Drug Approval | January 03, 2022
Emcure to launch oral Covid-19 drug soon
A toll-free helpline to be set up to help doctors and patients
A toll-free helpline to be set up to help doctors and patients
The Subject Expert Committee (SEC), on Covid-19 of the Central Drugs Standard Control Organisation (CDSCO) on Monday recommended granting permission to manufacture and market anti-Covid pill molnupiravir for restricted emergency use
The product is expected to be available in a week’s time
DCGI approved the drug based on the review of clinical data
The drug will be marketed under the brand name Molnaflu
The recommendation was made by the Indian SARS-CoV-2 Genomics Sequencing Consortium (INSACOG), a network of national testing labs set up by the government to monitor genomic variations of Covid-19
The UK’s Medicine and Healthcare products Regulatory Agency has already approved the booster dose of AstraZenenca’s Covid-19 vaccine, which is administered in India
Preclinical data demonstrate sotrovimab, authorised in multiple countries around the world, retains activity against all tested variants of concern, including key mutations of Omicron
The Drug Controller General of India (DCGI), is reviewing clinical data of molnupiravir for the treatment of Covid-19 in adults in India
Applications remain under review by others including U.S. Food and Drug Administration and the European Medicines Agency
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