Tag: Dcgi

"The company has received permission from Drugs Controller General of India (DCGI) to import Moderna's COVID-19 vaccine for restricted emergency use in the country."

The National Regulator of the country, the Drugs Controller General of India (DCGI), after careful examination, has accepted the recommendation of Subject Expert Committee (SEC) and accorded permission to conduct the Phase II/III clinical trial of Covaxin (COVID vaccine) in the age group 2 to 18 years

Ahmedabad: Zydus Cadila on Friday announced it has received restricted Emergency Use Approval from the Drug Controller General of India (DCGI) for the use of antiviral ‘Virafin’ in treating moderate…

New Delhi: Drug firm Hetero on Sunday said it has received approval from regulator DCGI to launch investigational antiviral drug Remdesivir for the treatment of COVID-19. Domestic pharma firm Glenmark Pharmaceuticals had on Saturday launched antiviral drug Favipiravir, under the brand name FabiFlu, for the treatment of patients with mild to moderate COVID-19 at a […]

Hyderabad: Bharat Biotech, has successfully developed COVAXIN, India’s 1st vaccine candidate for COVID-19, in collaboration with the Indian Council of Medical Research (ICMR) – National Institute of Virology (NIV). The SARS-CoV-2 strain was isolated in NIV, Pune and transferred to Bharat Biotech. The indigenous, inactivated vaccine developed and manufactured in Bharat Biotech’s BSL-3 (Bio-Safety Level […]

New Delhi: The Drugs Controller General of India (DCGI) has given nod to the Serum Institute of India (SII) for conducting phase 2 and 3 human clinical trials of the Oxford University developed COVID-19 vaccine candidate in the country. Government officials told PTI that the approval for conducting phase 2 and 3 clinical trials by […]

New Delhi: The central drug regulator has issued a show-cause notice to the Serum Institute of India (SII) for not informing it about pharma giant AstraZeneca pausing the clinical trials of the Oxford vaccine candidate for COVID-19 in other countries and also for not submitting casualty analysis of the “reported serious adverse events”. The show-cause […]

New Delhi: The government has been alerted about the massive black marketing of Covid drug Remdesivir, which according to some evidence is selling for as high as Rs 50,000, over…

New Delhi: Serum Institute of India’s (SII) COVID-19 vaccine candidate – Covishield – has been recommended by the Subject Expert Committee (SEC) which met today to examine the emergency-use authorisation (EUA) application sought by the pharmaceutical firm. With the SEC giving a green signal to Oxford-AstraZeneca’s COVID vaccine candidate, India is one step away from […]

New Delhi: The All India Drug Action Network (AIDAN) said it is shocked to learn of the SEC’s recommendation to grant REU approval to Bharat Biotech’s COVAXIN in “clinical trial mode” and “specially in the context of infection by mutant strains”. “In light of the intense concerns arising from the absence of efficacy data and […]