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.
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.
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