After the clamp-down by the US Food and Drug Administration (FDA), Indian drug makers have come under the radar of Health Canada, the medical regulator of Canada.
In a report issued on Tuesday, Health Canada said that the importers have decided to stop the importation and distribution of products manufactured by Dr Reddy’s Labs and IPCA Labs at Srikakulam and Pithampur facilities respectively. However, the regulator has not asked Indian companies to recall drugs from the market.
According to the statement, Canadian importers have agreed to quarantine health products from the two India-based sites at Health Canada’s request.
“Health Canada, has taken this action as an interim precautionary measure to help mitigate any potential risk. Quarantine means that the Canadian importers have agreed to stop the importation 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,” it said.
This action comes in light of recent information from a trusted regulatory partner that raises concerns about the reliability of the laboratory data generated at these sites. Health Canada is taking this action as an interim precautionary measure to help mitigate any potential risk, the regulator said in the statement.
However, analysts believe this move will have less impact over the revenue of IPCA and Dr Reddy’s Labs.
“Health Canada is likely to rely on US FDA’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,” report from Angel Broking said.
Health Canada said it 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.
Shares of Dr Reddy’s declined by 1.58% at Rs 3154.70 intraday on BSE. IPCA shares are traded at 718.95, up bu 0.13% on BSE.
In August, the US FDA has had listed six serious deviations in operation of IPCA’s Ratlam plant. With regards to the IPCA’s Form 483 on the Ratlam API facility in Madhya Pradesh, the US FDA has listed six serious deviations on inspection done between July 14-18 of 2014. Besides Ratlam, IPACA’s plant at Pithampur, Indore also came under the FDA scanner.
In November, Dr Reddy’s Laboratories had received inspectional observations from the US FDA for one of its active pharmaceutical ingredients (APIs) manufacturing plants located in Srikakulam district of Andhra Pradesh.
It had received nine inspectional observations from the US FDA after their visit to the API manufacturing facility in Srikakulam.