Even as experts urge caution on the drug’s efficacy against COVID-19, production of chloroquine in India is being ramped up to cater to US demand
As the world continues to grapple with the novel coronavirus, diagnosed cases of the COVID-19 respiratory disease has surpassed 700,000. With little breakthrough on a prospective vaccine, preventive social containment strategies continue to remain as the primary prescription of medical professionals.
Amidst the resultant anxiety of cities under lockdown, US President Donald Trump has been touting a combination of medicines to be efficacious. Earlier this month via a tweet, the US president said, the combination of hydroxychloroquine and the common antibiotic azithromycin can be “one of the biggest game changers in the history of medicine”. Since then, Chloroquine and Hydroxychloroquine — a less potent version, has continually been touted by Trump in his daily Coronavirus Task Force briefings. The drug is commonly used to treat malaria and at times, prescribed against lupus and rheumatoid arthritis.
Absent of clinical trials however, the US Food and Drug Administration (FDA) is reported to have reached out to drug manufacturers on “ramping up production of the drugs to handle a spike in demand and to ensure that people with life-threatening conditions such as lupus can still obtain it.”
Although the World Health Organisation (WHO) includes chloroquine on its list of “essential medicines” — meaning “it should be kept affordable and accessible at all times”, drug manufacturers are ramping up production as the American Society of Health-System Pharmacists recently listed the drug on its shortage list.
This has triggered US manufacturers to rely on subsidiaries or partner producers in India, as Indian imports “accounted for 24 percent of medicines and 31 percent of medicine ingredients” in the US (as per 2018 FDA data). Hence, after having received “five times as many orders as usual” for chloroquine this month, New Jersey-based Rising Pharmaceuticals for instance, announced that it “is ramping up production in India to meet demand, purchasing “extraordinary amounts” of more active ingredients, bottles and labels.”
On anti-malarial drugs especially, India is known to be “self-sufficient” owing to the prominence anti-malaria efforts hold in the country’s national health initiatives. As a result, Ipca Laboratories and Zydus Cadila have reportedly received orders to produce chloroquine for the American market.
Furthermore, in line with the Trump administration’s announced plan to “eliminate outdated rules and bureaucracy” on procurement and testing, the FDA lifted the “three-year-old ‘import alert’” on Ipca to seek the import of hydroxychloroquine sulphate and chloroquine phosphate. Three Ipca facilities had been under an FDA ‘import alert’ since 2015, after inspectors “discovered multiple violations of its manufacturing guidelines, including “systemic data manipulation” in tests meant to ensure the drugs’ efficacy and safety.”
Moreover, India’s ban on exporting the drug may not apply to these instances as the ban does not apply to cases where the “outbound shipment is made to fulfil export obligation under any advance authorisation license issued on or before the date of” March 25, 2020.
These measures by the US seem to have been triggered at the hands of President Trump’s relentless advocacy of those drugs in the fight against coronavirus.
In a recent tweet, the US president shared a New York Post report of a Florida man diagnosed with coronavirus, claiming to have been “saved” by chloroquine. Moreover, Trump recently also said, “The nice part is,” that chloroquine has been “around for a long time, so we know that if things don’t go as planned, it’s not going to kill anybody.”
With continued questions over its efficacy, Trump’s relentless advocacy eventually even triggered the FDA to announce fast-track testing of the drug. Moreover, FDA Commissioner Stephen Hahn also announced that the drug would be available for “compassionate use” i.e. using “a drug off-label when other treatment options aren’t available.”
Trump even went on to announce: “At my direction, the federal government is working to help obtain large quantities of chloroquine”. Concurrently, it was reported that multinational pharmaceutical giant Bayer has “donated 3 million doses of Resochin, its brand name for chloroquine” to the US federal government.
State-level dispensations have also begun to procure the drug, and that has spurred Trump to even commend his otherwise political critics. Recently, the US president hailed two clinical trails announced by Democratic New York Gov. Andrew Cuomo.
As New York has emerged as the American epicentre of the outbreak, the two leaders have clashed over states assuming a heightened role in face of an inadequate federal response. However, one of the announced trails, which would combine the antibiotic zithromax (azithromycin) and hydroxychloroquine, prompted Trump to acknowledge Cuomo as having “been working very hard“. Following through, the Cuomo dispensation is reported to have acquired 750,000 doses of chloroquine and 70,000 doses of hydroxychloroquine.
Absent of large-scale definitive clinical trials to support Trump’s claims, experts have cautioned against overpromising on chloroquine.
The consequence of overstating the drug’s efficacy — without commensurate trials, has led to people scrambling to get their hands on the drug, and even self-medicate.
Dr. Anthony Fauci — Director of the National Institute of Allergy and Infectious Diseases and a central member of the Trump administration’s Coronavirus Task Force, has tempered Trump’s positive outlook on the drug by underscoring that there is no “magic drug” to treat coronavirus. He has also referred to evidence that the drug could be helpful as being merely “anecdotal.”
Further, Dr. Deborah Birx, US Vice President Mike Pence’s coronavirus response coordinator clarified that the drug has to-date only shown “promise in the test tubes.” Lastly, testing of chloroquine warrants long-term follow-ups as it is known to trigger side-effects like seizures, nausea, vomiting, deafness, vision changes and low blood pressure.
However, across the world, panic-buying has ensued. For instance, Nigeria’s government recently reported three people to have been hospitalised after overdosing on chloroquine, and its city of Lagos reported running out of stock. Similar events were also reported in Uganda, Ghana, Kenya, Morocco and Pakistan.
Even in the US, attempts to dampen panic-buying and self-medication have borne little effect. According to a recent report, American hospitals’ orders for chloroquine were “up 3,000%”.
Furthermore, a man in Arizona died and his wife was put under intensive care after the couple sought to self-medicate with chloroquine. The woman reportedly told NBC News that the couple got the idea to protect themselves from the novel coronavirus via Trump’s televised Coronavirus Task Force briefings. She added, “Don’t believe anything the president says… And his people. Because they don’t know what they’re talking about”.
In India, a death possibly linked to the use of chloroquine was recently reported. The deceased, who was a doctor in Assam was known to have self-medicated with hydroxychloroquine. That report closely followed the Indian Council of Medical Research issuing an advisory on permitting the use of Hydroxychloroquine only for “restricted use in emergency situations” only. Possibly, it is now time to also consider a campaign advising the common populace to refrain from panic-buying and self-medicating.
India must recognise that the induction of various US acoustic naval platforms cannot alone meet the challenge presented by the underwater expanse of the Indian Ocean.
At the Raisina Dialogue early this year, the US Deputy National Security Advisor Matt Pottinger announced the expansion of the Indo-Pacific construct to now also include the eastern coast of the African continent. Given India’s westward interests –– the centrality of the Gulf in India’s energy security, the region as a major source of migrant worker remittances, and planned connectivity projects with like-minded partners such as Japan, this recalibration of the American conception (“stretching from California to Kilimanjaro”) stood as a belated recognition of the strategic importance of the North-Western Indian Ocean region.
Moreover, the US’ decision to now align its conception with India’s, underscores the centrality of the latter in the former’s calculus over the Indo-Pacific region. Although American courtship of India as a strategic partner has been underway for the better-half of the post-Cold War era, the same in context of the Indo-Pacific construct has been nascent.
As a geopolitical matrix which seeks to marry the destinies of the Indian Ocean to that of the East China Seas – and the Western Pacific at-large, the cultivation of India as a “natural balancer” to China has assumed a maritime dimension. The same aims to oversee India’s rise as a regional goods provider in the Indian Ocean – towards rendering the US to “share the burden” with India by reducing “the strain on U.S. forces” deployed in the Western Pacific.
The US’ central approach to overseeing India’s “socialisation” into an activist role in the Indian Ocean has been to pursue India’s maritime capacity building. For instance, the US has been deft on clearing export of maritime surveillance platforms like the Boeing P-8I aircraft. With eight already in service and another four due in 2020-21, India’s P-8I fleet is “equipped with a Magnetic Anomaly Detector (MAD) for detection of subsurface vessels”. Moreover, even before the Indian Ministry of Defence’s Defence Acquisition Council (DAC) recently cleared the procurement for six more Boeing P-8I aircraft, India was the largest (second only to the US itself) operator of the long-range maritime surveillance and anti-submarine aircraft.
With this enhanced maritime surveillance capability, India has indeed sought greater Maritime Domain Awareness (MDA). Significantly, the same has also translated into India assuming the role of a regional goods provider. A case in-point being, India inaugurating the Information Fusion Centre – Indian Ocean Region (IFC-IOR), aimed to “engage with partner nations and multinational maritime constructs to develop comprehensive maritime domain awareness and share information on vessels of interest.” Hence, one may argue, the impetus to US-India defence trade in the naval platforms realm, has also meant Washington’s export of Mahanian thinking towards New Delhi pursuing MDA in the Indian Ocean region.
In addition, more avenues of enhancing India’s MDA stand in order out of the commercial congruence posed by India’s status as the world’s second largest arms importer and the US being the largest arms exporter in the world. For instance, India is set to procure 24 Lockheed Martin-Sikorsky MH-60R naval helicopters, aimed at strengthening the Indian Navy’s “anti-submarine and anti-surface warfare and surveillance capabilities.” Similarly, speculations continue if India will follow through, on the Donald Trump administration’s adoption of executive overrule to make India “the first non-treaty partner to be offered a MTCR Category-1 Unmanned Aerial System”. In late 2019, the Indian Navy was reported to have been interested in procuring 10 Sea Guardian Drones – the “maritime variant of the Predator B” fitted with a Raytheon SeaVue multimode maritime radar under its belly that would provide “wide-area intelligence and surveillance.”
However, this overt integration of US-imported naval platforms ignores the variable posed by the tropical littoral waters of the Indian Ocean. By that extension, this development of MDA, which largely pertains to the use of acoustic technology in myriad platforms, ignores the incorporation of Underwater Domain Awareness (UDA) into India’s holistic understanding of MDA.
Globally, the MDA is largely surface-driven and more of a security formulation. The MDA, in its present form, is grossly inadequate to handle the underwater threats emerging in the new world order. Further, the security tag brings multiple limitations in terms of involvement of other stakeholders like the blue economy entities, environmental regulators and disaster management authorities, and the science and technology providers into the larger effort of bringing state-of-the-art strategy and tools for managing the emerging challenges and opportunities.
The tropical littoral waters in the Indian Ocean Region (IOR) presents sub-optimal performance of the sonars being deployed for any underwater surveillance efforts, both for military as well as non-military efforts. The degradation of performance is of the order of 60 to 70 percent, and requires substantial indigenous efforts in terms of soft acoustic capabilities to facilitate effective deployment of the imported hardware in our waters.
The acoustic capacity building includes underwater channel modelling and ambient noise modelling and simulations to be able to mitigate the local medium fluctuations. Such modelling and simulation efforts supported by field experimental validation is extremely resource intensive. Developing nations with competing socio-economic requirements are not able to politically prioritise heavy spending on such long term Research & Development (R&D) programmes. Hardware spending – in the absence of such soft acoustic capability building, limits their effectiveness on ground and remains mere political theatrics for electoral gains. Moreover, the IOR, with its geopolitical fragmentation and instability, poses substantial security threats both from the state and non-state actors.
Thus, for India to play a critical role in the emerging Indo-Pacific formulation, it needs to balance hardware acquisition and indigenous acoustic capacity building to achieve effective UDA in the tropical littoral IOR.
The effective UDA framework needs to focus on pooling of resources and synergising of efforts across stakeholders so that a long-term R&D initiative with field experimental validation is taken up. For instance, with the import of US naval platforms, soft acoustic capacity and capability building support should be part of the sale contracts. Certainly, the same would be coupled with safeguards mechanisms for security of data and transferred technology, as in the case of the recently signed US-India Industrial Security Annex (ISA) towards fostering industry collaboration on co-development and co-production of arms.
This keenness for undersea awareness from the security perspective translates into defending our underwater and above water assets against the proliferation of threats through the underwater route intended to limit the access to the seas and its resources. The earth’s underwater geophysical activities have a lot of relevance to the wellbeing of the human kind and monitoring of such activities could provide vital clues to minimise the impact of devastating natural calamities.
The commercial activities in the underwater realm also need precise inputs on the availability of resources to be able to effectively and efficiently explore and exploit them for economic gains. The regulators, on the other hand, need to know the pattern of exploitation to manage a sustainable plan. With so many activities, commercial and military, there is a significant impact on the environment. Any conservation initiative, thus, would also need to precisely estimate the habitat degradation and species vulnerability caused by these activities and assess the ecosystem status. Concurrently, the scientific and the research community would need to engage and continuously update our knowledge and access to the multiple aspects of the underwater domain.
A comprehensive perspective of the UDA underlines the requirement for all the stakeholders to know the developments in the underwater domain, make sense out of these developments, and then respond effectively and efficiently before they take shape of an event.
The UDA on a comprehensive scale needs to be understood in its horizontal and vertical construct. The horizontal part would be the resource availability in terms of technology, infrastructure, capability and capacity specific to the stakeholders or otherwise. The vertical part is the hierarchy of establishing a comprehensive UDA. The first level or the ground level would be the sensing of the underwater domain for threats, resources and activities. The second level would be making sense of the data generated to plan security strategies, conservation and resource utilisation. The next level would be to formulate and monitor a regulatory framework at the national, regional and global level.
An effective UDA framework can encourage Safe, Secure and Sustainable Growth model to manage the challenges and opportunities in the tropical littoral waters of the IOR, whilst also ensuring that it is well aligned to the ‘Security And Growth for All in the Region’ (SAGAR) vision proposed by the Indian Prime Minister. It will require efforts on all the three fronts, viz. Policy, Technology & Innovation and Human Resource Development.