Sun Pharma Ltd and Cipla Ltd have received emergency use authorisation (EUA) from Drug Controller General of India (DCGI) to market and manufacture antiviral drug Molnupiravir in India.
Molnupiravir is developed by US-based biotechnology company Ridgeback in collaboration with US Pharma giant Merck.
Meanwhile, Torrent Pharma has also said it will launch the Molnupiravir drug under the brand name Molnutor in India.
Earlier this year, Sun Pharma, Torrent Pharma and Cipla had signed a non-exclusive voluntary licensing agreement with Merck to manufacture and supply a generic version of molnupiravir in over 100 low and middle-income countries (LMICs) including India.
The DCGI, based on the review of clinical data of molnupiravir has approved the drug for treatment of adult patients with Covid-19, with SpO2 > 93% and who have high risk of progression of the disease including hospitalisation or death.
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.
The regulatory approval comes on the back of a five-month collaborative trial conducted by a consortium of companies. Molnupiravir will be manufactured in India by a total of 13 companies for restricted use under emergency situation for treatment of adult patients with Covid-19.
Molnupiravir is the oral antiviral approved by the UK Medicines and Healthcare products Regulatory Agency (MHRA) and US Food and Drug Administration (FDA) for emergency use authorisation for the treatment of mild-to-moderate Covid-19 in adults.
The antiviral drug has been shown to reduce hospitalisations and deaths by around 30% in a clinical trial.
India's vaccination drive so far has been dominated by a domestically produced version of the AstraZeneca Covid-19 shot by Serum Institute and Bharat Biotech's inactivated vaccine Covaxin.
India has so far administered 143 crore Covid-19 vaccine doses and 62% of its eligible population have received both doses. The country plans to start vaccinating those aged 15-18 from 3 January.
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After Cipla, Sun Pharma gets DCGI nod to launch Merck's Covid drug in India - Mint
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