The once touted 'wonder drug' has been battling global controversies around its safety and efficacy as a prophylactic against COVID-19.
However, India has stood by studies conducted by the ICMR and has recently even expanded the use of HCQ, reports Sohini Das.
Amidst a raging global controversy, hydroxychloroquine (HCQ) makers in India continue to produce the drug for regular rheumatoid arthritis and diabetes patients apart from catering to export orders.
India is the world's largest manufacturer of HCQ, which is also an anti-malaria drug.
The once touted 'wonder drug' has been battling global controversies around its safety and efficacy as a prophylactic against COVID-19.
India continues to use the drug as a preventive for frontline workers like health care professionals and police personnel, apart from high-risk individuals, like close contacts of COVID-19 patients.
A source in one of India's leading HCQ manufacturing companies said, "We were making HCQ even before the pandemic broke out and continue to do so. It is a Rs 100 crore brand for us.
"The government had placed a big order, which we have already supplied. India continues to use the drug, and we can again supply when the government inventory for HCQ ends."
He added that the drug has been in use for decades and is used daily by rheumatoid arthritis patients.
"There is a hue and cry on whether a high dosage of HCQ is toxic. India is administering HCQ in 400 mg doses -- two doses on the first day, followed by one per week for three weeks for household contacts, or for seven weeks for healthcare workers.
"Arthritis patients take 400 mg of the drug daily, and in all these years we have never had a medico-legal case of toxic side effects of HCQ," said the senior official quoted above.
The Indian government had placed orders for 100 million tablets which have been delivered by two drug majors Ipca and Cadila Healthcare.
Each patient requires either five to nine tablets. Going by that, the stock would last for months as it can cater to about 10 million people.
In fact, in April, sales of the anti-malarial drugs saw an 11 per cent spike in the domestic market.
At one point, Ipca used to make 600 tonnes per annum of chloroquine phosphate and had an 80 per cent share in the global market.
However, the demand for the drug has reduced over the years with the particular malaria variant cases coming down.
"We are getting queries from lots of small countries in Latin America and Europe. We are catering to these orders. India also continues to use HCQ. As of now there is no fresh order for HCQ from the government as they have enough stock," the source added.
By May, India had scaled up its HCQ capacity to 300 million tablets per month.
Controversy
The inexpensive drug that has anti-inflammatory effects (the reason it is used in arthritis) came into limelight after US President Donald Trump promoted it. Industry insiders feel this may well have also been the drug’s undoing.
"The drug became a political issue and also caused a certain divide in the medical community. On top of that, one country in the world, suddenly shot to fame by supplying the drug to world," felt a drug firm owner, who did not wish to be named.
Reputed peer reviewed medical journal The Lancet carried a study in May that said HCQ could lead to increased mortality rates and also came with the risk of adverse effects like cardiac arrhythmia.
Lancet, however, red-flagged the study last week after several researchers and doctors wrote to it questioning the reliability of the data.
Surgisphere, the company that supplied the data allegedly from over 96,000 patients across the globe, came under the scanner.
In fact, another study published in The New England Journal of Medicine (NEJM) that also used the same data was later retracted.
This study was on cardiovascular disease, drug therapy and mortality in COVID-19.
The World Health Organisation (WHO) suspended HCQ trials, which were part of the global Solidarity Trials. Last week it resumed the study after the Lancet study was red flagged.
Meanwhile, there was another study in NEJM that also cast doubts on the use of HCQ.
The study on 821 people had limitations though as most participants could not be tested using RT-PCR method.
In an editorial in NEJM, Myron S Cohen, an American physician scientist, noted: "Some observational studies have suggested benefits of hydroxychloroquine for the treatment of COVID-19, whereas other treatment reports have described mixed results."
Cohen further noted: "Drugs for the prevention of infections must have an excellent safety profile. When hydroxychloroquine was initially promoted as a possible solution to SARS-CoV-2 infection, the safety of the drug was emphasised.
"Under closer scrutiny, however, the potential for cardiac toxic effects and overall adverse outcomes have been emphasised, especially in persons with underlying coexisting conditions that increase the risk of severe COVID-19."
India, meanwhile, has stood by studies conducted by the Indian Council of Medical Research and has recently even expanded the use of HCQ.
Whether India will commission more studies to assess the risks and benefits of this drug is to be seen.
