Drug Controller General Of India

Dr Reddy's Initiates Process For Emergency Use Authorisation Of Sputnik V

India News | ANI | Friday February 19, 2021

Dr Reddy's Laboratories said on Friday it has initiated the process with the Drugs Controller General of India (DCGI) for emergency use authorisation of human adenoviral vector-based platform vaccine candidate Sputnik V.

Beginning Of End Of Covid: Union Health Minister Ahead Of Vaccination Drive

India News | Press Trust of India | Friday January 15, 2021

A day before a massive countrywide vaccination drive against coronavirus is set to commence, Union Health Minister Harsh Vardhan today said the step is "probably the beginning of the end" of COVID-19.

Zydus Cadila Gets Nod For Phase 3 Trials Of Its Covid Vaccine Candidate

India News | Press Trust of India | Sunday January 3, 2021

The Drugs Controller General of India (DCGI) has approved conducting phase III trials of the country's first DNA vaccine candidate against COVID-19 being developed by Zydus Cadila, the Department of Biotechnology said on Sunday.

India's Wait Over, Drug Regulator Says Covid Vaccines Cleared "110% Safe"

India News | Reported by Sukirti Dwivedi, Edited by Anindita Sanyal | Monday January 4, 2021

Two vaccines for coronavirus, Oxford University's Covishield, which is being developed by the Pune-based Serum Institute, and Bharat Biotech's Covaxin, received emergency approval from the country's drug regulator on Sunday. "We'll never approve anything if there is slightest of safety concern. The vaccines are 110 per cent safe," Drug Controller G...

India A Step Closer To Covid Vaccine, Drug Regulator Approval Awaited: 10 Facts

India News | Reported by Sukirti Dwivedi, Edited by Swati Bhasin | Sunday January 3, 2021

India has moved a step closer to getting a coronavirus vaccine as two candidates - Hyderabad-based Bharat Biotech's Covaxin and the Serum Institute of India's Covishield - have been recommended by a government-appointed panel to the Drugs Controller General of India (DCGI) for emergency use in the last two days. The country has been preparing for t...

Bharat Biotech's Vaccine Cleared By Panel, Regulator's Approval Awaited

India News | Reported by Sukirti Dwivedi, Edited by Chandrashekar Srinivasan | Saturday January 2, 2021

Covaxin, the coronavirus vaccine from Hyderabad-based Bharat Biotech, has been recommended for "restricted use in emergency situation, " by a government-appointed panel, which submitted its findings to the Drugs Controller General of India

Oxford COVID-19 Vaccine Cleared By Expert Panel For India

India News | Reported by Sukirti Dwivedi, Edited by Debanish Achom | Saturday January 2, 2021

The Oxford COVID-19 vaccine manufactured by the Serum Institute of India will be sent for approval to the regulator Drugs Controller General of India (DCGI) by a government-appointed panel of experts.

Coronavirus India Highlights: Oxford COVID-19 Vaccine Cleared By Expert Panel For India

India News | Edited by Deepika Pundir | Saturday January 2, 2021

The Oxford COVID-19 vaccine manufactured by the Serum Institute of India will be sent for approval to the regulator Drugs Controller General of India (DCGI) by a government-appointed panel of experts, sources have said.

Seeking More Data For Emergency Use Won't Impact Vaccine Rollout: Centre

India News | Press Trust of India | Tuesday December 15, 2020

The applications of Bharat Biotech, Serum Institute and Pfizer seeking emergency use authorisation for their COVID-19 vaccines are being examined, the centre said on Tuesday, asserting that Drugs Controller General of India (DCGI) seeking more data from these companies will not impact the vaccine-roll out timeline.

6 Covid Vaccines Undergoing Clinical Trials In India: Centre

India News | Press Trust of India | Tuesday December 15, 2020

Informing that the Drugs Controller General of India has granted clearance for the clinical trials of one more candidate vaccine from India, NITI Aayog Member (Health) Dr VK Paul on Tuesday said six vaccines are currently undergoing clinical trials in the country.

Gennova Biopharmaceuticals Gets Conditional Nod For Human Trial Of Its Covid Vaccine

India News | Press Trust of India | Thursday December 10, 2020

The Drugs Controller General of India (DCGI) on Wednesday granted conditional permission for phases 1 and 2 human clinical trial of the COVID-19 vaccine candidate developed by the Pune-based Gennova Biopharmaceuticals Ltd in collaboration with HDT, USA, officials said.

What Pfizer Said On Key Challenge In Coronavirus Vaccine Storage In India

India News | Reported by Sukirti Dwivedi, Edited by Swati Bhasin | Monday December 7, 2020

American pharmaceutical firm Pfizer, which has asked the DCGI (Drugs Controller General of India) for emergency approval of its coronavirus vaccine, has said it is prepared to address a key challenge in the distribution of its vaccine - ultra-cold storage.

Pfizer Seeks India Approval For Covid Vaccine, First To Do So: Sources

India News | Reported by Arvind Gunasekar, Sharad Sharma, Sukirti Dwivedi, Edited by Swati Bhasin | Monday December 7, 2020

American pharma giant Pfizer has sought approval from the country's drug regulator - the DCGI (Drugs Controller General of India) - for emergency use authorisation of its coronavirus vaccine, say sources. The vaccine is ready to be rolled out in the United Kingdom and Bahrain.

Zydus Cadila Covid Therapy "PegiHep" Gets Nod For Phase 3 Clinical Trial

India News | Press Trust of India | Friday December 4, 2020

Drug firm Zydus Cadila said today that it has received the approval from the Drugs Controller General of India (DCGI) to start phase 3 clinical trials with its biological therapy PegiHep in COVID-19 patients.

Drug Authority Says Reaction In Volunteer Not Linked To Covid Vaccine: Report

India News | Press Trust of India | Wednesday December 2, 2020

A probe initiated by the Drugs Controller General of India (DCGI) into an alleged "serious adverse event" reportedly suffered by an Oxford COVID-19 vaccine trial participant in Chennai has found that it was not related to the shot administered to him, official sources said.