OTTAWA – Health Canada has asked an Indian company to voluntarily stop shipment of products to Canada, based on a review of recent manufacturing practices by the U.S. Food and Drug Administration.
The FDA found falsification and manipulation of data issues at pharmaceutical company IPCA Laboratories, which manufactures more than 350 drug formulations.
IPCA has not disputed the FDA findings with Health Canada, which estimates that about 21 active pharmaceutical ingredients are involved.
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The federal department has also asked Canadian companies that import products containing the active ingredients from IPCA facilities to temporarily quarantine the products.
To date, there has been no indication that the issues identified by the FDA inspection pose a risk to health, so neither Health Canada nor the FDA has requested a recall of products already on the market.
Health Canada says it is working with other international regulatory partners, Canadian importers and IPCA to gather more information about affected products.
This information includes any additional testing being done, the medical necessity of the products involved, their market share and risk assessments — a process that will likely take a few weeks to complete.
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“At this time, we do not expect that there will be an immediate impact on the availability of these products,” a Health Canada advisory said Wednesday. “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 it is satisfied that adequate measures are in place to confirm the quality of the products from IPCA facilities.
The 60-year-old company’s website says its clients include such global pharmaceutical giants as AstraZeneca, GSK, Merck, Roche and Sanofi Aventis.
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