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Explained: What has led to a crippling shortage of Remdesivir? India News

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NEW DELHI: Amid an unprecedented surge in new Covid-19 infections, several states, including Maharashtra, Gujarat, and Delhi, have reported a shortage of the antiviral drug Remdesivir. The shortage prompted the government to halt the export of Remdesivir’s drug and active pharmaceutical ingredients (APIs) until the spread of Covid is contained.
As the country witnesses a fierce resurgence of the virus, so has the demand for this drug. Why can’t the supply chain keep up?
How was Remdesivir started to be used?
Remdesivir is an investigational antiviral drug to combat Sars-Cov 2, the virus that causes Covid-19. The U.S. Food and Drug Administration (FDA) approved Gilead Sciences Inc’s antiviral therapy Remdesivir in October 2020, making it the first drug to gain formal clearance to treat coronavirus disease.
How does Remdesivir help Covid-19 patients?
The medicine works by inhibiting a substance that the virus uses to make copies of itself. Certain kidney and liver tests are required before patients start using it to ensure that it is safe for them and to monitor for any possible side effects. The drug was first developed to treat Ebola, a viral hemorrhagic fever.
Based on research, the drug is known to reduce recovery time by five days, from 15 days to 10 on average, in a large study led by the US National Institutes of Health.
What WHO says about Remdesivir
The World Health Organization (WHO) had previously said that its global trial of Covid therapies found that Remdesivir did not have a substantial effect on the length of hospital stay of patients or the chances of survival. This study has not been reviewed by external experts. Gilead has questioned the potential for bias in the WHO study. Gilead has questioned the potential for bias in the WHO study.
India Booth on Using Remdesivir for Covid Treatment
India has approved Remdesivir under the National Clinical Management Protocol for Covid-19 which was developed after many interactions by a committee of experts. The protocol acts as a guiding document for the treatment of Covid-19 patients in India.
Refuting the claim made by the World Health Organization (WHO) about remdesivir, the main Covid-19 treatment group at Sawai Man Singh Medical College in Jaipur has said the drug has been effective in preventing mortality.
In the protocol, Remdesivir is listed as an investigational therapy, that is, where informed and shared decision-making is essential, in addition to taking note of the contraindications mentioned in the detailed guidelines.
How is the medicine priced in India?
Zydus has priced it at Rs 2,800 ($ 37.44) per 100mg vial in India. It is sold under the Remdac brand to public and private hospitals that treat patients with Covid-19.
How is Remdesivir administered to Covid-19 patients?
Remdesivir, which is given by injection, was one of the first drugs to show relative promise in shortening recovery time in some coronavirus patients. The medicine works by inhibiting a substance that the virus uses to make copies of itself. Certain kidney and liver tests are required before patients start using it to ensure that it is safe for them and to monitor for any possible side effects.
What has caused the shortage of the drug?

  • Reduction or interruption of production amid a small number of cases

One of the key reasons behind the current shortfall in supply is the reduction or interruption of production of the drug in January and February due to the low number of Covid-19 cases since December 2020 and the resulting low demand, sources said. the pharmaceutical industry. Manufacturers have said they are unlikely to get the numbers right away. “Manufacturers cannot risk having to carry large inventories, as Remdesivir has a short shelf life of six to eight months,” said a source from the pharmaceutical industry, confirming that production was low.

  • Demand skyrockets due to increased cases

The other reason for the crisis is the rapid increase in cases that appears to be more widespread.
“As of April 11, India has over 11.08 lakhs of active cases and they are steadily increasing. This has led to a sudden increase in demand for Remdesivir injection used in treating Covid patients,” the Ministry of Union Health.
“In the first wave, the impact of Covid and the demand for Remdesivir was restricted only to metropolitan areas and Tier 1 cities. But in this second wave, there is an increase in cases even in Tier 2, 3 cities and towns. and 4 because the distribution network is struggling to keep up with demand and Remdesivir stocks have dispersed, “said a senior official from one of the drug’s manufacturers.
“It is not just about scarcity. The increase in the second wave has been so rapid that it has resulted in a mismatch in the production curve and the demand curve, ”added an official from another pharmaceutical company.
Pharmaceutical industry officials insisted this is only a temporary situation and in the next week to 10 days about a couple million doses should hit the market.
What Indian companies make Remdesivir?
Currently, seven Indian companies are producing Injection Remdesivir under a voluntary license agreement with the US pharmaceutical company Gilead Sciences which holds the patent for the product. The companies are: Cipla, Dr Reddy’s Laboratories, Hetero Labs, Jubilant Life Sciences, Biocon’s Syngene, Zydus Cadila Healthcare and Mylan’s Indian unit.
What is the production capacity?
The Union Minister of State (Chemicals and Fertilizers), Mansukh Mandavia, said on April 7 that these companies had been asked to increase production. Currently, its production capacity is 31.60 lakh vials per month. Of the 31.60 lakh vials, Hetero produces 10.50 lakh vials per month, Cipla produces 6.20 lakhs and Zydus Cadila 5 lakhs.
What is the government doing about its acute shortage?

  • The government bans exports of Remdesivir

In the wake of growing demand for Remdesivir for the treatment of Covid-19 amid an increase in severe cases, the Center has banned exports of Remdesivir injection and Remdesivir active pharmaceutical ingredients (APIs) until improvement improves. Covid-19 situation in the country.

  • ‘Show stock and dealer lists’

In addition, companies have been asked to increase production of the drug and all local manufacturers of Remdesivir have been advised to display details of their stockists or distributors on their website to facilitate access to the drug.

  • Drug shortages gave way to black marketing

In recent days, some state governments have raised concerns about the hoarding and black marketing of Remdesivir, which in some cases sells for more than 10 times the maximum retail price. Drug inspectors and other officials have also been ordered to check stocks and verify their malpractices and also take other effective actions to curb hoarding and black marketing.

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