More than 40 drugs originating from three factories in India recently slapped with import bans are now allowed for sale because Health Canada has deemed them “medically necessary.”
The drugs, including popular hypertension and attention deficit hyperactivity disorder (ADHD) medications, are manufactured at two factories owned by Apotex, a Toronto-based generic pharmaceutical company, and a third facility, IPCA Laboratories. U.S. inspectors found data manipulation problems at all three factories.
Despite serious problems remaining unresolved at the Indian plants, Health Canada said the drugs can be sold in Canada after they undergo testing by an independent third party.
Some drugs and drug ingredients made at these Indian plants are also marketed by other pharmaceutical companies, from well-known brand-name manufacturers such as AstraZeneca to another giant generic company, Teva, Health Canada said. These companies’ affected drugs must also undergo independent quality tests before they are distributed.
“No company is allowed to sell or distribute products originating from these three plants until Health Canada’s strict conditions are fully met, thereby ensuring the health and safety of Canadians,” a government spokesman said in a statement.
One company, International Pharmaceutical Generics, told the Star it expects to complete testing and get its affected products to Canadian consumers before the end of the month.
The company imports finished dosages of atenolol, a hypertension medication, from IPCA Laboratories.
A full list of the affected drugs can be accessed through the Health Canada website.
All drugs and drug ingredients made at the two Apotex Indian factories were banned last month after a Star investigation revealed Health Canada had so little sway over the company that Apotex refused its request to stop imports from one of the troubled plants.
The Star investigation has also shown that the U.S. regulator, the Food and Drug Administration, has a stricter enforcement regime. When the FDA probed issues at an Apotex factory in Bangalore, it successfully barred imports to the United States after finding that Apotex staff had manipulated data, retested samples until they got favourable results and destroyed records.
When Health Canada subsequently moved to ban products from Apotex and IPCA Laboratories, the regulator said it stemmed from “significant concerns” and “serious doubts” about the company’s drug safety and quality data.
Health Canada said its decision to allow some drugs from these beleaguered factories into the market was “so that Canadians can have access to affected medically necessary products.”
Meanwhile, the Indian factories have not yet fixed the problems that prompted the ban.
Nearly 70 other drug products remain banned, including antipsychotic medications olanzapine and risperidone, as well as the generic form of Viagra. They will remain banned, the regulator said, “until Health Canada is satisfied that the data integrity issues at the plants have been addressed.”
After a series of Toronto Star articles revealed Canadian drug companies knowingly sold defective products, Apotex sent a letter to pharmacists providing talking points if customers raised concerns about their medications.
“It is imperative that we reinforce the fact that all of Apotex’s products are safe and effective. Every product shipped to Canada for distribution is subject to a thorough retesting process upon receipt,” said the Sept. 19 memo obtained by the Star.
The memo advises pharmacists to “reassure patients that Apotex products are safe to use” and there is “no need to switch medication.
“Inform patients abruptly stopping medication can have serious consequences. Use your professional judgment to provide alternatives if patients still insist on switching products,” the document said.
An Apotex spokesperson could not be reached for comment.