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Drugs Controller General of India

Director of CDSCO

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Drugs Controller General of India: Director of CDSCO

Drugs Controller General of India (DCGI) is the head of department of the Central Drugs Standard Control Organization of the Government of India responsible for approval of licences of specified categories of drugs such as blood and blood products, IV fluids, vaccines, and sera in India. Drugs Controller General of India, comes under the Ministry of Health & Family Welfare. DCGI also sets standards for manufacturing, sales, import, and distribution of drugs in India.

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Covid vaccine news: SII's Covovax approved as heterologous booster dose for adults

DCGI has approved market authorisation to COVID-19 vaccine Covovax as a heterologous booster dose for adults.
DNA - Published

Bharat Biotech's Intranasal Covid-19 Booster gets DCGI nod for emergency use

For individuals 18 years of age and older, the DCGI has authorised the use of Bharat Biotech's five arms heterologous booster, ANI reported.
DNA - Published

DCGI approves '5-arms intranasal heterologous booster dose' for restricted use


IndiaTimes - Published

India's first intranasal Covid vaccine by Bharat Biotech gets DCGI approval

Bharat Biotech's intranasal vaccine has been approved for primary immunization against Covid in adults for restricted use in emergency situation.
DNA - Published

Corbevax Covid booster expected to get final approval from government soon: Report

Earlier on June 4, DCGI approved Corbevax as a precaution dose for those aged 18 and above.
DNA - Published

Bharat Biotech's intranasal Covid-19 vaccine to get DCGI nod soon? Here's what we know

The Drug Controller General of India gave its nod to conduct clinical trials for BBIL's intranasal vaccine as a booster dose.
DNA - Published

DCGI grants emergency use authorisation to India's first mRNA Covid-19 vaccine: Sources

The Subject Expert Committee under India's drug regulator has found data submitted by Gennova Biopharmaceuticals "satisfactory".
DNA - Published

Covid-19 vaccine: SII's Covovax gets nod for emergency use in children aged 7 to 11 years

The DCGI had approved Covovax for restricted emergency use in adults on December 28, 2021, and in 12-17 years age group on March 9, 2022.
DNA - Published Also reported by •IndiaTimes

India's first mRNA Covid-19 vaccine to get Emergency Use Authorisation soon

The Subject Expert Committee (SEC) in a meeting held on Friday recommended Emergency Use Authorisation (EUA) for India's first mRNA COVID-19 vaccine, sources have said. The Drugs controller general of..
IndiaTimes - Published

Allowing Corbevax as booster for those vaccinated with Coivishield, Covaxin likely to be considered by NTAGI

The Drugs Controller General of India (DCGI) on June 4 approved Corbevax as a precaution dose for those aged 18 and above. India's first indigenously-developed RBD protein subunit vaccine, Corbevax, is..
IndiaTimes - Published

Govt panel recommends emergency approval for SII's Covovax for 7-11 year olds

An expert panel of India's central drug authority on Friday recommended granting emergency use authorisation to Serum Institute's Covovax for children aged 7 to 11 years, official sources said. The..
IndiaTimes - Published

Bharat Biotech's Covid nasal vaccine phase 3 trials completed

The company will submit its data to the Drugs Controller General of India (DCGI) next month, said Dr Krishna Ella, Bharat Biotech chief.
DNA - Published

DCGI clears Corbevax as Covid booster shot for those aged 18 and above

In April, DCGI had given emergency use authorisation (EUA) to Corbevax for children between 5 and 12 years.
DNA - Published

Mixed-vax trial has yielded positive data: CMC Vellore

A study by Christian Medical College, Vellore, on the effectiveness of mixed booster doses has yielded positive results and is currently being evaluated by central agencies, officials from the..
IndiaTimes - Published

Bharat Biotech seeks DCGI nod for phase 2/3 Covaxin booster trial among two to 18-year-old

Bharat Biotech has sought permission from India's drug regulator to conduct a phase 2/3 study of its Covid vaccine Covaxin as a booster dose among those aged two to 18 years, sources told PTI...
IndiaTimes - Published

DCGI gives approval for Bharat Biotech's Covaxin for children aged 6-12

The Drug Controller General of India (DCGI) has given a restricted emergency use approval for Bharat Biotech's Covid-19 vaccine, Covaxin, for children between the age of six and 12. A Subject Expert..
IndiaTimes - Published Also reported by •DNA

DCGI grants approval to Corbevax for kids aged 5-12, Covaxin for 6-12 age group

The Drug Controller General of India (DCGI) on Tuesday granted emergency use approval to Covid-19 vaccines, Covaxin and Corbevax, for children below 12. Bharat Biotech's Covaxin has got nod for use in..
IndiaTimes - Published

Bharat Biotech asked to provide more data on Covid-19 vaccine Covaxin for children aged below 12

The Subject Expert Committee (SEC) of the Drug Controller General of India (DCGI) has asked Bharat Biotech for additional data on its Covid-19 vaccine, Covaxin, for administering it to children aged..
IndiaTimes - Published

Novavax says its Covid vaccine gets India authorisation for adolescents

Novavax Inc on Tuesday said that the Drugs Controller General of India (DCGI) has granted emergency use authorisation for its Covid-19 vaccine for adolescents aged 12 to 17 in the country. The..
IndiaTimes - Published

Phase 2,3 trial data of India's first mRNA Covid vaccine submitted to DCGI

Pune-based Gennova Biopharmaceuticals has submitted the phase-II and phase-III trials data of India's first mRNA Covid vaccine to the regulator Drugs Controller General of India (DCGI) on Friday, said..
IndiaTimes - Published

Covid-19: Covovax gets DCGI’s EUA nod for 12-17-year-olds

In a move that will further expand the basket of Covid vaccines approved for adolescents, the drug regulator has given emergency approval to Serum Institute of India’s Covovax for use in 12-17 year..
IndiaTimes - Published

DCGI's EUA nod to Covovax for 12-17 years age group

India's drug regulator has granted restricted emergency use authorisation to Serum Institute of India's COVID-19 vaccine Covovax for the 12-17 years age group subject to certain conditions, official..
IndiaTimes - Published

Biological E seeks EUA for Covid vaccine Corbevax for children in 5-12 age group: Official sources

Recently, the subject expert committee recommended emergency use authorization (EUA) for Biological E's Covid-19 vaccine Corbevax for the age group of 12 to 18 years under certain conditions. The drugs..
IndiaTimes - Published

Covid-19: SII's Covovax vaccine recommended for Phase 3 trial as booster dose in adults

The Pune-based SII had sought the permission from the DCGI to conduct Phase 3 study to evaluate the safety and immunogenicity of Covovax.
DNA - Published

Government panel recommends EUA for Covid vaccine Covovax for 12-17 age group

Prakash Kumar Singh, director-government and regulatory affairs at Serum Institute of India (SII), had submitted an application to the DCGI on February 21, seeking EUA for Covovax for the 12 to 17..
IndiaTimes - Published

SII seeks permission for Covovax vaccine phase-3 study of booster dose in adults

The Drugs Controller General Of India (DCGI) had approved Covovax for restricted use in emergency situations in adults on December 28.
DNA - Published

Corbevax gets emergency use nod for 12-18 age group

Hyderabad-based pharmaceutical company Biological E Ltd has received an emergency use approval from Drugs Controller General of India for use in children aged 12 to 18 years
IndiaTimes - Published

Covid: DCGI grants EUA to BE's Corbevax for use in kids aged 12-18 years

Vaccine maker Biological E Limited’s (BE), receptor binding domain (RBD) protein sub-unit Covid-19 vaccine Corbevax has bagged emergency use authorisation (EUA) from the Drugs Controller General of..
IndiaTimes - Published

Corbevax Covid-19 vaccine recommended for emergency use in 12-18 years age group

The Drugs Controller General Of India (DCGI) has already approved Corbevax for restricted use in emergency situation in adults on December 28.
DNA - Published

DCGI gives emergency use nod to Sputnik


IndiaTimes - Published

DCGI grants emergency use permission to single-dose Sputnik Light Covid vaccine

The Drugs Controller General of India (DCGI) on Sunday granted emergency use permission to single-dose Sputnik Light Covid vaccine in the country. This comes following recommendations of an expert..
IndiaTimes - Published

Single-dose Sputnik Light Covid Vaccine receives emergency use permission from DCGI

Union Health Minister Mansukh Mandaviya on Sunday said that the Drugs Controller General of India (DGCI) grants emergency use approval to single-dose Sputnik Light COVID-19 vaccine.
DNA - Published

Submitted proposal to DCGI to test Sputnik Light as Covid booster dose: Dr Reddy's


IndiaTimes - Published

Covaxin granted Emergency Use Listing in 13 nations as on Jan 31 according to WHO: Govt

Covaxin has been granted Emergency Use Listing (EUL) in 13 countries as on January 31 according to the WHO, Minister of State for Health Bharati Pravin Pawar informed the Lok Sabha on Friday...
IndiaTimes - Published

SII gets DCGI nod to manufacture drug substance, test it for developing jab against Omicron


IndiaTimes - Published

Biological E gets DCGI nod for Phase 3 clinical trials of Corbevax as booster dose

Biological E, Hyderabad-based pharmaceutical company on Tuesday received the emergency-use authorisation for manufacturing and marketing of Corbevax.
DNA - Published

Pharma firms to roll out anti-Covid pill shortly as DCGI approves emergency use

With the Drugs Controller General of India (DCGI) approving the anti-Covid-19 pill Molnupiravir for emergency use in the country, Strides Pharma on Tuesday said it will launch the capsule immediately..
IndiaTimes - Published

Covaxin gets DCGI nod for emergency use for kids aged 12-18 years

Indigenously developed Covid-19 vaccine Covaxin has received approval from the Drugs Controller General of India (DCGI) for emergency use in children aged between 12-18 years. The drug regulator’s..
IndiaTimes - Published

DCGI nod to Covaxin for use in children above 12 years with certain conditions


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DCGI seeks more data from SII over its application seeking emergency authorisation for Covovax


IndiaTimes - Published

Bharat Biotech seeks DCGI's nod for its intranasal COVID-19 booster dose clinical trials

The company is hoping for early approval for the trails of the intranasal COVID-19 booster given the fast spread of the Omicron variant.
DNA - Published Also reported by •IndiaTimes

As Omicron fear intensifies, Serum Institute of India seeks DCGI's approval for Covishield booster shot

Recently, Kerala, Rajasthan, Karnataka, and Chhattisgarh have also urged the Centre to decide on allowing booster doses of the COVID-19 vaccine.
DNA - Published Also reported by •IndiaTimes

Bharat Biotech gets DCGI nod for shelf-life extension of its COVID-19 vaccine Covaxin

Bharat Biotech had submitted its data to the drug regulator and sought a shelf-life extension for its vaccine.
DNA - Published

We are waiting for DCGI approval for children's Covid-19 vaccine: Bharat Bitoech Chairman

Chairman and Managing Director of Bharat Biotech, Dr. Krishna Ella on Saturday said that they are waiting for approval from the Drugs Controller General of India (DCGI) for the Covid-19 vaccine for..
IndiaTimes - Published

Covaxin's approval for children aged 2-18 years under experts' opinion, evaluation: Sources

The final approval for Bharat Biotech's Covaxin for children aged 2-18 years is under experts opinion and evaluation, stated Government sources on Thursday. Earlier on Tuesday, official sources had..
IndiaTimes - Published

AstraZeneca Pharma India gets DCGI nod to import, market Selumetinib capsules


IndiaTimes - Published

Covaxin kids trial over, Bharat Biotech to submit data to DCGI next week


IndiaTimes - Published

Sputnik Light COVID-19 vaccine gets DCGI nod for Phase 3 trials in India

Earlier in the month of April, the two-dose version of the vaccine, Sputnik V, was approved for 'emergency use' by the DCGI.
DNA - Published Also reported by •IndiaTimes

Hetero’s Tocilizumab biosimilar gets DCGI nod for hospitalised Covid-19 patients


IndiaTimes - Published


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