Counterfeit is a threat that hits not just the pharmaceutical market but it affects our everyday’s life: forgeries of currency, imitations of art, clothing, food, toys, software, hi-tech, company logos and brands are only some examples.
Besides the economic aspect, whose impact is definitively relevant, there is the increasing concern on the obvious consequences for human health.
Being more specific and focusing on drugs, according to the World Health Organization, SFFC (spurious/falsely-labelled/falsified/counterfeit) medicines are found everywhere in the world.
They range from random mixtures of harmful toxic substances to inactive, ineffective preparations. They can result in treatment failure or even death.
Counterfeiting is greatest in regions where regulatory and enforcement systems for medicines are weakest.
In most industrialized countries with effective regulatory systems and market control (i.e. Australia, Canada, Japan, New Zealand, the United States of America, and most of the European Union), incidence of SFFC medicines is extremely low – less than 1% of market value according to the estimates of the countries concerned.
But in many African countries, and in parts of Asia, Latin America, and countries in transition, a much higher percentage of the medicines on sale may be SFFC:
Up to 15% of all medicinal products in the world are counterfeit (WHO estimate)
Global sale of counterfeit drugs projected at $75 billion in 2010 (Center for Medicines in the Public Interest estimate)
92% increase in counterfeit drugs 2005-2010 (Center for Medicines in the Public Interest estimate).
In a world where pharmaceutical industries are constantly facing the counterfeit threat, supply chain security, though serialization and the ability to authenticate the e-Pedigree of a product, are essential to the battle against fake drugs.
Institutions such as the European Federation of Pharmaceutical Industries and Associations (EFPIA) and the US Food and Drug Administration (FDA) are calling for unique identification on every medication package. Laws to implement such measures are being introduced in many parts of the world, but progress and requirements vary from country to country.
As a matter of fact, thanks to the modular constructive designs and to the many applications available, the flexibility of IMA LIFE’s labelling machines are the right answer to meet both the country as well as the specific pharmaceutical industry requirements.