FDA bans imports of Ipca Lab drugs

The FDA has banned the import into the U.S. of drugs manufactured at three facilities in India operated by Ipca Laboratories as a result of ongoing concerns about data manipulation and falsification of records, the company said in a Bombay Stock Exchange filing.

The facilities include Ipca’s API plant in Ratlam, its formulations plants in Pithampur in Madhya Pradesh and Piparia in Silvassa, which have been under U.S. regulatory scrutiny for several years. The company halted product shipments from the trio of plants after the FDA put them on an import alert list in 2015 following inspections conducted in 2014.

In the stock exchange filing reported by livemint, Ipca said it received notification from the FDA that drugs manufactured at three facilities won’t be allowed into the U.S. until the company can demonstrate that products from the sites are in compliance with prescribed norms.

The news sent Ipca’s stock down 15% last Friday, livemint reported.

According to the Ipca filing, only the malaria treatment API product chloroquinine phosphate manufactured at the Ratlam plant is currently exempted from the ban and “will be reconsidered (by the FDA) if shortage and/or medical necessity implications change.”

In a warning letter issued in January 2016, the regulatory agency said Ipca employees regularly deleted failed testing data from computers and overwrote them with data that indicated APIs and products met standards. Data falsification was also uncovered at the company’s microbiology labs where records were routinely changed and backdated.

The company has said on several occasions that it was working with outside consultants to resolve its regulatory issues as quickly as possible. 

The Swiss-based Global Fund, which fights the spread of AIDS, tuberculosis and malaria, dropped Ipca as a source for malaria treatment drugs several months after the FDA’s 2016 warning letter was issued.