Medicines Made in India Raise Safety Questions

The U.S. Food and Drug Administration (FDA) has recently started scrutinizing over-the-counter and prescription drugs manufactured in India. India is the second-largest exporter of pharmaceutical drugs to the U.S., providing 40 percent of all over-the-counter and generic prescription drugs consumed in the United States.

Although some of India's drug-making factories meet Western safety standards, the FDA is still concerned with lingering quality control issues. The World Health Organization estimates that one in five drugs made in India are fake. India has its own agency similar to the FDA, the Central Drugs Standard Control Organization, but it only has authority to regulate new drugs.

FDA commissioner Dr. Margaret A. Hamburg expressed concern for safety lapses, falsified drug test results, and selling counterfeit medication. Because of the amount of Indian drugs sold in the U.S., increased safety inspections could noticeably impact consumers. The FDA recently banned the export of generic versions of some popular drugs, including Accutane and Neurontin, because it was determined that they were made with a mix of substandard ingredients.

The FDA's focus on the safety of Indian drugs is part of a wider effort to regulate the quality of all drugs and food coming into the United States from countries worldwide.

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