Canadian drug importers have decided to quarantine health products from Dr Reddy’s Laboratories’ manufacturing unit located at Srikakulam in Andhra Pradesh.
This follows restrictions imposed by Canadian regulator Health Canada on import of products from Dr. Reddy’s Srikakulam unit, as also from IPCA Laboratories’ Pithampur unit.
“This action (restrictions) comes in the light of the 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 Canadian regulator said in a posting on its web site.
Dr Reddy’s said the company has voluntarily placed under quarantine all APIs and formulations based on APIs produced at its Srikakulam facility, intended for use in Canada. “Our APIs and finished drug products manufactured using these APIs pose no risk to the health and safety of Canadian people. At this stage, production is on normal course and we are working with the (Canadian) agency for a satisfactory resolution of this matter,” a spokesperson of the company said.
Canadian importers have agreed to stop the import and distribution of products from these two manufacturing units. However, the Canadian regulator has made it clear that at this juncture, there was no “identified risk to health” and hence it has not opted for a recall of any of the products.
Health Canada’s action applies to active pharmaceutical ingredients from Dr Reddy’s Lab and finished drug products from the IPCA unit. It has already compiled an initial list of products affected by the quarantine—the list will be updated as new information became available.
The development may not have any significant impact on the financials of the company, Sarabjit Kour Nangra, vice-president (Research) of Angel Broking, said.
“Both the companies do not derive significant revenues from these facilities and hence we do not think the development would have an impact on the companies,” Nangra said.
Dr Reddy’s shares fell 2.06 per cent on the BSE to close at Rs 3139.15.