Health Canada, the North American country’s food and drug regulator, has asked Canadian importers to quarantine health products made at Dr Reddy’s Laboratories’ Srikakulam plant in Andhra Pradesh and IPCA Laboratories’ Pithampur facility in Madhya Pradesh due to data integrity concerns. In response to the alert, which was issued on December 23, Dr Reddy’s says the company is working with Health Canada 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. Quarantine means Canadian importers have agreed to stop the import and distribution of products from these two sites. At this time there is no identified risk to health and Health Canada has not requested a recall of any of the products,” said a statement from Health Canada.
“We have voluntarily placed all the active pharmaceutical ingredients (APIs) manufactured at the Srikakulam facility under quarantine. However, we are yet to assess the impact of the Health Canada action on operations and financials,” a DRL spokesperson said, adding there was no production loss yet.
“Health Canada’s action applies to active pharmaceutical ingredients (APIs) from Dr Reddy’s as well as to finished drug products from a different IPCA Laboratories facility that is currently subject to import restrictions by Health Canada. USFDA being the reference, 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 and hence we don’t think the development would have an impact on the companies,” said, Sarabjit Kour Nangra, vice-president – research, Angel Broking.
“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,” the statement added.
Non-medically necessary products include products manufactured with APIs from Dr Reddy’s Laboratories for companies like Mylan, Pharmascience, Sandoz Canada and
Teva Canada, besides finished products from Ipca Laboratories.
While Dr Reddy’s Laboratories had received Form 483 for inspectional observations from the USFDA for one of its API manufacturing plants in Srikakulam district of Andhra Pradesh, IPCA also got Form 483 in August with six serious deviations for its Madhya Pradesh facility.