India is the largest producer of hydroxychloroquine in the world, producing 70 per cent of the world's supply

Earlier this week, the central government relented to US President Donald Trump's demand for India to partially lift its export ban on the anti-malarial drug, hydroxychloroquine – a drug the US president has previously called a 'game-changer' in the world's battle against the novel coronavirus pandemic. US President Trump appeared to send a stark warning to India stating that unless exports of the drug resumed to the US, it could expect 'retaliation,' opting not to elaborate further.

The Ministry of External Affairs later issued a statement saying “all existing orders will be cleared,” indicating that India would honor its commitments to, not just the US, but Brazil, Spain, Germany, Israel, Australia, the UK and several Gulf countries.

Why is hydroxychloroquine in such high demand?

Hydroxychloroquine (HCQ) is believed to be a safer derivative of chloroquine used in the treatment of malaria. As an anti-inflammatory drug, it has also been used to treat rheumatoid arthritis and lupus. Since the outbreak, some studies have shown that the drug has had success in reducing the viral loads of patients infected with COVID-19.

Clinical trials are still ongoing in several countries, but experts have warned that larger trials will still need to take place, to more accurately determine the effectiveness of the drug. That though, has not stopped numerous countries from approving its use in the treatment of COVID-19, despite it being associated with side effects like arrhythmia, irregular heartbeat, and retinal damage, when taken in combination with another drug, Azithromycin.

The Indian Council for Medical Research has only recently approved the use of the drug in the treatment of patients at more advanced stages of COVID-19. It has also allowed the use of the drug as a preventive measure for 'high risk' individuals such as doctors and other healthworkers.

India's role in global HCQ production

India is currently the largest producer of hydroxychloroquine in the world, reportedly, producing 70 per cent of the world's supply. With a monthly production capacity of 40 tonnes of hydroxychloroquine, amounting to 20 crore 200 mg tablets, it is believed to have exported as much as $ 36.41 million worth of the drug between April 2019 and February 2020, according to data from the Pharmaceutical Export Promotion Council.

There are, reportedly, several formulators of HCQ in India, but a large majority of them rely on critical active pharamaceutical ingrediants (APIs) from China in order to manufacture it. Since the outbreak in China, and its decision to quarantine the Hubei province, massive supply disruptions have led API prices to soar in recent months, from between Rs 75,000 to Rs 1,50,000 per kg.

As such, several formulators have revealed that, while demand for the drug was high, the lack of APIs meant they could not ramp up production. Yet, this has not been the case for some pharmaceuticals namely, IPCA Laboratories and Zydus Cadila Healthcare Ltd.

IPCA, in particular, is one of the largest producers of not just hydroxychloroquine, but its API as well. During the first half of the decade, the company grew at an astronomical rate as it sought to claim a huge share in the world's largest market for generic drugs. However, its ambitions took a huge hit when three of its manufacturing plants, and one API plant were prohibited from exporting to the US market in 2016, by the US' Food and Drug Administration.

Following the FDA's action, the Global Fund to Fight Aids, Tuberculosis and Malaria also curtailed all purchases of anti-malarial drugs from the pharma manufacturer. It has been reported that about a fourth of IPCA's export revenue came via the sale of anti-malarial drugs. Between FY13 and FY19, IPCA's revenue in the anti-malarial drug segment fell from 17 per cent to 6 per cent.

IPCA has since managed to turn the tide by focussing instead on the domestic market, but the current pandemic has now provided renewed opportunity. In light of the extraordinary situation, the US' FDA has recently opted to temporarily suspend its import ban on IPCA facilities, allowing the pharma manufacturer to resume exports of HCQ and its APIs.

Courtesy: Times Now