The government has decided to ease its ban on the export of hydroxychloroquine, a drug that has garnered global interest in the treatment and prevention of COVID-19. On Tuesday, US President Donald Trump tweeted about “retaliation” if India did not heed his request for the drug. Later, India said it would supply to countries that needed it the most, and to neighbours who were “dependent on India’s capabilities”.
What is hydroxychloroquine and what is it used for?
It is an antimalarial drug option, considered less toxic than chloroquine, and prescribed in certain cases. Doctors also prescribe hydroxychloroquine for patients of rheumatoid arthritis and lupus.
Who makes this drug in India?
Hydroxychloroquine had a market size of only around Rs 152.80 crore in the 12 months ended February 2020, according to pharmaceutical market research firm AIOCD Awacs PharmaTrac. However, several countries source the drug from India.
Mumbai-headquartered Ipca Laboratories had nearly 82% of the market, with its brands HCQS and HYQ. Around 80% of the volumes produced by Ipca are exported. Ahmedabad-headquartered Cadila Healthcare (Zydus Cadila) prepares the brand Zy Q, with 8% of the market. Wallace Pharmaceuticals (OXCQ), Torrent Pharmaceuticals (HQTOR) and Overseas Healthcare Pvt Ltd (CARTIQUIN) have smaller shares.
Why has the COVID-19 outbreak spotlighted hydroxychloroquine?
In a study last month in the International Journal of Antimicrobial Agents (IJAA), French scientists reported: “Twenty cases were treated… and showed a significant reduction of the viral carriage… compared to controls, and much lower average carrying duration than reported of untreated patients in the literature. Azithromycin (an antibiotic) added to hydroxychloroquine was significantly more efficient for virus elimination.”
The study was flagged as being too small to draw a definitive conclusion. On April 3, the International Society of Antimicrobial Chemotherapy, which owns the IJAA, said the study did “not meet the society’s expected standard, especially relating to the lack of better explanations of the inclusion criteria and the triage of patients to ensure patient safety”.
However, by March 21, Trump had begun to call the drug a “game changer”, and has since been pushing it.
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At the end of last month, the Indian Council of Medical Research (ICMR) issued an advisory recommending the use of hydroxychloroquine in asymptomatic healthcare workers treating COVID-19 patients, and also allowed doctors to prescribe it for household contacts of confirmed COVID-19 patients. However, the government has stressed that the drug can only be used in COVID-19 treatment on prescription, and that it should not instill a sense of “false security”.
Since when has India stopped exporting the drug?
The US has been looking to procure the drug for emergency use. On March 21, Ipca told stock exchanges here that the US Food and Drug Administration had “made exception” to its import alert against the company so that it could get stocks.
India decided to ban exports of the drug on April 4. On Tuesday, the government decided to ease the ban.
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Is hydroxychloroquine actually effective?
Two large trials are under way on the effectiveness of hydroxychloroquine, and even chloroquine, in COVID-19 treatment. In the World Health Organization (WHO) solidarity trial, of which India is a part, clinicians worldwide are to follow a common protocol to treat patients with hydroxychloroquine. The second is the chloroquine accelerator trial, largely funded by the Wellcome Trust and the Bill and Melinda Gates Foundation.
As of now, the jury is still out on how effective these drugs can be against the virus, according to virologist and CEO of the Wellcome Trust/DBT India Alliance Dr Shahid Jameel. “Both of these are testing very large numbers of patients according to the random testing protocol used to test medicines. The results of those trials are not available yet,” he said. “If people in high exposure situations such as health workers are taking hydroxychloroquine/chloroquine as a preventive measure in limited ways, it may be fine. But, it is not all right for the general public to go around popping these drugs hoping that they will be protected. They may not be protected, but they will definitely cause themselves some harm,” said Dr Jameel.
How has the outbreak impacted patients who take the drug for other reasons?
In March, Trump’s statement promoting the drug not only led to panic buying in the US, but also impacted stocks in India. Fortis Memorial Research Institute rheumatology consultant Dr Naval Mendiratta said he had already begun receiving calls from his patients about lack of stocks due to panic buying. While it “should be fine” for some arthritis and lupus patients to skip “a few days to a week” since the drug is long-acting, breaks longer than that would be “difficult to manage”, he said.
Following the ICMR’s advisory on the drug, various patients and healthcare professionals alike are learnt to have stocked up on hydroxychloroquine. According to Prashant Tandon, founder of 1mg, some patients who had never used the drug had also attempted to source it from his e-pharmacy but were unsuccessful as they did not have valid prescriptions.
The drug has since been moved to a Schedule H1 status, which means patients who need the drug would have to get a fresh prescription every time they needed to purchase it.
Nearly a month on, stocks are still not available easily in pharmacies, affecting several patients who actually use the drug for auto-immune diseases. Some patients The Indian Express spoke to have been struggling to get their required dosage even after showing prescriptions.
“The stock is still limited, and whatever little stock is available is being prioritised and bought by the central and state governments. We have been told that we will receive stocks soon, hopefully within a week, but we don’t know,” 1mg’s Tandon said.
What are pharmaceutical companies doing to resolve the issue?
According to Ipca joint managing director Ajit Kumar Jain, the company has the ability to ramp up production to meet much of the government’s requirements, as only 10 per cent of its manufacturing capacity of hydroxychloroquine had been used for the domestic market so far.
However, to make sure the drug is not misused or stocked out due to panic buying, the company has decided to make hydroxychloroquine available at “select” pharmacies across the country, in communication with rheumatoid arthritis specialists.
“Now, the patient can just reach out to their doctor and they should be able to connect them with the pharmacy that has the available stock,” he said. “Maybe after the lockdown eases up, we might be able to slowly make the drug available more widely.
A spokesperson for Zydus Cadila said the company has ramped up production of hydroxychloroquine to 20-30 tonnes per month from three tonnes previously. It will scale it up further to about 40-50 tonnes per month in the coming months “if need arises”.
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