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Canada bans imports from three API facilities in India

Generics/General | Posted 17/10/2014 0 Post your comment

Just days after Canada’s federal department responsible for health was reported to be in talks with the US Food and Drug Administration (FDA) about Canadian generics maker Apotex, Health Canada has announced that it is to ban imports from two of Apotex’s facilities and from one site belonging to IPCA Laboratories in India.

Health Canada announced on 30 September 2014 that it had taken action to stop the import of medicines from the following manufacturing sites in India:

Apotex Pharmachem India Pvt Ltd (APIPL)
Apotex Research Private Limited (ARPL)
IPCA Laboratories

The decision comes after FDA informed Health Canada about its inspections of the three plants, which had highlighted data integrity problems at the sites. Based on this information, the agency said that it ‘has significant concerns with the manner in which data are collected and reported, raising serious doubts about the quality and safety of finished products and active pharmaceutical ingredients (APIs) produced at these sites’.

Apotex, responded in a press statement, wanting to ‘set the record straight’ regarding its facilities. The company stated that ‘both facilities have been inspected by Health Canada, as well as one other major international regulatory agency this year, and have been given a compliant rating’. Apotex also adds that it goes above and beyond Health Canada’s testing requirements and ‘is absolutely confident’ in the safety and effectiveness of its products.

IPCA Laboratories already voluntarily stopped shipments of APIs to the US from its APl manufacturing facility situated at Ratlam (Madhya Pradesh) in July 2014 until the issue of data integrity is addressed.

Although the agency said that it had ‘significant concerns’ and ‘serious doubts’ about the company’s drug safety and quality data, no recall has been issued. Health Canada said ‘no specific’ safety issues have been identified with drugs already in pharmacies. According to the Health Canada press release ‘consumers should not make any change to their medication without first consulting with a healthcare professional’.

Canada’s Health Minister, Rona Ambrose, stated that ‘the import ban will remain in place until such time as [Health Canada] is satisfied that the data integrity problems have been resolved’.

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Source: Apotex, Canadian Government, IPCA, Health Canada