With infant formula scandals, mine collapses and pollution and contamination problems, China is not well regarded for its industrial safety record, and today the story continues with 13 different drugs produced in China being pulled from the market by the Government regulator.

In a statement issued on Sunday, The State Food and Drug Administration confirmed that it had requested local authorities to inspect capsule manufacturers in their provinces. The problem appears to stem from very high chromium levels in the capsules rather than their contents, thus it affects products varying from herbal medicines through to antibiotics in a variety of locations.

CCTV said in a report that the gelatin from companies in northern Hebei Province and eastern Jiangxi Province and used in the capsules manufacture was made from scraps of leather material. It’s clear that Chinese authorities face many challenges as they attempt to prevent the use of illegal additives often manufactured in fly-by-night factories.

There are no reports of the medicines being distributed beyond China, but there have been incidents in the past, including the dramatic baby formula that contained no nutritious value whatsoever, and the deaths of 80 people in the United States due to Heparin (a blood thinning product) and marketed by Baxter International that was crudely made.

Countries around the world are growing increasingly wary of product standards from China, especially in the healthcare industry. The FDA has been criticized for not inspecting imported products more thoroughly, and it has taken action by banning ingredients from certain Chinese companies. The heparin incident from 2008 was caused by oversulfated chondronitin sulphate; the FDA has asked manufacturers only to use heparin from pig intestines and avoid cost saving dodges.

The FDA has released a statement in regard to product safety. Christopher Hickey, Ph.D., who leads FDA’s 13-person staff in China, says the agency has trained more than 1,600 manufacturers and regulators on United States safety standards over the past two years. He continues that :

“The FDA’s China office represents a new era in cooperation between the United States and China on the safety of food and medical products.”

Michael Kravchuk, who served as deputy director in Beijing until he retired in September, says FDA has built solid relationships with Chinese regulators and exporters since officially opening an office in the capital city of Beijing in November 2008. After a two-year stint in China, Kravchuk says he realized that FDA and their Chinese counterparts are working toward a common goal :

“What I realize is we are all trying to ensure quality products are on the market, regardless of where they are sold. They want to learn how we approach product safety and use as many of our techniques as possible.”

The FDA is seeking additional funding for 2013 to be able to better inspect and analyze imported products, especially those from China. They are also planning to inspect manufacturing sites in China and conduct evaluations of sites that are undertaking clinical trials of products planned for import to the US.

The agency certainly has its work cut out for it, with some 24 million shipments of FDA-regulated products arriving into the USA during 2011. Murray Lumpkin, M.D., FDA’s senior advisor and representative on global issues, says the foreign outposts give FDA a way to address safety issues before products leave the country of origin :

“By helping other nations develop stronger regulatory systems and helping industry to understand our expectations and realize they will benefit from them, we’re also helping ourselves and keeping U.S. consumers safe.”

Written by Rupert Shepherd