A U. S. Congressional committee The U. S. Department of Defense said it is involved in foreign drug inspections in India and China.
In a letter to Food and Drug Administration Commissioner Robert M. Califf, Chairman of the Energy and Commerce Committee, Cathy McMorris-Rodgers, said the FDA’s recent resolution to address critical drug shortages by allowing the transient importation of unapproved drugs from India and China in a different way makes it imperative to have effective foreign inspection systems in those countries.
Chinese and Indian brands get the highest letters of caution from the FDA, McMorris-Rodgers said, adding that those violations are in drugs, destruction or falsification of knowledge and non-sterile production processes.
“Given that approximately 32% of generic drugs and 45% of active pharmaceutical ingredients (APIs) come from those two countries, we are involved in the U. S. and the U. S. The U. S. government relies too heavily on sourcing foreign brands with a history of violating FDA protection rules.
“From 2014 to 2015, the FDA conducted a pilot program in India that eliminated the lengthy advance for inspections. Instead, the FDA conducted brief or unannounced visits and decided on sites for the program that the company said had significant problems. The pilot program appears to have been successful in exposing widespread misconduct and significant violations of FDA regulations, adding falsified quality records,” the letter adds.
Despite the good fortune of the pilot program, the FDA decided to suspend it.
The covid-19 pandemic halted maximum in-person inspections of foreign drug brands from March 2020 to April 2022. Instead of in-person inspections, the FDA turned to alternative solutions, such as interactive remote inspections of drug production services on a voluntary basis, the letter adds.
Once FDA inspections resumed, they did so at a much lower point than before the pandemic. One study found that of approximately 2800 foreign production facilities, the FDA inspected 6 percent, with 3 percent of Indian brands inspected, the letter concludes.
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