Safety and Security Concern in Pharmaceutical Supply Chain
The Pharmaceutical world is not anyway exception to the marketing malpractices, as according to statistics of World Health Organization (WHO), counterfeit medicines of worth $32 billion are in circulation in drug market. On the other hand, Food and Drug Administration (FDA) told the number of investigations done by it, has just doubled from the total numbers as it occurred in previous year.
One of the worst cases of counterfeit medical scam was registered in US medical history in 2003 when Pfizer discovered tens of thousand of counterfeit bottles of top selling cholesterol medicine, Lipitor. And this discovery of false medicine soon spread to 15 U.S states.
Apart from the monitoring of production of counterfeit medicines, the drug administration authorities also look after the other area of concern that is product expiration. One of the prominent reasons found for product expiration as its being collated in the supply chain for too long before they can be distributed to the retailers.
The Healthcare Distribution Management Association presented a stat that phrama industry annually incur $ 2 billion a year in returns and product losses and another $ 2 billion annually in the costs related to processing returns, expirations and recalls.
In order to regulate the system, the public as well as Congress are trying their lot to bring about a process where a secure supply chain can be established for prescription drugs and counterfeiting can be minimized. To strengthen the process, the US Congress passed the Prescription Drug Marketing Act in 1988, which requires a detailed record of drug’s movement thorough the supply chain from the manufacturer to the medical store. And supplier to the defense authorities is expected to use active and passive RFID tags on shipments to the military.
For a Pharmaceutical firm while tracking a drug through the supply chain there are many points that are needed to be kept in mind. The issues like detecting which drug, from which batch, has been counterfeited needs to be checked out, however, the process of creating a drug from raw material than its packing and shipping is a complex process.
Presently Pharma Industry handles supply of finished product at the batch or lot level and incase any counterfeit is detected then entire batch is recalled thus increasing cost for the manufacturer and the retailer and lost in consumer confidence as well. Moreover, in system of contract manufacturing there are more chances of counterfeit as product is passed through many hands.
However, use of technology can provide a viable solution to this problem as use of barcoding and RFID tags during every stage of supply chain from receipt into and out of inventory to the picking, packing and shipping processes. Track and trace capability from product recalls and product quality. Bar coding and RFID proves to be very effective method for a greater control over product recalls and product quality, and most importantly, pedigree and serialization capabilities can be used with aligning the standards and norms.
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