Health Canada has asked Canadian importers to quarantine drug products manufactured at two facilities in India as a precautionary measure.
This comes after Indian pharmaceutical manufacturers faced a clampdown on standards by the U.S. Food and Drug Administration.
The Canadian federal department said last week that there were data integrity issues relating to Dr. Reddy's Laboratories in Srikakulam and IPCA Laboratories in Pithampur after recent information from a "trusted regulatory partner" raised concerns about the reliability of laboratory data generated at these two sites.
Importers have agreed to stop the importation and distribution of products from the two facilities. There is no known risk to health, and Health Canada is not seeking a recall of products that are already available in the market.
Specifically, the quarantine concerns active pharmaceutical ingredients (APIs) from Dr. Reddy's Laboratories which are used by Mylan Pharmaceuticals, Pharmascience, Sandoz Canada and Teva Canada. It also covers certain finished drug products from the IPCA Laboratories plant — a different facility than is currently subject to import restrictions by Health Canada following an announcement in September 2014.
None of the products affected by the new announcement are classed by Health Canada as medically necessary.
According to a stock market expert quoted by the Indian Express, neither Dr. Reddy's Laboratories nor IPCA Laboratories derive significant revenues from these facilities, so Health Canada's action is not expected to have a significant impact on the two companies.