The U.S. has banned drugs made by certain manufacturers in India because of quality concerns.
The U.S. Food and Drug Administration (FDA) will establish an Office of Pharmaceutical Quality to better inspect drugs, Bloomberg reported.
The FDA only receives drug quality information during inspections The agency will try to sniff out quality issues before larger penalties (such as bans) are implemented.
"We want to use leading indicators," Janet Woodcock director of the Food and Drug Administration's Center for Drug Evaluation and Research said,
Bloomberg reported." These people aren't in trouble yet but they could be."
Ranbaxy Laboratories Ltd. (RBXY) and Wockhardt Ltd. (WPL) have already been banned from selling drugs in the U.S., Bloomberg reported.
"All companies must understand that quality is the basis for the public's trust and confidence in their products and maintaining high quality standards is part of the cost of doing business," FDA commissioner Margaret Hamburg wrote in a blog post, Bloomberg reported.
"[The new office will] improve our oversight of quality throughout the lifecycle of a pharmaceutical product," she said.
Hamburg recently visited India to speak with certain drug companies about quality control. In a further effort to improve drug quality the FDA chief signed an agreement with her Indian counterpart that regulators in the country would be notified when an inspection was taking place so they could observe and gain more insight into U.S. standards.
The FDA is working to determine how often they will require drug makers to submit quality data.
"On the home front, we at the FDA will also continue to increase our focus on quality. One way we are doing this is through the creation of a new Office of Pharmaceutical Quality that will create one voice for drug quality at the FDA and improve our oversight of quality throughout the lifecycle of a pharmaceutical product," Hamburg wrote in her blog post.
