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Canadians kept in the dark about prescription medication
Go Public uncovers problems at foreign labs that make drug ingredients for Canadian companies
A CBC News investigation found Canadians are being kept in the dark about their prescription medications. The investigation has also raised questions about how much Health Canada knows about the chemical ingredients in pharmaceuticals in this country and where they come from.
Go Public obtained U.S. government documents that suggest a serious lack of testing and standards at some foreign labs making medical ingredients for export to Canada.
Health Canada said the manufacturing location of APIs is "confidential business information."
Mitchell learned the APIs in her drug were manufactured in Western Europe, but experts say most of Canada's APIs are manufactured in China and India, where costs are lower.
Through a Freedom of Information request, Go Public obtained dozens of FDA inspection reports that outline numerous and serious infractions at foreign manufacturing labs, mostly in India, used by Canadian and U.S. drug companies. The infractions include:
Failure to properly test drug batches to ensure quality.
Improper sterilization of equipment and packing material.
Ignoring test results that showed problems with APIs, then destroying all the samples and any record of the test results.
Failure to notify consumers of a potentially contaminated API batches.
Health Canada slow to react
Jillian Kohler, an associate professor at the University of Toronto, says Health Canada has been slow to react to the growing number of foreign companies manufacturing ingredients for Canadian prescriptions. It's now a multi-billion dollar industry.
"Health Canada has to get its act together — really be more proactive instead of reactive — and really start prioritizing where these risky facilities are [and] how to deal with this problem in a smarter way," says Kohler, who specializes in the outsourcing of Canadian drug ingredients and potential problems.
The lack of information and transparency aren't the only issues, according to Kohler. Health Canada doesn't have the resources to travel to foreign countries to inspect even a fraction of the labs to ensure safety standards are met.
http://www.cbc.ca/m/news/health/doc...ed-hypothyroid-symptoms-to-reappear-1.3222953
Canadians kept in the dark about prescription medication
Go Public uncovers problems at foreign labs that make drug ingredients for Canadian companies
A CBC News investigation found Canadians are being kept in the dark about their prescription medications. The investigation has also raised questions about how much Health Canada knows about the chemical ingredients in pharmaceuticals in this country and where they come from.
Go Public obtained U.S. government documents that suggest a serious lack of testing and standards at some foreign labs making medical ingredients for export to Canada.
Health Canada said the manufacturing location of APIs is "confidential business information."
Mitchell learned the APIs in her drug were manufactured in Western Europe, but experts say most of Canada's APIs are manufactured in China and India, where costs are lower.
Through a Freedom of Information request, Go Public obtained dozens of FDA inspection reports that outline numerous and serious infractions at foreign manufacturing labs, mostly in India, used by Canadian and U.S. drug companies. The infractions include:
Failure to properly test drug batches to ensure quality.
Improper sterilization of equipment and packing material.
Ignoring test results that showed problems with APIs, then destroying all the samples and any record of the test results.
Failure to notify consumers of a potentially contaminated API batches.
Health Canada slow to react
Jillian Kohler, an associate professor at the University of Toronto, says Health Canada has been slow to react to the growing number of foreign companies manufacturing ingredients for Canadian prescriptions. It's now a multi-billion dollar industry.
"Health Canada has to get its act together — really be more proactive instead of reactive — and really start prioritizing where these risky facilities are [and] how to deal with this problem in a smarter way," says Kohler, who specializes in the outsourcing of Canadian drug ingredients and potential problems.
The lack of information and transparency aren't the only issues, according to Kohler. Health Canada doesn't have the resources to travel to foreign countries to inspect even a fraction of the labs to ensure safety standards are met.
http://www.cbc.ca/m/news/health/doc...ed-hypothyroid-symptoms-to-reappear-1.3222953
