Health Canada has lifted its ban against two Apotex facilities in India, allowing the pharmaceutical giant to import its products under strict conditions.
Dozens of drugs and pharmaceutical ingredients from the two Bangalore plants had been barred from entering Canada since September 2014, after U.S. inspectors found staff had manipulated data and were retesting drug samples until they got favourable results.
Canada’s drug regulator reinspected the two plants in June and determined “satisfactory progress” had been made to address its concerns about the company’s data integrity.
“Health Canada concluded that the corrective work implemented has progressed to a point where products from these facilities may now be imported on the Canadian market under specified conditions,” the regulator said in an announcement quietly posted to its website on Sept. 1.
Apotex, which has decried the costly ban as illegal, has always said its Indian-made products are safe and effective.
Under Health Canada’s new conditions, staff at Apotex’s Canadian labs must retest all of the products from the two Indian plants before they can be released to market: a safeguard the company has said it already employed before the ban.
The company must also report all “deficient testing results” for products originating from the Indian plants so that Health Canada can monitor the firm’s internal investigations into the suspect drugs.
“Health Canada will not hesitate to take immediate action at any time should a risk to the health and safety of Canadians be identified,” the government said in its statement.
The end of the 11-month ban comes two weeks before Apotex, Canada’s largest drug company, is scheduled to square off in federal court with the country’s drug regulator.
Apotex had turned to the court to have the ban quashed, alleging Health Minister Rona Ambrose acted with “malice” toward the company and buckled under political pressure after a Star investigation exposed widespread problems in the company’s Bangalore facilities.
“The minister’s decision to implement the import ban was politically motivated and, in particular, was calculated to deflect public and parliamentary criticism of the minister as a result of the Toronto Star articles,” Apotex alleged in its court filing.
An Apotex spokesman would not comment on whether the case would be dropped now that the ban has been lifted, saying only, “Apotex cannot comment on ongoing matters that are with the court.”
The company had also asked the court to order Ambrose to retract her online statements justifying the ban, in which she declared the trust between Apotex and the regulator was “broken.”
A 2014 Star investigation found Health Canada so lax that it allowed the import of Apotex drug products that are banned from the United States because the adulterated medications are potentially unsafe.
Agents from U.S. Food and Drug Administration said they found staff at the Indian plants discarding unfavourable lab results and retesting suspect samples until they yielded the desirable outcome. A quality control manager at one of the facilities told inspectors that senior management knew about the practice of retesting without investigating the suspect product sample, according to the FDA, who said the company’s management “failed to prevent” the practice.
Apotex previously told the Star that, in some cases where undesirable results were discarded, “retesting was required and appropriate because the unfavourable result was caused by analytical error.” All drugs distributed to market were safe, the company said.
Products from the two Apotex Indian facilities remain banned from the United States, according to the most recent information available on the FDA website, dated August 21.
The U.S. regulator did not respond to questions from the Star.