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Health Canada has imposed an import ban on the products manufactured by Apotex Pharmachem India Pvt Ltd, Apotex Research Pvt Ltd and IPCA Laboratories in India raising concerns over reliability of data on “safety and quality” issues.
According to a statement issued by the Canadian health regulator yesterday, the action applies to finished products from ARPL, as well as active pharmaceutical ingredients (APIs) and products made with APIs from APIPL and IPCA.
“The department has ordered an import ban after it received new information yesterday from the United States Food and Drug Administration (USFDA). This latest information puts into question Health Canada’s trust in the reliability of data that all three plants are required by law to provide to demonstrate safety and quality of their products,” Canadian Health Minister Rona Ambrose said in a separate statement.
She said however that the ban is a precautionary step and Health Canada has received no evidence that the products pose an immediate risk. Like the FDA, Health Canada does not feel that a recall of any products made at these plants is required at this time.
Last Month, Health Canada asked IPCA Laboratories to voluntarily stop shipment of products to Canada based on a review of a recent good manufacturing practices (GMP) inspection report by the FDA.
The US regulator identified ‘falsification and manipulation’ of data issues at the company’s facility in Madhya Pradesh.
The Canadian regulator said IPCA has not disputed the FDA findings with Health Canada even as the FDA has not issued a recall of any of the affected products.
“Till such time this issue is resolved to the satisfaction of the USFDA, no dosage formulations manufactured at this manufacturing unit will be commercialised for the US market,” IPCA had earlier said.
Health Canada further said it continues to gather information about the situation at these three sites from trusted regulatory partners, including the FDA.
Until Health Canada can be satisfied that the production processes used at these three sites meet internationally recognised GMP, it is taking this additional precautionary step to keep these products off the Canadian market, it said.
The US health regulator had in June issued a warning letter to Canada-headquartered Apotex Pharmachem over violations of manufacturing norms at its Bangalore plant.
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