After a strong push to build an emergency stockpile of chloroquine drugs due to its possible effectiveness in COVID-19 treatment, U.S. government sources familiar with the matter told Reuters that there is reason to be concerned about the quality of some of the drugs.
Bayer, who discovered chloroquine in 1934, donated three million tablets, which it sells under the brand name Resochin, to the U.S. government.
According to Reuters sources, the FDA may have dropped its quality control standards too far as it searched for supplies of chloroquine drugs, and there is some reason to be concerned about the quality of Resochin and the plants that make it, which are located in India and Pakistan.
The plants that make Resochin ingredients and finished doses in India and Pakistan have never been registered with or inspected by the FDA, found Reuters research. Pakistani regulators who inspected Bayer’s Resochin plant in Karachi in 2015 noted failures in the manufacturing processes there.
This is not the first time foreign drug and API makers have been called into question. Last year, a spate of recalls triggered by contaminated APIs, many of which were produced overseas, wiped out a significant supply of heart medications in the U.S.
The FDA sampled and tested the donated Resochin and found them acceptable. Bayer told Reuters that the FDA had tested Resochin “and found it to be of appropriate quality for release to the (stockpile) for emergency use."
Read the Reuters exclusive