Covid-19: Remdesivir output to be doubled to 7.4 mn doses by April-end

18 new sites get DCGI consent to make antiviral used for treating Covid-19

India’s Remdesivir shortage may be shortlived as a stock of 7.4 million doses is likely to be available by the end of this month or the first week of May, claimed sources.

The seven manufacturers who have a licence from US drug company Gilead Sciences, Inc. to make this investigational injectable drug have been given approval by the drug regulator to activate 18 new sites where they can make Remdesivir.

This will enable them to produce an additional 3.5 million doses per month, doubling the existing installed capacity of 3.8 million doses per month.

Clinical trials have shown that the antiviral drug, originally developed for Ebola, may help speed up the recovery time of Covid-19 patients with moderate to critical symptoms.

“Work has been happening on a war footing to ensure Remdesivir production is ramped up. India was making 2.7 million doses per month in March, which has already been scaled up to 4.1 million. By the end of this month, an additional 3.5 million doses per month capacity will come onstream, taking our total manufacturing capacity to 7.4 million doses per month,” explained a senior government official.

Daily supplies have already more than doubled. From around 70,000 doses per day hitting the market as on April 10, supplies have now touched 140,000-200,000 doses per day.

“Twice last week, supplies touched 200,000 doses in a day,” said a source close to the development. Last week, around 400,000 doses were diverted from the scheduled export plan.

On top of this, the Drugs Controller General of India has also allowed some relaxations in the production process requirements, needed to meet regulatory compliance, to speed up supplies.

“Typically, a batch of Remdesivir takes 15 days to make. This includes sterility testing requirements. If a manufacturer is using a certain type of sterile equipment in manufacturing, this testing requirement can be bypassed for now. This can halve the time required to make one batch,” said another government official.

Jagannath Shinde, chairman of the All Indian Origin Chemists & Distributors, the umbrella organisation of chemists and pharmaceutical distributors covering over 800,000 outlets across the country, said supplies have started to increase.

“By next week, several batches will hit the market. In May, we expect to have a surplus of Remdesivir in the market,” said Shinde, adding, “Cadila Healthcare alone has promised to supply 2 million doses in May. Regular supplies are available from Cipla and Hetero too. Things will ease up soon.”

He said that in Maharashtra, district collectors have now formed committees that are looking into the distribution and allotment of the drug. “For example, I run a distribution agency in Kalyan. I have been asked to distribute to 60 hospitals in the area,” said Shinde.

The government is trying to ensure that Remdesivir supplies reach hospitals directly. This will curtail the current situation where Covid-19 patients’ relatives try to source it on the black market.

The national pricing regulator said on Saturday that manufacturers have voluntarily announced a price reduction. Currently, the price ranges between Rs 899 per vial and Rs 3,490 per vial, depending on the brand. Earlier, they were Rs 2,800-5,490 per vial.  

A government official in Delhi added that while supplies would improve soon, it was important to ensure judicious use of the drug, namely, only for hospitalised patients. “If people in home-care are prescribed, there will never be enough supplies in India,” he said.

The health ministry has urged doctors firmly to prescribe it only to hospitalised patients on oxygen support and no one else.

Supplies of the drug ran short in April for two reasons: manufacturers had cut down production after coronavirus cases started to decrease and even when they realised demand was going to rise, along with rising cases, the fact is that it still takes a fortnight to make a batch.

Since its launch around July last year, about Rs 510 crore worth of Remdesivir had been sold up to January 2021. Sales started to slip soon after as India’s caseload fell.

According to the data from pharmaceutical market research firm AIOCD Pharmasofttech AWACS, Remdesivir recorded monthly sales of Rs 124 crore last November. By January, this had fallen to Rs 41 crore.