SID&GP presented results of manufacturers survey

On September 10 at the BIOTECHMED-2018 forum, Vladislav Shestakov – Director of the State Institute of Drugs and Good Practices – took part in the meeting dedicated to labeling of pharmaceutical products where he discussed prospects of pharmaceutical labeling and presented results of a survey of drug manufacturers’ preparedness for implementation of the labeling system.

Russia implements the pharmaceutical labeling system as of January 01, 2020 in order to drown out adulterated products from the Russian market. The system is primarily a protectibe means for consumers.

The survey of the pharmaceutical manufacturers had four phases: assessing manufacturers’ anticipated costs of packaging lines re-equipment; tracing the number of packaging lines to be connected to the digital ID labeling as well as manufacturers of required equipment; scheduling pharmaceutical products data to be transferable to the automated monitoring system of international non-proprietary names. Phase 4 developed simultaneously with the three others and covered foreign manufacturers.

Almost half of the Russian pharmaceutical license holders failed to provide information requested in the survey. Foreign manufacturers are still submitting the required data.

“We understand the challenge and complexity of introduction of mandatory labeling with centralized emission code and crypto protection into an industry of such social impact as pharmaceutical manufacture. Each facility apart from installing the equipment and fine-tuning the processes will have to validate it, evaluate the impact on quality, and prepare all necessary documentation. We have accumulated unique experience in each of these areas, and our institute is ready to make every effort to ensure the most efficient transition to the digital ID labeling. We will offer maximum assistance to pharmaceutical manufacturers so that all implemented processes at the facilities are in line with the good manufacturing practices,” said Vladislav Shestakov.