Drug Ingredients from China Continue to Raise Safety Concerns

Many of the China-based manufacturers of active pharmaceutical ingredients (APIs) have not had their products tested before they’re released on the open market, according to a new Reuters investigation.

The problem with Chinese drug makers, or at least those that make the ingredients that are eventually mixed with others to finish drugs, came under an infamous light a few years ago when the Active Ingredient used to make the blood thinner drug heparin was found to be contaminated. More than 150 people died in the U.S. after they received the drug that contained a counterfeit API.

In fact, since that time, there has been almost no effort to guarantee the safety of any Active Ingredients that are manufactured in China. Further, the Chinese have gone to the lengths of creating a facade designed to fool would-be inspectors who visit the facility looking to make sure it is maintaining safety standards.

According to the Reuters report this week, “Interviews with more than a dozen API producers and brokers indicate drug ingredients are entering the global supply chain after being made with no oversight from China’s State Food and Drug Administration (SFDA), and with no Good Manufacturing Practice (GMP) certification, an internationally recognized standard of quality assurance.”

Alongside Reuters reporters, the Belgian head of a pharmaceutical auditing firm based in Tianjin, China, visited one of these “showroom” factories designed to fool an inspector. On both the figurative and literal surface, there seemed to be no signs of anything amiss. Workers donned safety gear. The floors, walls, and manufacturing equipment were immaculate. Certainly, this was not one of those facilities that manufactured contaminated or counterfeit APIs but in reality, the factory did nothing other than provide a ruse. Machines were not connected to anything that allowed them to vent outside. Inspection records appeared to have been written all at once even though they were supposed to have covered a span of eight years.

The World Health Organization admits it is aware of the problem with pharmaceutical counterfeiting but appears powerless to alter this trend at the moment. More drug companies every year turn to China for less expensive APIs. By reducing the cost on APIs, drug companies can either offer lower prices or extend profit margins.

WHO believes the problem with counterfeit pharmaceuticals from China is a major problem for developing countries with less strict standards for importing drugs from another country. In the U.S., it believes, regulations in place are designed to catch these counterfeit products before they reach the market but that’s hard to believe considering the problems caused by heparin and that the FDA has done little to ensure facilities in China are following safe manufacturing protocol. Not knowing where the products are actually made presents its own set of problems.

At least 70 to 80 percent of the world’s supply of APIs are manufactured in China or India, the report adds.

Many of the China-based manufacturers of active pharmaceutical ingredients (APIs) have not had their products tested before they’re released on the open market, according to a new Reuters investigation.

The problem with Chinese drug makers, or at least those that make the ingredients that are eventually mixed with others to finish drugs, came under an infamous light a few years ago when the Active Ingredient used to make the blood thinner drug heparin was found to be contaminated. More than 150 people died in the U.S. after they received the drug that contained a counterfeit API.

In fact, since that time, there has been almost no effort to guarantee the safety of any Active Ingredients that are manufactured in China. Further, the Chinese have gone to the lengths of creating a facade designed to fool would-be inspectors who visit the facility looking to make sure it is maintaining safety standards.

According to the Reuters report this week, “Interviews with more than a dozen API producers and brokers indicate drug ingredients are entering the global supply chain after being made with no oversight from China’s State Food and Drug Administration (SFDA), and with no Good Manufacturing Practice (GMP) certification, an internationally recognized standard of quality assurance.”

Alongside Reuters reporters, the Belgian head of a pharmaceutical auditing firm based in Tianjin, China, visited one of these “showroom” factories designed to fool an inspector. On both the figurative and literal surface, there seemed to be no signs of anything amiss. Workers donned safety gear. The floors, walls, and manufacturing equipment were immaculate. Certainly, this was not one of those facilities that manufactured contaminated or counterfeit APIs but in reality, the factory did nothing other than provide a ruse. Machines were not connected to anything that allowed them to vent outside. Inspection records appeared to have been written all at once even though they were supposed to have covered a span of eight years.

The World Health Organization admits it is aware of the problem with pharmaceutical counterfeiting but appears powerless to alter this trend at the moment. More drug companies every year turn to China for less expensive APIs. By reducing the cost on APIs, drug companies can either offer lower prices or extend profit margins.

WHO believes the problem with counterfeit pharmaceuticals from China is a major problem for developing countries with less strict standards for importing drugs from another country. In the U.S., it believes, regulations in place are designed to catch these counterfeit products before they reach the market but that’s hard to believe considering the problems caused by heparin and that the FDA has done little to ensure facilities in China are following safe manufacturing protocol. Not knowing where the products are actually made presents its own set of problems.

At least 70 to 80 percent of the world’s supply of APIs are manufactured in China or India, the report adds.