Canadian importers have been asked to quarantine health products made at IPCA Laboratories' Pithampur facility in Madhya Pradesh and Dr Reddy's Laboratories' Srikakulam plant in Andhra Pradesh due to data integrity concerns.
The order was issued by Health Canada, the North American country's food and drug regulator.
AdvertisementIn response to the alert, which was issued on December 23, Dr Reddy's says the company is currently working with the food and drug regulator to resolve the issue.
"At Health Canada's request, Canadian importers have agreed to quarantine health products due to data integrity concerns from Dr Reddy's Laboratories in Srikakulam and IPCA Laboratories in Pithampur. Health Canada has taken this action as an interim precautionary measure to help mitigate any potential risk," said a statement from Health Canada.
"All the active pharmaceutical ingredients (APIs) manufactured at the Srikakulam facility have voluntarily been placed under quarantine. However, the impacts of the Health Canada action on operations and financials are yet to be assessed," a DRL spokesperson said, adding there was no production loss yet.
"Health Canada is likely to rely on USFDA's inspection and their reports to take future course of action. Both DRL and IPCA Labs do not derive significant revenues from these facilities. Hence, we don't think the development would have an impact on the companies," said, Sarabjit Kour Nangra, vice-president - research, Angel Broking.
"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," Sarabjit Kour added.