Health Canada has imposed an import ban on the products manufactured by Apotex Pharmachem India Pvt Ltd (APIPL), Apotex Research Pvt. Ltd. (ARPL) 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 on Tuesday, 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 on Tuesday 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.
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She , however, said the ban was a precautionary step and Health Canada had received no evidence that the products posed 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.
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The U.S. regulator identified ‘falsification and manipulation’ of data issues at the company’s facility in Madhya Pradesh.
The Canadian regulator said IPCA had not disputed the FDA findings with Health Canada even as the FDA had not issued a recall of any of the affected products.
Health Canada further said it continued to gather information about the situation at these three sites from trusted regulatory partners, including the FDA. — PTI