Pharmaceutical Serialization - Track and Trace Act -India
India's start with Serialization towards Pharmaceutical companies
India’s Trace and Track act has requirements that the products should be barcoded, serialized, aggregated, reported to the government.
Serialization in packaging is the process of assigning traceable number to each sealable unit.
Assigning traceable number to an individual unit is done in according to country regulations, RFID is preferred in US and 2D barcodes and matrix are preferred in EU and India. These Bar-codes are mandatory to be in GS1 guidelines.
Aggregation is the term defined for creating relationships among hierarchies for Tertiary level (Case), Secondary level (Saleable unit), Mono-Carton Packaging level. Packaging at all of these levels must be sealed and labeled properly with the above given serialization reforms. In between the Manufacturer and the End-Customer a product changes hands 10 times minimum. Indian act for serialization needs tracking to be done at each of these levels.
Reporting consists of gathering serialized data for manufactured and shipped pharmaceutical products. The product, their unique IDs and shipment details are captured and configured into XML reports, which is submitted on Govt Websites (In case of India - DAVA).
Serialization brings a paradigm shift in the Pharmaceutical industries as well as Contract manufacturing and packaging partners. Earlier the products the labeled same as their lot number or batch number so they can be identified that they are similar products, now with the regulations imposed by government it is a mandate to have unique ids for every single product.
Serialization concept was introduced in 2007 in Indian industries that could facilitate customer verification of the genuineness. Serialization was more focused on customer usage of the product, this verification could be done through SMS or call services.
Using SMS or call for authenticity by entering a given serial on the product is flawed from both sides. First of all the serial number given on the packaging can be easily replicated and even the SMS services can be hacked to present a fake product as an original one.
Not verifying the originality of the product is a problem but presenting a counterfeit product as an original one is even a bigger problem.
After some time Holograms made their way into the market but it was easy for the counterfeiters to crack this technology. Holograms being ineffective were not used in the market after some time as they were reduced to visual verification that could be duplicated easily. After holograms, 2D-Barcodes were introduced that had information encoded into them. The counterfeiters are ahead of the industry in any case. Barcode software started getting hacked and the same barcode series that was proprietary to the company was being used by counterfeiters. As a conclusion 2D barcodes could also be replicated and misused for fake reassurance. Every day in the serialization industry is a challenge.
The solution we need in the pharma serialization industry should be an easily visible for the customer, hard for the counterfeiters to be cracked, durable for the supply chain as well as should be cost effective for the manufacturer.
A serialization solution in a market as big as India should have all these qualities to control counterfeit to an extent. Is there any such solution? Find out.