Dr Reddy's, IPCA facilities under Health Canada radar

Dr Reddy's and IPCA will not be able to export drugs from facilities under US scrutiny to the Canadian market

After the clamp by the US Food and Drug Administration (FDA), Indian drug makers seem to have come under the radar of Canada’s medical regulator. In a report issued on Tuesday, Health Canada, the entity there said the country’s importers had decided to stop importing and distribution of products manufactured by Dr Reddy’s Labs (DRL) and IPCA Labs at the Srikakulam and Pithampur facilities, respectively.

“Health Canada has taken this action as an interim precautionary measure to help mitigate any potential risk. Quarantine means 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.” a statement  said.

US TROUBLES FOLLOW ELSEWHERE

• Canadian importers have agreed to quarantine health products manufactured by Dr Reddy's Labs and IPCA Labs at Srikakulam and Pithampur facilities at Health Canada’s request
• Health Canada is taking this action as an interim precautionary measure to help mitigate any potential risk
• Analysts believe this move will have less impact on the revenue of IPCA and Dr Reddy’s Labs
• Shares of Dr Reddy’s declined by 2.06 per cent to close at Rs 3,139.15 on the BSE
• IPCA shares were closed at Rs 719.25, up 0.17 per cent on the BSE

This action comes in the 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 on the revenue of IPCA and DRL.

“Health Canada is likely to rely on US FDA’s inspection and their reports to take the 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 a report from Angel Broking.

Health Canada said it would 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 DRL declined by 2 per cent to close at Rs 3,139.15 on the BSE. IPCA shares were closed at Rs 719.25, up 0.2 per cent on the BSE. An email questionnaire sent to DRL spokesperson did not elicit any response till the time of going to press.

In August, the US Food and Drug Administration listed six serious deviations in operation of IPCA’s Ratlam plant. IPCA’s plant at Pithampur, Indore, also came under the FDA scanner and got issued a Form 483,  comprising inspectional observations and concerns discovered during plant visits.

In November, DRL had received inspectional observations from the FDA for its Active Pharmaceutical Ingredients (API) manufacturing plants in Andhra Pradesh’s Srikakulam district. It had received nine inspectional observations from the US FDA, which issued Form 483, after its visit to the API manufacturing facility in Srikakulam.