Bridging The Value Chain – The Pedigree Way

By Arun Ramesh, Lead Analyst, Beroe Inc.

 

Abstract

1 Serialization – Need of the Hour
Lack of global co-operation on agreement with one common technology over the years has delayed the process of serializing the drugs. By and large, majority of the regions have come up with consensus to have a Unique level Identification Code (UIC) on unit level pharmaceutical products. With almost 40% of drugs being fake in the developing markets like Turkey, China and Argentina; these countries have been the prime movers in serializing drugs. However every region has its own technology and deadlines to meet the same. For e.g. China, one among the early movers implemented linear code serialization instead of 2D-style packaging. Other markets will be following the suite in coming years and that includes South Korea, Brazil, the U.S, and the EU. The requirements and guidelines for serialization are country specific, which is why pharmaceutical companies operating internationally need flexible solutions to meet the regulation.

2 Synopsis
Counterfeiting is a multi-billion dollar issue and is a threat to the pharma industry. Counterfeiters have started using advanced technology to manufacture and label products, sometimes even better than the original products. Off the total counterfeit market, less than 5% contribute to the developed drug market and 40% from the emerging markets. On account of this, though not a complete solution but to ensure patient safety, to track the value chain of drugs and to protect the brand of pharma companies, Serialization was introduced in the year 2011. In 2013, the US and Europe mandated this as a law and intimated manufacturers to serialize their drugs and aggregate the supply chain manufactured by 2023. Since the whole process would take some time to fall into place, in the initial phase (by mid-2015) drugs are to be labelled with unique “Product Identifier” code followed by aggregation of the whole value chain in other words the pedigree way. This whitepaper would discuss on how the contract manufacturers and pharma companies have acted on this regulation with case studies. The paper would also focus on cost involved in implementation and maintenance of serialization in the product lines and how top CMOs like Vetter, Recipharm etc. have achieved success with serialization in respective regions

3 Recommendation
Upgrading production and packaging lines with serialization process would aid pharmaceutical companies and CMOs in achieving a better visibility in the drug value chain and in maintaining the brand image of companies by eradicating fake drugs in the market thus providing patients with safe drugs.

 

Please click on the link below to access the white paper:

Whitepaper on Bridging the Value Chain – The Pedigree Way