The US Pharmacopoeia report finds a high dependence on Indian manufacturers for active ingredients


The United States Pharmacopeia (USP) has launched a Vulnerability Insights Series in Drug Supply to identify and highlight vulnerabilities in the global active pharmaceutical ingredient (API) supply chain.

The USP’s insights come from its global Medicine Supply Map, which uses more than 40 external datasets and 250 million data points to quantify risk and resilience in the upstream pharmaceutical supply chain.

A non-profit scientific organization, USP develops and sets standards in compounding, biologics, pharmaceutical manufacturing and other fields in the United States.

The first results published by the USP underscore the US dependence on large Indian API manufacturers. Over 80% of all Essential Drug APIs used in the US have no domestic manufacturing source, with the US relying heavily on API manufacturing facilities in India and China for key ingredients.

According to the USP, more than half of the 342 manufacturing facilities worldwide with more than 10 active US-approved API products are located in India. Of those with more than 30 active API products approved in the US, 65% are in India.

US pharmaceuticals: a fragile supply chain

The US’ dependency on foreign API makers means its supplies of essential medicines — from antibiotics to painkillers — are precarious. A study released last year by the Center for Analytics and Business Insights (CABI) at Washington University’s Olin Business School found that less than 5% of major API manufacturing facilities are located in the United States.

The lack of API manufacturing footprint in the US is largely due to “the ‘race to the bottom’ in pricing versus global players, lower input costs and reduced regulatory burdens” at overseas facilities, according to the report.

Anthony Sardella, Senior Research Advisor at CABI, previously said pharmaceutical technology that the US needs to build a diverse supply chain to secure its access to APIs.

“It’s not just about moving everything to the United States with new technology, but also about diversification and partnerships with other countries that could be producers,” he said.

“A more balanced, resilient and diversified supply chain is a very important aspect of building US supply chain resilience and reducing our vulnerabilities.”

Manufacturing delays accounted for 11% of all drug shortages in the US, according to an analysis of FDA data last year. About 5% of drugs found to be in short supply were due to ingredient shortages.

The Medicine Supply Vulnerability Insights Series will examine the global distribution of APIs and risks associated with specific drug classes to identify potential supply chain vulnerabilities that could impact the availability of critical drugs, the USP said in a statement.

The organization’s Medicine Supply Map will also be discussed at the upcoming USP Convention meetings, where members will identify specific solutions to improve supply chain resilience, develop recommendations to ensure facilities are prepared for demand, and at the Build collaboration between supply chain partners such as governments and manufacturers.

Ronald Piervincenzi, CEO of USP, said: “USP’s Medicine Supply Map is an innovative early warning system that helps identify ingredients and finished products at risk of shortages so suppliers, manufacturers and governments can take action to address to prevent bottlenecks from occurring.”

“Preparing for the next crisis is not possible without insight into the drug supply chain.”



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