Dieter Mobner of Edelmann explained the legal framework of FMD under which the prescription drugs' outer package should contain two safety feature. The first one being the unique identification feature and the second one being tamper-proof evidence or tamper verification feature.

 

Mobner said, "After 9 February 2019, all the EU members will have to comply with these rules, which according to the directive will enable end-to-end verification of the medicines."

 

He added, "Having said this; it will require a major overhaul of the package printing operations. For the pharmaceutical companies, the onboarding process to register itself should start at least six months in advance and hence, pharma companies and tshould prepare for the same immediately."

 

Speaking about the consequences of the implementation, Mobner said, "It will undoubtedly increase the cost of medicines and the health system. It will also result in some products being phased out of the market, as it will be expensive to produce them."

 

The post-lunch session saw Jurgen Dambacher of Edelmann highlighting the types of folding box cartons, and the tamper verification features available in the market as well as the patented packaging applications from Edelmann.

 

Edelmann’s Baddi plant in Himachal Pradesh became the first in India to install a 12-unit Heidelberg Speedmaster CX 102

Munish Aggarwal, the managing director of Edelmann Packaging in India spoke about the objective of the conference. He said, FMD is important. It is a step taken by European Union to curtail the increasing risk of counterfeit medicines entering the legal supply chain as well as reaching patients. However, the pharma industry is struggling to grasp the implications of the new regulation and about how to overcome the possible hurdles which may be encountered during implementation. In such a scenario, Edelmann India hopes to throw more light on the subject and guide the Indian industry to the right path. Our main aim was to clear the ambiguity surrounding the regulation and provide expert guidance."

 

Edelmann India is a wholly owned subsidiary of Germany-based Edelmann GmbH. As a whole, the globally operating Edelmann Group employs more than 2,800 people in its 19 plants worldwide. The Indian factory sites include Baddi plus the three locations of MK Printpack in Nani Daman, Mota Ponda and Haridwar. Edelmann has inked a JV with MK Printpack which was announced in December 2017. 

The Edelmann Group designs and manufactures folding cartons and rigid boxes for: the healthcare sector, including prescription medications, over-the-counter medications and diagnostic tools; the beauty care sector—including perfume, skincare cosmetics, makeup and hair color—and consumer brands that sell home electronics and multimedia, wine and spirits, food and confectionary, and tobacco and other nonfood products.

As Munish Aggarwal strssed in his welcome address, the group is committed to excellence in the production of paperboard packaging worldwide. Aggarwal concluded, "Edelmann in India strives to set standards in quality management, efficiency, delivery, reliability and sustainability."