Health Canada Requests Quarantine Of Ipca Laboratories' Products Following Falsification And Manipulation Of Data Issues

Health Canada Requests Quarantine Of Ipca Laboratories' Products Following Falsification And Manipulation Of Data Issues

September 19, 2014

By Riley McDermid, BioSpace.com Breaking News Sr. Editor

Health Canada has asked Indian company IPCA Laboratories to stop its shipment of products to Canada, after the U.S. Food and Drug Administration found the falsification and manipulation of data issues involved in its manufacture of more than 350 drug formulations.

Health Canada estimates that about 21 active pharmaceutical ingredients are involved but stressed the FDA has not issued a recall of any of the affected products. The 60-year-old biopharma services several major pharmaceutical firms, including Sanofi Aventis (SNY), Merck (MRK), AstraZeneca (AZN), GloxoSmithKline (GSK) and Roche (RHHVF) .

“The department has also asked Canadian companies that import product containing APIs from the IPCA facilities to temporarily quarantine these products,” the company said in a statement.

Health Canada said that in the interim, it would cooperate with authorities on their investigation efforts. The information being sought includes any additional testing being done, the medical necessity of the products involved, their market share and risk assessments. It said it did not expect the stoppage to affect available supply.

“At this time, we do not expect that there will be an immediate impact on the availability of these products,” said the company. “The department will work with the provinces and territories to monitor the supply situation and, if necessary, develop mitigation strategies.”

The process will likely take several weeks.

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