Canadian regulator asks Ipca to stop API exports
22 Sep 2014
Health Canada has asked Ipca Laboratories to stop shipments of active pharmaceutical ingredients (API) to Canada, after the drug maker in July voluntarily stopped exports to US of products made at its plant at Ratlam in Madhya Pradesh.
The Canadian pharma sector regulator said it has taken the precautionary step of asking Ipca Labs on a review of a recent good manufacturing practices (GMP) inspection report by the US Food and Drug Administration (FDA) where they identified falsification and manipulation of data issues at the company.
''Ipca had not disputed the FDA findings with Health Canada,'' it said, adding that the FDA has not issued a recall of any of the affected products.
Ipca had, in July, voluntarily stopped exporting active pharmaceutical ingredients from its Ratlam plant in Madhya Pradesh to the US following regulatory observations made by the US regulator.
Health Canada's recent directive covers about 21 APIs. The department has also asked Canadian companies that import products containing APIs from the Ipca facilities to temporarily quarantine these products, it added.
Since there is no indication that the issues identified during the FDA inspection pose a risk to health, the Canadian regulator said that it was not requesting a recall of products already on the market. But that could change if the situation changes, it added.
The development that come on top of USFDA scrutiny of several plants belonging to drugmakers Ranbaxy, Wockhardt and Sun Pharm, would weigh down on the country's pharma industries.
Health Canada said it would continue to work with other international regulatory partners, Canadian importers and Ipca, to gather more information about the products involved.
The information being sought includes any additional testing being done, the medical necessity of the products involved, their market share, and risk assessments, it said.
Ipca said the voluntary quarantine of its products in Canada would continue until the department was satisfied that adequate measures were in place to confirm the quality of the products from these facilities.
