working regular clinical formulation adults sma cases death access patients second molnupiravir gambia restricted oxygen hepatitis pfizer children manufacturing coronavirus ministry uk phase deaths vaccine pradesh available developed source launches

Articles for Dcgi, search results for human

Covid News: At High-level Meet, PM Modi Cautions Against Complacency, Advises Increased Tests
2 years ago

Covid News: At High-level Meet, PM Modi Cautions Against Complacency, Advises Increased Tests

News 18  

Covid-19 News Updates: Prime Minister Narendra Modi on Thursday chaired a high-level meeting to review the situation related to Covid-19 in the country and the preparedness of health infrastructure and logistics, the status of the vaccination campaign in the country and the emergence of new Covid-19 variants. The meeting comes a day after Union Health Minister Mansukh Mandaviya reviewed the …

India China Minister Pm Modi Situation Variant Other Countries
Explained: As India Unveils SII's CERVAVAC, Know How Cervical Cancer Vaccines Work
2 years, 3 months ago

Explained: As India Unveils SII's CERVAVAC, Know How Cervical Cancer Vaccines Work

ABP News  

Pune-based pharmaceutical firm Serum Institute of India will soon launch CERVAVAC, India’s first indigenously developed Quadrivalent Human Papillomavirus vaccine against cervical cancer. On June 15, 2022, the DCGI’s Subject Expert Committee recommended the qHPV vaccine developed by the SII for cervical cancer patients belonging to the age group of nine to 26 years. HPV vaccines are important because they could …

India Cancer Vaccines Cervical Cervical Cancer Dcgi Caused
Why Serum Institute’s qHPV vaccine, India’s first against cervical cancer, is a game-changer
2 years, 3 months ago

Why Serum Institute’s qHPV vaccine, India’s first against cervical cancer, is a game-changer

Firstpost  

Cervavac, India’s first vaccine to fight cervical cancer, will be launched today. The country’s first ‘Made in India’ quadrivalent Human Papilloma Virus vaccine for the prevention of cervical cancer will be launched today. However, there is a risk for all women that HPV infection may become chronic and pre-cancerous lesions progress to invasive cervical cancer, says the WHO. According to …

Health India Cancer Women Cent Vaccine Cervical
DCGI Grants Marketing Authorisation to SII's QHPV Vaccine Against Cervical Cancer
2 years, 5 months ago

DCGI Grants Marketing Authorisation to SII's QHPV Vaccine Against Cervical Cancer

News 18  

The Drugs Controller General of India on Tuesday granted market authorisation to Serum Institute of India to manufacture indigenously-developed India’s first Quadrivalent Human Papillomavirus vaccine against cervical cancer, official sources said. Prakash Kumar Singh, director at Serum Institute, had applied to the DCGI seeking market authorisation of qHPV after the phase 2/3 clinical trial was completed with support of the …

India Cancer Singh Vaccine Hpv Cervical Cancer Dcgi
Govt panel recommends permission for phase 3 trial of Sputnik Light vaccine as booster dose
2 years, 9 months ago

Govt panel recommends permission for phase 3 trial of Sputnik Light vaccine as booster dose

India Today  

An expert panel of India’s central drug authority has recommended permission to conduct a phase-3 clinical trial of the single-dose Covid-19 vaccine ‘Sputnik Light’ as a booster dose, official sources said on Saturday. "The Subject Expert Committee on Covid-19 of the Central Drugs Standard Control Organisation, which reviewed the application on Friday after detailed deliberation, recommended granting permission for the …

India Light Covid Vaccine Dcgi Dose Sputnik
Dealing with fake drugs
3 years, 6 months ago

Dealing with fake drugs

The Hindu  

THE Indian pharmaceutical industry has a domestic turnover of more than Rs.20,000 crore and exports over Rs.10,000 crore. The Hathi Committee Report of 1975, for example, had recommended measures to strengthen and streamline the Central and State Drug Control Organisations. The upper limit is from a report in the medical journal Lancet in 2001 by an Indian journalist, ostensibly based …

Delhi Death Penalty Drugs States Indian Regulatory Control
Zydus Cadila Seeks DCGI Nod for Human Clinical Trials of Antibodies Cocktail to Treat Covid-19
3 years, 6 months ago

Zydus Cadila Seeks DCGI Nod for Human Clinical Trials of Antibodies Cocktail to Treat Covid-19

News 18  

Zydus Cadila on Thursday said it is seeking permission from Drugs Controller General of India to initiate human clinical trials for monoclonal antibodies cocktail for treatment of COVID-19. “Zydus is currently seeking permission to initiate phase 1/3 human clinical trials from the DCGI… ZRC-3308, a cocktail of two SARS-CoV-2-neutralizing monoclonal antibodies can emerge as one of the main treatments for …

India Treatment Treat Zydus Human Clinical Trials Dcgi Nod Zrc
Covaxin approval row: How India approves vaccines explained
3 years, 11 months ago

Covaxin approval row: How India approves vaccines explained

India Today  

The restricted emergency approval given to a Covid-19 vaccine developed by Bharat Biotech on January 3 has created a huge furore with several experts questioning the government's decision. A key aspect of granting approval to a vaccine or a drug in India is the requirement of clinical trials conducted within the country - from phase-I to phase-III. Read: Covishield vs …

India Safety Data Trials Clinical Trials Drug Cdsco
Coronavirus | Data on Covaxin phase-3 trials submitted to DCGI: Bharat Biotech
3 years, 11 months ago

Coronavirus | Data on Covaxin phase-3 trials submitted to DCGI: Bharat Biotech

The Hindu  

Bharat Biotech in a statement issued on Saturday said the publication of its COVID vaccine ’s phase II trial data is undergoing the peer review process and that as a part of the regulatory guidelines all data has been submitted to the DCGI and CDSCO. The firm said that product development and clinical trial data for Covaxin has so far …

India Trial Vaccine Bharat Biotech Covaxin Phase
Serum Institute seeks emergency use nod for Covishield in India
4 years ago

Serum Institute seeks emergency use nod for Covishield in India

India TV News  

The Serum Institute of India on Sunday became the first indigenous company to apply to the Drugs Controller General of India seeking emergency use authorisation for the Oxford COVID-19 vaccine in the country citing unmet medical needs due to the pandemic and in the interest of the public at large, official sources said. The phase-three clinical trial of the Oxford …

India Country Vaccine Oxford Dcgi Icmr Serum Institute Of India
Serum Institute’s lawsuit against trial volunteer uncalled for; transparent approach needed, say experts
4 years ago

Serum Institute’s lawsuit against trial volunteer uncalled for; transparent approach needed, say experts

Firstpost  

Even in the most well-developed drug or vaccines, where the odds of an adverse event may be slim, the redressal process for issues raised by volunteers is tricky. SII said that the volunteer’s illness had nothing to do with the vaccine trial – a statement that was validated by the Institutional Ethics Committee of the Covishield trials in India. It’s …

India Volunteer Volunteers Lawsuit Process Event Dcgi
After Pfizer, Serum Institute Seeks Emergency Use Nod for Oxford Covid-19 Vaccine Covishield in India
4 years ago

After Pfizer, Serum Institute Seeks Emergency Use Nod for Oxford Covid-19 Vaccine Covishield in India

News 18  

x The Serum Institute of India on Sunday became the first indigenous company to apply to the Drugs Controller General of India seeking emergency use authorisation for the Oxford COVID-19 vaccine in the country citing unmet medical needs due to the pandemic and in the interest of the public at large, official sources said. The phase-three clinical trial of the …

India Country Vaccine Oxford Dcgi Icmr Serum Institute Of India
Coronavirus | Pfizer seeks emergency use authorisation for its COVID-19 vaccine in India
4 years ago

Coronavirus | Pfizer seeks emergency use authorisation for its COVID-19 vaccine in India

The Hindu  

Pfizer India has become the first pharmaceutical firm to seek from the Drugs Controller General of India an emergency use authorisation for its COVID-19 vaccine in the country, after its parent company secured such clearance in the UK and Bahrain. “Pfizer India has submitted an application on December 4 to the DCGI seeking emergency use authorization for its COVID-19 vaccine …

India Trials Country Clinical Trials Vaccine Dcgi Clinical
Pfizer seeks emergency use authorisation of its COVID-19 vaccine in India
4 years ago

Pfizer seeks emergency use authorisation of its COVID-19 vaccine in India

Firstpost  

In its application to the Drugs Controller General of India, Pfizer has sought permission to import the vaccine for sale and distribution in India, as per official sources New Delhi: Pfizer India has become the first pharmaceutical firm to seek from the Drugs Controller General of India an emergency use authorisation for its COVID-19 vaccine in the country after its …

India Trials Country Clinical Trials Vaccine Dcgi Clinical
Serum Institute seeks emergency use approval from DCGI for Oxford Covid-19 vaccine in India
4 years ago

Serum Institute seeks emergency use approval from DCGI for Oxford Covid-19 vaccine in India

India Today  

The Serum Institute of India in Pune on Sunday applied to the Drugs Controller General of India seeking emergency use authorisation for the Oxford-AstraZeneca Covid-19 vaccine in the country. SII cited "unmet medical needs due to the pandemic" and "interest of the public at large," as the reasons for seeking emergency use authorisation, official sources said. The phase-three clinical trial …

India Country Pti Vaccine Oxford Dcgi Icmr
After UK, Pfizer seeks emergency use approval of Covid vaccine in India: Report
4 years ago

After UK, Pfizer seeks emergency use approval of Covid vaccine in India: Report

India Today  

Days after its parent company secured clearance in the UK and Bahrain for mass use, Pfizer India has become the first pharmaceutical firm to seek from the Drugs Controller General of India an emergency use authorisation for its Covid-19 vaccine in the country. "Pfizer India has submitted an application on December 4 to the DCGI seeking Emergency Use Authorization for …

India Trials Country Clinical Trials Covid Pti Vaccine
DCGI approves Dr Reddy's request to conduct Phase 2, 3 clinical trials with Russia's Sputnik V COVD-19 vaccine
4 years, 2 months ago

DCGI approves Dr Reddy's request to conduct Phase 2, 3 clinical trials with Russia's Sputnik V COVD-19 vaccine

Firstpost  

After being denied their request to conduct a phase three clinical trial with Russia’s Sputnik V covid-19 vaccine and asked to submit a new request, the Controller General of Medicines of India has given Dr Reddy’s Laboratories its approval. After the first application was evaluated by the Subject Expert Committee on COVID-19 at Central Drugs Standard Control Organisation, the regulator …

India Russia Trial Trials Clinical Trials Phase Vaccine
Dr Reddy's asked to resubmit phase 2,3 trial application for Russia's Sputnik V COVID-19 vaccine by DCGI
4 years, 2 months ago

Dr Reddy's asked to resubmit phase 2,3 trial application for Russia's Sputnik V COVID-19 vaccine by DCGI

Firstpost  

Dr Reddy’s trials will have to be first assessed in a small group of volunteers to study its efficacy before it can be tested on a larger population. Hyderabad-based Dr Reddy’s Laboratories has been asked to resubmit their application to conduct clinical trials with the Russian Sputnik V vaccine in India. After the application was evaluated by the Subject Expert …

India Russia Trial Trials Covid Russian Phase
DCGI Nod to Phase-1 Human Trials of 'Antisera' with Potential to Treat Covid-19
4 years, 2 months ago

DCGI Nod to Phase-1 Human Trials of 'Antisera' with Potential to Treat Covid-19

News 18  

The Drugs Controller General of India has given permission for conducting Phase-1 human clinical trial for an "antisera" that was developed by injecting inactivated SARS-CoV-2 in horses and can be a potential treatment for COVID-19, ICMR officials said on Tuesday. "With Biological E Limited we have developed an horse 'antisera' and we have just got clearance for conducting clinical trials …

Icmr Human Trials Antisera
Covid-19 vaccine: Bharat Biotech's vaccine to use ViroVax's adjuvant to boost immune response
4 years, 2 months ago

Covid-19 vaccine: Bharat Biotech's vaccine to use ViroVax's adjuvant to boost immune response

India Today  

Bharat Biotech has said its Covid-19 vaccine candidate Covaxin, which was approved for human trials, will use adjuvant Alhydroxiquim-II to boost immune response and longer-lasting immunity. Dr Reddy's seeks DCGI nod for conducting phase-3 clinical trial of Russian Covid-19 vaccine candidate Last week, sources said the Hyderabad-based Dr Reddy's Laboratories has applied to the Drugs Controller General of India for …

India Centre Russian Vaccine Dcgi Clinical Bharat Biotech
Dr Reddy’s seeks DCGI nod to conduct phase-3 clinical trial of Russian COVID-19 vaccine Sputnik V
4 years, 2 months ago

Dr Reddy’s seeks DCGI nod to conduct phase-3 clinical trial of Russian COVID-19 vaccine Sputnik V

Live Mint  

The Hyderabad-based Dr Reddy's Laboratories has applied to the Drugs Controller General of India for permission to conduct phase-3 human clinical trials of the Russian vaccine Sputnik V against COVID-19 in India, sources said. The Indian pharma giant has collaborated with The Russian Direct Investment Fund to conduct clinical trials of Sputnik V as well as its distribution. "The Dr …

India Russia Russian Dcgi Clinical Trial Sputnik Rdif
Will resume Covid-19 vaccine trials after DCGI nod: Serum Institute
4 years, 3 months ago

Will resume Covid-19 vaccine trials after DCGI nod: Serum Institute

India Today  

Serum Institute of India will resume clinical trials of AstraZeneca''s COVID-19 vaccine candidate after getting the permission from the Drugs Controller General of India, the Pune-based vaccine maker said on Saturday. Pharma giant AstraZeneca on Saturday said that clinical trials for the AstraZeneca Oxford coronavirus vaccine, AZD1222, have resumed in the UK following confirmation by the Medicines Health Regulatory Authority …

Trials Clinical Trials Vaccine Oxford Dcgi Resume Serum Institute Of India
Coronavirus | Serum Institute pulled up for not pausing vaccine trial
4 years, 3 months ago

Coronavirus | Serum Institute pulled up for not pausing vaccine trial

The Hindu  

The Drug Controller of India has demanded that the Serum Institute of India, Pune, which is conducting Phase-3 trials on people in India involving U.K.-based AstraZeneca’s COVID-19 vaccine candidate, explain why tests have not been paused in India too until safety has been established. AstraZeneca on late Tuesday put global trials on hold after reports emerged of “ severe adverse …

India Safety Trial Trials Hindu Vaccine Serum
Covid-19: Serum Institute of India Gets Nod for Phase 2, 3 Clinical Trials of Oxford Vaccine Candidate on Adults
4 years, 4 months ago

Covid-19: Serum Institute of India Gets Nod for Phase 2, 3 Clinical Trials of Oxford Vaccine Candidate on Adults

News 18  

The Drugs Controller General of India has given nod to the Serum Institute of India for conducting phase 2 and 3 human clinical trials of a COVID-19 vaccine candidate, developed by the University of Oxford, in the country. Government officials told PTI that the approval for conducting phase 2 and 3 clinical trials by the SII was granted by DCGI …

India Trial Trials Covid Phase Vaccine Oxford