India has banned the export of a malaria drug backed by US President Donald Trump amid a run on supplies globally, even as scientists continue to search for conclusive evidence of its effectiveness against the novel coronavirus.
Exports of hydroxychloroquine will be limited to fulfilling fully paid existing contracts, while certain shipments on humanitarian grounds may also be allowed on a case-by-case basis, said a statement issued on Wednesday by the Directorate General of Foreign Trade.
The ban also does not apply to factories in its special economic zones.
India has some of the world’s largest manufacturers of the finished drug as well as its component ingredients, and the move is likely to crimp global supply at a time when the medicine is receiving unprecedented global attention.
“India is probably buying time to ensure its local needs are met first,” said Kunal Dhamesha, an analyst at SBI Capital Markets.
Hospitals and consumers in the US are stockpiling the drug after Mr Trump called it a “game-changer” in the treatment of the coronavirus and vowed to make it widely available.
China, Europe and South Korea have also said it could be one of several treatments for Covid-19 patients, while India itself recommends that healthcare workers take it regularly as a preventive measure.
Jordan has begun testing hydroxychloroquine on patients with Covid-19 and Bahrain on Tuesday said it has had some success.
But the studies are far from conclusive, and doctors advise against self-medicating, especially after a man in the US state of Arizona died after taking the drug’s more toxic predecessor, chloroquine.
There is no conclusive scientific evidence that hydroxychloroquine can treat the infection from the novel pathogen.
A small Chinese study published in the Journal of Zhejiang University showed that patients who received the medicine did not defeat the virus any more effectively than those who did not take it.
Some top scientists, including immunologist and White House advisor Anthony Fauci, say reports that hydroxychloroquine might work are anecdotal.
They say the studies need further investigation before the drug’s use is encouraged.
As the pandemic spreads and shuts down large parts of the global economy, hundreds of clinical trials are being launched.
Scientists are studying the effectiveness of everything from anti-flu drugs and antibody-containing plasma from recovered patients to traditional Chinese herbal medicine.
More than 420,000 people have been infected worldwide and almost 20,000 killed in the widening pandemic.
While the verdict is still out on the treatment’s effectiveness, pharmaceutical companies have been racing to increase production of the cheap and decades-old medicine.
Before the export ban was announced, Indian pharma company Cadila Healthcare, the world’s largest maker of the drug, said it plans to boost capacity more than tenfold to meet surging global demand.
Cadila’s shares fell as much as 7.7 per cent in Mumbai on Wednesday.
Sharvil Patel, the drugmaker’s managing director, said all of Cadila’s hydroxychloroquine capacity was currently banned from export.
The company has one factory in a special economic zone, but that plant is not approved by the Food and Drug Administration to make the medicine for the US market. Mr Patel said Cadila will apply to the FDA immediately for such permission.
“We’re still scaling up – there’s no restrictions on that,” he said. “If we are able to meet the Indian government’s supply needs then we can ask to lift the export ban.”
Malaria and lupus drug
Hydroxychloroquine was put in the spotlight after a small study of about 40 patients admitted to hospital with Covid-19 in France.
In that research, the drug appeared to help clear the virus from patients’ bodies, samples taken from nasal swabs suggested. Experts have criticised the design of the study, calling it interesting but far from definitive.
Some researchers believe the drug may have antiviral and anti-inflammatory properties that might suppress virus replication while also avoiding the body mounting an excessive immune response that could cause further damage to the lungs.
Hydroxychloroquine and the more toxic drug it is derived from, chloroquine, are also commonly used to treat rheumatoid arthritis and lupus. Neither drug has been approved by the US FDA to treat Covid-19.
In the Chinese study, one patient treated with the malaria drug progressed to severe disease. Four patients given the medicine developed diarrhoea and signs of potential liver damage, compared with three who received conventional treatment.
The researchers concluded that additional studies using larger numbers of patients were needed to fully investigate the drug’s risks and benefits.