NEW DELHI — The United States Food and Drug Administration (FDA) lifted import curbs on hydroxychloroquine produced by a tainted Indian pharma company on the same day that President Donald Trump promoted his controversial theory that the anti-malarial drug could help COVID-19 patients, documents show.
As late as August 2019, the US FDA had censured India’s Ipca Laboratories, a company producing close to 70% of the world’s hydroxychloroquine, for a “cascade of failures”. In one particular case, the FDA said, the firm’s quality control analysts had deviated from standard test procedures, or STPs, “for over twelve (12) years.”
The US FDA’s years-long investigation into Ipca’s manufacturing processes had prompted the Switzerland-based Global Fund to Fight AIDS, Tuberculosis and Malaria to drop Ipca from its list of suppliers of antimalarial drugs in 2016.
But a Trump-inspired global race to stockpile hydroxychloroquine appears to have forced the FDA to overcome its squeamishness in dealing with a drug company the agency has previously accused of a litany of violations including the falsification of clinical data. The FDA volte face reveals the extent nations are willing to go to secure medical supplies in their battle against the global coronavirus pandemic.
On March 21, Ipca informed the Indian stock exchange that a day ago, the FDA had temporarily lifted import curbs on the company’s hydroxychloroquine products “due to the shortage implications and/or medical necessity of certain drugs and finished products.” The exchange filing was reported by news outlets including Bloomberg.