Page 2 - Drug Controller General Of India

Stempeutics gets DCGI nod for Phase 3 trial to treat Covid patients

Stempeutics said it has received DCGI clearance to conduct Phase 3 clinical trial on its product for treating COVID-19 patients suffering from acute respiratory distress syndrome (ARDS).

Biological E gets approval to conduct trials of Corbevax as booster dose

DCGI has given approval to the Hyderbad-based pharmaceutical company Biological E to conduct phase 3 clinical trials

Ensure Covaxin availability if cocktail policy for booster is adopted: IMA

IMA said that the Centre should ensure the large-scale availability of Covaxin if a mixed match policy is adopted for booster doses for healthcare workers

Decision to vaccinate children 'unscientific': Senior AIIMS epidemiologist

A senior epidemiologist at AIIMS termed the Centre's decision to vaccinate children against Covid "unscientific" and said it will not yield any additional benefit

India would need nearly 250 million more doses to cover new cohorts

Nearly 40 per cent of the 76 million children between the ages of 15 and 18 reside in states where the vaccination pace has been slowest

Bharat Biotech seeks approval for Phase 3 trials of intranasal vaccine

Bharat Biotech has sought the approval of the Drug Controller General of India (DCGI) to conduct Phase 3 trials of its Covid-19 intranasal vaccine

Health regulatory agencies likely to come under DCGI ambit

Single-window system to take care of regulatory need for drugs, vaccines

Covid: DCGI approves Hetero's Tocilizumab for hospitalised adults

Hetero, a globally renowned vertically integrated pharmaceutical organization, on Monday announced that the DCGI has issued EUA for the generic version of Tocilizumab in India

DCGI nod to phase-I clinical trial of Reliance Life Sciences' Covid vaccine

DCGI on Friday granted permission to the Mukesh Ambani-owned Reliance Life Sciences to conduct phase-I clinical trial of its indigenous COVID-19 vaccine with certain conditions, sources said.

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.