The label on the original
Deputy Prime Minister Olga Golodets said that the recent increase in complaints from the public due to the presence in the Russian market of counterfeit drugs.
“This problem needs to be solved systemically. According to experts, the most effective way to do this is mandatory labelling of all medicines,” — said Golodets.
Such an approach, the government is confident, will allow consumers and employees of the inspection departments to better control the quality of drugs. Preparation for transition to mandatory labeling of all drugs, the government instructed the Ministry of health and Ministry of industry. The Agency did not respond to requests .
A pilot project for the labelling of medicines with special characters will start already on 1 January 2017, said in subordinated to the Ministry of health Roszdravnadzor. At this stage, the control signs will be placed on medicines manufacturers-volunteers. It will be a limited set of expensive medicines to treat rare diseases, said the Agency.
2018 to mark their products will be obliged to have all producers of medicines. As the control characters will be used two-dimensional bar codes (Data Matrix Code). The authenticity label, you can check with your smartphone.
The level of adulteration in the market is around 0.2%, according to development Director of the analytical company RNC Pharma Nikolai Bespalov with reference to the data of Roszdravnadzor.
The first concept for the labelling of medicines with special control signs Roszdravnadzor developed at the end of 2015. Such work the Agency has done, by order of the President of Russia Vladimir Putin on 20 February 2015. He ordered the Ministry of health to develop and gradually implement a computerized system of monitoring the movement of drugs from manufacturer to the end consumer. For this purpose it was proposed to use a phased introduction of labeling of drugs. The Ministry had planned that from 1 January 2017 will begin to label medicines for rare diseases, in 2018 — all vital and essential drugs, as from 2019 all the rest.
Economic or social reasons why the labeling of all drugs has decided to enter early, no, I’m sure the Deputy Director General of the pharmaceutical company STADA CIS Ivan Glushkov. The problem of drug counterfeit is not as severe, he says. Apparently the authorities hope to introduce a labeling for the presidential elections in 2018, says the source .
The reason for its rapid introduction of the labelling of medicines can be associated with the business interests of certain market players, says Bespalov from the RNC. On 10 October, the Ministry announced the Ministry of health, which supports the idea of participation in the program of monitoring the movement of drugs from private companies and attached to his letter an appeal of the Director of SMP Bank, Artem Obolensky, gave Life. Obolensky was the founder of the JSC “national pharmaceutical register” (NPR) company, which would combine all existing state registries and complement them with new information about the flow of drugs.
The main shareholders of SMP Bank are the brothers Arkady and Boris Rotenberg (occupy the 75-th and 76-th place in rating of the richest businessmen of Russia in 2016, according to Forbes, the assessment of the status of each — $1 billion). The family of Rotenberg behind the introduction of a system of charging heavy “Platon”, which belongs to the son of Arkady Rotenberg Igor. General Director of “NFR” Nicholas Doxin insists that the registry is the personal project of Obolensky.
“No room for error”
To get to 2018, manufacturers must purchase the necessary equipment in the 1 quarter of 2017, says Glushkov. “Many people simply physically do not have time to do so, even if you really want to. In particular, it is a question of Finance,” he points out.
Approach of terms negates the meaning of the pilot project in 2017, I’m sure Glushkov. “The results will not be able to use other manufacturers because it will be forced to purchase equipment and software to the completion of the pilot project,” — said the expert. — For a project of this scale, start with the wheels right thing is extremely risky.”
The pilot project will work out issues of cooperation for the marking of manufacturers and pharmacies, do not agree development Director of the wholesale company of JSC NPK Katren Anatoliy Tentser. This will bring the market to understand the role that the marking system should play a pharmaceutical distributor, the expert believes.
Priority project of the Ministry of health
The introduction of labelling of products — one of the priority projects of the Ministry of health. According to the Ministry for its implementation need to lay of 14.22 billion.
All the expenses will fall on manufacturers, distributors and pharmacies, said the Bespalov. One pharmaceutical formochka scanner will cost 12-15 thousand rubles., industrial scanner manufacturer will cost millions of rubles, he says. This can lead to higher drug prices on average by 3%, says Bespalov.