China investigates 43 drug manufacturers tied to adulterated drug capsules
Illustrating the regulatory challenges emanating from drug manufacturing in China, authorities there have recalled 13 medications filled in capsules believed to contain excessive amounts of chromium.
China's State Food and Drug Administration said Sunday it was suspending sale of the medications because their capsules may have been made from industrial-grade gel instead of the required edible product. Authorities were investigating 43 manufacturers in Xinchang County in Zhejiang Province and had arrested 22 people related to the incident, according to an Associated Press report in The Washington Post.
A report on CCTV says the gelatin used in the capsules had been made from scraps of leather material, reports Broadcast24. The gelatin reportedly came from companies in northern Hebei Province and eastern Jiangxi Province. Managing food and drug safety in the country is challenging as Chinese authorities try to eliminate the use of illegal additives often manufactured in makeshift factories, the AP report points out.
While there was no indication any of these medications were distributed beyond China, it comes roughly four years after 80 people in the U.S. died when adulterated crude heparin from that country made its way into finished products marketed by Baxter International ($BAX). That incident served as a wake-up call that China's problem is the world's problem.
The fallout from that incident continues to be seen here, as the FDA, criticized for not better inspecting foreign manufactures, tries to get a handle on both foreign-made drugs and ingredients. The agency recently added to a list of Chinese companies whose ingredients were banned from use in drugs shipped to the U.S. It also has asked drug manufactures to test crude heparin to ensure the ingredient comes only from pig intestines. The adulterated heparin in 2008 contained oversulfated chondroitin sulfate, which some Chinese ingredient makers use to save money, according to the FDA.