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
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
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
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.
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
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
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