More pain for Trump as US officials doubt India's pills

Washington: On March 21, two days after President Donald Trump first touted chloroquine drugs as a "game-changer" in the fight against COVID-19, administration officials privately described what they felt was a "win" in the President's efforts to build an emergency stockpile of the drugs: a hefty donation of pills from Bayer AG.

In an exchange of enthusiastic emails among federal health officials reviewed by Reuters, Keagan Lenihan, chief of staff of the US Food and Drug Administration (FDA), cautioned that "3-4 days" of testing would be needed.

Nearly 4,500 Coronavirus Deaths have been reported In US in 24 hours. The total death toll has gone up over 34,000.

"Potentially serious issues with product so let's be careful when we take that win," she wrote. Bayer has since donated three million tablets of the drug, called Resochin, to the US national stockpile for treatment of COVID-19, the disease caused by the coronavirus.

After a brief period of testing, its use in the United States was approved on an emergency basis. But three US government sources familiar with the matter told Reuters that there is reason to be concerned about the quality of Resochin and its makers, located in India and Pakistan.

Although some rules can be waived in an emergency, the FDA dropped its quality-control standards too far as it scoured the world for scarce supplies of chloroquine drugs, according to the sources, who spoke on condition of anonymity.

The plants that make Resochin ingredients and finished doses in India and Pakistan have never been registered with, or inspected by the FDA, according to the three government sources, as well as FDA documents compiled in the private online database FDAzilla.com

Some chloroquine drugs were already approved by the FDA before the pandemic as antimalarial medications, a process that required plant inspections.

And though the FDA has never screened the Indore, India, plant that supplies ingredients for Resochin, the US agency has inspected other Indian plants run by the same Indian supplier and found serious deficiencies, including falsification of records, inspection documents spanning 2014 through 2019 show.

Responding to questions from Reuters about Resochin, FDA spokesman Michael Felberbaum said that the agency "sampled and tested the donated drugs to evaluate acceptability for importation" and they met appropriate standards.

Asked about Lenihan's March 21 email, the FDA spokesman said the agency "does not comment on alleged, leaked emails."