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Tag: Dcgi

Nasal Vaccine
Bharat Biotech Gets Nod For COVID-19 Intra-Nasal Vaccine Phase-3 Trials

Bharat Biotech has received approval from the Drug Controller General of India to conduct phase-3 trials for its COVID-19 intra-nasal vaccine (BBV154), sources in the company said on Friday.

Covishield, Covaxin
Regular Market Approval Granted For Covishield, Covaxin For Use In Adult Population

The DCGI approval came after the SEC on COVID-19 of the CDSCO on January 19 recommended granting regular market approval to the SII's Covishield and Bharat Biotech's Covaxin for use in adult population subject to certain conditions.

Molnupiravir
Covid antiviral drug Molnupiravir launched in India

Along with Molnupiravir, the CDSCO has also granted emergency use authorisation to the Serum Institute of India's Covid vaccine COVOVAX, Hyderabad based Biological E RBD Protein CORBEVAX.

Hydroxyurea Gets DCGI Approval For Treatment Of Sickle Cell Anaemia
Hydroxyurea Gets DCGI Approval For Treatment Of Sickle Cell Anaemia

SCA is a common genetic disorder among Indians affecting red blood cells. It is transmitted by parents who carry a defective beta-globin gene without suffering themselves.

Covaxin Approved
Finally, Covaxin Approved For Children In 2-18 Yrs Age Group, DCGI Gives Nod

The Drugs and Comptroller General of India (DCGI) has given a go-ahead to Bharat Biotech's Covaxin for vaccination of children in the 2-18 years age group.

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DCGI Approves Phase 2/3 Trials Of First mRNA Vaccine
DCGI Approves Phase 2/3 Trials Of First mRNA Vaccine

Gennova submitted the proposed Phase 2 and 3 study titled 'A Prospective, Multicentre, Randomised, Active-controlled, Observer-blind, Phase II study seamlessly followed by a Phase III study to evaluate the Safety, Tolerability, and Immunogenicity of the candidate HGCO19 (COVID-19 vaccine) in healthy subjects' which was approved by the office of the DCGI, CDSCO.

COVID-19: Zydus Seeks DCGI Approval For Clinical Trial Of Monoclonal Antibodies Cocktail
Zydus Cadila Applies For Emergency Use Authorisation For COVID-19 Vaccine With DCGI

Zydus Cadila on Thursday said it has applied for emergency use authorisation (EUA) with the Drug Controller General of India (DCGI) for its COVID-19 vaccine ZyCoV-D.

Cipla Gets Nod From DCGI To Bring Moderna's Covid Vaccine To India
Cipla Gets Nod From DCGI To Bring Moderna's Covid Vaccine To India

"The company has received permission from Drugs Controller General of India (DCGI) to import Moderna's COVID-19 vaccine for restricted emergency use in the country."

 Covaxin
DCGI Approves Phase II/III Clinical Trial Of Covaxin In 2 To 18 Yrs Age Group

The National Regulator of the country, the Drugs Controller General of India (DCGI), after careful examination, has accepted the recommendation of Subject Expert Committee (SEC) and accorded permission to conduct the Phase II/III clinical trial of Covaxin (COVID vaccine) in the age group 2 to 18 years

DCGI Gives Emergency Nod To Zydus' COVID-19 Drug 'Virafin'
DCGI Gives Emergency Nod To Zydus' COVID-19 Drug 'Virafin'

Ahmedabad: Zydus Cadila on Friday announced it has received restricted Emergency Use Approval from the Drug Controller General of India (DCGI) for the use of antiviral ‘Virafin’ in treating moderate…

Remdesivir
DCGI Alerted About Black Marketing Of Remdesivir

New Delhi: The government has been alerted about the massive black marketing of Covid drug Remdesivir, which according to some evidence is selling for as high as Rs 50,000, over…

COVAXIN
AIDAN Asks DCGI To Withdraw Approval For Bharat Biotech's Covid-19 Vaccine

New Delhi: The All India Drug Action Network (AIDAN) said it is shocked to learn of the SEC’s recommendation to grant REU approval to Bharat Biotech’s COVAXIN in “clinical trial mode” and “specially in the context of infection by mutant strains”. “In light of the intense concerns arising from the absence of efficacy data and […]

Oxford-AstraZeneca's 'Covishield' Gets Expert Panel's Clearance, Awaits DCGI Nod
Oxford-AstraZeneca's 'Covishield' Gets Expert Panel's Clearance, Awaits DCGI Nod

New Delhi: Serum Institute of India’s (SII) COVID-19 vaccine candidate – Covishield – has been recommended by the Subject Expert Committee (SEC) which met today to examine the emergency-use authorisation (EUA) application sought by the pharmaceutical firm. With the SEC giving a green signal to Oxford-AstraZeneca’s COVID vaccine candidate, India is one step away from […]

Astrazeneca
DCGI Issues Notice To Serum Institute Over Oxford COVID-19 Vaccine Trial Suspension By AstraZeneca Abroad

New Delhi: The central drug regulator has issued a show-cause notice to the Serum Institute of India (SII) for not informing it about pharma giant AstraZeneca pausing the clinical trials of the Oxford vaccine candidate for COVID-19 in other countries and also for not submitting casualty analysis of the “reported serious adverse events”. The show-cause […]

Oxford-Vaccine
COVID-19 Updates: DCGI Nod To Serum Institute For Phase 2, 3 Clinical Trials Of Oxford Vaccine

New Delhi: The Drugs Controller General of India (DCGI) has given nod to the Serum Institute of India (SII) for conducting phase 2 and 3 human clinical trials of the Oxford University developed COVID-19 vaccine candidate in the country. Government officials told PTI that the approval for conducting phase 2 and 3 clinical trials by […]

Covaxin
COVAXIN-India’s 1st COVID-19 Vaccine Candidate Gets DCGI Nod For Human Trials

Hyderabad: Bharat Biotech, has successfully developed COVAXIN, India’s 1st vaccine candidate for COVID-19, in collaboration with the Indian Council of Medical Research (ICMR) – National Institute of Virology (NIV). The SARS-CoV-2 strain was isolated in NIV, Pune and transferred to Bharat Biotech. The indigenous, inactivated vaccine developed and manufactured in Bharat Biotech’s BSL-3 (Bio-Safety Level […]

Covifor
Hetero Gets DCGI Nod To Launch COVID-19 Drug 'Covifor'

New Delhi: Drug firm Hetero on Sunday said it has received approval from regulator DCGI to launch investigational antiviral drug Remdesivir for the treatment of COVID-19. Domestic pharma firm Glenmark Pharmaceuticals had on Saturday launched antiviral drug Favipiravir, under the brand name FabiFlu, for the treatment of patients with mild to moderate COVID-19 at a […]

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