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Torrent Pharmaceuticals Ltd on Tuesday said it would sell MSD (Merck & Co., Inc, Kenilworth, NJ, USA) and Ridgeback’s oral anti-viral drug molnupiravir under the brand name Molnutor in India.
Late on Monday night, the Drugs Controller General of India (DCGI), based on the review of clinical data of Molnupiravir, granted restricted emergency use authorisation for the drug to treat Covid-19 in adults with SpO2 > 93% and who have high risk of progression of the disease, including hospitalisation or death.
The development comes after Torrent Pharma inked a non-exclusive voluntary licensing pact with MSD earlier this year for the right to manufacture, distribute and market Molnupiravir in more than 100 low- and middle-income markets, including India, for treatment of Covid-19.
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Gets DCGI nod to manufacture and market an investigational oral antiviral.Cipla Ltd, on the other hand, plans to launch Molnupiravir under the brand name Cipmolnu. Cipla will soon make Cipmolnu® 200mg capsules available at all leading pharmacies and Covid treatment centres across the country. The company has adequate manufacturing capacities and a solid distribution mechanism in place to ensure speedy access to this effective treatment pan-India, the company informed in a regulatory filing on Tuesday.
Also, Sun Pharmaceuticals informed that it will sell Molnupiravir in India under the brand name Molxvir. “Molnupiravir is an important addition to the portfolio of oral therapies available for treating Covid-19 patients,” said Kirti Ganorkar, CEO of India Business, Sun Pharma. The recommended dose of the drug is 800 mg twice a day for five days. The duration of treatment of molnupiravir is much shorter compared to other therapies, which is a significant advantage as it reduces the pill burden and enhances compliance.
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The drug, molnupiravir, could provide a much-needed weapon against the virus as colder weather pushes case counts higher.None of the companies have disclosed the price of the drug or their manufacturing capacities for the same.
Notably, in June this year, in a unique alliance between the drug makers, India's five leading pharma majors including Cipla Ltd, Dr Reddy’s Laboratories Ltd, Emcure Pharmaceuticals Ltd, Sun Pharmaceutical Industries Ltd and Torrent Pharmaceuticals Ltd collaborated to conduct clinical trials of the investigational oral anti-viral drug Molnupiravir for treatment of mild Covid-19 infections.
The Subject Expert Committee (SEC) of the Central Drugs Standard Control Organisation had issued directives then, under which Dr Reddy’s would conduct the clinical trial using its product, and the other four pharma companies would be required to demonstrate equivalence of their product to the product used by Dr. Reddy’s in its clinical trial.
Molnupiravir is the oral anti-viral that inhibits the replication of multiple RNA viruses, including SARS-CoV-2. The investigational drug is approved by the UK Medicines and Healthcare products Regulatory Agency (MHRA) and the US Food and Drug Administration (FDA) for Emergency Use Authorisation (EUA) for the treatment of mild-to-moderate Covid-19 in adults.
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