New Delhi [India], June 1 (ANI): Eli Lilly and Company India said on Tuesday it has received permission for restricted emergency use of its antibody drugs bamlanivimab 700 mg and etesevimab 1,400 mg in India for treatment of patients with mild to moderate coronavirus disease 2019 (Covid-19).
NEW DELHI: India s drug regulator will take a decision on applications seeking approval for restricted emergency use of foreign-produced vaccines within three working days from the date of submission, the government said on Thursday.
The Central Drug Authority, CDSCO, will process applications for registration certificates (registration of overseas manufacturing site and product; in this case Covid vaccine) and import license within three working days from the date of approval of restricted use in an emergency situation.
The CDSCO issued detailed guidelines specifying regulatory pathway for approval of foreign approved Covid-19 vaccines after the central government on Tuesday decided to fast-track emergency approvals for all coronavirus jabs that have been given a similar nod by the WHO or regulators in the United States, Europe, Britain or Japan.
The restricted emergency use approval of Covaxin should now be revised
Vaccine efficacy of 80.6% for Bharat Biotech’s Covaxin at the first interim analysis of phase-3 trials in India is indeed promising, though it took two months for the data to become available after the vaccine was approved for ‘restricted emergency use’ by the Indian drug regulator. The vaccine efficacy was measured based on symptomatic COVID-19 disease mild, moderate or severe two weeks after the second dose. The interim analysis undertaken at the first endpoint of 43 COVID-19 cases in the phase-3 trial carried out across 26 sites in India found 36 cases in the placebo group while only seven COVID-19 cases in the arm that received two doses of the vaccine given 28 days apart. The phase-3 trial that began last November recruited 25,800 participants, with one half receiving the vaccine and the other, a placebo. While the phase-3 trial will continue till 130 participants in both groups put together devel