Health Canada has asked Ipca Laboratories, to voluntarily stop shipment of products to Canada on account of on a review of recent GMP inspection report by US FDA where they identified falsification and manipulation of data issues. Ipca has not disputed the FDA findings with Health Canada. However, the FDA has not issued a recall of any of the affected products. Health Canada estimates that this affects approximately 21 active pharmaceutical ingredients (APIs).
Commenting on the same, Sarabjit Kour Nangra, VP Research, IT, Angel Broking, said, ''The department has also asked Canadian companies that import product containing APIs from the Ipca facilities to temporarily quarantine these products. To date, there has been no indication that the issues identified during the FDA inspection pose a risk to health. Therefore, like the FDA, Health Canada is not requesting a recall of products already on the market. If the situation changes, the Department will take immediate action and inform Canadians.
As part of a normal process, regulators around the world share information and inspection reports. Health Canada continues 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.
In terms of numbers, the recall will not have major impact on the financials of the company. We maintain our buy with a target of Rs 986.''
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