Health Canada has requested that Canadian importers voluntarily quarantine drug products with active pharmaceutical ingredients (APIs) manufactured or tested by Polydrug Laboratories, in Ambarnath, Maharashtra, India, due to data integrity concerns. Health Canada is taking this interim precautionary measure to help mitigate any potential risk in light of recent findings from trusted regulatory partners that raised concerns about the reliability of data generated at this site.
At this time there is no identified risk to health, and Health Canada is not requesting a recall of any products with API from Polydrug Laboratories currently on the Canadian market.
APIs are used to make finished drug products that are sold to consumers. A quarantine will mean that Canadian importers and distributors will stop distributing products in Canada with APIs linked to this site.
Health Canada continues to review information from the trusted regulatory partners and from Canadian importers. Canadians will be updated about the list of products affected by the requested quarantine through updates on the Inspection Tracker.
Canadians should not make any changes to their medication without first consulting with a healthcare professional.
Health Canada will continue to work with international partners and Canadian importers to gather and assess information regarding the situation and take action as necessary to help protect Canadians.
Health Canada will also engage the provinces and territories to share information about the situation.