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Natco gets CDSCO nod for emergency use of Baricitinib tablets for COVID-19 treatment

CDSCO is responsible for approval of drugs, conduct of clinical trials, laying down the standards for drugs, control over the quality of imported drugs in the country and coordination of the activities of state drug control organisations.

May 03, 2021 / 11:19 AM IST
 
 
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Drug major Natco Pharma on Monday said it has received emergency use approval for Baricitinib tablets, for the treatment of COVID-19 positive patients, from the Central Drugs Standard Control Organization (CDSCO) in India.

CDSCO is responsible for approval of drugs, conduct of clinical trials, laying down the standards for drugs, control over the quality of imported drugs in the country and coordination of the activities of state drug control organisations.

'Natco Pharma Ltd has received emergency use approval for Baricitinib tablets, 1mg, 2mg and 4mg strengths from Central Drugs Standard Control Organization (CDSCO) in India,' the company said in a regulatory filing.

Baricitinib in combination with Remdesivir, is used for treatment of COVID-19 positive patients, the company said.

Natco said it will request a compulsory license based on emergency use and in light of the grave and serious public health emergency across India due to the pandemic.

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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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The company is ready to launch the product this week, so as to make the product available to suffering patients across India, it added.

Shares of Natco Pharma were trading 3.35 per cent higher at Rs 926.70 apiece on BSE.
PTI
first published: May 3, 2021 11:19 am

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