OTTAWA, Sept. 17, 2014 /CNW/ - Health Canada has taken the precautionary step of asking IPCA Laboratories in India to voluntarily stop shipment of products to Canada based on a review of a recent good manufacturing practices (GMP) inspection report by the U.S. Food and Drug Administration (FDA) where they identified falsification and manipulation of data issues at the company. IPCA has not disputed the FDA findings with Health Canada. The FDA has not issued a recall of any of the affected products.
Health Canada estimates that this affects approximately 21 active pharmaceutical ingredients (APIs). The Department has also asked Canadian companies that import product containing APIs from the IPCA facilities to temporarily quarantine these products.
To date, there has been no indication that the issues identified during the FDA inspection pose a risk to health. Therefore, like the FDA, Health Canada is not requesting a recall of products already on the market. If the situation changes, the Department will take immediate action and inform Canadians.
As part of a normal process, regulators around the world share information and inspection reports. Health Canada continues to work with other international regulatory partners, Canadian importers and IPCA to gather more information about the products involved.
The information being sought includes any additional testing being done, the medical necessity of the products involved, their market share, and risk assessments. This process will likely take a few weeks to complete given the complexity of efforts. At this time, we do not expect that there will be an immediate impact on the availability of these products. The Department will work with the provinces and territories to monitor the supply situation and, if necessary, develop mitigation strategies.
Health Canada has requested that the voluntary quarantine continue until the Department is satisfied that adequate measures are in place to confirm the quality of the products from these facilities and protect the health and safety of Canadians.
The Department will continue to keep Canadians informed as information becomes available.
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SOURCE: Health Canada
For further information: Media Inquiries: Health Canada, (613) 957-2983; Public Inquiries: (613) 957-2991, 1-866 225-0709