NEW DELHI, 28 Dec: Union Health Minister Mansukh Mandaviya on Tuesday said that the Central Drugs Standard Control Organization (CDSCO) has approved the Serum Institute of India’s Covid-19 vaccine Covovax, Biological E’s jab Corbevax and anti-Covid pill Molnupiravir for restricted use in emergency situation.
The announcement comes a day after the subject expert committee (SEC) on Covid-19 of the CDSCO recommended granting emergency use authorization (EUA) to the Covid-19 vaccines Covovax and Corbevax with certain conditions.
It had also recommended granting restricted EUA to the drug Molnupiravir for treatment of adult patients with Covid-19 and who have high risk of progression of the disease.
In a tweet, the minister said, “Congratulations India. Further strengthening the fight against Covid-19, CDSCO, @MoHFW_INDIA has given 3 approvals in a single day for: – CORBEVAX vaccine – COVOVAX vaccine – Anti-viral drug Molnupiravir For restricted use in emergency situation.”
With this approval, the number of Covid vaccines which have received EUA in the country has increased to eight.
Six Covid-19 vaccines – Serum Institute’s Covishield, Bharat Biotech’s Covaxin, Zydus Cadila’s ZyCoV-D, Russia’s Sputnik V and the US-made Moderna and Johnson & Johnson – had already received EUA from the Indian drug regulator earlier.
“Corbevax vaccine is India’s 1st indigenously developed RBD protein sub-unit vaccine against #Covid19, Made by Hyderabad-based firm Biological-E. It’s a hat-trick! It’s now 3rd vaccine developed in India,” Mandaviya said in another tweet.
The Nanoparticle vaccine, Covovax, will be manufactured by Pune-based firm Serum Institute of India, he said.
“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,” Mandaviya said.
The SEC on Covid-19 of the CDSCO, which reviewed the EUA applications of the SII for the second time on Monday, noted that the vaccine is manufactured by technology transfer from Novavax and is approved by the European Medicines Agency for conditional marketing authorization and also granted emergency use listing by the WHO, an official source had said. (PTI)