DCGI

‘Remdesivir shelf life now 12 months’

On Wednesday, some news channels carried reactions of the relatives of patient administered with Remdesivir at the hospital, showing that old expiry date was covered by a new sticker. 

published on : 4th June 2021

Serum Institute seeks test licence from DCGI to manufacture Covid vaccine Sputnik V

Russia's Sputnik V vaccine is currently being manufactured in India by Dr Reddy's Laboratories.

published on : 3rd June 2021

Norms for clearing foreign-made Covid-19 vaccines eased by DCGI

The decision by the Drugs Controller General of India comes in the backdrop of Pfizer and Cipla putting forth similar demands during negotiations to supply imported vaccines to India.

published on : 2nd June 2021

DRDO's anti-COVID drug reducing oxygen dependence approved for emergency use

Clinical trial results have shown that this molecule helps in faster recovery of hospitalized patients and reduces supplemental oxygen dependence.

published on : 8th May 2021

Bharat Biotech seeks DCGI's nod to extend shelf life of Covaxin

The Hyderabad-based Bharat Biotech was given permission for sale and distribution of Covaxin with shelf life of six months when stored at two to eight degrees Celsius.

published on : 25th April 2021

DCGI extends shelf life of Covishield from 6 to 9 months

In a letter to the Serum Institute of India, Drugs Controller General of India V G Somani said the SII is permitted to apply the shelf life of nine months to unlabelled vials available on hand.

published on : 31st March 2021

Expert panel reviews emergency use application for Sputnik V vaccine; seeks immunogenicity, safety data

Dr Reddy's Laboratories on February 19 said it had approached drugs regulator DCGI for emergency use authorisation (EUA) for the Russian vaccine.

published on : 24th February 2021

Zydus Cadila gets DCGI nod to initiate Phase-III clinical trials for COVID-19 vaccine ZyCoV-D

The trial has reviewed by an independent data safety monitoring board and reports were submitted to the Central Drugs Standard Control Organisation regularly for the update on safety outcome.

published on : 3rd January 2021

COVID-19 vaccines 110 per cent safe, impotency rumours complete nonsense: DCGI

COVID-19 vaccines of Serum Institue of India and Bharat Biotech have been granted permission for restricted use in an emergency situation.

published on : 3rd January 2021

Drugs Controller General of India to brief media on COVID-19 vaccine update

The SEC made its recommendations in respect of the accelerated approval process request of the SII, Bharat Biotech International Ltd as well as about phase-III trials of Cadila Healthcare Ltd.

published on : 3rd January 2021

Expert panel set to recommend granting emergency use authorisation for Oxford COVID vaccine

The Pune-based Serum Institute of India, the world's largest vaccine manufacturer, has tied up with AstraZeneca to manufacture 'Covishield'.

published on : 1st January 2021

DCGI seeking more data for granting emergency use authorisation won't impact timeline for vaccine roll-out: Government

The applications filed before the DCGI are being examined by the subject expert committee on COVID-19 of CDSCO for emergency use authorisation.

published on : 15th December 2020

Covid vaccine: Expert panel asks for more data on Covaxin, Covishield before granting licences

A top health ministry official said a series of meetings could be held before the committee submits its recommendations.

published on : 9th December 2020

Pfizer seeks emergency use authorisation for its COVID-19 vaccine in India

The British regulator said the jab, which claims to offer up to 95 per cent protection against COVID-19, is safe for roll-out.

published on : 6th December 2020

DCGI rejects direct phase 3 trial of Sputnik V in India, asks for trial on smaller group first

The development comes less than a month after the Russian government announced its partnership with Dr Reddy’s Laboratories for mass vaccinations by the year-end.

published on : 7th October 2020
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