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Merck’s anti-COVID pill may get drug regulator nod soon

With data on over 700 patients submitted, the emergency-use approval to American pharmaceutical giant Merck’s anti-Covid pill Molnupiravir is likely to be given soon, the chief of the Covid Strategy Group at the Council of Scientific and Industrial Research (CSIR) told News18.com on Thursday.

Hailed as a “game-changer”, Merck has entered into voluntary licensing agreements with at least eight Indian drug makers, including Cipla, Dr Reddy’s Laboratories, Sun Pharma, Hetero, Aurobindo Pharma, and others, for the oral medication. Some of these drug makers have finished conducting the late-stage clinical trials and have submitted the data to the country’s apex drug regulator for a marketing nod.

Dr Ram Vishwakarma, chairman of the Covid Strategy Group, CSIR, said that Molnupiravir was one of the 24 molecules selected by the institute for repurposing against Covid-19. “Three CSIR institutes have already developed the processes and technologies which we are ready to share with as Indian pharma companies to add to the capacity of their manufacturing in India,” he said.

More ammo against Covid
Calling the anti-Covid19 pills by Merck and Pfizer “big breakthroughs”, Dr Vishwakarma said that the clinical trial data of Molnupiravir has been submitted to the Drug Controller General of India and the marketing approval is expected to come soon.

“Three CSIR institutes have already developed the processes and technologies which we are ready to share with Indian pharma companies to add to the capacity of their manufacturing in India,” he said. “The United Kingdom’s regulator has already approved the drug. Now we have both global and local data to consider. I am hopeful that the regulator will clear the drug soon for Indian patients. The data of more than 700 people have already been submitted for consideration.”

The antiviral medication is for the treatment of mild-to-moderate Covid-19 in adults with a positive SARS-CoV-2 diagnostic test and who have at least one risk factor for developing severe illness. The risk factors include obesity, older age (above 60 years), diabetes mellitus and heart disease.

Drug may cost just Rs 25 per tablet
A specialist in drug research and manufacturing, Vishwakarma is the director at CSIR’s Indian Institute of Integrative Medicine (IIIM). CSIR-IIIM plans to work with pharmaceutical companies to boost the manufacturing of Molnupiravir in India.

“Molnupiravir is a relatively simple molecule to manufacture involves just 3-4 step synthesis. It can be reasonably priced and availability should never be an issue,” he added while estimating that pharma companies can sell the drug for Rs 500-1000 per cycle which includes 15-20 tablets. “It is much simpler than the manufacturing of Remdesivir which was extremely difficult and consists of several steps including chiral synthesis.”

It’s the “AZT moment” for Covid-19 and nothing short of a “breakthrough”, he said.

“AZT was the first anti-AIDS drug that was launched in 1991 in the middle of a crisis when millions of patients were dying of AIDS across the globe. The successful results of anti-Covid pills of Merck and Pfizer are the biggest breakthrough in Covid times. It’s nothing short of developing a vaccine against Covid-19,” said Vishwakarma. News18