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Sen Grassley Seeks Surprise Checking Of Drug Making Units In India, China


Senate Finance Committee Chairman Chuck Grassley has urged the US Government to carry out surprise inspections of prescription drug manufacturing facilities in foreign countries, especially in India and China, where the majority of active pharmaceutical ingredients bound for the U.S. drug market are produced.

In a letter sent to Department of Health and Human Services (HHS) Secretary Alex Azar and Food and Drug Administration (FDA) Acting Commissioner Norman Sharpless, Grassley (R-Iowa) urged them to reinstate unannounced inspections in light of the Trump administration's new "Safe Importation Action Plan".

The senior Republican Senator from Iowa said it is important to determine more accurately if these facilities meet quality and safety standards for both domestic and importation purposes.

Grassley noted that the FDA only inspected one in five registered human drug manufacturing facilities abroad last year.

This is a follow up to another letter that Grassley wrote on the topic to Azar and Sharpless in June.

In that letter, Grassley had sought information on the quality controls for prescription drugs and their components manufactured in foreign countries, specifically China and India.

He also wanted to know the measures taken by FDA to uphold safety standards in the United States, China and India via inspections of manufacturing facilities.

80 percent of active pharmaceutical ingredients for US drugs are produced in China and India. The Congressman cited reports that the drug manufacturing units in those countries have not maintained adequate quality control standards.

Grassley also noted that the FDA generally does not perform unannounced visits of drug manufacturing facilities in foreign countries but does so in the United States.

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