Russia introduces total control over the quality of drugs. This is the goal of the bill submitted by the Ministry of Health and approved by the State Duma in the first reading.
The amendments include the introduction of a federal state information system for monitoring the circulation of medicines in Russia. The system will track the circulation of drugs from the manufacturers to the end consumers. To ensure this, the bill proposes to use special labeling.
The main purpose of this novelty is to guarantee “the supplies of high-quality, effective, and safe medicines to the customers.”
Speaking at the meeting of the State Duma, Natalia Khorova, the Deputy Minister of Health, described another goal of the bill as allowing the public to verify the legality of registered medicinal products.
In this regard, the Ministry of Health proposes to label all medicines available in the Russian market with special control identification marks. Ms. Khorova added that the bill establishes the obligation to apply the marks on packaging from January 1, 2018. The Ministry of Health reminds, that so far, labeling in Russia is performed as a pilot project.
Anna Popova, the Head of Rospotrebnadzor, said that, based on the international experience, the introduction of this novelty will take from three to five years. “The information available to Rospotrebnadzor suggests that the introduction of labeling will not lead to increase of prices,” added Ms. Popova.
Russian pharmaceutical company NovaMedica, a portfolio company of RUSNANO, announces the start of construction of a plant for the production of sterile injectable drugs as part of its long-term strategy to localize innovative medicines and technologies of their development and production in Russia. The plant will be built in the industrial park “Vorsino” in the Kaluga region.