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COVID-19 | Hetero, Cipla get nod to manufacture, market antiviral drug remdesivir

Remdesivir, administered in the form of injection, should be given at a dose of 200 mg on day one followed by 100 mg daily for five days.

June 22, 2020 / 10:27 PM IST

India's Drug Regulator on June 20 gave permission to Hetero and Cipla to manufacture and market antiviral drug remdesivir for "restricted emergency use" on hospitalised COVID-19 patients, official sources said. This comes a day after the Drug Controller General of India (DCGI), considering the emergency and unmet need for medicines in light of the coronavirus outbreak, granted domestic firm Glenmark Pharmaceuticals the permission to manufacture and market favipiravir for "restricted emergency use" in mild to moderate cases.

"The approval to Hetero and Cipla was given on Saturday," a source said.

Hetero’s generic version of remdesivir will be marketed under the brand name ‘COVIFOR’ in India, as per the company's press release.

Written informed consent of each patient is required before the use of remdesivir and results of additional clinical trials, active post-marketing surveillance data and reporting of serious adverse events have to be submitted.

The Union health ministry, in its 'Clinical Management Protocols for COVID-19', recommended the use of the remdesivir on patients in moderate stage of the disease that is, those on oxygen. The drug has been included as an "investigational therapy" only for restricted emergency use purposes.

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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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It is not recommended for those with severe renal impairment and high level of liver enzymes, pregnant and lactating women, and those below 12 years, the document on 'Clinical Management Protocols for COVID-19' stated.

The drug, administered in the form of injection, should be given at a dose of 200 mg on day one followed by 100 mg daily for five days.

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Cipla and Hetero Labs have already entered into non-exclusive licensing agreements with US pharma giant Gilead Sciences, which is the patent holder of the drug remdesivir.

Gilead Sciences had applied to the Indian Drug Regulatory Agency, CDSCO, for import and marketing of Remdesivir on May 29. After due deliberations, permission under emergency use authorization was granted by DCGI on June 1 in the interest of patient safety and obtaining further data.

Besides Hetero and Cipla, three other firms BDR, Jubilant, Mylan and DR Reddy's Labs have also applied to CDSCO for permission to manufacture and market the drug in India and are still awaiting permission.

These applications are being processed by the CDSCO in accordance with the laid down procedures. The companies are at various intermediate stages of inspection of manufacturing facilities, verification of data, stability testing, emergency laboratory testing as per protocol etc, the health ministry had earlier said.

Being an injectable formulation, testing for assay, identity, impurities, bacterial endotoxin test and sterility become very critical for patient safety and this data need to be provided by the companies, the ministry had said.

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PTI
first published: Jun 21, 2020 10:58 am
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