Major drug retailers named in FDA complaint

Made in the USA Foundation has filed a complaint with the Food and Drug Administration (FDA) against major drugstores (CVS, Walgreens, Rite Aid and Costco) for selling prescription drugs and supplements without a country of origin label, which is a requirement of the FDA, U.S. Customs and International Trade Commission.

About 40 percent of over-the-counter and generic drugs are produced in India and a similar amount made in China.

In 2014, FDA inspectors examined 160 plants in India and found them to be often filthy or infested with insects. Some drugs were contaminated. As a result, the FDA banned importation of drugs from several factories in India. The World Health Organization estimates that one in five drugs manufactured in India is a fake.

“If I have to follow U.S. standards in inspecting facilities supplying to the Indian market, we will have to shut almost all of those,” G.N. Singh, India’s top regulator, said in an interview.

The Made in the USA Foundation’s Project COLD: Country of Origin Labeling for Drugs seeks to ensure that medications sold through American drugstores are labeled correctly.

In the United States, 1,000 manufacturing plants are inspected each year as compared with the inspections held in foreign production facilities.

Topics: Clinical , Regulatory Compliance