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Hydroxychloroquine - The Bone of Contention between India and USA

Two matters have dominated the headlines for over a week - the efficacy of Hydroxychloroquine as medication for treating COVID-19, and the reversal of India's export ban on the supply of the medicine after talks with United States' (US) President Trump. Given the rising anecdotal evidence of the positive effect of Hydroxychloroquine and the extent of the population affected in the United States, it seemed fairly urgent that USA secure help from India, who is currently the largest manufacturer and supplier of the medicine in the world.

The US President has continued to place his faith on the drug as a prophylactic medicine and has confirmed that he has been taking the drug along with a zinc supplement after two White House staff members tested positive for COVI-19 in the first week of May. This announcement came at a time when the Food and Drug Administration [FDA] of the United States has restricted the usage of hydroxychloroquine to cases of hospitalized patients under cardiac monitoring and for off-label use pose-emergency use authorization.

The events related to the reversal of the ban on export unfolded over a few days only. On March 25, the Directorate General of Foreign Trade (DGFT) imposed restrictions on the export of Hydroxychloroquine, allowing exports only from Special Economic Zones and Export Oriented Units, as well as when the payment was already made, or a Letter of Credit had been irrevocably issued. It was allowed to be exported if the Union Government approved on humanitarian grounds. However, on April 4, India banned the export of the drug “without any exceptions”.

Despite USA having placed orders for the drug before the restrictions were imposed, President Trump contacted Prime Minister Modi on April 5 when the supply of Hydroxychloroquine seemed indeterminate. While the public was still deliberating on President Trump's remark of retaliating against the continuation of the ban, India evoked the ban on April 7 on grounds of helping the worst affected. This was, however, accompanied by a statement calling for the “depoliticization” of the export of essential drugs for combating the COVID-19 pandemic.

Hydroxychloroquine - An Overview

Hydroxychloroquine sulphate was first synthesized in 1946 after chloroquine, discovered in 1934, was deemed to be too toxic for human use. Known for its prophylactic effects, the medication is used to prevent or treat malaria, largely endemic to India, and autoimmune diseases (rheumatoid arthritis [RA], lupus). Manufactured in large quantities, it is a cheap, safe and easily available drug in India. In fact, India is the world's largest manufacturer of the generic drug and handles the majority of the drug's worldwide demand.

While it is known for its efficacy in treating the above diseases, there is a dearth of empirical evidence regarding its effectiveness against COVID-19, and its reported benefits against the virus are limited to anecdotal reports. However, it came into prominence after political leaders started hailing it as a potential medication for treating the COVI-19 patient.

Significance of this development

Scaling up of production

The greatest impact of the reversal of the ban is on the escalation of the manufacturing capacities of the country for managing the required supply. The current official communication is optimistic - the Indian Drug Manufacturer's Association has assured that not only will the drug be kept under a licensed category and its demand be monitored, but that India can comfortably cater to both the global and domestic markets.

The Department of Pharmaceuticals would assess the request made by a second country, check its effect on India's accessibility needs, and recommend the DGFT to approve it only if it does not compromise India's requirements. Moreover, any export is contingent on maintaining a buffer stock of 100 million tablets of chloroquine and hydroxychloroquine. It has further been clarified that it shall be shipped only to foreign governments and not private companies.

Major Indian manufacturers like Zydus Cadila and Ipca Laboratories have already assured a rise in the monthly production of the medication as they have backward integration production capacity - they can convert raw materials into intermediates, then APIs and the final formulation.

Despite these encouraging statements, a general shortage of the drug for lupus, RA, and malaria patients has been reported in India. In Rajasthan, the government procured a large stock of hydroxychloroquine for COVID-19 treatment. Subsequently, the State Department of Medical Health and Family Welfare had to warn that RA patients were facing a shortage of the drug for their treatment.

Consequently, the government had to return the stock to the pharmaceutical companies. It is pertinent to note, however, that the Indian Council of Medical Research (ICMR) has restricted the drug's preventive use to only two high-risk groups of people - the medical personnel treating COVID-19 patients and the contacts of the patients.

Effectiveness in light of potential mutations

There are reports of a separate mutated strain of COVID-19 being in India, which may potentially impact the efficacy of hydroxychloroquine in comparison with other countries. It is safe to assume, however, that being an RNA virus, COVID-19 is mutating at a slower pace and is yet to show any significant increase in the virus' aggressiveness. In fact, Indian agencies observe that apart from a study that is yet to be peer-reviewed, there is no conclusive proof of a separate strain spreading in India. Accordingly, the impact of hydroxychloroquine, which is greater in effect on mild cases, is likely to remain consistent across nations.

India-USA Diplomatic Relations

India and the United States have had a volatile relationship since the beginning of the Cold War. With India leading the Non-Aligned Movement and cultivating friendship with the Soviet Union in light of US extending support to Pakistan, India and US could substantially strengthen ties only after the US lifted sanctions in the early 2000s, which was originally imposed to condemn India's development of nuclear capabilities. Over the years, the two countries have exuded bonhomie towards each other as they boosted partnership and extended cooperation for defense, energy, civil nuclear cooperation, trade and a rise in soft power.

The growing diplomatic and economic ties between the two have been occasionally marred by issues such as climate change, immigration, and access to each other's markets. More recently, the abrogation of Article 370 of the Indian Constitution and the Citizenship Amendment Act of 2019 have also been topics of debate, though they have not adversely impacted bilateral communications.

However, the COVID-19 pandemic has highlighted the necessity to maintain the full strength of their partnership for curbing the pandemic, as US faces the peril of bearing the highest number of COVID-19 casualties and India gains greater traction as a potential lifesaver with its capacity to deliver medicines that have been displaying anecdotal benefits.

Hope for Ipca Laboratories?

An interesting development during this exchange between the leaders has been the change in the stance of the US' Food and Drug Administration (FDA) towards the Indian Ipca Laboratories. On March 20, the FDA lifted import an import alert on the hydroxychloroquine manufactured by Ipca- the same day that President Trump promoted the drug as a potential cure for COVID-19.

However, until as late as August 2019, the FDA had repeatedly flagged issues at Ipca's facilities, ranging from “systemic data manipulation” to non-compliant quality control units of Ipca's manufacturing facilities. The import alert meant that FDA could detain products that seem to violate the agency's rules and regulations. This resulted in Ipca losing out on 60% of the US market share it had held until 2014 and Zydus becoming the largest player with a 32% share.

Nevertheless, in light of the fact that Ipca is one of the world's largest manufacturer of hydroxychloroquine, import curbs were lifted on the company to mitigate the severe shortage of hydroxychloroquine US is currently facing. This was despite the fact that US orders were already exempted by the previous Indian restrictions on the export of the drug.

Critical Analysis
The COVID-19 virus is unlike anything the world has ever prepared for. There have been extremely infectious diseases like influenza which are not very deadly, and there have been viruses like the SARS (Severe Acute Respiratory Syndrome) which are generally deadly but not as infectious. COVID-19 has managed to be both infectious and deadly at a previously unknown rapidity.

Its one-of-a-kind spread and the uncertainty regarding its cure raise a potential concern - can India manage to balance both the global and the local supply for prolonged periods of time? Was India in the right to revoke the ban on the export of the drug post-President Trump's request?

Even if there exists no widespread empirical evidence that hydroxychloroquine is effective against the virus, India is justified to let the US orders come through on humanitarian grounds. The United States is already at a much higher risk than India, possibly due to the difference in the rapidity and intensity of preventive measures undertaken.

In such a scenario, since hydroxychloroquine has at least anecdotal evidence of efficacy and does not have major side effects if consumed in controlled dosages, it appears to be reasonable that India uses its high production of the drug for beneficial purposes, as long as the domestic needs are balanced.

It is also debatable if or how the US would reciprocate this gesture of goodwill extended by India. Diplomatic relations for nations have always been of a transactional nature and based on mutual advantage to the leaderships.

In the present circumstances, would the US grant early access to any vaccine that may be developed in their country? Should there be a surplus in the US, would India receive assistance in the form of medical equipment or food?

It may also be possible that a potential display of gratitude towards India may be in the form of relaxing trade or immigration restrictions. At this stage, the reciprocity seems nebulous due to the dire situation in the countries. All that is certain is that India's gesture of goodwill may very likely be one of the major contributors to a decline in cases and deaths in the US, and that the US may consider India's requests related to the pandemic more favorably than before.

Probable Future

As multiple large-scale randomized trials across nations are underway regarding hydroxychloroquine's efficacy against COVID-19, the demand for the drug may fluctuate accordingly. If the clinical studies show that the drug is largely effective only for milder cases, the need for the drug may see a decline in countries where infections are more severe. The urgency to procure the drug may also be adversely impacted by the introduction of a vaccine.

The choice between the vaccine and the drug may then depend on the intensity of their prophylactic nature. It may also depend on whether the vaccine is created by a governmental or a private entity - if private entities create the vaccine, then it is equally likely that they would patent the same. Consequently, the supply of hydroxychloroquine would continue at the same rate unless the States impose compulsory licensing on the private entity to ensure the easy accessibility to the patented vaccine.

As India expands its production capacity, the priority assigned to both the global and domestic needs may also be revised. Unlike most of the other countries, the demand for the drug for malaria is far higher in India. Accordingly, India may have to implement a framework different than other countries as it would seek to prioritize the local requirements before extending help internationally.

While some companies like Zydus can manufacture the Active Pharmaceutical Ingredient (API) on their own, 70% of the APIs required by Indian firms have to be shipped from China by sea and air. However, since there has reportedly been a consistent decline of COVID-19's impact in China, it would become easier to procure the APIs from China over time.

Regardless of the various concerns, it is clear that India is going to continue being a potential savior to other countries due to its massive production capabilities and its willingness to provide help. It is uncertain if other countries would be willing to reciprocate, but that need not discourage India from living up to its image of being a generous country while protecting its own citizens from the pandemic.

In these tumultuous times, it becomes even more imperative to realize that the India-US relationship goes far beyond their present leaders - their shared history lies on the anvil of democratic values, economic cooperation and a long-term perspective of their relationship. At a time when a pandemic pays little attention to the North-South divide or the political tensions that may have been simmering before, countries are prima facie better off openly relying on each other and extending assistance in good faith.

While President Trump's statements and the timing of the revocation of the export ban on hydroxychloroquine may be a bone of contention for some, greater emphasis needs to be put on the resourceful utilization of the countries' production capabilities, be it medication, medical equipment, economic aid or food. As long as India's citizens can be assured of sufficient buffer stock and easy access to hydroxychloroquine, the country can offer relief to those hard-hit countries.

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