HomeNewsTrendsHealthDCGI pulls up Glenmark for false claim on Favipiravir

DCGI pulls up Glenmark for false claim on Favipiravir

DCGI issued notices based on a representation by a Member of Parliament (MP), who complained about the cost of the drug and the false claims.

July 19, 2020 / 15:07 IST
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The Drug Controller General of India (DCGI) issued notices to Glenmark seeking clarification from the company regarding false claim that its antiviral drug Fabiflu, is effective on COVID-19 patients with co-morbodities.

"It has been mentioned in representation that Glenmark has claimed that this drug is effective in co-morbid conditions like hypertension, diabetes whereas in reality, as per protocol summary, this trial was not designed to assess the Fabiflu in co-morbid conditions. No clinically sufficient data specific to these conditions are available," said VG Somani, DCGI in the notice to the company.

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Fabiflu is the generic version of Favipiravir, which was approved by DCGI for treating mild COVID-19 patients in June.

Also Read: If Rouhani's COVID-19 numbers are true, Iran is heading for herd immunity

COVID-19 Vaccine
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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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