New Delhi | Jagran News Desk: The Central Drugs Standard Control Organisation (CDSO) on Tuesday cleared country’s first anti-viral COVID-19 pill: Molnupiravir. Developed by the US-based biotechnology company Ridgeback Biotherapeutics along with US pharmaceutical giant Merck. Molnupiravir will now be manufactured by 13 Indian drug manufacturers.
The drug, in India, has been cleared for the treatment of adults patients with Covid-19 and “who have a high risk of progression of the disease”.
Molnupiravir, an antiviral drug, will now be manufactured in the country by 13 companies for restricted use under emergency situation for treatment of adult patients with COVID-19 and who have high risk of progression of the disease. (4/5)— Dr Mansukh Mandaviya (@mansukhmandviya) December 28, 2021
Which Indian pharma players will manufacture Molnupiravir?
Dr Reddy's Laboratories in consortium with Cipla, Mylan, Torrent, Emcure and Sun pharma had presented their proposal for approval of Molnupiravir 200mg capsules for approval in emergency situation along with various supporting documents including clinical data in the country, official sources were quoted as saying by news agency PTI.
How the drug will be sold in retail and to whom?
As per conditions, the drug should be sold by retail only under prescription of medical specialists. According to the conditions, the drug is not authorised for use in patients less than 18 years and for initiation of treatment in patients requiring immediate hospitalisation due to COVID-19 at that stage.
However, if it was initiated before hospitalisation due to COVID-19, it may be continued, news agency PTI had quoted its sources as saying.
The drug is, however, not authorsied for use for longer than five consecutive days and for pre-exposure or post exposure prophylaxis for prevention of COVID-19 for pregnant women.
The US Food and Drug Administration recently authorised Merck's Molnupiravir for treatment of mild-to-moderate COVID-19 cases in adults who are at risk for severe disease.
Before that in November, Britain granted conditional authorisation to Merck's coronavirus antiviral, the first pill shown to successfully treat COVID-19. The pill is intended to be taken twice a day for five days by people at home with mild to moderate COVID-19. In a clinical trial of high risk people during the early course of illness, Merck's drug was shown to reduce hospitalisations and deaths by around 30 per cent.
Earlier on November 4, the United Kingdom became the first country to approve Molnupiravir. The UK regulator said, “This prevents it from multiplying, keeping virus levels low in the body and therefore reducing the severity of the disease,” the Medicines and Healthcare products Regulatory Agency (MHRA) said.
With inputs from PTI
Posted By: Mukul Sharma