First anti-Covid pill to be launched soon in India, drug regulator reviewing data

First anti-Covid pill to be launched soon in India, drug regulator reviewing data

It is under review by the US Food and Drug Administration (FDA) for Emergency Use Authorisation (EUA).

Mumbai-based pharmaceutical company will be soon launching Merck Sharp Dohme and Ridgrback’s molnupiravir pill, the first oral antiviral Covid treatment, under the brand name ‘Molxvir’ in India

India’s drug regulator, the Drugs Controller General of India (DCGI), is currently reviewing clinical data of anti-Covid pill for the treatment among adults.

Sun Pharmaceutical Industries on Thursday said that they are waiting for the approval from the drug regulator.

“The recent authorisation of molnupiravir, licensed from MSD and Ridgeback, by the UK regulator is a positive step. In line with our consistent efforts to accelerate access to new drugs for COVID-19 treatment, we are gearing up to make Molxvir available to patients and healthcare providers across India at an economical price post-approval by DCGI,” Sun Pharma India Business CEO Kirti Ganorkar said in a statement.

Molnupiravir has already been approved by the UK Medicines and Healthcare products Regulatory Agency (MHRA) for the treatment of mild-to-moderate COVID -19 infection among adults.

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It is under review by the US Food and Drug Administration (FDA) for Emergency Use Authorisation (EUA).

Earlier this year, Sun Pharma had signed a non-exclusive voluntary licensing agreement with MSD to manufacture and supply molnupiravir in India and to over 100 low and middle-income countries (LMICs).

Molnupiravir, which is administered orally, reduces the ability of SARS CoV 2 (the virus that causes COVID-19) to multiply in the body.

It does this by increasing the number of alterations (mutations) in the virus’s genetic material (known as RNA), in a way that impairs the ability of SARS-CoV-2 to multiply.

Meanwhile, India recorded 12,516 new coronavirus infections, taking the country's total tally of Covid cases to 3,44,14,186, while the active cases declined to 1,37,416, the lowest in 267 days.

The number of deaths climbed to 4,62,690 with 501 fresh fatalities, according to the data.

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