Page 3 - Drug Controller General Of India

DGCI gives nod for phase 2/3 trials of Biological E's Covid vaccine

DCGI granted permission to Biological E Limited to conduct phase 2/3 clinical trials of its 'Made in India' COVID-19 vaccine on children aged between 5 and 18 years with certain conditions

Gennova's mRNA vaccine gets DCGI nod to start phase-2 and 3 trials

If things go according to plan, the vaccine would be available in the market by the end of this year, sources said

Expert panel green signals Cadila's 3-dose DNA plasmid vaccine ZyCoV-D

DCGI nod expected soon; vaccine stable at room temperatures

Govt panel recommends against SII testing Covovax on 2-17 age group: Report

"The Subject Expert Committee on Covid-19 of Central Drugs Standard Control Organisation, which deliberated on the application, noted that vaccine has not been approved in any country", a source said

Zydus Cadila seeks emergency use approval for Covid vax for 12 years, above

Zydus Cadila applied for Emergency Use Authorisation seeking approval from the Drugs Controller General of India for the launch of their ZyCoV-D vaccine for 12 years and above

India approves Moderna's vaccine for emergency use; Cipla to import jab

Cipla had filed an application on Monday seeking permission for import of Moderna's vaccine.

Biophore applies for DCGI emergency-use approval for Covid treatment drug

Biophore India Pharmaceuticals on Friday said it has applied to the Drugs Controller General of India (DCGI) for obtaining emergency-use approval for Aviptadil, used in Covid treatment

DCGI waiver may bring foreign vaccines like Pfizer, Moderna a step closer

Earlier, vaccines that had completed clinical studies outside the country were required to carry out "bridging trials" or limited clinical trials on the Indian population

Eli Lilly's antibody cocktail gets DCGI nod to treat moderate Covid

Bamlanivimab and etesevimab combination has been authorised under Emergency Use Authorisation in the US and select EU countries for the treatment of the disease

Covid-19: Govt waives import duty on Remdesivir injection, raw materials

Given the shortage of supplies, the Union government last week banned the export of Remdesivir

DCGI extends shelf life of Covishield vaccine from six to nine months

India's drug regulator DCGI has extended the shelf life of Covishield, the Oxford-AstraZeneca COVID-19 vaccine, from six to nine months from its manufacturing date.

AstraZeneca Pharma gets DCGI nod for lung cancer treatment drug

AstraZeneca Pharma India on Wednesday said it has received marketing approval from the Drugs Controller General of India (DCGI)for its product for the treatment of non-small cell lung cancer.

A bitter pill: Domestic pharma market growth slides to 1.1% in February

Recovery slow, top drug firms post muted growth in February

Healing a weak regulator

Weaknesses in India's drug regulatory regime and the constraints and questionable decisions of the drug regulator could mar the country's reputation in global markets

AstraZeneca's Dapagliflozin tablets get DCGI nod for chronic kidney disease

AstraZeneca Pharma India on Saturday said it has received approval from the Drugs Controller General of India (DCGI) for Dapagliflozin

V G Somani: The DCGI chief, a man known by his actions, 'not of words'

To the media, Somani may be a man of few words but among peers he's known for quick responses

Govt clears air on Bharat Biotech's vaccine, says relied on safety data

Minutes of expert panel meeting made public

A shot at transparency

Approval to Covaxin raises many questions

India gets Covid-19 vaccine: DCGI nod for Serum Institute, Bharat Biotech

Health Minister Harsh Vardhan termed it a 'watershed moment in India's battle against Covid-19'

India likely to approve AstraZeneca vaccine by next week: Sources

This could be the first country to give the regulatory green light for the British drugmaker's vaccine as the British medicine regulator continues to examine data from the trials