary volumes and range without state support in the coming years — this position was voiced during the Parliamentary hearings on April 18, 2023.
The authors of the project state that it is necessary to develop, approve, and implement a large-scale import substitution program for veterinary drugs in the shortest possible time. During the preparation of the corresponding program, manufacturers from friendly states, primarily China, India, and Latin American countries, can prevent disruptions in supplying farmers and pet owners with the necessary veterinary drugs.
However, there has been no significant increase in veterinary drug supplies from friendly countries. In recent years, their share in total imports remains low and does not exceed 14%. Legislative barriers, regular tightening of market access conditions, and the high cost of accompanying work on GMP certification and registration of new drugs hinder the broad access of domestic consumers to veterinary drugs from friendly countries. Suspending the complication of market access for veterinary drugs until the share of supplies from friendly countries reaches 70% in the total volume will help change the situation.
The bill proposes to suspend for two years the operation of part 3 of Article 52.2 of the Federal Law of April 12, 2010, No. 61-FZ “On Circulation of Medicines,” which defines the requirement for a certificate of compliance with good manufacturing practice for the introduction of veterinary drugs into civil circulation. The “moratorium” is expected to last until January 1, 2026.
Photo: maks_lab / Freepik
