"This action comes in light of recent information from a trusted regulatory partner that raises concerns about the reliability of the laboratory data generated at these sites. Health Canada is taking this action as an interim precautionary measure to help mitigate any potential risk," Health Canada said.
The US Food and Drug Administration (FDA) recently pointed out as many as nine procedural deviations in the manufacturing plant belonging to Dr Reddy's Laboratories in Srikakulam district of Andhra Pradesh, during its recent inspection.
Health Canada's action applies to active pharmaceutical ingredients (APIs) from Dr Reddy's Laboratories as well as to finished drug products from a different IPCA Laboratory facility that is currently subject to import restrictions by Health Canada.
The drug regulator will continue to work with global partners and Canadian importers to gather and assess information regarding the situation and take action as necessary to help protect Canadians, it further said.
"To date no products manufactured at these sites for the Canadian market have been determined to be medically necessary. Products will continue to be assessed for medical necessity and the list will be updated...," the Canadian drug regulator said.
According to information provided by the regulator, the companies that make products manufactured with APIS from Dr Reddy's Laboratories and IPCA include Mylan Pharmaceuticals, Sandoz Canada Inc, Teva Canada, Ranbaxy Pharmaceuticals and Riva Laboratories.