How serialization will reduce counterfeiting in the pharmaceutical industry

How serialization will reduce counterfeiting in the pharmaceutical industry

Serialisation pharma

The counterfeiting of medication, particularly in third world countries, is rampant–and an issue that urgently needs to be solved. In fact, according to the World Health Organization (WHO), approximately 30 to 40% of the drug sourcing in developing countries is counterfeit. How can medical packaging companies and others in the industry stop this problem before it gets out of control?

Enter pharmaceutical serialisation. Serialisation is a system designed to track and trace pharmaceutical drugs as they go through the supply chain. Every package is labeled with a unique identifier that allows it to be traced from its birth all the way to when it is placed in the hands of a patient.

With opportunities for malpractice at every step in the pharmaceutical supply chain process and so many different players in the game, serialisation aims to minimize the risk through maximum security initiatives. It requires extremely detailed information including everyone who may have touched the drug during the manufacturing process, basic drug dosage and name, shipping information, lot and batch number, etc. The goal is to completely authenticate every single package, down to the last pill, that a patient receives at the pharmacy counter.

Because the pharmaceutical supply chain
is so complex, trying to implement serialization on a larger scale is incredibly difficult. Hence why the United States government has even gotten involved, introducing the Drug Quality and Security Act (DQSA) in 2013. The new law, spanning multiple years, set deadlines for serialisation that all pharmaceutical packaging companies must meet by 2017. Other countries have set their own standards as well, in a desire to stop the threat of counterfeit and adulterated drugs.

Serialisation is vital in maintaining the integrity of the pharmaceutical industry. Companies want to increase profits and revenue, as well as improve brand equity and avoid damaging lawsuits. But even more than that, serialisation is key in keeping patients safe and healthy. It will ensure they receive the proper medication that they need and won’t put them at risk of ingesting the wrong (and possibly fatal) drugs.

While the pharmaceutical industry still has a long ways to go, it is clear that there is a universal push towards improving the market. Serialisation is the first step in that movement and the first step in ensuring better, standardized quality and safety when it comes to pharmaceutical and medical packaging.


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