Complex regs and unknown markets top API shippers' logistics headaches

A drug sold in the US may contain an API produced in China, an excipient made in India and a capsule created in Europe and, in general, the systems required to ensure raw materials and finished products safely reach key markets are well established.

Transporting ingredients and drugs to new markets in Africa, Asia and Latin America is more of a challenge according to Dan Gagnon from UPS Europe, who told in-Pharmatechnologist.com such issues were a hot topic for executives recently surveyed by the logistics firm.

“Concerns about product protection and security are likely to remain and grow as healthcare supply chains become longer and products become more complex and high-value. As products travel farther to reach new global markets, the number of hand-offs in the supply chain can increase, making supply chain visibility even more important​.”

UPS quizzed executives in the pharmaceutical, biopharmaceutical and medical devices sector and found that 46% cited product security as a top supply chain challenge. While this is actually lower than the 53% who raised it last year, the finding is still indicative of a key topic according to Gagnon.

“Even though the concern level has dropped slightly, this marks the second year in a row that product security surpassed cost management as a top supply chain concern, indicating the increasingly complex security issues healthcare companies are facing​.”

UPS’ response has been to expand its network by opening three new distribution hubs in Brazil, Chile and Mexico in the summer and launching a plan to revamp its chain of 36 medical device field stocking locations in the US.

Regulations​

Another major concern for executives involved in the shipment of APIs, excipients and finished dosage forms is regulations.

“In addition to the US Drug Quality and Security Act, the upcoming Falsified Medicines Directive and the revised Good Distribution Practices (GDP) guidelines in Europe both require increased supply chain management and documentation processes​” Gagnon said.

He added that healthcare companies are grappling with changing, complex regulations around the world, especially as they expand.

This is particularly the case in Europe where variations in national laws are a real headache according to UPS’ man in Belgium.

“The regulatory environment is especially complex in Europe, where different requirements among countries in close proximity to one another make it difficult to stay on top of regulatory demands. Regulations also create a potential barrier to leveraging new distribution models, or extending them into other countries​.”

These concerns are driving drug industry strategy according to Gagnon, who said 57% of the execs asked had called in regulatory consultants, 54% said they had partnered with local firms in the markets they are targeting and 38% had called in distribution services firms.

UPS has also taken note of the complex regulations in Europe, buying UK-based Polar Speed in February and Hungarian shipper Cemelog in April.