Monday, May 16, 2022

MONITORING THE SAFETY OF FOREIGN-MADE PHARMACEUTICALS

In April 2022, just five months after granting approval for use of Covaxin, a COVID-19 vaccine developed and manufactured in India, the World Health Organization (WHO) publicly warned United Nations agencies against procuring the vaccine. An inspection of a Covaxin production facility revealed deficiencies in what are called good manufacturing practices (GMP) – standards that must be met to ensure medicines are produced in hygienic conditions (sterile where necessary) and consistently of high quality. The nature of the deficiencies wasn’t disclosed, but they must be important for public health for the WHO to broadcast this shaming.

Why should this be of concern to Canadians? After all, Covaxin is not approved for use in Canada and is unlikely to ever be.

The concern is that many raw pharmaceutical materials are imported from India to manufacture drugs for use in Canada and many medicines used here are made entirely in India. India is a major exporter of active pharmaceutical ingredients. Canada’s trade data show the total value of these imports in 2021 was more than $13 billion – 84 percent coming from just 10 countries. A third of this total came from the United States, our largest trading partner by far.

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