Pharma serialization: More than a mandate

The counterfeit drug market is continuously growing with a current worth of approximately USD 200 billion. The serialization of pharmaceuticals is considered one of the robust ways to curb the rising threat of counterfeit drugs and ensure patients’ safety. As a result, stringent serialization and ‘track & trace’ regulations are now springing up in almost every country. Most of these regulations call for additional requirements in the existing pharmaceutical manufacturing and packaging facilities. They involve a reorientation of the supply chain which requires checkpoints at every step, thus making the manufacturer-to-customer journey of drug products tedious and lengthy. Consequently, pharma companies were initially apprehensive about serialization and its impact on business and revenue. However, a change is coming through as pharmaceutical companies are now having a strategic business view on the implementation of serialization. Besides regulatory compliance, serialization brings a lot of opportunities to the drug manufacturers which can help them to overcome the limitations of the current systems and processes. Let us have a look at these benefits:

  1. Protection of brand – The most serious consequence of counterfeit drugs is the damage to brand reputation. Building a brand that patients can trust takes an inordinate amount of time and efforts by the company. A brand reputation is crucial because compromised drugs can cause potential harm to patients. By serializing and incorporating traceability features into a product, a pharma company can be assured of patients’ safety and positive brand image.
  2. Harmonized processes – Serialization is an excellent opportunity for pharma manufacturers to standardize the operational process across manufacturing facilities, warehouses, and distribution hubs. The resulting efficient processes can help in the removal of expired, faulty, or damaged products, ensuring that only the authentic products reach the consumers.
  3. Minimal scope for parallel trading – Parallel trading involves purchasing goods at low prices and reselling the same when market prices rise. Such tradings are illegal in certain industries for which product costs are cumulative and determined by actual cost in addition to import and export taxes. Track & trace has the potential to control parallel trading effectively.
  4. Cost-effective – Although serialization is a complex process and demands huge investment in terms of money, time, and resources, pharma companies often tend to overlook the revenue loss incurred by counterfeit medication and batch recall which is higher than the cost of serialization. By implementing serialization, pharma companies can curtail such losses. Besides, automated serialization machines can eliminate manual errors such as the incorrect entry of GTIN or batch number, thus avoiding the loss of time and revenue caused by human interventions.


Pharma companies have been fighting against counterfeit drugs for a long time. With serialization, as a regulatory mandate, they should look at it as an opportunity for increased consumer safety and business gains rather than as an obstacle. With the help of an experienced and trusted solution provider, pharma companies can achieve and implement successful serialization and traceability.

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