Covaxin

Photo: Business Standard

DCGI Gives Nod To Bharat Biotech For Administering Covaxin To Kids

Hyderabad-based Bharat Biotech was granted emergency approval to administer the COVID-19 vaccine to kids between the age of 12 to 18 years by the Drug Controller General of India (DCGI), on December 25. Reportedly, the company has further started the regulatory process to make it available on CoWin platform. Biotech's vaccine has become the second vaccine to receive approval after Zydus Cadila's three-dose needle-free vaccine ZyCoV-D in India… read-more

Sun, 26 Dec 2021 - 09:02 AM / by Brijesh Goswami

Tags: Covaxin, Bharat biotech, DCGI, approval, kids

Courtesy: Money Control

Bharat Biotech

Photo: The Economic Times

Hyderabad's Bharat Biotech Seeks Phase 3 Trial Of Intranasal Vaccine Booster Shot

Hyderabad based Bharat Biotech, on December 20, sough approval for phase 3 trial of its COVID-19 booster shot. The company urged the DCGI to approve trials for intranasal vaccine against COVID-19, especially amid Omicron scare. "The application has been filed and the company is awaiting approval from the drug regulator," reported PTI.  Notably, the company already conducted phase I and phase II trials and submitted a detailed report… read-more

Tue, 21 Dec 2021 - 11:22 AM / by Varsha Joshi

Tags: Intranasal vaccine, Covid-19, Bharat biotech, DCGI, Omicron Strain

Courtesy: The Indian Express

Covaxin

Photo: Firstpost

Bharat Biotech Awaits Approval To Roll Out Covaxin To Children Aged 2-8 Yrs

Bharat Biotech after submitting vaccine trial reports of "Covaxin" amongst beneficiaries aged between 2-8 years, said that they are awaiting the approval from the drug regulators. Upon receiving approval, Covaxin will become "one of the first vaccines in the world" to be administered to beneficiaries belonging to the said age group. After reviewing the results, the Subject Expert Committee (SEC) recommended the grant of the vaccine.

Tue, 12 Oct 2021 - 09:02 PM / by Shibu Immanuel S

Tags: Bharat biotech, Covaxin, DCGI, Vaccine Trial

Courtesy: ANI News

Sputnik light Russian vaccine

Photo: Odisha Tv

Sputnik Single-Dose Vaccine Trial Gets Approval From DGCI

The third Phase trial of the Sputnik light, a single-dose vaccine in India has been granted permission by the Drugs Controller General of India (DCGI). A study published in The Lancet showed Sputnik light has 78.6 to 83.7% efficacy against Covid. It is higher than two shot vaccines. The CDSCO committee stated that Sputnik light is the same as Sputnik V. Its safety or immunogenicity has been previously tested. 

Wed, 15 Sep 2021 - 03:27 PM / by Ettishree Shukla

Tags: covid 19, Sputnik-V, Russia, DCGI, Covid Vaccine

Courtesy: The Siasat Daily

Hetero's Tocilizumab

Photo: Business Line

Severe COVID-19 Adults Patients To Be Treated With 'Tocilizumab'

For the treatment of Covid-19 patients, the DCGI on September 6 approved Hetero's Tocilizumab vaccine for emergency use. It will be used for adults receiving systemic corticosteroids or requires oxygen supply. "We are pleased with approval... crucial to supply security in India considering a global shortage of Tocilizumab. we will be working closely with the government to ensure equitable distribution," said Dr. B. Partha Saradhi Reddy, … read-more

Mon, 06 Sep 2021 - 06:00 PM / by Ettishree Shukla

Tags: Covid-19, Coronavirus Vaccines, DCGI, Hyderabad

Courtesy: Ani News

Mankind.

Photo: The Economic Times

Mankind Pharma Launches Drug To Cure Deadly Black Fungus

Indian pharmaceutical company Mankind Pharma on June 10 launched the antifungal drug Posaforce-100 for affordable treatment of deadly black fungus. Recommended by AIIMS and ICMR, the Posaconazole Gastro resistant tablet has also been approved by the Drug Controller General of India. Seeing its minimal potential for nephrotoxicity and excellent tolerability profile, the USFDA also cleared it. Notably, India has seen a nationwide sharp rise in… read-more

Thu, 10 Jun 2021 - 05:29 PM / by Sohini Mandal

Tags: Black Fungus Treatment, mankind pharma, drug, DCGI

Courtesy: The Economic Times

SII Vaccine Sputnik V

Photo: BioSpectrum

Serum Institute Seeks Govt Nod To Manufacture Sputnik V In India

Indigenous vaccine-maker Serum Institute of India on June 2 requested the DCGI to grant approval for manufacturing of Russia's COVID-19 vaccine Sputnik V in India. The company has also applied for conducting clinical trials of the vaccine. While six Indian companies are already in an agreement to manufacture the vaccine, SII will be the seventh one to join the league. Currently, Dr Reddy's Laboratories is manufacturing Sputnik V in India.

Thu, 03 Jun 2021 - 03:35 PM / by Nikita Thakur

Tags: Sputnik V, Serum Institute of India, DCGI, Covid-19, Coronavirus Vaccines

Courtesy: India Today

DCGI declares exemption on trials of foreign vaccines

Photo: The Economic Times

DCGI Waives Bridging Trials For Foreign Approved COVID Vaccines

The Drugs Controller General of India on June 2 waived the requirement of foreign companies to conduct ‘post-launch bridging trials’ of COVID vaccines. The announcement came for the vaccines approved by specific countries and the WHO. The drug regulatory body cited ‘huge vaccination requirements in India decision was taken because of. Notably, the bridging trials are conducted to generate data in India-specific context assessing efficacy on… read-more

Wed, 02 Jun 2021 - 07:30 PM / by Vanshika Sharma

Tags: Covid-19, Covid Vaccine, Vaccination, WHO, DCGI

Courtesy: Hindustan Times

Zydus Cadila

Photo: The News Minute

DCGI Nods Emergency Use Of Zydus Cadila's 'Virafin' For Moderate COVID-19

The Drugs Controller General of India on April 23 approved the emergency use of Zydus Cadila's Pegylated Interferon alpha-2b (PegIFN), ‘Virafin' to treat moderately infected COVID patients. Reportedly, Zydus claims that 91.5% of patients administered with this drug have shown fast recovery while requiring less oxygen for treatment. Interestingly, they also tested negative on RT-PCR test by day 7. India recorded 3.32 lakh fresh COVID-19 cases… read-more

Fri, 23 Apr 2021 - 07:28 PM / by Neha Sanjeev

Tags: Virafin, DCGI, Covid-19, drug, Indian Pharma

Courtesy: Times Now news

AstraZeneca

Photo: The Economic Times

DCGI Allows Usage Of Covishield Vaccine For 9 Months From Manufacture

Drug Controller General of India on March 31 extended the usage time limit of Oxford-AstraZeneca's COVID-19 vaccine Covishield. The vaccine earlier permitted usage for six months after the date of manufacture, can now be used for nine months from its manufacturing date. Writing to the Serum Institute of India, the DCGI stated that all details about the stock should be submitted to DCGI's office and Central Drugs Authority.

Wed, 31 Mar 2021 - 09:45 PM / by Nikita Thakur

Tags: COVISHIELD, Serum Institute of India, Coronavirus Vaccines, DCGI

Courtesy: Times Now