New Delhi: Stated by ICMR chief Dr Balram Bhargava that Molnupiravir has “major safety concerns” and is not included in the national protocol for coronavirus treatment, Aurobindo Pharma Ltd has launched this COVID anti-viral drug under the brand name “Molnaflu” in the country. Did.
Molnupiravir, according to a press release by the city-based drugmaker, is intended for the treatment of adult patients hospitalized with Covid-19.
This COVID anti-viral drug was earlier approved under Emergency Use Authorization (EUA) from the Central Drugs Standard Control Organization (CDSCO).
Aurobindo Pharma Limited had signed a bilateral non-exclusive voluntary licensing agreement with Merck Sharp Dohme, Singapore (MSD), a subsidiary of Merck & Co (US), early last year, which is engaged in over 100 low and middle income was for the manufacture and supply of Molnupiravir. countries including India, PTI reported.
Expressing happiness over the timely permission from DCGI for the licensed version of Molnupiravir (Molnaflu), K Nityananda Reddy, Vice President and Managing Director, Aurobindo said, “It opens up access to an affordable treatment option for COVID-19 patients and enables us to help fight the pandemic with effective and high quality pharmaceutical products”.
Aurobindo enjoys backward integration with in-house API (Active Pharmaceutical Ingredient) manufacturing for the licensed version of Molnupiravir, which equips it with strong control over quality systems and supply chain.
The product will be manufactured at the company’s manufacturing facilities in India approved by global regulatory agencies including the US Food and Drug Administration (FDA) and the UK Medicines and Healthcare products Regulatory Agency (MHRA).
Aurobindo said the company has enough capacity for the product to meet global demand in over 100 low and middle income countries.
Earlier on Wednesday, ICMR major World Health Organization (WHO) and UK did not include Molnupiravir for the treatment of Kovid.
“We have to remember that this drug has major safety concerns. It can cause teratogenicity, mutagenicity and it can also damage cartilage and also damage muscles,” Dr. Bhargava said at a media briefing. Told, PTI reported.
“If this drug is given, it will be necessary for men and women to have contraception for three months because the child born may have problems due to the teratogenic effect,” he said.
The ICMR chief said that the United States has approved it only on the basis of 1,433 patients showing a three percent reduction in symptoms in patients with mild to moderate disease.
Stating that it is not part of the national treatment protocol for COVID, Dr Bhargava said: “We have concerns about its use in children, soft-tissue injuries, in the reproductive age group, while on medication and breastfeeding, “That said, they have debated its use twice and will debate it further.”
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