Knowledge Series 1-Serialization in Pharma (Episode 1)

Pharma Packaging line serialization

Pharmaceutical Serialization - Introduction

What is the need for Serialization or what are the problems are faced by pharmaceutical industries that creates a scope for Serialization?

With the increase in third party vendors the supply chain gets longer, this facilitates the counterfeiters to find a loop hole in the long Supply chain delivery process. Illegal sales of drugs on internet and even in physical market slows down a company’s revenue by 20%.

This number is huge to cover up, that creates an urgency for the companies to update their machinery. Not only is the illicit sales hampering the profits of the company, but also is harmful for the end users, if not regulated. Market for these duplicates have grown to 75 Billion USD globally in the last decade. Serialization is the solution for pharma industries to regulate the market.

Some of the basic supply chain problems are Counterfeit, Product Mix-Ups, Grey Marketing, Disparate Regulations.

Counterfeit is making and providing illegal fake copies of the genuine product in the market. Market for counterfeit is as big as a Multi-national company. Some the products are not even released in the market and their duplicate product is already present in the market, that’s how deep its roots are in the industry.

Product Mix-ups is the event when a wrong product goes into manufacturing and reaches in distribution channels. Mix- ups are resulted by ignorance of the manufacturer or sometime taking one element to be another element, in the formulation/compounding process.

Grey Marketing is the selling of a product outside its distribution channel. Some products are customized to physician’s need of another company’s need, leaking of these specific medicines leads to unknown side-effects on the end user who is unaware of these product’s side effects.

Disparate Regulation is the biggest cause to the illegal supply of pharmaceutical products.

Before 2012’s Meningitis breakout in USA, the government did not have any hard and fast rules for the pharmaceutical companies and their supply chain management. This incident that killed nearly 60 people was an eye-opener not only for USA government, but also all the other countries.

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