CDSCO approves Corbevax, Covovax and Molnupiravir for restricted use

Dr Reddy’s, Natco, MSN, Hetero, Optimus, Aurobindo, Mylan, Strides, Emcure, Cipla, Sun Pharma, Torrent and BDR.

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CDSCO DCGI FDA

Last Updated on December 31, 2021 by The Health Master

The government yesterday announced that it has approved emergency use of two more C-19 vaccines and anti-viral drug Molnupiravir.

Taking to Twitter, Dr Mansukh Mandaviya, Union Minister, Health and Family Welfare, said, “Further strengthening the fight against C-19, CDSCO, and @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.”

Regarding Corbevax, he stated- “It’s a hat-trick! It’s now 3rd vaccine developed in India!”
Corbevax is India’s first indigenously-developed RBD protein sub-unit vaccine against C-19, made by Hyderabad-based firm Biological-E.

The nanoparticle vaccine, Covovax, will be manufactured by the Serum Institute of India (SII). 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 C-19 and who have high risk of progression of the disease.

These firms are Dr Reddy’s, Natco, MSN, Hetero, Optimus, Aurobindo, Mylan, Strides, Emcure, Cipla, Sun Pharma, Torrent and BDR.

Earlier, the UK MHRA had granted approval for Molnupiravir under special conditions for treatment of mild-to-moderate C-19 in adults with a positive SARS-COV-2 diagnostic test and who have at least one risk factor for developing severe illness.

The US FDA has also granted Emergency Use Authorisation (EUA) for Molnupiravir for the treatment of mild-to-moderate C-19 in adults with positive results of direct SARS-CoV-2 viral testing, and who are at high risk for progression to severe C-19, including hospitalisation or death, and for whom alternative C-19 treatment options authorised by the FDA are not accessible or clinically appropriate.

CDSCO has received total of 22 applications for manufacturing and marketing of the drug Molnupiravir in the country. Out of which, eight, including five applicants of a consortium (total 13), have submitted their clinical trial report interim or complete report.

SEC recommendations: Considering the emergency and unmet medical need in C-19, the Subject Expert Committee (SEC) has recommended in its meeting held recently for grant of permission to manufacture and market the Molnupiravir 200mg capsule with recommended dose of 800 mg twice daily for five days for restricted use under emergency situation in the country for treatment of adult patients with C-19, with SpO2 >93% and who have high risk of progression of the disease including hospitalisation or death subject to various conditions including (a) the drug should be sold by retail only under prescription of medical specialists and (b) the recommended dose should be 800mg twice daily for five days.

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