Mandatory labeling of drugs, which started in Russia on July 1, 2020, will not lead to their shortage or increase in cost. Denis Manturov, Minister of Industry and Trade of the Russian Federation, spoke about this in an interview with TASS.
According to him, labeling cannot cause such consequences by definition. Manturov noted that the Ministry of Industry and Trade is already seeing the results of the new rules, since they make it possible to identify medicines in pharmacies intended only for dispensing to patients in medical institutions.
The minister emphasized that the labeling makes it possible to identify patterns when unscrupulous medical workers resell hospital drugs. It is the new rules that make the drug market transparent.
In addition, a number of mechanisms are envisaged to prevent shortages, including assistance to those companies that, for objective reasons, were unable to label certain series of drugs after July 1.
Foreign manufacturers are encouraged to apply means of identification on drugs in customs warehouses that are licensed for pharmaceutical activities. Now in Russia there are only seven such warehouses.
Also, Russian and foreign manufacturers can apply to the interdepartmental commission under Roszdravnadzor in order to obtain approval for the import or introduction of drugs into circulation without applying identification means. All these mechanisms are designed for drugs manufactured before October 1, 2020.
Manturov also spoke about the cost of marking. According to the minister, the operator of the labeling – the Center for the Development of Advanced Technologies (CRPT) – is obliged to provide labeling codes for drugs free of charge, at its own expense, no more than 20 rubles. As for the expensive segment of drugs, the cost of labeling is only 50 kopecks per code.
On July 15, it was reported that six associations of pharmaceutical manufacturers are asking to simplify the procedure for introducing unlabeled drugs into circulation. Otherwise, medication interruptions will begin in about three months.
On May 18, the Russian government issued a decree making labeling a mandatory licensing requirement for drug manufacturers from July 1.
According to the document, all manufacturers’ medicines must be registered without fail in the system for monitoring the movement of medicines for medical use.