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FILE PHOTO: Signage is seen outside of the Food and Drug Administration (FDA) headquarters
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ANDREW KELLY
In a tightening of regulatory measures on overseas production plants, the US Food and Drug Administration has indicated to more “unannounced inspections” at foreign manufacturing facilities that produce foods, essential medicines, and other medical products intended for American consumers and patients.
“This change builds upon the agency’s Office of Inspection and Investigations Foreign Unannounced Inspection Pilot program in India and China and aims to ensure that foreign companies will receive the same level of regulatory oversight and scrutiny as domestic companies,” the USFDA said.
“For too long, foreign companies have enjoyed a double standard—given advanced notice before facility inspections, while American manufacturers are held to rigorous standards with no such warning. That ends today. This is a key step for the FDA as part of a broader strategy to get foreign inspections back on track,” said FDA’s recently appointed Commissioner Martin A. Makary.
India is home to over 600 production facilities, regulated by the US regulator, and the announcement comes even as the Trump administration paves the way for more pharmaceutical manufacturing to be done in the US.
The Indian pharmaceutical industry, that sells about $ 9 billion worth medicines in the US, also awaits clarity on tariffs that the US President has indicated will come shortly on pharma imports into the country.
No accommodation, limos etc
The FDA further added, that it would evaluate its policies and practices for improvements to the foreign inspection program to ensure that the FDA is “the gold standard for regulatory oversight”.
These changes included clarifying policies for FDA investigators “to refuse travel accommodations from regulated industry including lodging and transportation arrangements (taxi, limousine, and for-hire vehicle transit), to maintain the integrity of the oversight process.”
The FDA conducts approximately 12,000 domestic inspections and 3,000 foreign inspections each year in more than 90 countries, the FDA said. “While US manufacturers undergo frequent, unannounced inspections, foreign firms have often had weeks to prepare, undermining the integrity of the oversight process,” the regulator said, expressing a long-held view of US drugmakers. “Despite the advanced warning that foreign firms receive, the FDA still found serious deficiencies more than twice as often than during domestic inspections..” the FDA pointed out.
“Only in specific programs and cases are the FDA’s domestic inspections pre-announced to assure that appropriate records and personnel will be available during the inspection. But regulated companies do not have the authority to negotiate the day or time of the inspection— nor should foreign companies have the capability to do so either,” the regulator explained.
The policy shift ensures every product entering the US is “safe, legitimate, and honestly made,” it said, adding that “Unannounced inspections will also help expose bad actors—those who falsify records or conceal violations—before they can put American lives at risk.”
FDA Assistant Commissioner for Inspections and Investigations Michael Rogers, added that the inspections “provided real-time evidence and insights that are essential for making fact-based regulatory decisions to protect public health.”
Published on May 7, 2025
This article first appeared on The Hindu Business Line
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