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FDA calls for drug safety efforts in cooperation with India

The Food and Drug Administration (FDA) works continually to ensure that only safe and effective prescription pharmaceuticals and medical devices are allowed onto the marketplace. Not every drug and device that the FDA approves is completely safe for every person. However, the FDA does try mightily to ensure that drugs and devices utilized by patients are reasonably safe, effectively labeled with any necessary warnings and are effective at achieving uses for which they have been approved.

Unfortunately, many dangerous and defective drugs and medical devices manufactured in other countries seem to consistently find their way into the hands of American consumers. Though the FDA and other federal agencies try to keep dangerous and defective foreign products off the market, there are only so many mechanisms they can use to ensure that defective drugs and devices manufactured abroad do not reach American patients.

Recently, the head of the FDA requested that domestic and foreign regulators cooperate more broadly and effectively in order to advance the cause of patient safety. Specifically, she requested that Indian authorities cooperate more fully with American authorities in order to keep dangerous and defective drugs manufactured in India from harming American patients.

Cooperation between the two nations is particularly critical given that India currently supplies 40 percent of the over-the-counter and generic prescription medications used by American patients, according to the Chicago Tribune. This kind of cooperation may go far in fostering patient safety, but only if all parties involved are willing and eager participants. Time will tell whether or not this effort will produce beneficial results.

Source: Reuters, “U.S. regulator on India visit calls for greater drug safety collaboration,” Sumeet Chatterjee and Zeba Siddiqui, Feb. 18, 2014

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