Shamsuzzaman Ansari
- Hydroxychloroquine’s efficacy in treating COVID-19 patients is yet to be shown in large randomized clinical trials
- India can produce up to 70 MT (~35 crore tablets) of hydroxychloroquine 200 mg per month
- The Indian government has already placed an order of 10 crore tablets of hydroxychloroquine with Indian manufacturers which will be able to treat more than 70 lakh COVID-19 patients considering each patient would need 14 tablet-course
- The US is one of key buyers of hydroxychloroquine from India,nearly half of the US supply of hydroxychloroquine last year came from India only
Hydroxychloroquine and COVID-19:
According to an article published in the British Medical Journal (BMJ), approximately 80 trials evaluating chloroquine and hydroxychloroquine, in combination with other drugs for treating COVID-19 patients, have been registered worldwide. Both chloroquine and hydroxychloroquine belong to the quinolone family, making hydroxychloroquine only a less toxic derivative of chloroquine.
While currently these drugs are approved to treat malaria, lupus erythematosus and rheumatoid arthritis, a few small scale studies suggested it might be effective against the coronavirus. World leaders including US President Donald Trump, meanwhile, have been touting its use as a game-changer to cure COVID19 patients. Some researchers in first affected China have also claimed that chloroquine/hydroxychloroquine could inhibit SARS-CoV-2 in vitro, showed apparent efficacy in treating COVID-19 in humans. Following this, a French trial was also recorded where 20 (some sources claim 36) COVID-19 patients were evaluated for the same. Additionally, US Food & Drug Administration (FDA) and other regulatory bodies across the globe including India and France have put strict protocols in place to allow the experimental use of chloroquine/hydroxychloroquinein patients with COVID-19
But all the claims have little clinical evidence, as health research experts claim, as its efficacy in treating COVID-19 is yet to be shown in large randomized clinical trials.
India’s ban on Export of Hydroxychloroquine:
Amid increasing COVID-19 cases across the country, on March 23, Indian Council for Medical Research (ICMR) had recommended hydroxychloroquine as a preventive medication for high-risk population. This was done in response to including asymptomatic frontline healthcare workers and asymptomatic household contacts of laboratory confirmed cases, with approval from the Drug Controller General of India. on March 25, the Directorate General of Foreign Trade had also restricted the export of certain drugs including hydroxychloroquine and paracetamol in order to ensure the adequate stockpiles for domestic use.
Finally on April 4, India put blanket ban on export of hydroxychloroquine considering its potential efficacy against COVID-19.
President Trump’s Alleged Threat to India:
It remains a surprise that despite hydroxychloroquine’s efficacy yet clinically proven, US President has been continuously advocating its use, compelling many US hospitals to use it as first-line therapy for hospitalized patients with COVID-19.The US government claims to have stockpiled as many as 29 million (~ 2.9 crore) doses of the drug, and is still seeking supply of the same from other countries including India.
On April 6, President Trump in a press briefing at the White House said that he had asked Indian PM Narendra Modi to ensure supply of already placed order of hydroxychloroquine but chances of decline from India’s side surfaced soon. Sounding threat at a crucial time when world leaders must come together, Trump even went ahead threatening that if India declined to ship the medicine, there may be retaliation.
Partial Lift of ban on Export of Hydroxychloroquine:
On April 7, India announced to partially lift the ban on exports of certain drugs including hydroxychloroquine, azithromycin and paracetamol. Many alleged this decision was taken under pressure from Trump.
Ministry of External Affairs, however, denied the allegation and stated that decision to partially lift the ban had been taken in view of the humanitarian aspects of the coronavirus pandemic. Accordingly, India will now allow limited export of hydroxychloroquine, azithromycin and paracetamol among others to its neighboring countries, Nepal and Sri Lanka who are dependent on India for these medications. The supply will also be done to countries which are badly impacted by the pandemic including US, Spain, Germany, Brazil and Israel.
If we pay heed to Sudarshan Jain, General Secretary of Indian Pharmaceutical Alliance, India is in a better position to meet the current demand, and in case further need arises, Indian companies have the capacity to ramp up the production to meet the local as well as export obligations to promised countries.
Is the Decision to Lift the ban on Export of Hydroxychloroquine Right?
Accounting for nearly 70% of the world’s total supply, India is the world’s biggest manufacture of hydroxychloroquine. India generally produces 10 metric tonnes (MT) i.e. 5 crore of hydroxychloroquine tablets of 200 mg every month. In the wake of its usage for treating COVID19, the country has recently raised its capacity to four times i.e. 40 MT (~20 crore tablets) every month and is slated to escalate the production to 70 MT (~35 crore tablets) by next month.
Zydus Cadila, Ipca Laboratories, Wallace Pharmaceuticals, Dr. Reddy Laboratories, Intas Pharmaceuticals, Cipla and Macleods Pharmaceuticals are the major pharma companies manufacturing the drug in India. Of these, Zydus Cadila and Ipca Laboratories have backward integrated production capacity that allows them to convert key raw materials to intermediates and then finally to APIs that subsequently lead to the final formulations. Other manufacturers have to rely on API suppliers for formulations production.
The Central government claims to have more than three times the supply of hydroxychloroquine that is needed for domestic consumption as it has already placed an order of 10 crore tablets of hydroxychloroquine with Zydus Cadila and Ipca Laboratories which will be able to treat more than 70 lakh COVID-19 patients considering each patient would need a 14 tablet-course.
If the above claimed data by the government of India is correct, and the government is very confident about the adequate stocks of medicines for domestic use, then the decision to allow the restricted export of hydroxychloroquine to US and other countries should be seen positively as it is one of key buyers of hydroxychloroquine from India.
According to the Bloomberg Intelligence, nearly half of the US supply of hydroxychloroquine last year came from India only; Zydus Cadila and Dr. Reddy Laboratories were the major suppliers.Though President Trump’s comment with respect to hydroxychloroquine’s supply for India was not in good taste, the same could be ignored considering the long-term bilateral trade relationship between both the countries.
According to commerce ministry, bilateral trade between India and the US was estimated at USD 87.95 billion, slightly more than between India and China during 2018-2019. In near future, both countries might enter into free trade agreement (FTA) and then this bilateral trade value would reach at a much higher level, resonating that India’s decision to allow global export of hydroxychloroquine, especially to the US will certainly strengthen the country’s bilateral trade relations with many countries. It only remains to see whether the government claimed production stats match the original production rate.
Source: Health Ministry, FDA Label, BMJ, NIH, Business Today,NBC, medrxiv,NATURE,ThePrint,Economic Times, Bloomberg
Author’s disclaimer:Shamsuzzaman Ansari is a pharmacy graduate with MBA. He is currently working as a Healthcare Research Analyst with an MNC based in Noida. He has more than 6 years of experience in healthcare business research and pharma consulting. The opinion expressed here is his personal and has nothing to with author’s employer