Hydroxychloroquine and Coronavirus: All you need to know about drug that may be key in COVID-19 fight

According to government data, India is capable of producing 40 metric tonnes of hydroxycholoroquine every month, that is 20 crore 200 mg tablets

Archana Shukla April 10, 2020 11:05:07 IST
Hydroxychloroquine and Coronavirus: All you need to know about drug that may be key in COVID-19 fight

Editor's note: The drug hydroxycholoroquine has been in the news for the past couple of weeks due to its possible use in curing coronavirus. While such world leaders as Donald Trump and Jair Bolsonaro have been seeking Indian exports of the drug to battle COVID-19, concerns are being raised at home about supply and how long stocks will last/can be regenerated. 

US president Donald Trump has thanked Prime Minister Narendra Modi for lifting the ban on the export of anti-malaria drug hydroxycholoroquine (HCQ), which is being touted as a game-changer in the world's fight against the deadly coronavirus.

On 7 April, Trump had threatened, “US could retaliate if India does not release stocks of hydroxychloroquine.” When the country announced that it was beginning to export the drug, there was a change in US president's stance who tweeted: "Extraordinary times require even closer cooperation between friends. Thank you India and the Indian people for the decision on HCQ. Will not be forgotten! Thank you Prime Minister @NarendraModi for your strong leadership in helping not just India, but humanity, in this fight!"

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India, the largest supplier of the drug, had banned its exports in early March. Although it not 100 percent proven that hydroxychloroquine could cure COVID-19, it has generated massive interest after Trump endorsed the drug.

Here's all you need to know about the drug, which reportedly can beat coronavirus:

What is hydroxychloroquine used for?

Hydroxychloroquine is an anti-malaria drug, which is used to treat the disease in areas where malaria is sensitive to chloroquine. It is an anti-inflammatory drug, hence is used for treatment of rheumatoid arthritis and lupus as well.

Is HCQ really a cure for COVID-19?

The answer to this question is "no". HCQ has not yet been proven to cure coronavirus.

Anecdotal studies have shown that the drug can reduce viral loads in COVID-19 patients. Clinical trials are on in certain countries like the US, UK, Spain and Australia, but experts suggest that larger clinical trials are needed on patients to test the effectiveness of the drug.

However, after Trump's public endorsement of the drug, the US Food and Drug Administration (FDA) has given Emergency Use Authorisation to two anti-malaria drugs — chloroquine and hydroxychloroquine — to treat patients infected by coronavirus.

The USFDA has said that the drugs can be prescribed “as appropriate, when a clinical trial is not available or feasible". The drug is being used on 1,100 coronavirus infected people in New York and the results are being monitored.

Hydroxychloroquine and Coronavirus All you need to know about drug that may be key in COVID19 fight

Representational image. AP

Has India lifted the ban on export of HCQ?

After a 12-day ban, the Indian government lifted curbs on the drug to meet export commitments. The government has decided to licence HCQ in appropriate quantities to neighboring countries and nations that have been badly affected by the pandemic.

Who are the producers of hydroxychloroquine in India?

India is the largest supplier of HCQ in the world. Mumbai-based Ipca Laboratories is the largest manufacturer in the country. Over 80 percent of the Indian domestic HCQ market is held by Ipca, followed by Ahmedabad-based Zydus Cadila. Other players like Wallace Pharmaceuticals, Intas, McW Healthcare, Macleods and Cipla also produce HCQ.

Ipca Labs told CNBC-TV18 that only 10 percent of the country’s production is being utilised in domestic market, while the rest is being exported across 50 countries.

Do Indian companies have enough raw material to manufacture HCQs?

Ipca Labs has said that it is vertically integrated for HCQs, meaning they manufacture raw material APIs, key starting material and the finished drug (formulations) at their facilities in India. Even Zydus Cadila manufactures raw material in-house. Other companies import certain ingredients and APIs from China. Industry experts said that supplies from China have resumed to near normal levels, so a shortage of raw material may not be a concern going forward.

How much HCQ does India manufacture?

According to government data, India is capable of producing 40 metric tonnes of HCQ every month, which is approximately 20 crore 200 mg tablets. The government has said that current stocks are adequate to service domestic demand and export commitments, but it is monitoring the sale of the drug.

The government has also placed an initial order of 10 crore tablets with Ipca Laboratories and Zydus Cadila. Drug Pricing Authority NPPA chairman has said that manufacturers have started meeting government orders. If clinical trials of HCQ prove that it can treat patients successfully, production of the drug can be scaled up.

How much HCQ does India export?

According to Pharmaceutical Export Promotion Council, India exported $36.41 million worth of HCQS in April-February 2019-20.

Can HCQ be bought from a chemist without a prescription?

After the Indian Council of Medical Research (ICMR) advised the use of HCQ as a preventive treatment for COVID-19 on March 24, patients, the general public and healthcare workers reportedly started stocking the drug, creating partial shortage. The shortage affected those who were administered the medication for conditions like rheumatoid arthritis. Some chemists and stockists have still not received stocks.

General people stocking up HCQ also meant higher risks as people could be self-medicating on an “unproven” drug for COVID-19. Hence, the government on March 27 moved it from the Schedule H1 status, which means it can no longer be sold without a new prescription from a qualified doctor.

Is hydroxycholoroquine safe?

There have been associated side-effects of HCQ on patients. The drug taken in combination with Azithromycin increases the risk of side effects like arrhythmia or irregular heartbeat and even toxicity if taken in higher dosage. Medical experts around the world have warned against any using HCQ as a treatment without proper clinical studies.

Dr Michael Ackerman, a genetic cardiologist and director of the Mayo Clinic's Windland Smith Rice Genetic Heart Rhythm Clinic told CNBC that while it is likely to be safe for 90 percent of the population, HCQ could pose serious and potentially lethal risks to those susceptible to heart conditions, especially those with other chronic medical problems and are already on multiple medications. A recent study that he quoted showed that up to 11 percent of COVID-19 patients on HCQ and Azithromycin are in the so-called "red zone" for potential cardiac side effects.

Few hospitals, like in Sweden, have halted the use of HCQS due to reported side effects such as cramps and loss of peripheral vision in patients.

Does India use it to treat COVID-19 patients?

India does not use HCQ to treat coronavirus. ICMR has said that hydroxycholoroquine should not be used by healthy people and or seen as a proven cure for COVID-19 as yet.

As an experimental study, ICMR has allowed use of hydroxycholoroquine as a preventive treatment (prophylaxis) for high risk people, like healthcare workers in COVID care and direct contacts of COVID-19 positive patients. It has also allowed the use of hydroxycholoroquine with Azithromycin in severely ill COVID-19 patients. This is however under strict medical supervision.

ICMR added that while reduction in viral load has been observed in COVID- 19 patients, there is not enough data to say it can be used as a treatment.

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