India currently does not have any XBB 1.5 variant-based vaccines available.
The Union health ministry on Thursday termed as 'misleading' and 'fallacious' media reports which claimed that regulatory approval for COVID-19 vaccine Covaxin was rushed due to political pressure.
The DCGI's approval came following recommendation by the Subject Expert Committee of the Central Drugs Standard Control Organisation.
Most of the pharma units are failing in documentation, and validation processes, and many don't have full-fledged quality control laboratories.
As of now, Gennova Biopharmaceuticals has launched a vaccine, Gemcovac-OM, which is based on the Omicron variant.
It has been approved by the European Medicines Agency for conditional marketing authorisation.
The Pune-based Gennova Biopharmaceuticals has submitted phase 2 data of mRNA vaccine and has also completed the recruitment of phase 3 data.
India's apex drug regulator has granted permission for conducting the phase II/III clinical trial of Bharat Biotech's Covaxin COVID-19 vaccine in the age group of 2 to 18 years, the Union Health Ministry said on Thursday.
The Pune-based firm had submitted interim safety and immunogenicity data of phase 2/3 bridging clinical trial conducted in the country as well as interim clinical trial data of safety and efficacy from phase3 clinical trials conducted in the UK and the US along with its application.
Bharat Biotech recruited 13,000 participants for the Phase-3 clinical trial of Covaxin. This is one of the largest efficacy trials held in the country.
BE's Corbevax is the first such vaccine in India to be approved as a heterologous COVID-19 booster in the country.
The firm presented that Sputnik Light vaccine is approved in 29 countries, including Russia and Argentina.
Under the conditions, the firms shall submit data of ongoing clinical trials and the vaccines to be supplied for programmatic setting.Adverse event following immunisation will continue to be monitored.
An expert panel of the country's drugs regulatory authority had recommended against granting such approval to the firm at this stage just two days ago, officials said.
Covaxin has been indigenously developed by Bharat Biotech in collaboration with the Indian Council of Medical Research.
The Drugs Controller General of India will take a final call on the recommendation. If approved, it will be the third COVID-19 vaccine to be available in India.
The DCGI's nod came after the subject expert committee on COVID-19 of the CSDCO last week recommended granting emergency use authorisation to Covovax for the age group of 7 to 11 years.
The Subject Expert Committee (SEC) under the Central Drugs Standard Control Organisation has recommended the conduct of Phase III clinical trials of Russia's single dose COVID-19 vaccine Sputnik Light.
The trial will take place in 525 subjects at various sites, including AIIMS, Delhi, AIIMS, Patna and Meditrina Institute of Medical Sciences, Nagpur.
Pfizer sought to participate in the Subject Expert Committee consultations towards an emergency use authorisation for its Covid-19 vaccine. However, the company representatives have been unable to participate in the meetings because of extremely short notices of a few hours or less and time-zone limitations.
Gennova has also got permission for phase-2 and 3 clinical trials for its lyophilised mRNA vaccine for injection from the subject expert committee advising the Central Drugs Standards Control Organisation, reports Sohini Das.
The approval by the Drugs Controller General of India comes following recommendations by the Subject Expert Committee on COVID-19 of the Central Drugs Standard Control Organisation.
The expert committee sought more information from Serum Institute regarding the Oxford-AstraZeneca vaccine.
Confirming the Drugs Controller General Of India (DCGI) approval, Serum Institute of India CEO Adar Poonawalla on Tuesday tweeted: '@SerumInstIndia's brand Covovax has completed bridging studies in India and has been granted Emergency Use Authorisation by DCGI for adults and for children above the age of 12. Younger age groups will follow shortly.'
The Subject Expert Committee on COVID-19 examined the data and deliberated on the EUA application on Monday.
An expert panel of India's central drug authority on Wednesday recommended granting regular market approval to COVID vaccines Covishield and Covaxin for use in adult population subject to certain conditions, official sources said.
The Serum Institute of India (SII) had put in an application to the Drugs Controller General of India (DCGI) in October for grant of market authorisation of Covovax for restricted use in emergency situations.
In a series of tweets after the Drugs Controller General of India (DCGI) approved Oxford's vaccine Covishield and Bharat Biotech's Covaxin for restricted emergency use, Modi said it will make every Indian proud that both the vaccines are made in India.
The more people get vaccinated, the better it will be for the country and the economy, the National Conference vice president said.
Security breach came days after the firm got approval to conduct trials for Covid-19 vaccine candidate Sputnik V.
Covaxin is being indigenously developed by Bharat Biotech in collaboration with the Indian Council of Medical Research (ICMR).
Biological E has received approval for conducting phase II/III human clinical trial of COVID-19 vaccine candidate Corbevax on children above five years and adolescents, the Department of Biotechnology (DBT) said on Friday.
While Lupin is working on a Remdesivir powder for inhalation, Glenmark has tied up with a Canadian Biotech firm for nitric oxide nasal spray that reduces Sars-CoV-2 viral load and thus transmission.
The Subject Expert Committee on COVID-19 of the CDSCO on October 12 after deliberating Bharat Biotech's EUA application had recommended granting emergency use approval to Covaxin for use in the 12-18 years age group with certain conditions.
The panel also recommended giving approval to Bharat Biotech for carrying out a study on interchangeability of its Covaxin and the under-trial adenoviral intranasal vaccine candidate BBV154, but asked the Hyderabad-based firm to remove the word "interchangeability" from the study title and submit a revised protocol for approval.
Bharat Biotech is targeting to manufacture one billion doses of its intra-nasal vaccine in 2022 which is under clinical trials now.
If the DCGI grants regular marketing authorisation, Covishied will be the second vaccine in the world to receive such approval.
'No approval was given to Sputnik V on Thursday. Some queries have been asked on safety, efficacy, and logistics, which the firm will have answers to at the next meeting'
If things go according to plan, the vaccine would be available in the market by the end of this year.
According to the recommendations of the Subject Expert Committee (SEC) meeting held on July 30, which have been approved by the Drugs Controller General of India (DCGI), Sputnik-Light is the same as the component-1 of Sputnik V and as its safety and immunogenicity data in the Indian population has already been generated in a trial here, there seems to be inadequate data and justification for conducting a separate, similar trial.
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