Bitter Pill: Oral Anti-Covid Drug Molnupiravir Has Major Safety Concerns, Says ICMR Chief
3 years ago

Bitter Pill: Oral Anti-Covid Drug Molnupiravir Has Major Safety Concerns, Says ICMR Chief

News 18  

Molnupiravir, the first oral anti-Covid drug, has major safety concerns, said the head of the Indian Council of Medical Research on Wednesday. Thirteen Indian pharmaceutical companies, including Cipla, Sun Pharma and Dr Reddy’s Laboratories, are manufacturing the drug, which is being developed by US-based biotechnology company Ridgeback Biotherapeutics in collaboration with American pharma giant Merck. Bhargava clarified that while the panel has debated over the use of drugs twice and discussions continue, “we have concerns about the drug and its use during lactation, in children, soft-tissue injuries, reproductive age group”. The DCGI has cleared the drug on thirteen conditions including ​​the clause that the companies will conduct a post-marketing surveillance study on the first 1,000 patients to assess the safety of the pill.

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History of this topic

Health Matters: Dear Drug Regulator, Silence is Not Always Golden, Esp on WHO Pausing Covaxin Supply
2 years, 8 months ago

Health Matters: Dear Drug Regulator, Silence is Not Always Golden, Esp on WHO Pausing Covaxin Supply

News 18  

On April 2, the World Health Organization suspended the supply of Bharat Biotech’s Covaxin through the UN agencies after finding issues with the “good manufacturing practices”. For the past 15 days, not only health journalists, but even commoners who got Covaxin jabs are hoping to hear from the country’s drug regulatory agency – Central Drugs Standard Control Organization. Eventually, the …

No molnupiravir: ICMR team
2 years, 11 months ago

No molnupiravir: ICMR team

The Hindu  

The ICMR’s National Task Force for COVID-19 has decided against including antiviral drug molnupiravir in the Clinical Management Protocol for COVID-19 as of now, official sources said on Tuesday. The experts of the task force cited safety concerns, and argued that Molnupiravir was not of much benefit in COVID treatment to arrive at the decision in a meeting held on …

Covid antiviral drug Molnupiravir has major safety concerns: ICMR chief
3 years ago

Covid antiviral drug Molnupiravir has major safety concerns: ICMR chief

The Hindu  

ICMR Chief Dr. Balram Bhargava said on January 5 that Covid antiviral drug Molnupiravir has major safety concerns and has not been included in the national protocol for treatment of coronavirus. “Molnupiravir will now be manufactured in the country by 13 companies for restricted use under emergency situations for treatment of adult patients with COVID-19 and who have high risk …

Merck's Covid-19 pill Molnupiravir found to reduce hospitalisation, death risks
3 years ago

Merck's Covid-19 pill Molnupiravir found to reduce hospitalisation, death risks

India Today  

As Covid-19 cases peak across the world including the US and the UK, Molnupiravir, an oral drug developed by Merck, could act as a counter. In the phase-III clinical trials, the drug was found to reduce the risk of hospitalisation and death in at-risk, unvaccinated adults, Molnupiravir is an oral, small-molecule antiviral prodrug that is active against severe acute respiratory …

UK planning to rollout Merck's anti-Covid pill as soon as Christmas: Report
3 years, 1 month ago

UK planning to rollout Merck's anti-Covid pill as soon as Christmas: Report

Hindustan Times  

The government in the United Kingdom is planning to roll out the antiviral pill against Coronavirus disease as part of an offered treatment against the viral disease, according to a report by Sunday Telegraph. The pill -- Molnupiravir -- has been developed by American pharmaceutical company Merck and has been touted as "game-changing" as it can be taken from the …

2 Indian Firms Seek Regulator Nod to Cease Trials of anti-Covid Pill Molnupiravir on 'Moderate' Patients
3 years, 3 months ago

2 Indian Firms Seek Regulator Nod to Cease Trials of anti-Covid Pill Molnupiravir on 'Moderate' Patients

News 18  

Two pharmaceutical companies have sought permission from India’s drug regulator to discontinue the phase III trials of American firm Merck & Co’s experimental antiviral drug molnupiravir in moderate Covid-19 patients, a government document shows, though one of the two manufacturers told News18.com that the “results have come out exceedingly well” in mild cases. Aurobindo Pharma and MSN Laboratories have presented …

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