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Senior US Senator Chuck Grassley has urged the Trump administration to "reinstate unannounced" inspections of prescription drug manufacturing facilities in foreign countries, especially in India and China.The chairman of the Senate Finance Committee said this was needed as these facilities provided most of the ingredients for production inside the US.
In the light of the administration's new Safe Importation Action Plan, Grassley, said it was important to determine more accurately if these facilities meet set standards of quality and safety for both domestic and importation purposes.
Unbeknownst to many consumers 80 per cent of active pharmaceutical ingredients are produced abroad, the majority in China and India; however, the FDA only inspected one in five registered human drug manufacturing facilities abroad last year, he said
Grassley raised the issue in a letter, dated August 7, to Department of Health and Human Services (HHS) Secretary Alex Azar and Food and Drug Administration (FDA) Acting Commissioner Norman Sharpless.
"I strongly encourage the administration's demonstration projects to include unannounced inspections in foreign manufacturing facilities to determine whether they meet the required active pharmaceutical ingredients and drug quality and safety standards to include sufficient record-keeping, testing and protections against counterfeiting, the senator said.
Grassley had also sent a letter in June to Azar and Sharpless on the issue.The senator has sought information on the quality controls for prescription drugs and their components manufactured in foreign countries, specifically China and India...Read More
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