Articles about Drugs Controller General of India

Expert panel recommends emergency use authorization for Zydus's three-dose vaccine

20 Aug 2021

Expert panel recommends emergency use authorization for Zydus's three-dose vaccine

The Subject Expert Committee (SEC) on COVID-19 of the Central Drugs Standard Control Organisation (CDSCO) has recommended granting an emergency use authorization (EUA) to ZyCoV-D, the three-dose COVID-19 vaccine developed by Zydus Cadila, on Friday.

India's drug regulator approves study on mixing Covishield, COVAXIN jabs

11 Aug 2021

India's drug regulator approves study on mixing Covishield, COVAXIN jabs

The Drugs Controller General of India (DCGI) has approved a proposal to conduct a study on the mixing of Covishield and COVAXIN COVID-19 vaccines.

India offered 7.5mn doses of Moderna vaccine under COVAX program

20 Jul 2021

India offered 7.5mn doses of Moderna vaccine under COVAX program

India has been offered 7.5 million doses of Moderna's COVID-19 vaccine through the COVAX global vaccine sharing program, but it is not clear when the jabs will arrive in the country as a consensus on the indemnity clause is yet to be reached, sources said.

Hetero seeks Emergency Use Authorization for Molnupiravir in India

09 Jul 2021

Hetero seeks Emergency Use Authorization for Molnupiravir in India

The use of Molnupiravir, an experimental oral drug having antiviral properties, has resulted in early recovery of COVID-19 patients with mild symptoms when compared to standard treatment during Phase III clinical trials, Hetero said on Friday citing interim data.

DRDO nod for Mankind Pharma to manufacture COVID-19 drug 2-DG

08 Jul 2021

DRDO nod for Mankind Pharma to manufacture COVID-19 drug 2-DG

Pharmaceutical firm Mankind Pharma on Thursday announced that it has received approval from the Defence Research and Development Organisation (DRDO) to manufacture and market the COVID-19 drug 2-Deoxy-D-Glucose or 2-DG.

Expert panel says no to Covovax's children trials in India

01 Jul 2021

Expert panel says no to Covovax's children trials in India

A Subject Expert Committee (SEC) on COVID-19 of the Central Drugs Standard Control Organization (CDSCO) has denied permission to Pune-based Serum Institute of India (SII) for conducting clinical trials of its second COVID-19 vaccine, Covovax, in children.

Zydus applies for approval of its 3-dose, needle-free COVID-19 vaccine

01 Jul 2021

Zydus applies for approval of its 3-dose, needle-free COVID-19 vaccine

Zydus Cadila, the Gujarat-based drug firm, has applied for the Emergency Use Authorization (EUA) of its COVID-19 vaccine to the Drugs Controller General of India (DCGI), the company said today.

Bharat Biotech submits COVAXIN phase-3 trial data, review meet today

22 Jun 2021

Bharat Biotech submits COVAXIN phase-3 trial data, review meet today

Bharat Biotech has submitted the phase three clinical trial data for its coronavirus vaccine COVAXIN to the Drugs Controller General of India (DCGI).

COVID-19: DCGI gives approval for phase-2 clinical trials of Colchicine

12 Jun 2021

COVID-19: DCGI gives approval for phase-2 clinical trials of Colchicine

India's top drug regulator - the Drugs Controller General of India (DCGI) - has given approval to carry out phase-2 clinical trials of Colchicine on COVID-19 patients.

Foreign COVID-19 vaccines exempted from local trials, batch testing

02 Jun 2021

Foreign COVID-19 vaccines exempted from local trials, batch testing

The Drugs Controller General of India has scrapped the requirement of local trials for foreign-made coronavirus vaccines - a key move to upscale the dwindling COVID-19 vaccinations in the country.

DRDO's antibody detection kit DIPCOVAN approved by the DCGI

21 May 2021

DRDO's antibody detection kit DIPCOVAN approved by the DCGI

The Drugs Controller General of India (DCGI) has approved an antibody detection kit developed by a laboratory of the Defence Research and Development Organisation (DRDO), reports say.

DRDO's anti-coronavirus drug cleared for emergency use by DCGI

08 May 2021

DRDO's anti-coronavirus drug cleared for emergency use by DCGI

The Drugs Controller General of India (DCGI) has approved the emergency use of an anti-coronavirus drug developed by a laboratory of the Defence Research and Development Organisation (DRDO) to treat moderate to severe patients, reports say.

Expert panel recommended against granting EUA to Pfizer's vaccine: Officials

05 Feb 2021

Expert panel recommended against granting EUA to Pfizer's vaccine: Officials

Just two days before pharma major Pfizer announced the withdrawal of its application for emergency use authorization of its COVID-19 vaccine in India, an expert panel of the country's drugs regulatory authority had recommended against granting such approval to the firm at this stage.

Panel recommends permission for Phase I Intranasal COVID-19 vaccine trial

20 Jan 2021

Panel recommends permission for Phase I Intranasal COVID-19 vaccine trial

An expert panel, Central Drugs Standard Control Organisation, (CDSCO) on Tuesday recommended granting permission for conducting the Phase I clinical trial of an intranasal vaccine against COVID-19 developed by Bharat Biotech, official sources said.

Days after participating in vaccine trial, man dies in Bhopal

09 Jan 2021

Days after participating in vaccine trial, man dies in Bhopal

A 42-year-old volunteer named Deepak Marawi, from Bhopal in Madhya Pradesh died nearly ten days after he participated in the clinical trial for COVAXIN held at a private hospital, its vice-chancellor said on Saturday.

Sleeves up! Coronavirus vaccination drive could begin on January 13

05 Jan 2021

Sleeves up! Coronavirus vaccination drive could begin on January 13

The first dose of the coronavirus vaccine in India will most likely be administered on January 13, a statement from a top official of the Union Health Ministry indicated on Tuesday.

Global leaders hail India's scientific innovation to combat COVID-19

05 Jan 2021

Global leaders hail India's scientific innovation to combat COVID-19

Global leaders have lauded India's leadership in scientific innovation and decisive action to combat the COVID-19 pandemic.

SII, Bharat Biotech ensure 'smooth roll out' of vaccines globally

05 Jan 2021

SII, Bharat Biotech ensure 'smooth roll out' of vaccines globally

The Serum Institute of India (SII) and Bharat Biotech have taken a joint pledge to ensure global access of the COVID-19 vaccines developed by them.

All you need to know about vaccines approved in India

03 Jan 2021

All you need to know about vaccines approved in India

Earlier on Sunday, the Drugs Controller General of India (DCGI) announced the issuance of emergency approval to two COVID-19 vaccines for restricted use in India: Covishield and COVAXIN.

SII's Covishield, Bharat Biotech's COVAXIN granted emergency approval, says DCGI

03 Jan 2021

SII's Covishield, Bharat Biotech's COVAXIN granted emergency approval, says DCGI

Two COVID-19 vaccines, Covishield and COVAXIN, have been granted emergency approval for use in India, the Drugs Controller General of India (DCGI) Dr. VG Somani said on Sunday.

Coronavirus vaccine: Bharat Biotech's COVAXIN gets expert panel nod

03 Jan 2021

Coronavirus vaccine: Bharat Biotech's COVAXIN gets expert panel nod

A government-appointed panel on Saturday recommended emergency-use authorization (EUA) to the COVID-19 vaccine developed by Hyderabad-based Bharat Biotech.

All states to hold dry run for coronavirus vaccination today

02 Jan 2021

All states to hold dry run for coronavirus vaccination today

A dry run for vaccination, before the actual doses of the coronavirus vaccine are administered to people, will be held in all states and union territories today.

India set to start COVID-19 vaccination; panel approves Oxford vaccine

01 Jan 2021

India set to start COVID-19 vaccination; panel approves Oxford vaccine

In a development that will soothe the coronavirus-battered nation, the Central Drugs Standard Control Organization (CDSCO) panel on Friday gave approval to the vaccine developed by the University of Oxford and British-pharma giant AstraZeneca.

India could start 2021 with COVID-19 vaccine in hand: DCGI

31 Dec 2020

India could start 2021 with COVID-19 vaccine in hand: DCGI

The approval for a COVID-19 vaccine in India is likely just around the corner, with the Drugs Controller General of India, Dr. VG Somani, indicating the country might begin the New Year with a vaccine in hand.

Now, Bharat Biotech seeks emergency use approval for COVAXIN

08 Dec 2020

Now, Bharat Biotech seeks emergency use approval for COVAXIN

After US-based Pfizer and Pune's Serum Institute of India, Bharat Biotech has sought an emergency use approval for its coronavirus vaccine, named COVAXIN.

Pfizer seeks emergency approval for COVID-19 vaccine in India

06 Dec 2020

Pfizer seeks emergency approval for COVID-19 vaccine in India

United States-based pharmaceutical giant Pfizer has sought emergency approval for its COVID-19 vaccine from India's drug regulator.

AIIMS to submit proposal for COVAXIN's phase three trials soon

31 Oct 2020

AIIMS to submit proposal for COVAXIN's phase three trials soon

By early next week, AIIMS will submit a proposal to start the third phase of clinical trials of COVAXIN, a vaccine against coronavirus being developed by Bharat Biotech.

Oxford's coronavirus vaccine could be available by December: Adar Poonawalla

29 Oct 2020

Oxford's coronavirus vaccine could be available by December: Adar Poonawalla

In a welcome piece of development, Serum Institute of India's CEO Adar Poonawalla said on Wednesday that the coronavirus vaccine, being developed by Oxford University, could be available for use in India by December 2020.

Coronavirus vaccine to reach 25 crore Indians by mid-2021: Government

04 Oct 2020

Coronavirus vaccine to reach 25 crore Indians by mid-2021: Government

The Indian government is planning to provide vaccines to roughly 25 crore people by July 2021, Union Health Minister Dr. Harsh Vardhan said on Sunday.

Bharat Biotech signs deal for nasal COVID-19 vaccine: Details here

23 Sep 2020

Bharat Biotech signs deal for nasal COVID-19 vaccine: Details here

In a major move, Bharat Biotech has signed an agreement to license a nasal COVID-19 vaccine developed by the Washington University School of Medicine in St. Louis, United States.

NewsBytes Briefing: China won't approve TikTok deal, and more

23 Sep 2020

NewsBytes Briefing: China won't approve TikTok deal, and more

Even as TikTok, Oracle, and Walmart came close to finalizing a deal, China is not ready to let the service off the hook.

Coronavirus: What is the 'Feluda' test? How does it work?

21 Sep 2020

Coronavirus: What is the 'Feluda' test? How does it work?

The Drugs Controller General of India (DCGI) has approved for commercial launch of a CRISPR-based test for COVID-19, called 'Feluda'.

Biocon Chief Kiran Mazumdar Shaw tests positive for coronavirus

18 Aug 2020

Biocon Chief Kiran Mazumdar Shaw tests positive for coronavirus

As India reels under coronavirus catastrophe, Kiran Mazumdar Shaw, chairperson of Biocon Ltd., joined the long list of famous personalities to test positive for the highly-contagious disease.

SII gets nod for Oxford COVID vaccine phase 2/3 trials

03 Aug 2020

SII gets nod for Oxford COVID vaccine phase 2/3 trials

The Serum Institute of India (SII) has gotten the approval to conduct phase 2 and 3 human clinical trials of the COVID-19 vaccine candidate developed by Oxford University.

Coronavirus: How much would the vaccines cost?

30 Jul 2020

Coronavirus: How much would the vaccines cost?

As the coronavirus pandemic continues to surge, all hopes rest on the development of a vaccine to beat the virus.

You can enroll for AIIMS's COVID-19 vaccine trials: Here's how

19 Jul 2020

You can enroll for AIIMS's COVID-19 vaccine trials: Here's how

India's indigenous COVID-19 vaccine candidate, COVAXIN, is set to go into human trials at AIIMS Delhi.

All you need to know about India's COVID-19 vaccines

09 Jul 2020

All you need to know about India's COVID-19 vaccines

As the coronavirus outbreak continues to surge worldwide, efforts to develop a vaccine have been expedited.

Expert panel sets conditions, ICMR's COVAXIN August-15 target looks unachievable

07 Jul 2020

Expert panel sets conditions, ICMR's COVAXIN August-15 target looks unachievable

On July 2, the Indian Council of Medical Research (ICMR) revealed its plans to launch COVAXIN, the COVID-19 vaccine developed by Hyderabad-based Bharat Biotech and ICMR, by August 15.

India's second COVID-19 vaccine cleared for human trials: Details here

03 Jul 2020

India's second COVID-19 vaccine cleared for human trials: Details here

India is picking up pace to develop a preventive vaccine for COVID-19, the novel coronavirus disease.

Glenmark launches COVID-19 drug FabiFlu at Rs. 103 per tablet

20 Jun 2020

Glenmark launches COVID-19 drug FabiFlu at Rs. 103 per tablet

Glenmark Pharmaceuticals Ltd. launched the antiviral drug favipiravir on Saturday for the treatment of mild to moderate cases of COVID-19.