USP Medicine Supply Map to help improve the resilience of the pharmaceutical supply chain

By unveiling its drug supply map, the United States Pharmacopoeia (USP) has shown just how dependent the US pharmaceutical supply chain is on Indian API manufacturers.

The United States Pharmacopoeia (USP) revealed the importance of large Indian facilities in manufacturing Active Pharmaceutical Ingredients (APIs) for the United States. The findings are the first in a series – the USP Drug Supply Vulnerability Insights Series – based on data from the organization’s World Drug Supply Map.

The map is based on information from the use of USP quality standards in more than 22,000 locations worldwide, covering 92% of generic drugs approved in the United States, aggregating data from more than 40 datasets and 250 million data points to quantify risk and resilience. in the upstream pharmaceutical supply chain.

Information from the map will help guide regulatory and industry actions to guard against over-concentrated sources of APIs, reduce disruption, and inform public investments and policy reforms that build supply-side resilience, the agency said. USP.

The goal of the USP Medicine Supply Vulnerability Insights series is to examine the global distribution of APIs and the risks associated with specific drug classes, from widely used drugs such as antimicrobials and statins to those needed in small populations, such as pediatric oncology drugs. . Future results will identify potential supply chain risks that could impact the availability of essential medicines.

In the first release, USP revealed that not only does India have the most installations with >10 active US-approved API products, topping the charts at 183, but 114 of them have > 30 active US approved API products, also the largest globally.

Europe was the second largest with 83 installations with >10 and 45 with >30. China followed with 35 and four, respectively. The US has 19 facilities with >10 and three with >30, and an aggregate pool called “Other” had 22 with >10 and seven with >30.

Commenting on the card announcement, Ronald Piervincenzi, Chief Executive Officer of the United States Pharmacopeia, said, “The USP Drug Supply Card is an innovative early warning system to help identify ingredients and products finishes at risk of shortage so that suppliers, manufacturers and governments can take action. to prevent the shortage from happening. Without visibility into the drug supply chain, it is impossible to prepare for the next crisis. »

“To find an effective cure, you first need an accurate diagnosis,” added Dr. Dave Levin, chief medical and information officer of Phlow Corp, a US-based pharmaceutical company focused on the ‘impact. “The USP Drug Supply Map helps us identify vulnerabilities upstream in the supply chain for various essential drugs and determine where Phlow’s advanced manufacturing capabilities may have the greatest impact.”

The drug supply map will be discussed at future USP Convention meetings to identify specific solutions to increase supply chain resilience; develop recommendations to improve the continuous cycle of readiness, including implications for national stockpiles; and increasing international cooperation between supply chain partners such as governments and manufacturers, among other activities.