Hyderabad : 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, reports PTI.
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.