The Indian exporters who export medicines to different countries through Europe are in for more trouble with the European Union (EU) going ahead with its plan to implement the EU Falsified Medicine Directive from January next year.

This comes even after continued efforts by India to prevail upon the EU not to act tough on Indian exporters who are sending drugs to non-European countries. The Indian authorities had stepped up their efforts in this regard following the seizure of Indian drugs a couple of years ago.

The European Commission has invited stakeholder feedback on its plans to issue a delegated act concerning a new requirement of the Falsified Medicines Directive under which medicinal products being shipped through the EU for other destinations will have to face additional scrutiny by customs officials or other agencies to ensure they are not counterfeit.

Though the European Union claimed that the verification would not look at intellectual property aspects that had triggered sharp criticism far and wide, the new provision would definitely add burden on Indian exporters as it demands higher level of scrutiny in Europe, according to a leader of the industry.

The checking will not focus on intellectual property-related issues, but will instead involve verifying the medicinal product's identity (e.g. through analytical testing, or by comparing the packaging and labelling), its source (e.g. obtaining information on the manufacturer) and history (e.g. verifying documents concerning the product's distribution channel).

The EU Falsified Medicines Directive (2011/62/EU) is asking member states to prevent medicinal products being introduced into the EU, but are not intended to be placed on the EU market, "from entering into circulation if there are sufficient grounds to suspect that those products are falsified". Member states have to apply this provision from January 2, 2013.

To avoid unjustified disruptions of trade flows, the commission has recommended that the level and range of controls and verifications should be governed by the "principle of proportionality". While finalising the verification procedures, the commission says it would take into consideration the human resources available in all member states so that these procedures are enforced properly. The commission believes there should be flexibility in terms of letting the member states decide which verification tasks should be attributed to specific national authorities, such as customs, public health authorities etc. Also, it believes that it should be left to member states on how they should co-operate with each other on this issue.