New Delhi: A day after ICMR chief Dr Balram Bhargava said Molnupiravir has “major safety concerns” and not been included in the national protocol for coronavirus treatment, Aurobindo Pharma Limited launched this Covid anti-viral drug under brand name “Molnaflu” in the country.
Molnupiravir, as per a press release from the city-based drug maker, is for treatment of adult patients hospitalised with Covid-19.
This Covid anti-viral drug was earlier approved under Emergency Use Authorisation (EUA) from the Central Drugs Standard Control Organisation (CDSCO).
Aurobindo Pharma Limited had earlier last year signed a bilateral non-exclusive voluntary licensing agreement with Merck Sharpe Dohme, Singapore (MSD), a subsidiary of Merck & Co. (US), to manufacture and supply Molnupiravir to over 100 low and middle-income countries, including India, PTI reported.
Expressing his delight over timely permission from the DCGI for the licensed version of Molnupiravir (Molnaflu), K. Nithyananda Reddy, Vice Chairman and Managing Director, Aurobindo, said “it opens up access to an affordable treatment option for COVID-19 patients and enable us to help battle the pandemic with effective and high-quality pharmaceutical products”.
Aurobindo for the licensed version of Molnupiravir enjoys backward integration with in-house API (active pharmaceutical ingredient) manufacturing, which equips it with stronger control on the quality systems and supply chain.
The product will be made at the company’s manufacturing facilities in India approved by global regulatory agencies, including U.S. Food and Drug Administration (FDA) and UK Medicines and Healthcare products Regulatory Agency (MHRA).
Aurobindo said the company has adequate capacities to meet the global demand across the over 100 low and middle-income countries for the product.
Earlier on Wednesday, the ICMR chief the World Health Organization (WHO) and the UK have not included Molnupiravir for Covid treatment.
“We have to remember that this drug has major safety concerns. It can cause teratogenicity, mutagenicity and it can also cause cartilage damage and can also be damaging to muscles also,” Dr Bhargava told a media briefing, PTI reported.
“Contraception will have to be done for three months for male and female if this drug is given because the child born could be problematic due to teratogenic influence,” he added.
The ICMR chief said the United States has approved it based on only 1,433 patients in which three percent reduction was observed in symptoms in patients with mild to moderate disease.
Asserting it is not part of the national treatment protocol for Covid, Dr Bhargava said: “We have concerns about the drug and its use during lactation, in children, soft-tissue injuries, reproductive age group," he said, adding that they have debated on its usage twice and will further debate over it.”