Proceedings of the Tenth International Conference of Drug Regulatory Authorities (ICDRA) - Hong Kong, China, 24 - 27 June 2002
(2002; 166 pages) View the PDF document
Table of Contents
View the documentAbbreviations and acronyms used in this report
Open this folder and view contentsOpening ceremony
Open this folder and view contentsHerbal medicines
Open this folder and view contentsKeynote address
Open this folder and view contentsSafety of blood-derived products
Open this folder and view contentsAntimicrobial resistance - new initiatives
Open this folder and view contentsHarmonization I
Open this folder and view contentsHarmonization II
Open this folder and view contentsProtection of trial subjects in clinical trials
Open this folder and view contentsRegulating biotechnology products
Open this folder and view contentsRegulatory challenges: health sector reform and drug regulatory capacity
Open this folder and view contentsAccess to drugs and vaccines I
Open this folder and view contentsAccess to drugs and vaccines II
Close this folderCounterfeit pharmaceutical products
View the documentCounterfeit pharmaceutical products
View the documentThe fight against counterfeit drugs in the Russian Federation
View the documentCounterfeit medicines
View the documentRecommendations
Open this folder and view contentsHomoeopathy
Open this folder and view contentsSafety monitoring
Open this folder and view contentsE-Commerce
Open this folder and view contentsCurrent topics
Open this folder and view contentsRegulatory challenges of new technologies
View the documentList of participants
View the documentBack cover
 

The fight against counterfeit drugs in the Russian Federation

Dr Alexander Toporkov, Russian Federation

In recent years, the Russian Federation has faced a marked increase in counterfeit medicines. The data suggest that two-thirds of these fake medicines were made within the country. Most of the fake medicines were found by departments in the monitoring and approval system during quality control and medicine certification operations. In most cases, the counterfeits were discovered during the process of ensuring that their quality complied with the requirements of regulatory documentation, such as description, labelling, authentication and quality.

The most commonly counterfeited drugs are the antibacterials. Cases have been found where the fake medicines displayed the same serial number as the genuine ones.

The reasons behind the increase in fake medicines in the Russian Federation are believed to be:

• shortcomings in the current legislation governing the trade in medicines;

• a large number of intermediary distributors in the pharmaceutical market;

• the gulf between the cost of drugs and the purchasing power of the public;

• inadequate interdepartmental coordination in the fight against fake products;

• easy availability of sophisticated modern equipment for production and packaging of medicines;

• a large number of enterprises that do not conform to GMP.


The problem of counterfeit medicines also leads to economic problems, such as direct losses for Russian and foreign producers, the costs of combating the fake medicines and protecting trade marks, overall costs to the health sector caused by inappropriate treatments, and unpaid taxes and duties.

Because of the inadequacy of the existing legislation, an amendment is being drafted to the Federal Law on Medicines, to introduce the concept of counterfeit medicines, to ban their preparation, production, sale and import into the Russian Federation, and to criminalize their production, advertising, preparation, packaging, labelling, acquisition, storage, or transport for the purposes of sale. The amendment also covers medicines accompanied by false information concerning contents and/or producer.

In August 2001, the Russian Ministry of Health set up a Commission to combat the trade in fake medicines, including personnel from the Customs Committee, the Ministry of the Interior, the Federal Security Service, the Ministry of Industry, Science and Technology, the Prosecutor-General and the Supreme Court.

In December 2001, the Russian Ministry of Health set up the Pharmaceutical Inspectorate to:

• organize inspection checks;

• inform law enforcement and monitoring agencies of violations uncovered;

• collaborate on drafting regulations and laws dealing with quality control;

• set up a database on those parties involved in the trade in medicines for information and analysis.

 

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