Quality or quantity? The quality of hydroxychloroquine donated by Bayer

The anti-malarial drug hydroxychloroquine, as a cheap generic drug, is currently a possible treatment for COVID-19. But in the question of whether hydroxychloroquine accepts the true anti-COVID-19 efficacy, its quality problems have raised concerns.

Recently, Bayer has donated a batch of hydroxychloroquine generic drugs, about 3 million doses, which are currently sold under the trade name of Resochin. On April 17, relevant sources told Reuters that the US government is increasingly concerned that the batch of hydroxychloroquine donated by Bayer may be produced in facilities that do not meet FDA quality standards, and the quality is worrying.

According to Reuters, unlike other FDA-approved hydroxychloroquine versions, Bayer ’s generic version has not received FDA approval for use as an anti-malarial drug. In addition, the FDA has not inspected its production facilities, and the plant has experienced disturbing and serious production problems in the past.

Because President Trump has touted hydroxychloroquine combined with the antibiotic azithromycin as a possible treatment for COVID-19, the clinical demand for the drug has soared in recent weeks. And Trump's pursuit is not without supporting evidence. A previous French study of 36 COVID-19 patients (6 asymptomatic, 22 with upper respiratory tract infection symptoms, and 8 with lower respiratory tract infection symptoms) showed that, compared with 16 patients, 20 patients received 600 mg daily Chloroquine treatment, combined with azithromycin treatment according to its clinical manifestations, results showed that patients receiving hydroxychloroquine combined with azithromycin had a 100% nasopharyngeal swab virus conversion rate on day 6 and patients receiving hydroxychloroquine monotherapy turned negative The rate was 57.1%, while the negative rate in the control group was only 12.5%. At present, large pharmaceutical companies such as Bayer, Mylan, and Novartis have committed to use millions of inexpensive hydroxychloroquine generic drugs for emergency use, and support a series of ongoing clinical trials.

Bayer's hydroxychloroquine comes from its factories in Karachi, India and Pakistan. Reuters pointed out that when Bayer ’s plant in Karachi, Pakistan was inspected in 2015, the country ’s regulatory agency once said that “the plant has made serious mistakes in the production of its medicines.”

The other plant producing Resochin is in India, operated by Indian pharmaceutical manufacturer Ipca Laboratories, but the plant has not yet been evaluated and approved by the FDA. Ipca Laboratories had conflicts with the FDA during the FDA ’s inspection of other Indian factories producing chloroquine, hydroxychloroquine and their active ingredients. At the same time, the FDA issued a five-year ban on the products of three Ipca manufacturing plants in 2015 due to the serious problem of data manipulation and falsified records of the pharmaceutical manufacturer.

However, this restriction was broken in the event of a shortage of medicines. The FDA said in late March that it would lift the five-year ban on products from Ipca ’s Indian plant so that it can combine hydroxychloroquine sulfate, chloroquine phosphate API and hydroxychloroquine sulfate tablets. The agent is shipped to the United States to ensure domestic treatment needs.

Although there are many approved hydroxychloroquine generic drugs, the United States has fewer and fewer drug reserves and APIs. With the rapid spread of COVID-19, global resources tend to be in short supply. India, as the largest producer of hydroxychloroquine, had previously issued a ban on the export of the drug and its active pharmaceutical ingredients. According to a March report by Jefferies analysts, Ipca and Natco, another Indian pharmaceutical manufacturer, are the only two suppliers of chloroquine drugs in the United States. At the same time, Ipca is still supplying hydroxychloroquine and chloroquine to the Indian market. At present, these two drugs are one of the largest supply products. Both pharmaceutical companies are providing raw material production of these two drugs internally.

Ipsa said that due to a shortage of anti-malarial drugs, the FDA approved the entry of its drugs as an exception to the import alert.

However, in response to the shortage of medicines, factory inspections and the quality of medicines cannot be guaranteed as the source of the current problem. The US government chose the former among the trade-offs to ensure quantity or quality, but quality problems will follow.