The FDA suspended a drug import ban on India’s troubled Ipca to unleash its large capacity for a drug that might help against COVID-19 but the agency’s largesse may be foiled. India’s commerce department is cutting off exports of the malaria drug to the U.S. and other countries.
Shipments of hydroxychloroquine will be released if orders were made or paid for before today’s notice the Directorate General of Foreign Trade says. After that—zilch. The only exception, it says, is on humanitarian grounds on a “case-by-case basis.”
The halt comes as demand for the treatment has created a medical dust-up between the federal health regulators and the White House. Trump began trumpeting the drug in briefings as a potential treatment that is already approved and could be used to quickly quell the outbreak. But the FDA and other federal health officials have emphasized that while it is approved for malaria and lupus it is not proven or approved against COVID-19 virus and needs clinical trials before it can be available.
Interest in the drug spiked after a French study found 70% of patients who were given hydroxychloroquine tested negative for the virus after six days. In the control arm, only two out of 16 patients were negative after six days. Some of the hydroxychloroquine patients also received the antibiotic azithromycin; all six of them tested negative. A small study from China, however, found it no more effective than conventional care, Bloomberg reports.
Interest has led to a surge in demand, however, exacerbating a shortage that already developed. It has left some lupus patients struggling to find supplies, putting their own lives in danger.
ProPublica yesterday reported that some doctors are hoarding the drug by writing prescriptions of the unproven treatment for themselves and families. And an Arizona man died and his wife is in critical condition after they inhaled chloroquine phosphate, which is used to clean aquariums, The Hill reports. It wasn’t clear whether they had confirmed COVID-19 infections.
While there are a number of approved generics of hydroxychloroquine, some are made in India. Also, getting enough API to produce more may also be an issue. Ipca, which has continued to manufacture the drug for the Indian market, is one of the Indian companies that has the most capacity to produce the API and the drug.
The FDA in 2015 banned all of Ipca’s drugs coming out of three plants, including those where it makes the formulation and API for hydroxychloroquine. The ban, and a warning letter, came after the agency discovered the plants faked testing data that would show Ipca’s drugs were safe and effective. –Fierce Pharma