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How Serialization Can Save Lives


According to World Health Organisation estimates, 1 million people around the world die every year from the intake of counterfeit drugs.


While the situation paints a bleak and unfortunate reality the pharmaceutical industry is grappling with, the ingredients found in falsified medicines render the causes unsurprising. Research by pharmaceutical giant Pfizer has revealed that counterfeit medicines contain lethal ingredients like rat poison, floor wax, toxic pesticides, heavy metals, chalk and “worse”.


The pharmaceutical black market has worsened to the point where 1 in 10 drugs in distribution are either falsified or substandard (meaning they contain an insufficient amount of the original’s active ingredients). Even Pfizer’s latest reports have recorded that 105 of its medications across 113 countries are counterfeit—up from 29 products across 75 countries in 2008.

COUNTERFEIT MEDICINES CONTAIN LETHAL INGREDIENTS LIKE RAT POISON, FLOOR WAX, TOXIC PESTICIDES, HEAVY METALS AND CHALK.

As the counterfeit drug market grows—by an expected 8.5% CAGR from USD904.5 million in 2016 to USD1.4 billion by 2021—governments and pharmaceutical companies are aggressively fighting back with track and trace solutions.


In principle, there are 4 points along the pharmaceutical supply chain: the manufacturer, wholesaler, pharmacy and patient. But global trade has increased the number of transit points in between these stages, complicating the journey of medication from factory to counter and making it easier for counterfeit drugs to infiltrate the pathway.



However, through the latest advancements in data matrices and integrated online platforms, drug companies will be able to use serialization to filter out counterfeit drugs and work with law enforcement agencies to prevent them from reaching the counter. And if they do, the recall of products would be carried out more efficiently, as each individual product would be engraved with a unique imitation-proof code—a key feature of Identem’sTM traceability solutions.


Additionally, serialization needs to be paired with the streamlining of standards, so that drugs crossing various borders before reaching their intended destination can be consistently verified for signs of falsification.


Organisations like the European Union (EU) have already passed the European Falsified Medicines Directive (EU FMD), which recently came into effect on 9 February this year. It specifies that all medication being circulated in Europe adhere to stringent guidelines that consist of 2D data matrix codes and anti-tempering labels and devices. Harmonisation initiatives like the EU’s will make it harder for counterfeit drugs to penetrate any one European country as the methods of serialization are consistent and easily monitored.

97% OF THE WORLD’S COUNTERFEIT DRUGS ARE MADE IN CHINA AND INDIA

Considering that Asia contains the highest production of falsified medication—97% of the world’s counterfeit drugs are made in China and India—both pharmaceutical companies and regional governments should make it a priority to implement track and solutions and streamline counterfeit-proof serialization guidelines. Thousands—if not hundreds of thousands—of lives could be saved from a combination of bold innovation and political willpower.


To combat trading in counterfeits and in preparation for such industry-wide serialization regulations coming into force, PNMB InnoVentures has collaborated with Optel Group, a world-leading serialization, traceability and intelligent supply chain solutions provider. Through this collaboration, PNMB InnoVentures offers comprehensive hardware and software solutions, leveraging on Optel’s expertise in multiple industries including pharmaceuticals, food and beverage, consumer goods, as well as natural raw materials.


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