The Drugs Control General of India has permitted emergency use of Covid vaccine Sputnik V with certain conditions, clearing the way for a third vaccine in addition to Covishield and Covaxin.
Covid-19 vaccines- COVAXIN and COVISHIELD have been cleared for restricted use in emergency situation, DCGI, V G Somani said.
The expert panel has recommended granting permission for restricted emergency use of 'Covaxin' in "public interest as an abundant precaution, in clinical trial mode, especially in the context of infection by mutant strains.
The Drug Controller General of India (DCGI) will address a press conference on Sunday (January 3) at 11 am and it is being expected that the drug controller watchdog may announce the approval of emergency use of two vaccines.
The Drug Controller General of India (DCGI) will address a press conference today at 11 am and it is being expected that the drug controller watchdog may announce the approval of emergency use of two vaccines. The development comes after the government panels recommended — Oxford-AstraZeneca Covishield and Bharat Biotech's Covaxin — for emergency use.
An expert panel on COVID-19 of the Central Drugs Standard Control Organisation (CDSCO) on Friday recommended to grant emergency use authorisation for the Oxford COVID-19 vaccine Covishield, being manufactured by Serum Institute of India, sources said on Friday.
With preparations underway for a possible vaccine-rollout by January, the Indian drug regulator is looking at the UK, which sources believe may give its nod to the Oxford COVID-19 vaccine next week, before deciding on giving emergency use authorisation to the Serum Institute that is manufacturing the shots here.
The vaccine 'Covaxin' is being indigenously developed by the Bharat Biotech in collaboration with the Indian Council of Medical Research (ICMR).
The Drug Controller General of India (DCGI) has granted approval to Dr Reddy's, a global pharmaceutical company headquartered in India, to conduct phase 2 and 3 clinical human trials of the Sputnik V, a Covid-19 vaccine made by Russia.
The Drugs Controller General of India has approved the commercial launch of 'Feluda', the Tata CRISPR (Clustered Regularly Interspaced Short Palindromic Repeats) COVID-19 test, the Council of Scientific and Industrial Research (CSIR) said on Saturday.
Drugs Controller General of India (DCGI) Dr VG Somani on Tuesday gave permission to Serum Institute of India to resume the clinical trial of the Oxford COVID-19 vaccine candidate in the country while revoking its earlier order of suspending any new recruitment for phase two and three trial.
The Serum Institute of India (SII), which is conducting Oxford-AstraZeneca coronavirus vaccine phase 2 and 3 trials in India, has received a show-cause notice from the central drug regulator for not informing it about pharma giant AstraZeneca pausing the clinical trials of the Oxford vaccine candidate in other countries and also for not submitting casualty analysis of the "reported serious adverse events".
The tablet, which will be sold under the brand name 'Favizen', is being manufactured at Zenar's US FDA approved facility in Hyderabad, a press release from the drug maker said.
Serum Institute of India (SII) has been granted permission by Drugs Controller of General of India (DCGI) to conduct Phase 2, 3 human trials of Oxford-AstraZeneca coronavirus vaccine in India, a government official has said.
Biotechnology major Biocon on Saturday announced that its "breakthrough drug," Itolizumab has received Drugs Controller General of India's (DCGI) approval for its use in moderate to severe COVID-19 patients.
Rajesh Bhushan, the Officer on Special Duty, Union Health Ministry, told an online media briefing Thursday that it has been noticed that certain drugs are not available freely in the market.
The Certified Insurance Service Representative (CISR) Director General Dr. Shekhar C. Mande while talking about drugs that can be useful against COVID-19 informed that the Drug Controller General of India has given approval for clinical trials of Favipiravir which is used in influenza in Japan, China etc.
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