Quality Assurance of Overseas Manufacturer’s Is Shaky at Best

Reasons to Domestically Outsource OTC Generic Manufacturing

The manufacture of generic drugs, like so many other products that Americans consume, is being outsourced to facilities overseas where labor and other costs are lower than inside the United States. Many of the generic medications that Americans take for what ails them are made in China or India, along with a number of other countries. Even more drugs made in the United States use ingredients from foreign sources.

Quality Assurance of Overseas Manufacturer’s Is Shaky at Best

The problem with this arrangement is that it is more difficult to conduct proper quality control on generic drugs manufactured overseas. In theory the Food and Drug Administration has the power to regulate drugs made from both domestic and foreign vendors. The FDA has allied itself with regulatory bodies of other countries for this purpose. But in regards to generics made outside of the United States, the task is easier said than done.

A recent study by the National Center for Policy Analysis suggests that drug manufacturers in India and China occasionally substitute inferior, less expensive ingredients and fail to employ good manufacturing practices as a way to cut costs. One incident, involving a counterfeit ingredient used by a Chinese drug manufacturer resulted in 140 deaths despite the fact that it passed all tests. Only a more complex test, subsequently developed, managed to catch the substitution.

According to Consumer Reports, the FDA is beginning to crack down on drug manufacturers in India which have been employing shady practices, but the problem is by no means confined to India and China. Inadequate testing has been noted in plants in Australia, Austria, Canada, Germany, Japan, Ireland and Spain leading to shoddy and dangerous generic drugs.

While the FDA is attempting to rectify this situation, there is an argument for shifting the generic drugs to domestic manufacturers, where quality control is easier to enforce. This also may be easier said than done. Because of globalization, roughly 40 percent of the medications Americans use is manufactured outside of the United States. Also even for drugs manufactured in the United States, 80 percent of all raw drug ingredients used to make them come from other countries.

Public Confidence in Foreign Manufacturer’s Is Low

Still, with 54 percent of Americans distrusting drugs made in India and 70 percent distrusting those made in China, there would seem to be a market for any manufacturer who is able to create generics that are made in the USA.