Health Canada relies on India and China to test drug ingredients sent to Canada
by Romeo St. Martin

[PoliticsWatch updated 12:00 p.m. August  13, 2007]

Health Canada has just 80 inspectors responsible for both foreign and domestic pharmaceutical facility inspections.

OTTAWA -- The rise of China and India as major exporters of pharmaceutical products and ingredients is posing problems for drug regulators such as Health Canada.

Health Canada confirmed to PoliticsWatch that it relies on companies in those two countries to conduct their own testing of active drug ingredients for export to Canadian drug makers. 

"The foreign manufacturer is responsible for conducting active pharmaceutical ingredient testing," Health Canada told PoliticsWatch. 

"Canadian importers must conduct finished product testing only. The foreign fabricator must conduct raw material (active pharmaceutical ingredient) testing. Canadian fabricators who import active pharmaceutical ingredients for use as raw materials must test each lot, before using them to make finished products."

Concerns about product safety have increased recently due to a litany of recalls and the discovery of contaminated and counterfeit products from China in both Canada and the U.S. 

There are also concerns about just how reliable China's drug safety system is. Corruption in China's food and drug authority was so rampant that the government executed its former drug regulator in July after he was found guilty of taking bribes. 

In Canada, counterfeit pharmaceutical drugs are also a concern. In July, a British Columbia coroner's report concluded that a Vancouver Island woman died from "metal toxicity" from counterfeit pharmaceuticals she purchased over the Internet. 

Health Canada said it inspects Canadian drug manufacturers that import pharmaceutical ingredients to make finished products on a two-year cycle. 

"Part of the scope of the inspection is to confirm that the drug maker tests the raw materials prior to use, which is a regulatory requirement," Health Canada said. 

Companies that import finished drug products from China and India are inspected every three years. 

"Once a Canadian importer receives each lot or batch of a finished drug
product from China or India, the importer must perform finished product
testing (chemical, biological and physical verification) to assure that the finished drug product meets the specifications to which it should have been manufactured," Health Canada told PoliticsWatch. 

"Products which fail the testing cannot be released for sale on the Canadian market. Validation that finished product testing is conducted by the Canadian importer, among other Good Manufacturing Practices (GMP) requirements for importers, is performed by Health Canada on a three- year cycle."

Health Canada could not confirm to PoliticsWatch exactly how many inspections it has conducted at facilities in India and China that export to Canada. Health Canada also could not confirm how many inspectors are assigned to the two emerging economic super powers.  

Health Canada said it has "approximately 80 inspectors who are responsible for conducting both domestic and foreign" inspections.

"In order for a Canadian company to import a finished drug product from
India or China, they must provide Health Canada with evidence of GMP compliance for the foreign site," Health Canada told PoliticsWatch. "This can be accomplished in one of two ways.  Health Canada can go to the foreign site to perform a GMP Inspection, or the importer can provide an inspection report to Health Canada conducted by a qualified regulatory authority."

Health Canada considers qualified regulatory authorities to be any of the 31 members of the Pharmaceutical Inspection Co-operation Scheme
-- neither China nor India are members of this scheme -- and the U.S. Food and Drug Administration (FDA). 

However, questions are now being raised about just how effective and reliable the FDA's foreign inspections are.   

The Washington Post reported in May that the FDA offered only scant scrutiny of drugs from China and India. Over the past seven years, the FDA conducted just 200 inspections of pharmaceutical plants in those two countries. 

American analysts estimate that as much as 20 percent of finished generic and over-the-counter drugs, and more than 40 percent of the active ingredients for pharmaceuticals made in the U.S. are manufactured in China and India. 

William Hubbard, a former FDA associate commissioner, told the Washington Post earlier this year that the U.S.'s inspection system in China and India is so weak that many foreign manufacturers believe they "can play games without consequences."

Health Canada could not tell PoliticsWatch whether or not it relied on outside regulators' inspection reports more than its own inspections. 

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