In the next few weeks, India will face a grim reckoning with the coronavirus pandemic as it accelerates in every corner of the nation. Through April and May, the Narendra Modi-led government’s policy to restrict testing has fuelled the pandemic, and as July approaches, the worst of the outbreak is unfolding in the country’s hospitals.
All through June, coronavirus patients have had a slow, horrible realisation that the Indian government did not have a single vial of a one of the few promising experimental drugs being used to treat the disease: Remdesivir. The drug, patented by American pharmaceutical giant Gilead Sciences, first emerged as a possible treatment in January, when it showed anti-viral activity in COVID-19 patients in China. By May, it had gained a reputation for reducing the recovery time of COVID-19 patients after the New England Journal of Medicine published a study stating Remdesivir shortened the duration of the illness by four days. In India, however, the government had failed to anticipate the demand for the drug, and create a stockpile, despite granting an emergency, sweetheart deal to Gilead Sciences.
On 1 May, the United States Food and Drug Administration approved Remdesivir for “emergency use,” and Gilead Sciences, which had 1.5 million doses in its stockpile, gave the majority of it to the US. That’s when other nations truly began scrambling for the drug.
I tracked the journey of one Indian patient who was prescribed Remdesivir by a hospital. The patient’s family went on a roller coaster journey to access the drug, running from pillar to post, as the patient’s health deteriorated. The family’s journey exemplifies the struggles of Indian patients being prescribed Remdesivir.
To blunt concerns raised by activists and patients, Gilead Sciences announced, on 12 May, that it had entered into agreements—known as voluntary licenses—with Indian manufacturers who could produce and market generic versions of the drug. Gilead’s Indian licensees are Cipla, Hetero Labs, Zydus Cadila Healthcare, Dr Reddy’s Laboratories, Jubliant Lifesciences, and Mylan.
Subsequently, on 1 June, the Drugs Controller General of India approved the drug for emergency use in the country. On 13 June, the health ministry came out with guidelines on the use of Remdesivir—it allowed the drug to be used to treat moderately-ill patients. By 20 June, only two of the licensees—Cipla and Hetero Labs—had marketing approvals from the DCGI. All along, doctors had been prescribing patients Remdesivir injections, compelling families to turn either to Bangladesh, where it was available, or procure it from the grey market.
Pratibha Sivasubramanian, a legal researcher for the Third World Network, a non-profit advocating for access to affordable medicines, told me that the shortage of the drug— especially in cities like Delhi and Mumbai which are epicentres of the outbreak—had given rise to a grey market. “I heard Remdesivir was available in the grey market for the first time around the end of May,” she said. “Initially, I didn’t pay attention, but then I heard patients were getting it. Once Bangladesh started manufacturing it, around May, I have consistently been hearing of the black market where families are buying.”
Remdesivir was registered in Bangladesh in May, and Bangladeshi companies started making it available domestically immediately after approval. As the drug was not available in India from Gilead Sciences, the only registered supplier, it was being imported from Bangladesh, for “personal use” by individual patients. For this, families had to apply for an import license from the Indian drug regulator, approach a Bangladeshi manufacturer, and then arrange for patient's family or friends to hand-carry the drug into India.
Sivasubramaniam added that she was increasingly concerned at the kinds of hoops the families were having to jump through. The kicker was when she realised what the drug was costing in the grey market. “Families were paying upto Rs 40,000 per vial,” she told me. “This is super crazy. The vial should cost around Rs 70 if we go by manufacturing costs. If you include profit margins, it should cost Rs 150. This is a pandemic and, the hospitals, pharmaceutical companies, and the government are all taking advantage of the vulnerability of families. This is complete profiteering from the pandemic.” The cost estimates are from a study conducted by Andrew Hill, a senior research fellow at the University of Liverpool, who found that the drug could be made for less than $1 a day.
Sivasubramaniam compared what was happening in India it to the “Wild West,” especially drawing a comparison to the early days of the HIV epidemic, where patients would procure experimental and unregistered drugs, out of desperation. The 2013 movie “Dallas Buyers Club” captured the journey of an electrician in Dallas called Ron Woodroof, who was diagnosed with HIV in the 1980s. Since the treatment was still experimental and not available in the United States, Woodroof started procuring an antiretroviral drug called Zidovudine, from a Mexican Hospital. As India awaits generic supplies of Remdesivir, Indian patients have found themselves in an eerily similar situation.
The patient I tracked was critically ill and on a ventilator at Fortis Hospital’s Vasant Kunj facility in South Delhi, when the family was asked to procure Remdesivir. After briefly considering the black market, the family decided to approach the DCGI for an import license, pulling every string along the way, including reaching out to Gilead Sciences, and to the Bangladeshi pharmaceutical firms manufacturing Remdesivir. The patient’s family refused to participate in interviews, and requested that the identity of the patient be withheld. I spoke to the family’s lawyer, who assisted them through the process of acquiring the drug. He too spoke on the condition of anonymity. “They started with all sorts of anti-viral drugs,” the lawyer told me, referring to the hospital. “When that did not work, at the last stage, they prescribed Remdesivir, and told us if we can arrange from somewhere, on compassionate grounds, it could help the patient. Then we found out that it is so difficult to arrange this medicine.”
He continued, “We made a few calls and found that drug was costing between Rs 50,000-60,000 per vial, in the black market. We considered getting it from the grey market but eventually decided to get the drug through the proper channels.”
The lawyer reached out to Sivasubramaniam for assistance. “He wanted me to get in touch with the Bangladeshi pharmaceutical company making this drug, and help the family import it,” she said.
The lawyer told me that he further wrote to VG Somani, the drugs controller general of India, seeking an import license to procure the drug from Bangladesh. Somani heads the Central Drugs Standard Control Organisation, the country’s apex drug regulatory body. On 15 June, the patient was granted an import license. The family then approached Beximco Pharmaceuticals, a Bangladeshi company, to procure the drug and were in the process of bringing the drug to India. However, the patient died.
In the interim, on 14 June, the lawyer had also written to Gilead Sciences, requesting the medicine on compassionate grounds. He said he was shocked at the company’s response. “They said they are not looking at supplying anything to India right now,” the lawyer told me.
In its response to the lawyer, the company’s Medical Information Centre wrote, “While we have been able to provide emergency access to remdesivir outside of clinical trials in some countries via individual compassionate use requests, this has not been feasible in India.” Towards the end of the response, Gilead directed the family to try their luck with its Indian licensees. Gilead Sciences did not respond to questions I sent them about why it was not “feasible” to supply to Indian markets, and why the company had not allocated doses for India from its 1.5 million doses.
Preeti Sudan, the union health secretary, also did not respond to questions on when Remdesivir will be available in Indian markets and what the health ministry is doing to regulate the grey market. I also emailed Somani asking how many individual patients had been granted “personal use” import licenses. Despite a reminder, the query was not answered. This report will be updated if the government agencies respond.
On 23 June, I spoke to KM Gopakumar, a legal advisor for the Third World Network. “Legally speaking, patients at this point can only get Gilead’s drug,” he said. “Though Gilead got the marketing approval on 1 June, in the absence of marketing approval for generic producers, patients had depended on the costly Gilead products or the grey market to access the generic products from neighbouring countries. Thus patients were exposed to economic exploitation.”
Indian patients as well Indian activists I spoke to said they were alarmed that Gilead Sciences left patients high and dry, despite getting a sweetheart deal from the Indian government. The company got extraordinary fast registration for Remdesivir. They applied to register the drug on 29 May. On 1 June, it was registered in India.
Leena Menghaney, a lawyer who works on medicine law and policy, emphasised that the US corporation received approval within days of its application to the Indian drug regulator. “The government could have requested for supplies to cover emergency use till generic dossiers undergoing review for quality could be approved,” she said. “By not insisting on supplies for India, the government undermined the principle of equitable allocation between wealthy and developing countries of much needed COVID-19 drugs and vaccines.” She added, “The US corporation got away scot-free and shifted the blame and attention to the CDSCO and generic manufacturers regarding Remdesvir supply in India.”
Among Gilead’s Indian licensees, Cipla and Hetero Labs are now leading the pack in the race to supply the drug. In a press release, Hetero said it would price its generic version of Remdesivir at Rs 5,400 per vial. In the NEJM study, adult patients were prescribed Remdesivir for upto 10 days. “It is very sad to see that the generic companies are doing the same things that multi-national pharmaceutical companies did during the HIV epidemic, that is, charging exorbitant prices,” Anand Grover, a senior advocate and patent law expert, said.
As of 28 June, India had reported 5,12,763 COVID-19 cases and 16,095 deaths. As cases intensify, India—often known as the pharmacy of the world for its capacity to manufacture affordable medicines—is having to rely on Bangladesh. Meanwhile, patients who suffered the consequences of the government not stockpiling the drug, will now be paying outrageous amounts in the coming weeks for the generic, Indian-made Remdesivir.
Referring to the patient on the ventilator who had imported Remdesivir from Bangladesh, Sivasubramanian added, “Imagine, if this family did not know a lawyer, or could not reach activists like me. Imagine an ordinary patient, with no connection to lawyers or the pharmaceutical industry, and they were prescribed this drug, where will they go?”
Correction: An earlier version of this story misidentified the name of the Bangladeshi company that the family approached to procure the drug. The company is Beximco Pharmaceuticals. The copy has been updated to more accurately reflect that the family was ascertaining the logistics of transporting the drug into India, but the patient died. The Caravan regrets the error.