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COVID-19 drug | No approval yet for Indian companies to market remdesivir: Report

It is the only drug so far that has shown significant effect on patients infected with COVID-19.

June 03, 2020 / 09:00 AM IST

Indian pharmaceutical companies are yet to receive an approval to market remdesivir - the COVID-19 drug, the Business Standard has reported. It is the only drug so far that has shown significant effect on patients infected with novel coronavirus.

This comes despite the Indian drug regulator — the Central Drugs Standard Control Organisation (CSDSCO) — having granted conditional approval to Gilead Sciences to market the investigational drug.

Moneycontrol could not independently verify the report.

The conditional marketing authorisation for remdesivir was granted under an accelerated review process, considering the emergency situation and unmet medical needs in light of the novel coronavirus pandemic, Moneycontrol reported earlier.

Gilead Sciences' experimental drug Remdesivir has been found to aid in the recovery of COVID-19 patients.

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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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In India, the US-based company has licensing agreements for Remdesivir with four pharmaceutical companies — Cipla, Hetero Drugs, Jubilant Life Sciences and Mylan.

The newspaper report further suggests that firms have not yet approached the National Pharmaceutical Pricing Regulator (NPPA) formally to discuss pricing of the drug, which will be used on hospitalised patients.

Additionally, the Indian Council of Medical Research (ICMR), which will decide the dosage, it is yet to come up with an advisory.

It was also reported earlier that companies licensed to manufacture Remdesivir might have to sell it only to government institutions for now as the drug was still under trial.

Gilead Sciences is reportedly developing easier-to-administer versions of Remdesivir for COVID-19 that could be used outside of hospitals, including ones that can be inhaled, after trials showed moderate effectiveness for the drug given by infusion.

For critically-ill patients, Roche and Eli Lilly and Co are testing drugs in combination with remdesivir.
Moneycontrol News
first published: Jun 3, 2020 09:00 am

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