Drugs Controller General of India: News

Serum Institute seeks DCGI's approval for Covovax as booster dose

The Serum Institute of India (SII) has sought the Drugs Controller General of India's (DCGI) approval to roll out its Covovax in the market as a booster dose for adults.

13 Sep 2022

Narendra Modi

Lumpy skin disease kills 67,000 cattle across India: Details here

The lumpy skin disease (LSD) has claimed the lives of about 67,000 cattle in seven Indian states and one union territory, as per the data furnished by the central government on Monday.

19 Jun 2022

Paris

Clinical trials for nasal COVID-19 vaccine complete: Bharat Biotech

The phase 3 clinical trials of Bharat Biotech's COVID-19 nasal vaccine have been completed, according to Dr. Krishna Ella, the company's Chairman and Managing Director.

26 Apr 2022

COVID-19 Vaccine

DCGI clears COVAXIN, Corbevax for children aged 6-12, 5-12 years

In a significant move, the Drugs Controller General of India (DCGI) on Tuesday cleared two COVID-19 vaccines for use in children aged between five and 12 years.

22 Apr 2022

COVID-19

COVAXIN likely to get approval for children above 2yrs: Report

Bharat Biotech's COVID-19 vaccine, COVAXIN, is likely to get the Drugs Controller General of India's (DCGI) nod for use among children aged two to 12 years.

21 Feb 2022

COVID-19

Biological E's Corbevax vaccine approved for children aged 12-18 years

The Drugs Controller General of India (DCGI) has granted an emergency use authorization (EUA) to Corbevax—a COVID-19 vaccine developed by Hyderabad-based Biological E—for use in children aged between 12 and 18 years.

27 Jan 2022

COVID-19

COVAXIN, Covishield will now be available in hospitals and clinics

The Drugs Controller General of India (DCGI) on Thursday granted approval for regular market sale to India's two most prevalent COVID-19 vaccines—COVAXIN and Covishield.

30 Dec 2021

World Bank

New anti-COVID drug may cost up to Rs. 3,000: Report

Molnupiravir, an antiviral medication, is projected to cost between Rs. 2,000 and Rs. 3,000 for a full treatment.

06 Nov 2021

India

COVID-19 vaccine Corbevax's samples cleared by India's apex testing laboratory

Hyderabad-based pharmaceutical company Biological E's COVID-19 vaccine Corbevex's samples were cleared by the Central Drugs Laboratory in Kasauli on Tuesday.

03 Nov 2021

Johnson & Johnson

J&J vaccine's 1cr doses ready for export after CDL nod

American firm Johnson & Johnson's COVID-19 vaccine shots, manufactured in India by Hyderabad-based Biological E, are ready for export, News18 reported.

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

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.

20 Jul 2021

COVID-19 Vaccine

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

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

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

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.

01 Jul 2021

Zydus Cadila

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.

22 Jun 2021

COVID-19

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).

12 Jun 2021

Health & Wellness

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.

02 Jun 2021

Pfizer

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

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.

08 May 2021

India

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.

05 Feb 2021

Pfizer

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

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.

09 Jan 2021

Madhya Pradesh

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.

05 Jan 2021

NITI Aayog

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.

05 Jan 2021

India

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.

05 Jan 2021

Narendra Modi

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.

03 Jan 2021

Oxford University

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.

03 Jan 2021

Oxford University

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.

03 Jan 2021

Oxford University

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.

02 Jan 2021

India

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.

01 Jan 2021

Oxford

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.

31 Dec 2020

India

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.

08 Dec 2020

Pfizer

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.

06 Dec 2020

Pfizer

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.

31 Oct 2020

India

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.

29 Oct 2020

Oxford

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.

04 Oct 2020

NITI Aayog

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.

23 Sep 2020

Europe

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.