Bharat Biotech is targeting to manufacture one billion doses of its intra-nasal vaccine in 2022 which is under clinical trials now.
A statement issued by the WHO on Saturday said the suspension is in response to the outcomes of its post EUL (emergency use authorisation) inspection held between March 14-22, 2022 and the need to conduct process and facility upgrade to address recently identified GMP (good manufacturing practice) deficiencies.
This government's approval for use of the antiviral drug comes at a time when India's daily COVID tally is crossing the 3-lakh mark.
COVAXIN, developed by Hyderabad-based Bharat Biotech in collaboration with Indian Council of Medical Research and National Institute of Virology, has got the nod for human clinical trials from the Drug Controller General of India
The firm presented that Sputnik Light vaccine is approved in 29 countries, including Russia and Argentina.
Covaxin has been indigenously developed by Bharat Biotech in collaboration with the Indian Council of Medical Research.
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.
The vaccine option for this age group would only be Covaxin, according to guidelines issued by the Union Health Ministry on December 27.
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.
A probe has been initiated by India's drug regulator after the World Health Organisation (WHO) issued an alert saying cough syrups manufactured by an Indian firm could potentially be linked to the death of children in The Gambia, official sources said.
'We seem to be in a situation where we can do little, and nothing needs to be done anyway.'
India's drug regulator has given permission to Bharat Biotech to conduct phase-3 clinical trial for its intranasal Covid vaccine as booster dose on participants who have been previously inoculated with SARS-CoV 2 vaccines.
'Safety is my first priority.' 'I need to ensure that any drug or vaccine that our citizens get is first safe.'
As the COVID-19 vaccination of children falling into the age bracket of 15 to 18 years is scheduled to begin from January 3, the Kerala health department has prepared an action plan for inoculation of all eligible beneficiaries.
Dominic Xavier offers his take on the COVID-19 vaccine which experts feel should be expected in mid-2021 only. Till then we have to get used to live with the virus.
The joint inspections is to ensure the safety, efficacy, and quality of drugs available in the country
The vaccine maker Bharat Biotech said in a statement that preliminary reviews indicated that the death was unrelated to Covaxin.
India's first indigenously developed quadrivalent Human Papilloma Virus (HPV) vaccine for the prevention of cervical cancer will be launched in a few months and made available to the people in an affordable price range of Rs 200-400, Serum Institute of India CEO Adar Poonawalla said on Thursday.
Written informed consent of each patient is required before the use of this drug, he said
A senior health official said the probe will find out how the teenager was given the shot even though the government is yet to roll out any anti-COVID 19 vaccination programme for minors.
Codeine-based formulations are under the scanner for misuse as a narcotic product.
Favivir is the second drug developed by Hetero after Covifor (Remdesivir) used in the treatment of COVID-19.
There were no safety concerns arising from the study data and Covovax is safe and immunogenic in the adult population, Prakash Kumar Singh, Director, Government and Regulatory Affairs at the Serum Institute of India (SII), is learnt to have said in the application sent to the DCGI.
Samples of the cough syrup have been taken from the manufacturing premises in Noida and sent to the Regional Drugs Testing Laboratory (RDTL) in Chandigarh for testing, Mandaviya said.
The phase 3 clinical trial will cover around 28,500 subjects, aged 18 years and above, and it will be conducted in 21 sites across ten states, including Delhi, Mumbai, Patna and Lucknow.
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.
SII has been asked to submit to the DCGI's office details of medication used in accordance with the protocol for management of adverse events.
The DCGI also directed Serum Institute of India to increase the safety monitoring of the subjects already vaccinated as part of the trial, and submit the plan and report.
SII is the first indigenous company that has sought emergency approval for the vaccine developed along with global pharma giant AstraZeneca and Oxford University.
In a video, Ramdev was allegedly heard saying, "Allopathy is a stupid science and medicines such as Remdesivir, Fabiflu, and other drugs approved by the Drugs Controller General of India have failed to treat COVID-19 patients." His remarks caused massive outrage and the IMA sent over a legal notice to him.
"We have started the phase-III trials of the vaccine (candidate Covishield). We will administer dose to 150 to 200 volunteers," said Dr Muralidhar Tambe, Dean, Sassoon General Hospital.
Biological E Limited plans to complete production at a rate of 75 million doses of its COVID-19 vaccine Corbevax per month, anticipating over 100 million doses per month from February 2022 which will enable the Hyderabad-based company to deliver 300 Million doses as promised to the Centre, BE said on Tuesday.
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.
They said after examining and analysing the adverse event reports, causal relationship and all related details shared by or to be shared by the WHO, the committee will advise and recommend further course of action to the Drugs Controller General of India (DCGI).
The DCGI arrived at the conclusion on Wednesday based on the recommendations of an independent expert committee which has also opined that compensation should not be paid to the volunteer, they said.
"It has been decided that for approval of COVID-19 vaccines in India for restricted use in emergency situation which are already approved for restricted use by US Food Drug Administration, European Medicines Agency, UK Medicines and Healthcare products Regulatory Agency, Pharmaceuticals and Medical Devices Agency Japan or which are listed in WHO Emergency Use Listing and which are well established vaccines from the stand point that millions of individuals have already been vaccinated with the said vaccines, the requirement of conducting post approval bridging clinical trials and of testing every batch of vaccine by CDL, Kasauli can be exempted, if the vaccine batch/lot has been certified and released by National Control Laboratory of country of origin," it said.
In the letter, Somani said the samples of four made-in-India cough syrups linked to the deaths of 66 children in Gambia which were tested in government laboratory here were found to be complying with specifications and not to have been contaminated with DEG or EG according to the test reports.
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.
India's drug regulator has initiated a probe and sought further details from the WHO after the global health body issued an alert that cough syrups manufactured by an Indian firm could potentially be linked to the death of children in Gambia.
The Subject Expert Committee on COVID-19 examined the data and deliberated on the EUA application on Monday.
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