As a novel coronavirus spreads through China and rattles the rest of the world, the pharmaceutical industry is on guard over the adequacy of its global supply chain.
Over the past decade, China has become a bigger player in the market for active pharmaceutical ingredients, which are the building blocks found in each drug. China is now home to 13% of all facilities that make ingredients for medicines that are sold in the U.S., according to the Food and Drug Administration. By comparison, 28% of such facilities are in the U.S. and 26% are in the European Union.
Most ingredient production is concentrated in Zhejiang province, which is something of a manufacturing hub that lies along the East China Sea, far from the city of Wuhan, where the outbreak began, explained a source familiar with the Chinese pharmaceutical market but who asked not to be named.
But as the virus proliferates, illnesses and deaths mount, and the Chinese government increasingly locks down portions of the country, there are likely to be new questions about adequate production and supplies of active ingredients going forward, as well as the extent to which shipments can be made if transit hubs are out of commission.
“The time to worry is now,” said Steven Lynn, a former director of the FDA Office of Pharmaceutical Quality, who subsequently worked in global quality compliance for both Novartis and Mylan before leaving to start his own consulting firm.
“I would be asking my supply chain folks what do we have coming from China, what’s our inventory, and if we don’t have enough, can we get as much as fast possible? And remember, this isn’t just a U.S. problem. It’s a global problem if China starts shutting down its borders.”...
This was excerpted from the 27 January 2020 edition of STAT News.