Russian government to restrict sale of generics in national market

The Russian government is considering restricting the sales of generics in the national market, through making amendments to the law on Circulation of Drugs in Russia, which could lead to each original drug having only one generic competitor.

In this regard, the government plans to introduce a concept of so-called "substitutable" drugs. According to existing Russian legislation, in order to register a generic its manufacturer must provide data only on its equivalence to the original drugs, in terms of its chemical formula, and safety (non-toxicity).

However, in accordance with state proposal, in addition to the chemical formula the generics will be studied in terms of purity of raw feedstock, manufacturing technology and auxiliary components.