Early today morning, the Indian government rescinded a blanket ban imposed on the export of hydroxychloroquine, or HCQ, a 75-year-old drug used for the treatment of malaria and auto-immune diseases like rheumatoid arthritis and lupus. The decision to reverse the ban was taken barely 48 hours after it was put in place. On 4 April, the Director General of Foreign Trade, an office that comes under the ministry of commerce and deals with matters related to exports and imports, released a notification that stated, “The export of hydroxychloroquine and formulations made from hydroxychloroquine, therefore, shall remain prohibited, without any exception.”
Notably, the blanket ban was itself an amendment of another ban imposed on 25 March, when the government first banned HCQ exports, with certain exceptions. This was following a guideline released by the Indian Council of Medical Research on 22 March, which recommended the use of HCQ for treating healthcare workers handling suspected or confirmed COVID-19 cases, as a prophylactic.
The impositions and recalls are in line with the knee-jerk decisions that have come to exemplify the administration’s response to the COVID-19 pandemic. Whether considered individually or in entirety, each of these decisions suggests a lack of consultation with the industry and health experts. The government’s decision to revoke the ban also comes right after the president of the United States of America, Donald Trump, called the prime minister Narendra Modi on Sunday and followed the conversation up with threats of possible retaliation if India did not lift its ban.
The ministry of external affairs conveyed the latest decision, to rescind the ban, via a press statement, and a notification is to follow. In the press statement, the MEA’s official spokesperson, Anurag Srivastava, said: “Our first obligation is to ensure that there are adequate stocks of medicines for the requirement of our own people. In order to ensure this, some temporary steps were taken to restrict exports of a number of pharmaceutical products. In the meanwhile, a comprehensive assessment was made of possible requirements under different scenarios. After having confirmed the availability of medicines for all possible contingencies currently envisaged, these restrictions have been largely lifted. The DGFT has notified lifting restrictions on 14 drugs yesterday. With regard to paracetamol and Hydroxychloroquine (HCQ), they will be kept in a licensed category and their demand position would be continuously monitored. However, the stock position could allow our companies to meet the export commitments that they had contracted.”
The final decision to revoke the blanket ban was taken after an inter-ministerial meeting between the cabinet secretary, the health secretary, and representatives from the department of pharmaceuticals, which comes under the ministry of chemicals and fertilisers. With the latest decision, export of HCQ will be allowed on a case-by-case basis, after the manufacturers obtain a no-objection certificate from the government.
However, the latest decision has come in for criticism from the pharmaceutical industry and the health sector. Under the 25 March ban, the government had stopped HCQ exports but allowed companies to honour commitments already made, and added that the MEA would consider “humanitarian needs” on a case-to-case basis. As manufacturers were working on pre-existing orders, the 4 April notification of a blanket ban caught them unawares.
A health-rights activist, who wished to remain anonymous, told me, “Nobody can understand how that April 4 decision was taken. They simply deleted the exceptions they had made in the previous notification, and turned it into a blanket.” The activist added, “The industry was concerned because it’s their reputation at stake—no one wants to renege on their commitments, after having taken money in advance from countries that had placed the orders.”
The activist also expressed growing concern about Indian patients who will need the drug as well. The order came even as the number of positive cases of COVID-19 spiked in the country. At the time of publishing, India had recorded 4,312 active cases of the virus with at least 124 deaths, according to the ministry of health. In addition, the COVID-19 National Containment Plan has recommended HCQ for individuals in containment zones, and for caregivers of infected patients. “If the government is now saying they will allow exports, I hope they keep a close watch on the level of production, to ensure India’s national stockpile is not depleted. The government not only has to work closely with the industry but also has to allow health ministry to weigh in, instead of centralised decision being taken by MEA and the Prime Minister’s Officer,” the activist told me.
As demand for the drug soars, India, known as the pharmacy of the world for its capacity to make affordable generic drugs, has come under intense pressure to export drugs to different parts of the world. In the case of HCQ, demand for the drug sky-rocketed after Trump lauded it as a “Gift from God,” “the biggest game changers in the history of medicine,” and “miracle cure.” The US Food and Drug Administration has not approved any drug so far for the treatment of patients with COVID-19. Both, the World Health Organization and the USFDA have stated multiple times that more data is needed before HCQ can be recommended for treatment of COVID-19 patients. There are at least twelve clinical trials currently examining that very question in China, France, and the United States.
There is also a growing concern among activists that the export might result in shortages for patients already on HCQ for other diseases. “We have a lot of patients on this drug, including my mother. I hope the decisions do not result in shortages for people who need it for other ailments,” said Chinu Srinivasan, the co-convener of the All India Drug Action Network, a health watch dog.
Three domestic drug-manufacturers companies—IPCA Pharmaceuticals, Zydus Cadilla and Mangalam Drugs—make the raw material or ingredients required to manufacture HCQ. Apart from these three, two more firms, Cipla Pharmaceutical and Wallace Pharmaceuticals, manufacture HCQ. The companies have now assured the government that they will be able to meet domestic as well as export orders. “We have a national stockpile but that is based on projection of the past, when the drug was used for three conditions, not including coronavirus. We are in a comfortable position but our priority will be to meet domestic demands first. Our industry’s commitment to being the pharmacy of the world stands. We are nowhere withering from our responsibilities,” said Ashok Madan, the executive director of the Indian Drug Manufacturer’s Association.
Experts also see another big red flag fast approaching. What happens when the pandemic surges in India, and takes off in African nations in a month or two? “India is the pharmacy of the world but will we be able to meet the rising demands of a pandemic?” asked Srinivasan. He also raised another point, of whether the Americans would reciprocate India’s action on HCQ. He was referring to Remdesivir, which is the most promising treatment being developed for COVID-19. The drug is owned by the American pharmaceutical giant Gilead Science and is currently undergoing a multi-centre clinical trial. Srinivasan told me, “It also makes it amply clear that the world is a village. If India now helps American with HCQ, will they allow us access to Remdesevir?”
According to Srinivasan, “The pandemic just makes it clear that trade laws need to be revisited. They were one-sided—favouring rich nations, where pharmaceutical companies are based—even at the best of times.” He added, “Our governments should also be able to make drugs affordable in India’s national public health interest, for diseases like Tuberculosis and cancer. Patient monopolies on for life-saving drugs need to be urgently revisited in a way that is fair to India’s health needs.” An email, regarding these decisions, to the MEA, went unanswered. This story will be updated if and when the ministry responds.
In India, the scramble for HCQ is also being seen as a commentary on the lack of drug regulation in the United States. Even in the face of a raging pandemic, the Trump Administration tagged Remdesivir as an “orphan drug status.” This categorisation is generally reserved for drugs that treat rare illnesses and affect fewer than 2,00,000 Americans, and could potentially limit access to the drug. Following intense criticism, Gilead Science dropped the “orphan drug” designation, only two days after gaining the status from USFDA.
Watching these events from India, KM Gopakumar, a legal advisor to the Third World Network, a non-profit policy think-tank with special focus on the pharmaceutical industry, told me, “Is this a reciprocal relationship or will this continue to be an arm-twisting tactic in which American government will take what it wants, without consideration for the medical needs of other developing countries?” He added, “To be more specific, will the US government allow India to access Remdesivir at affordable prices, when it is ready?”