FDA Allowing Banned Indian Drug Manufacturer to Export Drugs to the United States
Americans at Risk of Taking Potentially Unsafe Drug from Facility Under FDA Import Ban WASHINGTON — Americans for Safe Drugs today...
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Americans for Safe Drugs is a group of doctors, patients, health care industry experts, and advocates fighting to ensure all generic medicines are safe, affordable, and always available. Unsafe generic drugs from foreign manufacturers in China and India have been sold in the U.S. We want every American to be able to trust the generics they take—every pill, every vial, every time.
Chinese and Indian manufacturers receive the most Warning Letters from the FDA for violating safety regulations and quality control measures. Yet they are still allowed to export generic medicines to the U.S.
Foreign facilities in China and India have received Warning Letters for violating FDA’s safety regulations, including for violations like hair in a vial, carcinogens in medicines, and manufacturing processes that are not sterile.
The FDA hasn’t inspected the majority of foreign manufacturers in China and India that are under Warning Letter since 2019. Incredibly, they have suggested doing virtual inspections of these sites.
Foreign manufacturers in China and India undercut U.S. producers to drive them out of the market and monopolize the industry. Then they raise prices dramatically—up to 2000%—gouging American patients.
Currently, the FDA allows generic medicines to be imported from foreign manufacturers in China and India that are under Warning Letter due to violations of FDA’s regulations. This jeopardizes the safety of millions of Americans patients and allows foreign manufacturers to violate the safety standards and quality control measures that are required of U.S. domestic manufacturers.
Indian executives approached the regulatory system as an obstacle to be gamed. They bragged about who had most artfully deceived regulators… Ranbaxy had not properly tested the stability of almost any drugs on the U.S. market. The most basic good manufacturing practices require continuous monitoring of drug quality.
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