Russia may start tracking the origin of active ingredients


PharmMedProm, September 19, 2022

It is suggested that Russian pharmaceutical manufacturers implement a system for tracking the origin of active pharmaceutical ingredients. We'll explain why this is necessary and how it will affect the availability of medicines.

The Association of Pharmaceutical Manufacturers of the Eurasian Economic Union (APMEEU) proposed establishing a system for tracking the origin of active pharmaceutical ingredients. The emphasis is on the main active ingredients, which serve as the foundation for all medicines. Such a system should ensure that pharmaceutical manufacturers who receive certain benefits and advantages for local full-cycle production in Russia actually manufacture medicines from the ground up. In cases where ingredients are purchased from outside the country in order to release the finished dosage form and package it at the Russian plant, the manufacturer will not receive additional support. This additional support includes, first and foremost, a competitive advantage in public tenders. As a result, the government encourages pharmaceutical manufacturers to work in Russia, ensuring independence from pharmaceutical raw material imports.

“We believe that a comprehensive program focused on tracking the origin of active pharmaceutical ingredients provides a fundamental answer. Such a program should be based on current digital technologies, with fully automated control over the origin of APIs and the prevention of unjustified preference granting in public tenders,” said Alexey Kedrin, Chairman of the APMEEU Board of Directors, on September 19 at the Biotechmed Forum.

The heads of several pharmaceutical companies that are members of the association, as well as physicians, commented on this proposal.


“Because full-cycle manufacturers are already given preferences in tenders under certain conditions established by Government Decree No. 1289, our company believes it is important and timely to develop an information system for tracking the origin of active pharmaceutical ingredients. Market participants must develop a trustworthy information system that proves the legality of any preferences”, said Grigory Potapov, Pharmstandard JSC.

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