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Import Restrictions Lifted for Indian Drug Manufacturer Despite Prior Safety Violations

Ipca manipulated quality control data in the past to make its drugs appear safe.

Tuesday, March 31, 2020 - COVID social distancing rules United States import regulators have relaxed restrictions on an Indian pharmaceutical company previously put on alert for sending poor-quality drugs to the U.S. and manipulating quality assurance data. The alert was lifted so that Ipca Laboratories, based in Mumbai, could export malaria medications that have not yet been tested for efficacy against COVID-19.

U.S. Food and Drug regulators lifted import restrictions put in place in 2015 after President Donald Trump touted chloroquine and hydroxychloroquine malaria medications as potential treatments for coronavirus and promised to make them more available.

So far, the only scientific evidence that shows hydroxychloroquine may be promising is a small French study of 26 people infected with coronavirus. In that study, six patients tested negative for presence of the virus when hydroxychloroquine was administered along with an antibiotic.

The drug's more toxic cousin, chloroquine, was examined in two small Chinese studies. One study found that the drug seemed to help, while the other study found it had no effect.

The FDA has made an exception to its prior alerts that, for all purposes, banned the company for selling medications to the U.S. to allow three Ipca facilities to supply tablets as well as raw materials for making chloroquine phosphate and hydroxychloroquine sulphate. Both drugs are used to treat rheumatoid arthritis and lupus, but have come into short supply following Trump's televised announcement that they are "game changers" against the deadly COVID-19 virus.

Three Ipca factories were put on alert in 2015 after inspectors discovered multiple violations in manufacturing guidelines, including "systemic data manipulation" in test results intended to ensure safety and effectiveness of their medications.

At one manufacturing plant in central India, which will now be allowed to ship the main ingredient of the two chloroquine-based drugs to the U.S., raw data and test results were found to have been manipulated so that drugs could pass quality-control checks.

At another facility, also now allowed to export chloroquine-based drugs to the U.S., quality control data was mysteriously deleted.

As recently as August 2019, FDA inspectors inspected the third facility operated by Ipca and called their quality assurance procedures "cascade of failure."

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