Drug makers have urged the government to remove export curbs on Remdsivir to clear bulging inventories as demand for the anti-viral jab given to hospitalised patients of COVID-19, has fallen sharply.
Manufacturers had aggressively expanded capacity to meet the sudden surge in demand during the second wave of the novel coronavirus pandemic.
"Things are unpredictable during a pandemic like COVID-19. We have expanded capacities responding to the government’s call," said Dharmesh Shah, Chairman of BDR Pharmaceuticals, which manufactures Remdesivir for Cipla.
"The government will have to do a stockpile just to ensure that we are not stranded in case of a third wave. I think the government has done strategic provisioning of the drug, now that there is no demand, it should allow exportation, to allow us clear inventory," Shah added.
In April, the government 'prohibited' the export of Remdesivir. Aware of falling domestic demand on June 14 it moved the drug to 'restricted' category, which means the manufacturers can export the drug but have to get certain clearances from relevant authorities. Manufacturers now want to remove these restrictions as well.
With adequate supplies all around, some states have cancelled purchase orders worth 4.63 lakh vials in mid June.
Falling demand
Remdesivir is produced by seven companies -- Cipla, Hetero, Cadila Healthcare, Dr Reddy's, Jubilant, Syngene and Mylan in license from US drug maker Gilead. Most of these companies rely on other manufacturers for supply of API and to do fill and finish.
According to the government, domestic production capacity was augmented from 38 lakh vials per month towards the end of March to nearly 122 lakh vials per month with the accelerated approval of 40 additional manufacturing sites by the Drug Controller General of India (DCGI) taking the number of sites to 62.
An official of a company manufacturing Remdesivir told Moneycontrol that they are sitting on a few lakh doses of inventory.
"My phone used to ring all the time, from the states, hospitals and individuals, now I don't get calls anymore because it is freely available," the executive above said.
New COVID-19 cases in India have fallen to less than 40,000 a day from 4 lakh during the peak of the second wave of the pandemic in the first week of May. Remdesivir is given to moderate to severe COVID-19 hospitalised patients. About 10-15 percent of COVID-19 cases end up in hospital. A patient would require 5-6 injections of Remdesivir.
Building buffer
The Centre took over the allocation of Remdesivir on April 21 to ensure fair and equitable distribution across the country for an interim period till production was ramped up and the drug became adequately available in the market.
The government has made a cumulative allocation of 98.87 lakh vials of Remdesivir to states, union territories and Central Health Institutions from April 21 to May 30, 2021. It discontinued the centralised allocation citing decrease in the number of active cases and sufficient availability at the end of the May 2021.
The government, in its latest affidavit filed on June 26 before the Supreme Court, said it had started providing the drug to the states through the central procurement, to build adequate stocks for future contingencies.
"Moreover, close coordination continues to be maintained with manufacturers to maintain adequate stocks of drug and raw materials to enable quick ramp up of production in case of any future sharp surge in demand," the government said.
The Supreme Court is hearing a suo motu writ petition on the government's COVID-19 response.
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