GMP News - Counterfeit Medicines

The issue of counterfeit medicines is often played down as it only affects the expensive blockbuster products anyway - mostly just products of the large pharmaceutical manufacturers. However, this is just as much a misconception as the belief that the products only show up in the internet trade and cannot be sold in the legal supply chain. Read more about a current counterfeit case affecting the company Desitin.

On 1 April the Indian Ministry of Commerce and Industry has supplemented a paragraph that substantiates the actual requirements and the timeline for the implementation of the Track and Trace system for the export of medicinal products. Read more about the Indian Track&Trace System.

Counterfeit medicines in the legal supply chain are increasingly becoming a problem. Experts are sure that counterfeiters will try more and more to sell fake medicines not only via the Internet, but through "infiltrating" them into the legal supply chain - meaning pharmaceutical wholesalers and pharmacies. Another case became known now. Read more in the news about the counterfeit drugs in the legal supply chain.

With the Drug Supply Chain Security Act (DSCSA) and the related implementation plan over a ten year period dated from 2013 new requirements were defined in the USA which are to improve the traceability of prescription drugs within the supply chain. Now the start has been postponed by means of an FDA Guideline that was released already in December 2014. Read more.

Further information has now been released about EU Commission's delegated acts on the Counterfeit Directive after a workshop involving stakeholders took place on 28 April 2014. Read more here about the recommendations made for the implementation of future safety features.

The EDQM has announced the launch of a database on counterfeit/falsified medicinal products. This should encourage collaboration between authorities and OMCL laboratories, and enhance knowledge and awareness of the issue of counterfeit/falsified medicines. More information can be found in this News.

First information has now been released about EU Commission's delegated acts on the Counterfeit Directive. Read more about the recommendations made for the implementation of future safety features.