FDA lifts curbs on Indian maker of virus drug touted by Trump

U.S. regulators have lifted import restrictions on an Indian pharmaceutical company in an effort to increase supplies of a malaria drug touted by President Donald Trump as a potential coronavirus treatment.

Mumbai-based Ipca Laboratories Ltd. said in a March 21 securities filing that the U.S. Food and Drug Administration “has made exception to the import alert” for three of its facilities, allowing it to supply tablets as well as raw materials for making chloroquine phosphate and hydroxychloroquine sulphate.

The U.S. is facing possible shortages of both drugs, which are also widely prescribed to treat rheumatoid arthritis and lupus. Hospitals have been stocking up on the treatments in recent weeks following reports from doctors outside the U.S. that they were effective against Covid-19, the disease caused by the novel coronavirus. There have been no large-scale clinical trials to support those claims.

The factories where Ipca makes the medications have been under an import alert from the U.S. regulator since 2015, after inspectors discovered multiple violations of its manufacturing guidelines, including “systemic data manipulation” in tests meant to ensure the drugs’ efficacy and safety.

Chloroquine and hydroxychloroquine were first approved in the U.S. decades ago. There is no definitive evidence of their effectiveness against the novel coronavirus that has sickened over 349,000 globally and killed more than 15,000, but after Trump called the drugs a “game changer” and promised to make them more available, demand surged.

“We are noticing an increase in the emergency demand and enquiries for” these drugs and their raw chemical ingredients from several countries, Ipca said in its statement, noting that the malarial drugs aren’t approved for use in treating Covid-19. The company said it “is gearing to manufacture and supply these products.”

On Saturday, Trump tweeted a link to a small French study of 26 people infected with coronavirus which found six patients cleared the virus from their body when hydroxychloroquine was administered along with an antibiotic. A similarly small Chinese study didn’t show any benefit to Covid-19 patients from chloroquine—its more toxic cousin—though another Chinese study did.

The inconclusive scientific evidence hasn’t stopped American hospitals from stockpiling the drug. Hydroxychloroquine is being snapped up by medical systems at more than twice the typical pace as U.S. hospitals seek to build large inventories in anticipation of the medication’s potential use in patients with Covid-19.

Three of Ipca Laboratories’ major plants have been under a U.S. import alert since FDA inspectors visited them in 2014.

Mysteriously Deleted

At one facility in central India, now permitted to ship the main ingredient of the two chloroquine drugs to the U.S., inspectors found raw data and test results were being manipulated so drugs could pass quality-control checks. At another facility where finished tablets are made, inspectors found data meant to decide quality-control tests mysteriously deleted.

A request for comment on whether Ipca can meet the surge in demand for the two chloroquine products, and how it can guarantee its compliance with FDA standards as it does, sent to its company secretary and counsel wasn’t immediately answered.

The FDA inspected the third Ipca factory again in August and cited “a cascade of failure” regarding quality measures drugmakers are required to take to ensure the safety of their products.

Workers at the manufacturing plant had ignored signs that drugs made there may contain impurities—similar to warning signs ignored by a Chinese drug manufacturer that set off a global recall of millions of heart pills starting in 2018. The impurities in the drugs made in China turned out to be probable carcinogens.