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Government fast tracks approvals for Remdesivir capacity expansion; firms commit to cut price

The current total installed capacity of the seven manufacturers of Remdesivir is 38.80 lakh vials per month.

April 14, 2021 / 07:12 PM IST
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The government on Wednesday after reviewing the supply and demand situation of Remdesivir with manufacturers and other stakeholders, decided to fast track approvals to raise production by 10 lakh vials per month.

Manufacturers of Remdesivir have also volunteered to reduce the price to less than Rs 3,500 per vial by the end of this week, to support the efforts of the government in the fight against COVID-19 second wave.

The current total installed capacity of the seven manufacturers of Remdesivir is 38.80 lakh vials per month.

Fast-track approval has been given for seven additional sites having the production capacity of 10 Lakh vials /month to six manufacturers.

Seven manufactures Cipla, Hetero, Dr Reddy's, Zydus Cadila, Jubilant, Mylan and Syngene have licenses from US drug maker Gilead to manufacture and export the drug in 127 low and middle income countries.

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COVID-19 Vaccine

Frequently Asked Questions

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How does a vaccine work?

A vaccine works by mimicking a natural infection. A vaccine not only induces immune response to protect people from any future COVID-19 infection, but also helps quickly build herd immunity to put an end to the pandemic. Herd immunity occurs when a sufficient percentage of a population becomes immune to a disease, making the spread of disease from person to person unlikely. The good news is that SARS-CoV-2 virus has been fairly stable, which increases the viability of a vaccine.

How many types of vaccines are there?

There are broadly four types of vaccine — one, a vaccine based on the whole virus (this could be either inactivated, or an attenuated [weakened] virus vaccine); two, a non-replicating viral vector vaccine that uses a benign virus as vector that carries the antigen of SARS-CoV; three, nucleic-acid vaccines that have genetic material like DNA and RNA of antigens like spike protein given to a person, helping human cells decode genetic material and produce the vaccine; and four, protein subunit vaccine wherein the recombinant proteins of SARS-COV-2 along with an adjuvant (booster) is given as a vaccine.

What does it take to develop a vaccine of this kind?

Vaccine development is a long, complex process. Unlike drugs that are given to people with a diseased, vaccines are given to healthy people and also vulnerable sections such as children, pregnant women and the elderly. So rigorous tests are compulsory. History says that the fastest time it took to develop a vaccine is five years, but it usually takes double or sometimes triple that time.

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Another 30 lakh vials/month production is lined up. This would ramp up the production capacity for manufacturing to around 78 lakh vials/month.

As an additional measure, Remdesivir, API and formulation were placed under Export ban on April 11  by the government to increase the supply of Remdesivir in the domestic market.

"On Government intervention, Remdesivir supplies of approximately 4 lakh vials meant for export is being diverted by manufacturers to fulfil domestic requirement," the government said in a release.

Manufactures of Remdesivir have been directed to give priority to fulfil hospital level supplies.

The Export Oriented Units are also being enabled to supply to the domestic market.

Mansukh Mandaviya, Minister of State, For Ports, Shipping and Waterways (Independent Charge) and Chemicals& Fertilizers, Government of India in met all-existing manufacturers of the Remdesivir drug and other stakeholders on 12th and 13th April 2021, where decisions have been taken to increase production/supply and reduce prices of Remdesivir.

Enforcement Authorities of States and Central government have been directed by the Drug Controller General of India (DCGI) to take immediate action on incidence of black-marketing, hoarding and overcharging of Remdesivir.

National Pharmaceutical Pricing Authority (NPPA) is continuously monitoring the availability of Remdesivir.

Remdesivir used in the hospitalised COVID-19 patients, who need 5-6 injections.

 
Viswanath Pilla is a business journalist with 14 years of reporting experience. Based in Mumbai, Pilla covers pharma, healthcare and infrastructure sectors for Moneycontrol.
first published: Apr 14, 2021 07:12 pm

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