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Regulatory News | 04 November 2015 | By Zachary Brennan
A Canadian federal court has ruled against Health Canada’s decision to restrict pharmaceutical imports from two Apotex facilities in India, though the US FDA still bans products from these facilities.
In its ruling from 14 October, the court noted that Health Canada and Health Minister Rona Ambrose proceeded unfairly and acted for an improper purpose. The ruling also requested Health Canada and Ambrose retract its statements on Apotex, which they did Tuesday.
And although the ruling dismissed the import ban from Health Canada, the regulator had already begun to allow imports as the Indian facilities were seen to be progressing as of 1 September following a June inspection.
“Apotex’s actions included the implementation of new computer systems, strengthened operating processes and procedures, as well as training and re-training of staff,” Health Canada said in a statement.
But still Health Canada remains cautious with products coming from Apotex Pharmachem India Pvt. Ltd. (APIPL), which manufactures raw materials, and Apotex Research Private Limited (ARPL), which makes finished products in India.
The regulator is requiring that products originating from either site be re-tested at an Apotex facility in Canada before entering the Canadian market. In addition, Health Canada is requiring Apotex to report any deficient testing results and investigations with products originating from the two sites.
Health Canada also said it plans to re-inspect both Indian sites in early 2016 and will inspect the Canadian facility’s operations and how it’s testing the products from India.
Investigations of Apotex by the US Food and Drug Administration (FDA), which date back to warning letters issued to the company’s Canadian sites in 2013, as well as pressure from the Toronto Star on Health Canada to act against the Indian sites after FDA uncovered further problems, sparked the court challenge in which Apotex alleged Ambrose acted with “malice.”
And although Ambrose and Health Canada were to found to be acting improperly, FDA hasn’t offered any updates on the Indian sites.
In June 2014, nearly three months after Apotex was put on import alert (both sites remain on FDA’s import alert list today) FDA released a warning letter recounting a series of major deficiencies it found during a January 2014 inspection of the company's manufacturing facility in Bangalore, India.
Like letters sent to at least 10 other India pharmaceutical manufacturers, Apotex was chided by FDA for a lack of control over its data. In at least one case, electronic records for one batch test revealed out-of-specification results regarding residual solvents. That test result was then discarded in favor of a later test, FDA found.
In another case, another out-of-specification result was found to have been replaced with the outcome of another sample tested an hour after the initial sample failed, FDA wrote.
FDA said interviews with Apotex facility staff determined this was a "common practice," and that employees regularly only recorded data results if the outcome was favorable. "If the results obtained were atypical, a fresh sample was to be prepared and analyzed," FDA claimed. "The original sample testing was not recorded."
However, a few months after the FDA warning letter came out, Apotex said that both facilities were inspected by Health Canada and one other unidentified regulator, and presented no threat of harm to patients. The company did not respond to a request for comment by press time.
Statement from Health Canada
Update from Health Canada
List of the Products from Apotex Impacted by Import Ban
Tags: Apotex, Health Canada, data integrity, India drug manufacturing, Rona Ambrose