Supply Chain Expert: Drugmakers Should Implement Track and Trace Immediately

Drugmakers that have not started complying with worldwide track and trace regulations are behind the curve, as most countries only allow for two to three years for implementation, a supply chain expert cautions.

More than 40 countries already have serialization legislation, and more than 150 countries are likely to follow. For example, Russia, Pakistan and Iran have proposed legislation in the past few months, said Evren Ozkaya, founder and CEO of Supply Chain Wizard, who conducted an FDAnews webinar in December.

The FDA’s track and trace regulation will be rolled out in stages, starting in 2017. At that time, information will need to be tracked at the product lot-level. By July 2023, companies will need to be able to trace individual items back to the original manufacturer.

The U.S. implementation deadline is longer than that of most other countries because its requirements are some of the most stringent, Ozkaya added. However other major countries have deadlines that are rapidly approaching or have passed.

Companies that have not begun compliance need to do so immediately, as a single packing line alone takes six to 12 months to upgrade, Ozkaya said.

Despite the need for track and trace, more than half of drugmakers across the globe do not budget for it, he said. What they fail to realize is that a well-run program minimizes compliance risk and protects a company’s bottom line, while maximizing visibility on supplier/site progress.

Further, such programs inform strategic decisions and initiatives like supplier rationalization, network design and supplier collaboration for better return-on-investment, Ozkaya said. — Kellen Owings



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