When it comes to serious quality issues at India’s Ipca Laboratories, the FDA is letting bygones be bygones in its effort to get more promising but untested treatments for COVID-19 to the market. Ipca Laboratories says the FDA is lifting a ban on products from two plants so it can ship hydroxychloroquine sulphate and chloroquine phosphate APls along with hydroxychloroquine sulphate tablets to the U.S.
The FDA in 2015 banned products from three Ipca manufacturing facilities because of rampant data manipulation and what the FDA in a warning letter called a “cascade of failure” at its plant in Silvassa. But that was then.
RELATED: FDA bans imports of Ipca Lab drugs
The drugmaker over the weekend reported that because of shortages of the drugs, the FDA has granted it an exception to its import alert. The FDA said the exception could change if shortages are resolved.
Ipca will join four other drugmakers that have pledged to expand production of hydroxychloroquine. President Trump through the weekend touted the potential of the chloroquine and hydroxychloroquine, a more tolerable formulation, even though NIAID director Anthony Fauci said there's no meaningful evidence to date on chloroquine and COVID-19, that so far evidence is only "anecdotal.” The drugs are approved for treating malaria and have shown some benefit against COVID-19 in a small trial.
Pharmacy boards in Texas, Ohio, Idaho and Nevada have put restrictions on use of the drugs for COVID-19, Reuters reports. The news service says Nevada and Ohio ruled the drugs can only be used for treatment of COVID-19, not prevention. Texas and Idaho said that the prescription needs a diagnosis “consistent with the evidence for its use.”
While there are a number of approved generics of hydroxychloroquine, it is in short supply in the U.S. Getting enough API may also be an issue. According to a note from Jefferies analysts, Ipca and Indian compatriots NATCO are the only U.S. suppliers for chloroquine. Ipca, which still provides both drugs to the Indian market, has one of the largest supplies and both have inhouse API production for both drugs.
As Jefferies said, the situation “could be positive” for Ipca, particularly since as recently as September the FDA ravaged the company’s Silvassa plant where it makes its hydroxychloroquine sulphate tablets. Its failures were detailed (PDF) in an FDA Form 483 that had only three observations but a list of issues that stretches to 10 pages.