CDSCO Approves COVID Jabs Covovax, Corbevax & Anti-COVID Pill Molnupiravir
All the recommendations have now been sent to the Drugs Controller General of India for final approval.
Union Health Minister Dr Mansukh Mandaviya on Tuesday, 28 December, announced that the Central Drugs Standard Control Organisation (CDSCO) had approved two more COVID-19 vaccines, Corbevax and Covovax, for restricted emergency use in India.
Mandaviya also announced that the CDSCO panel had granted emergency approval to the anti-COVID pill Molnupiravir for treatment of COVID patients in India.
Made by Hyderabad-based firm Biological-E, CORBEVAX vaccine is India's first indigenously developed RBD protein sub-unit vaccine against COVID-19, Mandaviya said in a tweet. Meanwhile, the nanoparticle vaccine, COVOVAX, will be manufactured by Pune-based firm Serum Institute of India, he added.
Meanwhile, 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, he informed.
All the recommendations have been sent to the Drugs Controller General of India (DCGI) for final approval, reported PTI.
About the Two Vaccines and the Anti-COVID Pill
In October, Prakash Kumar Singh, the director of government and regulatory affairs at the Serum Institute of India, had submitted an application to the DCGI, asking for the market authorisation for Covovax for restricted use in emergency situations.
On 17 May, SII had got permission from DCGI to manufacture and stock Covovax. After receiving the approval, SII manufactured and stockpiled the vaccine doses.
Later in August 2020, Novavax Inc, a US-based vaccine maker, and SII had announced a licence agreement for the development and commercialisation of its vaccine candidate NVX-CoV2373 in low and middle-income countries and India.
On 17 December, Covovax received the emergency use listing by the World Health Organization (WHO).
Meanwhile, Biological E's Corbevax had received recommendations of the Subject Expert Committee (SEC) on 10 December, after which it submitted a proposal for grant of market authorisation for Corbevax for restricted use in emergency situations in adults.
The vaccine is to be stored between 2 degrees celsius to 8 degrees celsius and administered intramuscularly in two doses of 0.5 ml each with an interval of 28 days, a source was quoted as saying by PTI.
As for the anti-COVID pill Molnupiravir is concerned, official sources said that Dr Reddy's Laboratories, in consortium with Cipla, Mylan, Torrent, Emcure, and Sun Pharma, had presented their proposal for approval of Molnupiravir 200mg capsules in emergency situations along with the necessary supporting documents and clinical data in the country.
As per the conditions, retailers should only sell the drug on seeing a prescription by medical specialists. The drug can't be used in patients less than 18 years or for starting treatment of those who require immediate hospitalisation due to COVID-19 at that stage. However, it can be continued if it was started before hospitalisation. The pill can't be used for longer than five consecutive days and can be taken twice a day by people at home with mild or moderate COVID-19.
India's drug regulator has now given emergency authorisation to a total of eight COVID-19 vaccines – Covishield, Covaxin, ZyCoV-D, Sputnik V, Moderna, Johnson and Johnson, Corbevax and Covovax.
(With inputs from PTI.)
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