U.S. regulators are mobilizing to shore up confidence in America’s generic-drug supply as alarm grows over the quality of products made in India, and the head of the largest U.S.-based maker of the medicines predicted more trouble lies ahead.
Indian companies supplying a quarter of the medicines used in the U.S. must take responsibility for the quality-control necessary to export their products, the top U.S. drug regulator said as it ramps up inspections.
China unveiled a plan to elevate the food and drug regulator to a ministry-level body with broader powers, underpinning the government’s pledge to crack down on safety violations and better protect consumers.
China ordered nationwide inspections of preserved-egg plants after media reports that toxic chemicals are being used as additives, the latest in a series of food scandals that have plagued the world’s most populous nation.
Merck & Co., Novo Nordisk A/S and other makers of popular treatments for diabetes may be asked to collect more data on a potential cancer link even as they try to reassure U.S. regulators this week of the drugs’ safety.
Hemofarm AD, a Serbian drugmaker owned by Stada Arzneimittel AG, said it fixed contamination threats in its aseptic production line found by the U.S. Food and Drug Administration, which halted its exports to the U.S.
Half of the 21 drugs pulled from the market in the U.S. for safety reasons since 1995 involved heart complications, a finding that is spurring Congress and doctors to call for closer government review of side effects.