Apotex says drugs are 'safe and effective' after Health Canada ban
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Besieged Canadian drug giant Apotex has swung back at Health Canada a day after the regulator banned imports from two of the company’s India factories.
Responding to the government’s decision to block imports of more than 60 drug and drug ingredients, the company said: “Health Canada’s intentions in this regard are unwarranted.”
“Upon careful review of all the facts, Health Canada will be fully satisfied as to the integrity and quality of all Apotex products imported from the Indian facilities,” the company said in a statement.
Apotex said it has also requested an immediate meeting with Health Canada “to address any concerns” that spurred the ban.
Health Canada told Torstar News Service Wednesday night that it stands by its actions. “We will not tolerate drug safety risks and we take these issues very seriously,” a spokesperson told Torstar.
Earlier this week, Health Canada announced it was banning imports from two Apotex facilities in Bangalore, India — one that makes finished drug tablets and capsules, another that manufactures chemical ingredients used to produce medications.
The regulator said it recently received information that raised “significant concerns” and “serious doubts” about the company’s drug safety and quality data.
The import ban came after an ongoing Torstar investigation revealed U.S. inspectors unearthed repeated problems at Apotex’s Indian facilities, including staff manipulating data and not recording undesirable test results.
In a strongly worded statement Tuesday evening, Health Minister Rona Ambrose, in announcing the ban, said trust between the regulator and the Toronto-based drug company has been “broken.”
“Our government will not tolerate a failure by drug companies to meet their obligations to abide by Canada’s high safety and quality standards,” Ambrose said.
The U.S. government banned imports from the Apotex ingredient facility in April. Health Canada initially pursued a gentler approach, asking Apotex to stop importing suspect products from the plant. The company refused, Ambrose said.
Instead, Apotex agreed to do additional quality testing on the products.
Ambrose then came under fire in Parliament, as critics lambasted her department as “feeble, inadequate and incompetent.”
Tuesday’s import ban affects numerous drugs, including the generic form of Viagra, the antibiotic azithromycin, and other medications used to treat hypertension, dementia, high blood pressure, asthma, convulsions and Lou Gehrig’s disease.
In its statement, Apotex said Health Canada’s import ban announcement incorrectly included several drug ingredients that the company says are, in fact, manufactured at a Brantford, Ont., facility.
In response to the company’s claim, Health Canada said, “Any clarifications from Apotex are welcome. . . . The list of products will be updated as new information becomes available.”
“We will continue to work with Apotex with the objective of ensuring Canadians have confidence in the safety and quality of their products,” Health Canada told the Star. “We have been in dialogue with Apotex and have committed to continue that dialogue through weekly teleconferences.”
The company said all of its products are safe and effective, adding that it tests every raw ingredient and finished drug product imported from its Indian plants “before releasing any goods for sale in Canada.”
No recall has been issued. Health Canada said “no specific” safety issues have been identified with drugs already in drugstores.
Health Canada said that certain drugs considered “medically necessary” may be excluded from the ban provided they are tested by an independent third party before being released for sale.
U.S. inspections in January and June found severe problems at the Apotex Indian facilities, including staff manipulating data, retesting samples until it got favourable results and destroying records.
Health Canada followed with their own inspections, which found the facilities were in compliance, Apotex said.