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drugs controller general of india

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Dr Reddy’s gets DCGI nod to conduct phase 3 Sputnik Light trials

The Drugs Controller General of India (DCGI) has allowed Hyderabad-based Dr Reddy’s Laboratories to conduct phase 3 bridging trials of Sputnik Light, the single dose formulation of the Russia-made Sputnik V Covid-19 vaccine
A health worker administers the Sputnik V coronavirus vaccine (AP)
A health worker administers the Sputnik V coronavirus vaccine (AP)
Updated on Sep 16, 2021 02:57 AM IST
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By Rhythma Kaul, Hindustan Times, New Delhi

'Need more scientific data to clarify’: Centre on mixing of Covid-19 vaccines

The Drugs Controller General of India in August approved a proposal by the CMC Vellore, Tamil Nadu, to conduct a study to analyse the mixing of one dose each of Covaxin and Covishield doses.
The study on mixing of Covid-19 vaccines is being conducted with 300 volunteers who are administered a dose each of Covaxin and Covishield – the first two vaccines to receive the DCGI nod.
The study on mixing of Covid-19 vaccines is being conducted with 300 volunteers who are administered a dose each of Covaxin and Covishield – the first two vaccines to receive the DCGI nod.
Published on Sep 14, 2021 09:51 PM IST
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Written by Sharangee Dutta | Edited by Avik Roy, Hindustan Times, New Delhi

Biological E’s Corbevax may be launched in October: Niti Aayog’s VK Paul

Corbevax, the second jab against the virus being made in the country, is an RBD protein sub-unit vaccine. On Wednesday, the Drug Controller General of India (DGCI) gave permission to Biological E to conduct phase 2/3 clinical trials of Corbevax on children between five-18 years with certain conditions.
In June, the Union health ministry had said Biological E would supply 30 crore doses of Corbevax to India by December.(PTI file photo. Representative image)
In June, the Union health ministry had said Biological E would supply 30 crore doses of Corbevax to India by December.(PTI file photo. Representative image)
Published on Sep 02, 2021 09:43 PM IST
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Written by Harshit Sabarwal | Edited by Sohini Goswami, New Delhi

DCGI allows Serum Institute to manufacture Sputnik V vaccine in India

The Pune-based SII has collaborated with Gamaleya Research Institute of Epidemiology and Microbiology, Moscow, in Russia for developing Sputnik V at its licensed Hadapsar facility.
A health worker prepares a dose of the Sputnik V vaccine against Covid-19 (Representational Image / AFP)
A health worker prepares a dose of the Sputnik V vaccine against Covid-19 (Representational Image / AFP)
Published on Jun 04, 2021 09:10 PM IST
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By hindustantimes.com | Written by Joydeep Bose

India records 18,088 Covid-19 cases in last 24 hours, death toll over 1.5 lakh

NITI Aayog member Dr V K Paul said an optimistic scenario is emerging with the pandemic situation in India consistently improving in terms of active cases and new deaths declining.
Healthcare workers prepare a vaccination room inside a classroom of a school, which was converted into a temporary Covid-19 vaccination centre in Ahmedabad, on January 4.(Reuters Photo)
Healthcare workers prepare a vaccination room inside a classroom of a school, which was converted into a temporary Covid-19 vaccination centre in Ahmedabad, on January 4.(Reuters Photo)
Updated on Jan 06, 2021 09:46 AM IST
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Hindustan Times, New Delhi | By hindustantimes.com | Edited by: Amit Chaturvedi

‘Bharat Biotech vaccine approved in clinical trial mode, consent of participants has to be taken’: ICMR

Industry experts and some opposition leaders have expressed concern over the absence of Phase 3 trial data on Covaxin.
Healthcare workers during a mock drill for dry run of Covid-19 vaccination programme, at MMG hospital in Ghaziabad on Tuesday.(Sakib Ali/HT Photo)
Healthcare workers during a mock drill for dry run of Covid-19 vaccination programme, at MMG hospital in Ghaziabad on Tuesday.(Sakib Ali/HT Photo)
Updated on Jan 06, 2021 10:17 AM IST
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Hindustan Times, New Delhi | By hindustantimes.com | Edited by: Amit Chaturvedi

Manish Tiwari hits out at the Centre for premature Covid vaccine roll-out

The Drugs Controller General of India on Sunday announced that it has approved Covaxin along with the Oxford University-AstraZeneca vaccine manufactured in India by the Serum Institute of India
Member of Parliament Manish Tiwari.(Sonu Mehta/HT PHOTO)
Member of Parliament Manish Tiwari.(Sonu Mehta/HT PHOTO)
Published on Jan 05, 2021 04:22 PM IST
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Hindustan Times, New Delhi | By Deeksha Bhardwaj

Serum Institute, Bharat Biotech pledge smooth Covid-19 vaccine roll-out

Both the vaccine makers on Tuesday communicated their combined intent to develop, manufacture and supply Covid-19 vaccines
Representational image.(AFP)
Representational image.(AFP)
Updated on Jan 05, 2021 05:03 PM IST
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Hindustan Times, New Delhi | By Rhythma Kaul

Drug regulator gives final approval for Covid-19 vaccines of SII, Bharat Biotech

Covaxin is the indigenous vaccine being developed by Bharat Biotech in collaboration with the Indian Council of Medical Research (ICMR).
A health worker takes part in a dry run or a mock drill for Covid-19 vaccine delivery at a model vaccination centre at Ansari Road in New Delhi.(Sanchit Khanna/HT Photo)
A health worker takes part in a dry run or a mock drill for Covid-19 vaccine delivery at a model vaccination centre at Ansari Road in New Delhi.(Sanchit Khanna/HT Photo)
Updated on Jan 03, 2021 01:55 PM IST
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Hindustan Times, New Delhi | By HT Correspondent

Drugs regulator chief’s press conference today, approval of Covid-19 vaccines likely

The development comes after the subject expert committee (SEC) under the Central Drugs Standard Control Organisation (CDSCO) recommended Oxford-AstraZeneca’s vaccine for emergency use and Covaxin for restricted use.
An employee in personal protective equipment (PPE) removes vials of AstraZeneca's Covishield from a visual inspection machine inside a lab at Serum Institute of India in Pune in this file photo.(REUTERS)
An employee in personal protective equipment (PPE) removes vials of AstraZeneca's Covishield from a visual inspection machine inside a lab at Serum Institute of India in Pune in this file photo.(REUTERS)
Updated on Jan 03, 2021 09:13 AM IST
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Hindustan Times, New Delhi | By hindustantimes.com | Edited by Meenakshi Ray

SII’s Covishield approval: Efficacy, cost and all about AstraZeneca’s Covid-19 vaccine

AstraZeneca had signed an agreement with Serum Institute of India (SII) to produce 1 billion doses of its experimental vaccine for low- and middle-income countries.
An employee in PPE removes vials of AstraZeneca's Covishield inside a lab at Serum Institute of India, in Pune, India.(REUTERS)
An employee in PPE removes vials of AstraZeneca's Covishield inside a lab at Serum Institute of India, in Pune, India.(REUTERS)
Updated on Jan 01, 2021 09:03 PM IST
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Hindustan Times, New Delhi | By hindustantimes.com | Edited by Kunal Gaurav

Covid-19: When, where and how to receive vaccine? All you need to know

The Drugs Controller General of India (DCGI) is examining the applications of Bharat Biotech, Serum Institute and Pfizer to grant emergency use authorisation for their Covid-19 vaccines.
The health ministry reiterated that the vaccination against the coronavirus disease (Covid-19) is voluntary.(PTI)
The health ministry reiterated that the vaccination against the coronavirus disease (Covid-19) is voluntary.(PTI)
Updated on Dec 18, 2020 06:43 PM IST
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Hindustan Times, New Delhi | By hindustantimes.com | Edited by Kunal Gaurav

Review of Covid vaccine applications of Pfizer, SII, Bharat Biotech tomorrow: Report

The decision was taken late on Monday evening after the Hyderabad-based Bharat Biotech became the third pharmaceutical firm to apply to the Drugs Controller General of India (DCGI) for emergency use authorisation for its indigenously developed Covid-19 vaccine Covaxin.
A woman holds a small bottle labelled with a
A woman holds a small bottle labelled with a "Coronavirus COVID-19 Vaccine" sticker and a medical syringe in front of displayed Pfizer logo.(Reuters File Photo)
Updated on Dec 08, 2020 06:16 AM IST
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New Delhi | By Press Trust of India | Posted by Kanishka Sarkar

Besides Bharat Biotech, who else has applied for emergency use authorisation in India

Bharat Biotech filed its application with the Drugs Controller General of India (DGCI) earlier as its candidate “Covaxin” is still in the phase-3 trials
A research scientist works inside a laboratory of India's Serum Institute, the world's largest maker of vaccines, which is working on vaccines against the coronavirus disease (COVID-19) in Pune.(REUTERS)
A research scientist works inside a laboratory of India's Serum Institute, the world's largest maker of vaccines, which is working on vaccines against the coronavirus disease (COVID-19) in Pune.(REUTERS)
Updated on Dec 07, 2020 11:34 PM IST
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Hindustan Times, New Delhi | By hindustantimes.com | Edited by Shivani Kumar

Covid-19: India won’t allow trial of Russia’s Sputnik V in large study

Instead of jumping straight to a large-scale trial, Dr Reddy’s has been advised to consider a small trial.
A nurse prepares Russia's
A nurse prepares Russia's "Sputnik-V" vaccine for inoculation in a post-registration trials stage at a clinic in Moscow.(REUTERS)
Updated on Oct 08, 2020 08:49 AM IST
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Hindustan Times, New Delhi | By hindustantimes.com | Edited by Poulomi Ghosh

DGCI asks Dr Reddy’s lab to revise protocol to conduct Russian Covid-19 vaccine Sputnik V trials

The Indian Drugmaker (Dr Reddy’s Lab) has joined hands with the Russian Direct Investment Fund (RDIF) to conduct clinical trials of the Sputnik V vaccine as well as its distribution.
A nurse shows a box with Russia's ‘Sputnik-V’ vaccine against the coronavirus disease (Covid-19) prepared for inoculation in a post-registration trials stage at a clinic in Moscow.(Reuters Photo)
A nurse shows a box with Russia's ‘Sputnik-V’ vaccine against the coronavirus disease (Covid-19) prepared for inoculation in a post-registration trials stage at a clinic in Moscow.(Reuters Photo)
Published on Oct 06, 2020 07:16 AM IST
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New Delhi | By Asian News International | Posted by Kanishka Sarkar

Bharat Biotech’s Covid-19 vaccine to use ViroVax’s adjuvant for longer-lasting immunity

Bharat Biotech is currently conducting Phase 2 human trials of its Covid-19 vaccine candidate after receiving approval from the Drugs Controller General of India
Kansas-based ViroVax LLC has licensed their adjuvant for the use of Covaxin, which is currently undergoing advanced stages of clinical trials in India.(Representational Photo/REUTERS)
Kansas-based ViroVax LLC has licensed their adjuvant for the use of Covaxin, which is currently undergoing advanced stages of clinical trials in India.(Representational Photo/REUTERS)
Updated on Oct 05, 2020 12:08 PM IST
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Hindustan Times, New Delhi | By Rhythma Kaul

Early lab studies offer hope for plant-based drugs to treat coronavirus

Research shows that constituents of Solanum nigrum bind with ACE 2 (an enzyme the Sars-Cov-2 virus uses to enter the body) and have the potential to inhibit viral replication; cytokine storm and inflammation.
In molecular docking studies conducted recently, Solanum nigrum (black nightshade; Makoy in Hindi), a weed and a vegetable commonly consumed in many parts of the country, the team says they found remarkable results. (HT Photo)
In molecular docking studies conducted recently, Solanum nigrum (black nightshade; Makoy in Hindi), a weed and a vegetable commonly consumed in many parts of the country, the team says they found remarkable results. (HT Photo)
Updated on Sep 02, 2020 07:08 PM IST
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Hindustan Times, New Delhi | By Jayashree Nandi

PGIMER to start Oxford Covid vaccine trials by end of August

Around 2,000 people will be examined and about 1,600 persons will be selected. Out of them the institute has committed around 250 people. Recruitment will be done in the first month
PGIMER has been selected for the trials after the Drugs Controller General of India granted approvals to the Serum Institute of India in Pune for conducting phase 2 and 3 of the Covishield trials.(HT Photo)
PGIMER has been selected for the trials after the Drugs Controller General of India granted approvals to the Serum Institute of India in Pune for conducting phase 2 and 3 of the Covishield trials.(HT Photo)
Updated on Aug 03, 2020 09:44 PM IST
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Hindustan Times, Chandigarh | By Amanjeet Singh Salyal, Chandigarh

Serum Institute asked to revise protocol for Covid-19 vaccine clinical trial

Serum Institute of India will perform an observer-blind, randomised controlled study enrolling at least 1,600 participants to determine the safety and immunogenicity of ‘Covishield’ for coronavirus treatment.
Nurse prepares a shot as the world's biggest study of a possible Covid-19 vaccine developed by the National Institutes of Health and Moderna Inc. gets underway on July 27, 2020 in Binghamton, NY.(AP File Photo)
Nurse prepares a shot as the world's biggest study of a possible Covid-19 vaccine developed by the National Institutes of Health and Moderna Inc. gets underway on July 27, 2020 in Binghamton, NY.(AP File Photo)
Updated on Jul 30, 2020 08:01 AM IST
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New Delhi | By Asian News International | Posted by Kanishka Sarkar

Polio surveillance enhanced in Uttar Pradesh, Maharashtra, Telangana

The health ministry on Wednesday said surveillance has been enhanced in Uttar Pradesh, Maharashtra and Telangana after traces of Polio Virus Type 2 were found in some batches of oral polio vaccine, and asserted the country remains polio-free.
Traces of Polio Virus Type 2 were found in some batches of oral polio vaccine manufactured by a Ghaziabad-based pharmaceutical company.(File Photo)
Traces of Polio Virus Type 2 were found in some batches of oral polio vaccine manufactured by a Ghaziabad-based pharmaceutical company.(File Photo)
Updated on Oct 04, 2018 01:39 PM IST
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New Delhi | By Press Trust of India
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Saturday, October 16, 2021