Made in the USA Foundation Files FDA Complaint Against Major Drug Retailers
The Made in the USA Foundation filed a complaint with the U.S. Food and Drug Administration against CVS, Walgreens, Rite Aid and Costco Pharmacy for failing to label the country of orgin of prescription drugs. The Foundation currently is pursuing a federal case against Costco, but wanted to open another front concerning this important issue. Both actions are part of our COLD: Country of Origin Labeling for Drugs project.
The complaint cites FDA, U.S. Customs and International Trade Commission rulings and regulations that require the drug labeling. About 40% of all over-the-counter and generic drugs used in the United States are produced in India. A similar amount of prescription drugs are imported from China.
In 2014, inspectors from the FDA investigated 160 drug plants in India. What they found was often quite alarming. Drugs were sometimes adulterated or contaminated. Facilities were often filthy or infested with insects. The FDA also caught some executives lying to them, leading to felony charges. Because of unhealthy conditions, the FDA banned the importation of drugs from several Indian factories.
The F.D.A.'s increased enforcement has already cost Indian companies dearly -- Ranbaxy, one of India's biggest drug manufacturers, pleaded guilty to felony charges and paid a $500 million fine last year, the largest ever levied against a generic company. "If I have to follow U.S. standards in inspecting facilities supplying to the Indian market," G. N. Singh, India's top drug regulator, said in a recent interview with an Indian newspaper, "we will have to shut almost all of those."
The World Health Organization estimated that one in five drugs made in India are fakes. One widely used antibiotic was found to contain no active ingredients after being randomly tested in a government lab. The test was kept secret for nearly a year while 100,000 useless pills continued to be dispensed. "Some of the fake tablets were used by pregnant women in the post-surgical prevention of infections," said Dr. M. Ishaq Geer, senior assistant professor of pharmacology at the University of Kashmir. "That's very serious."