US lawmakers question FDAs drug inspection programme in India and China

By Lalit K Jha

PTI, Jun 25, 2024, 8:47 AM IST

Representative image

Washington: Three top American lawmakers have questioned the foreign drug inspection programme of the Food and Drug Administration in India and China.

In a letter to FDA commissioner Robert Califf, the lawmakers on Monday wrote that the difference in inspection outcomes appears to be just another example of institutional weaknesses and dysfunction in the FDA’s foreign drug inspection programme.

The letter dated June 21 was written by House Energy and Commerce committee chair Cathy McMorris Rodgers, subcommittee on health chair Brett Guthrie, and subcommittee on Oversight and Investigations Chair Morgan Griffith following the analysis of the outcomes of FDA inspections in India and China from January 2014 to April 2024.

“The results of this analysis were surprising, revealing tremendous variation in inspection outcomes. Some FDA inspectors found compliance issues during all or almost all of their inspections. Other inspectors rarely reported finding a single compliance issue. Two inspectors never found a single compliance issue throughout a combined 24 inspections in India,” they wrote.

Another inspector found zero compliance issues in 20 out of 23 inspections (85 percent) in China while finding compliance issues in almost half of domestic inspections during the same period. These are unusual inspection outcomes, the opposite of what would be expected given the widely reported failures in quality control and lack of adherence to current good manufacturing techniques by drug manufacturing facilities in China and India, the lawmakers wrote.

“By contrast, 16 FDA inspectors, with over 325 inspections collectively in India, found compliance issues during every inspection they conducted. As a measure of what a pattern of rigorous inspections should look like, the committee reviewed the inspection outcomes for 3 FDA inspectors with a professional reputation for thoroughness who also had at least 10 inspections in China or India during the studied period,” they wrote.

These expert inspectors reported finding no compliance issues during inspections in China at a rate of only 6.7 to 11.4 percent and at a rate of zero to 9.5 percent in India, they said, adding that such large variations in inspection outcomes are troubling, and they merit further investigation. At a minimum, the committee is concerned that these findings suggest vast differences in the skill, thoroughness, and competence of FDA inspectors.

As such, the lawmakers pressed for more information regarding the agency’s foreign drug inspection programme.

Udayavani is now on Telegram. Click here to join our channel and stay updated with the latest news.

Top News

Court rejects Prajwal Revanna’s anticipatory bail plea

World’s hottest day record broken in 24 hours

‘Trust deficit between farmers, govt’: SC proposes panel to talk to protesters at Shambhu border

Intention was to kill me, my family members: Salman Khan’s statement in charge sheet

MUDA ‘scam’: BJP to hold “day-and-night” dharna in Karnataka Assembly, Council

Shirur landslide search ops: Missing truck found submerged in Gangavali River

Got raw deal in budget, no point in attending NITI Aayog meeting, says Deputy CM Shivakumar

Related Articles More

18 killed as plane crashes during takeoff at Kathmandu airport

‘Everything will be good’: Trump tells Palestinian President ahead of Friday meeting with Netanyahu

Harris campaign raises $100 million from 1.1 million people

Trump wants to take US backwards: Kamala Harris in her address to campaign staff

Kamala Harris’ presidential campaign raises $81 million in first 24 hours


Brahma Kumaris

Tapta Mudra Dharana

Banana Farming

Aghnashini River

Dr. Rajkumar

Latest Additions

Nita Ambani re-elected unanimously as IOC member

Court rejects Prajwal Revanna’s anticipatory bail plea

World’s hottest day record broken in 24 hours

Heavy rain: Two-day school holiday declared in 6 taluks of Belagavi

Kharge’s ‘mataji’, ‘pakoda-jalebi’ jibe at FM as he raises alleged discrimination against states in Budget

Thanks for visiting Udayavani

You seem to have an Ad Blocker on.
To continue reading, please turn it off or whitelist Udayavani.