CDSCO asks Bharat Biotech to submit complete immunogenicity data of Phase 2 trial of COVID-19 vaccine
The vaccine candidate, 'Covaxin', is being indigenously developed by Bharat Biotech in collaboration with the Indian Council of Medical Research
Dr Reddy's asked to resubmit phase 2,3 trial application for Russia's Sputnik V COVID-19 vaccine by DCGI
Dr Reddy's trials will have to be first assessed in a small group of volunteers to study its efficacy before it can be tested on a larger population.
Antisera are blood serum high in antibodies against specific antigens and are injected in humans to help kickstart the immune system to fight specific infections.
Antisera are blood serum high in antibodies against specific antigens and are injected in humans to help kickstart the immune system to fight specific infections
Dr Balram Bhargava, Director-General of ICMR said, "There are three things for a vaccine--(i) the safety, (ii) immunogenicity, and (iii) the efficacy."
This test uses an indigenously-developed, cutting-edge CRISPR technology for detecting the virus' genome sequence
The Serum Institute of India, which had paused phase 2 and phase 3 trials of the Oxford University's vaccine, received the go-ahead from the DCGI to resume the trials in India
SII has also been asked to submit to the DCGI's office details of medication used in accordance with the protocol for management of adverse events
Coronavirus Updates: Kolkata Police Commissioner Anuj Sharma tests positive for COVID-19, says report
Coronavirus Updates: Lok Sabha Speaker Om Birla on Thursday also said that 62 percent of the Parliament's operations have been "successfully" moved online will go "100 percent digital eventually"
Coronavirus Vaccine Tracker: Serum Institute of India pauses clinical trials after DCGI show-cause notice
The Pune-based company said that it's reviewing the situation and pausing India trials of the COVID-19 vaccine candidate till AstraZeneca restarts the trials
Coronavirus LIVE Updates: The Maharashtra health department said that 11,514 COVID-19 cases and 316 deaths were reported in the state on Thursday. Total number of cases in the state is now at 4,79,779, including 1,46,305 active cases, 3,16,375 recovered and 16,792 deaths.
Lupin launches antiviral drug Favipiravir under the name Covihalt to treat mild to moderate COVID-19 infection
The Covihalt tablet will be available in 200 mg tablets in a strip of 10 and will cost Rs 49 per tablet in India.
Sunpharma launches Favipiravir tablet Fluguard to treat mild to moderate COVID-19 infections at Rs 35 per pill
Favipiravir is an antiviral drug that was originally made to treat influenza in Japan under the brand name Avigan.
Coronavirus Updates: As many as 2,326 patients recovered during the day, the state health department said, taking the total number of recoveries to over 2.99 lakh
Serum Institute asked to revise protocols for Phase 2, 3 trials of Oxford COVID-19 vaccine candidate
The CDSCO expert panel also recommended that Pune-based firm's proposed clinical trial sites be distributed across India
The decision was taken after the drug controller found the companies' response to a 17 July show-cause notice asking them to explain why their licences should not be suspended unsatisfactory
Covaxin, Bharat Biotech's COVID-19 vaccine candidate, has been developed in collaboration with the ICMR and NIV
Serum Institute conducted a three-phase clinical trial of the vaccine in India along with trials in the West African nation of The Gambia.
Drugs Controller General of India approved monoclonal antibody injection Itolizumab for limited use to treat moderate to severe cases of COVID-19.
Indian pharma well-placed to develop, manufacture COVID-19 vaccine; but it must guard against rushing trials
Some experts told Firstpost that the government is willing to fast-track regulation, which is a risk they are willing to take, after completing "due protocols to check the safety of the drug"