Russian State Duma adopted a bill on labeling of medicinal products with Data Matrix labels. This procedure will become mandatory from January 1, 2020. The companies, that decided to join the system earlier on a voluntary basis, will be able to do that at any time starting from January 1, 2018.
In an interview with Izvestia, Mikhail Murashko, the head of Roszdravnadzor, spoke about the mobile app to monitor the pharmacies and how the introduction of labeling will affect the quality of medicines.
What was the number of falsified and counterfeit drugs on the market in the past year?
In 2017, we obtained the results of activities that had been built up during all the previous years. We were establishing the laboratory facilities with international accreditation that are among the best in the world. We were also building the legal framework by establishing the criminal liability (for circulation of counterfeit drugs and biologically active dietary supplements, manufacturing of medicines without a license and forging their documents) and labeling of medicines. We ratified the Council of Europe Convention on the counterfeiting of medical products and similar crimes involving threats to public health (Medicrime).
As a result, in 2017, the number of falsified, substandard and counterfeit medicinal products in circulation dropped by more than two times compared to two previous years. This is a very good first step and a sign that all earlier measures have been effective. We expect to maintain this trend in the future. In general, the offences in the area of circulation of medicinal products should become just the rare headline-making incidents that are possible only in case of some procedural failure.
When do you expect to achieve these results and completely get rid of counterfeit and falsified products?
In the licensed pharmaceutical market, we are planning to achieve these results as early as by the end of 2020 – all the more so because the system of drug labeling will work. Therefore, the counterfeit and falsified products will even not get into the licensed pharmacy chains.
The first calendar year of the pilot project for drug labeling is coming to an end. Could you sum up its results?
The pilot project is running normally. I would like to remind that the main objective was to elaborate the schemes for information interaction and develop a software product for manufacturers, distributors, and pharmacies. It was created. Today, more than 850 participants and 52 medicinal products are connected to the system. But this figure is growing every day.
Did the labeling already help identifying substandard or falsified drugs?
The use of labeling at the experiment stage allowed to identify the crimes in the area of circulation of medicinal products for more than 100 million rubles. The criminal proceedings have been already initiated, and the investigation is underway. We are very grateful to law enforcement agencies for their assistance and collaboration. In our view, the labeling project is a comprehensive quality control initiative.
Every consumer will be able to make sure that the medicine is circulating legally. Patients are often worried about the quality of drugs. Every pharmacy must be equipped with a special device for reading the relevant information. The system will even allow the buyers to monitor the pharmacies by using a smartphone app.
Is this app already available?
The app was created and is available in Google Play and AppStore. It is called “Proverka Markirovki Tovarov” (Goods Labeling Test). If a buyer identifies a substandard medicine, he can submit his complaint to supervisory authority. At the moment, the app can help checking only medicines connected to the pilot project, but not all drugs.