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Over the past few years, the government has taken measures to combat drug counterfeiting, and rightly so. It's a tremendous undertaking considering that medicines are manufactured at different places, distributed to thousands of retail pharmacies, and have varying shelf lives and storage requirements. So, everyone from the manufacturer to the regulator has a key role to play here.
In fact, the World Health Organization (WHO) estimates that 50% of medicines sold online are counterfeit. But favourably, pharma serialisation has proven to be an effective tool to ensure better operational efficiency in this regard.
Serialisation is, in fact, a basic need in the pharmaceutical industry. The entire supply chain, from packing to transportation, needs to be seamless and traceable, and serialisation makes it possible. Let's explore it in more detail.
Serialisation implies tracing pharma products through a unique code or serial number starting from the manufacturer through to the consumer. The structure and definition of the serial number are unique to the country's regulations. The code gives the complete information about the drug, such as its origin, production batch, manufacturing date, expiry date, etc. To implement serialisation, manufacturers must generate unique codes for products and print them on the product or its packaging as a QR code, an RFID, etc.
GS1 standards specialising in traceability are utilised for serialisation regulations in the pharmaceutical industry. Following the guidelines, 2D data matrix serial numbers are structured and added to the packaging in compliance with the country's regulations. Serialisation completes when the serial number is printed on drug packaging.
Noted below is the information needed for the implementation of pharmaceutical serialisation:
Pharma serialisation improves visibility and transparency by inhibiting parallel theft and trade. In addition, the process enables location tracking of drugs, which helps the supply chain to improve the accuracy of shipping and eliminates defective or recalled drugs. As a result, the stakeholders are assured that the drugs are genuine and safe.
Budget allocation to upgrade the system is the first step to consider for serialisation implementation. So, the cost of implementing and maintaining the serialisation scheme should be carefully thought out. However, there's no doubt that the cost of implementing pharma serialisation is minimal when compared to its benefits, such as better security and traceability, etc.
When serialisation is implemented, production could be slower, especially packaging. Since manufacturers must add serial numbers to every single package – product, case, pallets, etc., automation can increase efficiency.
To ensure effective serialisation implementation, manufacturers must collaborate with an expert partner. They must choose a provider with serialisation, integration, and experience in the pharmaceutical industry.
For effective serialisation, pharma companies must have systems right in place to facilitate secured data sharing across the supply chain. Handling data effectively is particularly crucial to prevent counterfeiting and ensure seamless drug traceability.
The facility needs systems to enable efficient data storage for serialisation and give users easy and quick access to data. As such, it needs hardware and software for successful data management and reporting. Having a tailored solution incorporated with the existing system is the need of the hour.
Pharma serialisation solutions should be scalable and flexible in the face of ever-changing regulatory standards. For instance, the government has made it mandatory to have QR codes on Active Pharmaceutical Ingredients (APIs) packaging from Jan 2023. Regulations like these entail the pharma sector to be agile to ensure all the regulations are followed, including any latest amendments.
While serialisation simplifies business processes, there are some obvious challenges to address before successful implementation:
Considering the scale of products manufactured in the pharmaceutical industry, generating and printing serial numbers on products at high speeds is a challenging task. Manufacturers and suppliers need to invest in technologies that can speed up the process.
As elucidated above, scanning packages and labelling each product slows down the process. Therefore, automation is the best solution for manufacturers, something that's often lacking in the sector.
Pharmaceutical companies must expand the IT architecture and data management to leverage serialisation and its benefits. It should have an agile IT department that generates, captures, stores, and transmits uncountable serial numbers from multiple supply chains.
Serialisation has become the lifeline for pharmaceutical supply chains and distribution networks. It streamlines the process and minimises risks associated with counterfeit drugs. With a robust system in place, pharma companies can ensure the safety and efficiency of their products.
At QodeNext, we help pharma companies quicken the process of product serialisation. Contact us today to learn more.
