What's behind India's Remdesivir shortage? Indiscriminate use, hoarding and black markets
India on Sunday halted the export of anti-viral drug Remdesivir and its active pharmaceutical ingredients used in Covid-19 treatment, in the wake of a sudden spike in demand due to a steady rise in coronavirus disease cases across the country. In an official press release, the central government said it is expecting a "further increase in demand" for the drug in the coming days. The World Health Organization (WHO) last year in November found no evidence that the drug improved survival and other outcomes in Covid-19 patients.
Several states in India have reported a shortage of the drug following a rise in its demand amid a record surge in Covid-19 infections across the country.
Here's a brief timeline, mapping the drug's journey:
Remdesivir, originally developed to treat hepatitis C and subsequently tested against Ebola, initially made the headlines during the early stages of research into the coronavirus disease treatment. It was WHO that first hit the brakes on Remdesivir's prospects on November 20 last year, recommending that doctors avoid using the drug altogether.
"There is currently no evidence that Remdesivir improves survival and other outcomes in these patients,” the WHO noted, citing detailed studies it sponsored. “The evidence suggested no important effect on mortality, need for mechanical ventilation, time to clinical improvement, and other patient-important outcomes.” Even so, Gilead Sciences Inc, the drug's manufacturer, pushed back, saying it stood by Remdesivir and citing other studies supporting its efficacy.
Gilead, which manufactures the drug under the brand name 'Veklury', issued a statement saying that it was "disappointed" in the WHO guidelines, which the company said ignored “robust evidence” from multiple randomised, controlled studies published in peer-reviewed journals that demonstrate its benefits. The company also listed key findings from the National Institute of Allergy and Infectious Diseases’ (NIAD) ACTT-1 trials, which showed that the drug led to a "five-day faster recovery in hospitalized patients overall, and a seven-day faster recovery in people who required oxygen support at baseline, compared with placebo." The findings from these trials were peer-reviewed and published in the New England Journal of Medicine, the company said, adding that the anti-viral drug's inclusion has been supported in multiple treatment guidelines. The data has also supported regulatory approvals or temporary authorisations to treat Covid-19 in approximately 50 countries worldwide, it said.
Speed is prized in the race to beat back Covid-19. In December later that year, researchers from University of Cambridge in the United Kingdom, gave the drug to a patient with Covid-19 and a rare immune disorder and observed a dramatic improvement in his symptoms and the disappearance of the virus. The journal Nature Communications carried the new study, and soon several countries, including India, were reported to be using the drug, banking on the insight. Remdesivir, researchers suspected, was likely to be the most beneficial when administered early in infection, before the virus is able to trigger a potentially catastrophic immune response.
As Covid-19 cases in India surged, so did the demand for Remdesivir and with it came indiscriminate usage, hoarding, and black marketers, causing artificial shortage to jack up prices. In a press conference this week, Maharashtra health minister Rajesh Tope said that the drug was being used indiscriminately without following appropriate official protocols. "The state is getting 50,000 doses every day and all of them are being consumed, leading to the shortage," said Tope, adding, "Pharmacists and stockists might be doing black marketing and that needs to be checked."
The anti-viral dose was being used to treat Severe Acute Respiratory Syndrome (SARS) patients before it was directed for Covid-19 treatment last year. Currently, doctors and hospitals are prescribing the injection even for those suffering from the mild problem of breathlessness, Tope said, adding that it’s a violation of the protocol. The minister directed all district officials to ensure that every injection is used judiciously and cap the prices to check illegal hoarding.
The owner of a medical store in Maharashtra's Parbhani district was arrested last Thursday for selling a single vial of Remdesivir for ₹6000, a much higher price than the MRP of ₹4800. To overcome a panic over the shortage of Remdesivir and to prohibit the black marketing and stocking of the drug, hospitals in Pune have been asked to provide the injection to the patients as opposed to their family members or relatives buying the drug.
The issue is not just limited to Maharashtra. As per a Reuters report, India's drug regulator, the Central Drugs Standard Control Organisation (CDSCO), and several state governments in the recent days raised concerns over the hoarding and black marketing of Remdesivir, which in some instances is being sold at over 10 times the maximum retail price. Social media posts on Sunday showed large queues of people in the western state of Gujarat waiting to buy Remdesivir injections for Covid-19 patients. Madhya Pradesh, too, had people queueing up outside medical stores for the drug, with some of them, agitated at not getting it, blocking a road in Indore for a brief period on April 9.
Presently, seven Indian companies have licensed the drug from Gilead Sciences, with an installed capacity of about 3.9 million units per month, for local use. In a statement, the government asked manufacturers to step up supplies and informed that for now, the export of Remdesivir will remain banned "till the situation improves".