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 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.
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.
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.
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 show-cause notice was issued following reports that human trials of the most promising COVID-19 vaccine candidate, being developed by the University of Oxford, have been put on hold after a United Kingdom participant had an adverse reaction to it.
Healthcare and frontline workers and citizens above 60 years of age with comorbidities would be administered the third dose of the same vaccine they had been given before.
The company claims that when the Nitric Oxide Nasal is sprayed over nasal mucosa it acts as a physical and chemical barrier against the virus.
Covaxin is being developed by Bharat Biotech, in collaboration with the Indian Council of Medical Research - National Institute of Virology.
'Once DCGI will give us the permission to restart the trials in India, we will resume the trials,' Serum Institute of India (SII) said in a statement.
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.
Union Health Minister Mansukh Mandaviya on Tuesday told Bharatiya Janata Party MPs that Covid vaccination for children is likely to start soon, sources said.
Prime Minister Narendra Modi is likely to announce a host of initiatives for the health sector on Independence Day with the highlights being the 'Heal in India' and 'Heal by India' projects and a roadmap to eliminate sickle cell disease by 2047, official sources said.
"The phase-III trial of 'Covishield' vaccine will begin at Sassoon hospital from next week. It is likely to start on Monday. Some volunteers have already come forward for the trial. "Around 150 to 200 volunteers will be administered the vaccine candidate dose," Dean of the state-run Sassoon General Hospital Dr Muralidhar Tambe said.
In the trial, the vaccine will be given by the intramuscular route in two doses on day 0 and day 28.
The Drugs Controller General of India (DCGI) has granted permission to the Serum Institute of India (SII) to manufacture the Sputnik COVID-19 vaccine in India for examination, test and analysis with certain conditions, official sources said.
Covaxin is being indigenously developed by Bharat Biotech in collaboration with the Indian Council of Medical Research (ICMR).
In a recent letter to Union Home Minister Amit Shah, SII said its employees have been working round the clock in spite of various challenges because of the pandemic.
The government is hopeful of a speedy launch of single-dose COVID-19 vaccine Sputnik Light in India and all stakeholders, including the Russian manufacturer and its Indian partners, have been directed to fast-track the application and regulatory approval procedures for the jab to boost the country's vaccination drive, sources said.
Bharat Biotech has completed the Phase 2/3 trials of COVID-19 vaccine, Covaxin for use in children under 18 years of age and is expected to submit the data by next week to the Drugs Controller General of India (DCGI), Chairman and Managing Director of Bharat Biotech International Ltd, Krishna Ella said
The PM directed officials to evaluate various technology tools to ensure efficient and timely vaccination in due course of time. He also emphasised that detailed planning for such large scale vaccination should be undertaken immediately.
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.
The current total installed capacity of the seven manufacturers of remdesivir is 38.80 lakh vials per month, the Ministry of Chemicals and Fertilizers said in a statement.
Poonawalla wished the country and Prime Minister Narendra Modi success for the vaccination programme.
Paul noted that "three to four months from now, there will be other vaccines and the stockpile will be even bigger. "And more acceleration can be brought about in the vaccination programme," Paul added.
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.
As for Bharat Biotech, the Subject Expert Committee (SEC) on COVID-19 of the CDSCO asked the firm to expedite volunteer recruitment for the ongoing clinical trial and said it may conduct interim efficacy analysis for further consideration of restricted emergency use approval for its vaccine Covaxin, they stated.
Taking people for ransom and winning business by defaming scientific medicine are unpardonable offenses, the IMA said.
Avigan comes in a complete therapy pack of 122 tablets with a two-year shelf life.
The Union home ministry said several steps have been taken to augment the production and supply of Remdesivir injections from 38.80 lakh units per month to 74 lakh units per month by early next month, and asked the states to ensure its seamless supply and transport.
The company had in December said that the CDSCO had approved a 12-month shelf life for Covaxin, which was nine months earlier, Sohini Das reports.
He explained, "Children between the age of 12 and 18 years, particularly those in the age group of 15 to 18 years, are very much like adults. Our research within the country also says that almost two-thirds of the deaths below 18 years which occurred due to COVID in India are within this age group. So, this decision was mainly taken to protect the adolescents."
The move comes even as India's drug regulator has extended Covishield's shelf life from six to nine months from its manufacturing date.
The Drug Controller General of India has sent a letter to the Glenmark seeking clarifications on pricing as well as claims of therapeutic efficacy. While Glenmark has claimed this drug is effective in comorbid conditions like diabetes, hypertension, according to protocol summary (of clinical trials) the trial was not designed to access the Fabiflu in comorbid conditions.
Thanking all, including doctors, nurses, healthcare staff, security personnel and journalists, who have been at the frontline in the fight against the pandemic, the minister said they ensured India reaches the stage when vaccine gets delivered to the people.
The trial is being conducted in three phases by segregating children into categories according to their age. The first trial was started in the age group of 12 to 18 years followed by the age group of 6 to 12. Trials for children between the ages of and 2-6 years are currently undergoing trials.
If the DCGI grants regular marketing authorisation, Covishied will be the second vaccine in the world to receive such approval.
The World Health Organisation's technical advisory group will meet on October 26 to consider the Emergency Use Listing (EUL) of Covaxin, a vaccine developed by Hyderabad-based Bharat Biotech protecting against COVID-19, the global health agency's chief scientist said.
According to sources close to ANI, "Bharat Biotech has informed Union health ministry that it will rectify the issues pointed out by WHO in 15 to 20 days." "World Health Organisation (WHO)'s suspension is not related to safety or efficacy issues but limited only to supply for United Nations agencies."
If things go according to plan, the vaccine would be available in the market by the end of this year.
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