FDA Ramps Up Manufacturing Inspections in India: Reuters
28 Feb 2024
Pictured: Facade of the FDA building in Maryland/iStock, Grandbrothers
The FDA is planning to increase its inspection of drug manufacturing facilities in India this year amid growing quality and supply concerns, Reuters reported Tuesday citing an agency executive.
“We are putting every effort into increasing the number of inspections,” Sarah McMullen, FDA Country Director for India, told Reuters, adding that the regulator is also “requesting more drug investigators to be stationed here.”
The decision to tighten regulatory scrutiny over Indian manufacturing facilities comes as the FDA grapples with two interconnected crises: The deteriorating quality of medicines and persistent drug shortages.
The FDA in its annual Report on the State of Pharmaceutical Quality, published in June 2023, documented a record number of drug recalls, which reached its highest level in five years. The report covered the agency’s fiscal year 2022, which ran from October 1, 2021 to September 30, 2022.
During that timeframe, the FDA issued 912 recalls across 166 manufacturing sites, most of which were due to violations of current good manufacturing practices (CGMP). Inspections of manufacturing sites also spiked to 328 in FY2022, which was “nearly triple the amount” of such visits in the year prior. The regulator also issued a high number of import alerts and warning letters, mostly affecting facilities in China, South Korea and India.
In July 2023, the House Committee on Energy and Commerce wrote to the FDA requesting detailed information regarding its inspections of foreign drug manufacturing facilities—particularly those in China and India.
Committee Chair Rep. Cathy Rodgers (R-WA), along with Subcommittee Chairs Reps. Brett Guthrie (R-KY) and Morgan Griffith (R-VA), expressed their concern that the U.S. might be becoming too reliant on “foreign manufacturers with a demonstrated pattern of repeatedly violating FDA safety regulations.”
The FDA is also struggling to keep up with significant shortages of hundreds of life-saving drugs. Currently, the regulator has listed over 300 medicines in short supply, the highest number since 2014. Medicines affected by the shortages include amoxicillin, quinapril, cisplatin, carboplatin and the wildly popular weight-loss therapy semaglutide.
Earlier this month, the House Ways and Means Committee held a hearing to investigate these shortages, noting that most of the treatments on the FDA’s list have seen limited availability for at least two years.
The growing manufacturing problems in overseas facilities has made the drug shortages worse. India-based Intas Pharmaceuticals has received a warning letter from the FDA over several quality control lapses and poor data integrity. Intas, which manufactures several generic drugs, is on the FDA’s import alert list.
Tristan Manalac is an independent science writer based in Metro Manila, Philippines. Reach out to him on LinkedIn or email him at tristan@tristanmanalac.com or tristan.manalac@biospace.com.
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