The US Food and Drug Administration has lifted a 3 year-long import ban on chloroquine products manufactured by Mumbai-based Ipca Laboratories, a company that it last investigated in August 2019.
that the USFDA had made a temporary exception on import curbs on Hydroxychloroquine Sulphate and Chloroquine Phosphate APls and Hydroxychloroquine Sulphate Tablets from the very same facilities the agency had castigated for failing quality standards. The FDA’s exception, Ipca said, will be reconsidered if “shortage implications change.”
The World Health Organisation is overseeing one such study, but the results are not yet in. Meanwhile scientists across the world, including the head of the US task force on COVID-19, Dr. Anthony Fauci, have cautioned against using the drug on COVID-19 patients.that violated all norms of randomised controlled trials — the gold standard for clinical testing.On July 15 2019, Ipca Laboratories published its annual report, noting that 2018-19 had been one of its most profitable years.
“Our investigators found that your firm routinely re-tested samples without justification, and deleted analytical data. We observed systemic data manipulation across your facility, including actions taken by multiple analysts, on multiple pieces of testing equipment, and for multiple drugs,” the FDA noted at one point.
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