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.
The "construct of the DPDP Act" cannot be changed at this stage, though there may be some minor tweaks in the language of the Rules and formats in certain legitimate cases.
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.
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.
Sarma said his government was looking forward to the legislation on the Uniform Civil Code, which will be considered during a special four-day session of the Uttarakhand assembly that is starting from February 5.
The trial will take place in 525 subjects at various sites, including AIIMS, Delhi, AIIMS, Patna and Meditrina Institute of Medical Sciences, Nagpur.
The expert committee sought more information from Serum Institute regarding the Oxford-AstraZeneca vaccine.
Covaxin has been indigenously developed by Bharat Biotech in collaboration with the Indian Council of Medical Research.
'Let's see how this love story shapes up in the run up to the municipal corporation election.'
A bench of Justices MR Shah and BV Nagarathna said there cannot be any deviation from the educational qualifications mentioned in an advertisement of job.
Sharing a government public notice on 'X', formerly Twitter, Sarma appealed to the people to send their suggestions on the proposed law to ban polygamy in Assam.
The report on the alleged liquor scam, a hot button issue in the run-up to the elections, claimed a loss of revenue to the tune of Rs 941.53 crore, saying timely permissions were not taken for opening the liquor vends in non-conforming municipal wards.
The firm presented that Sputnik Light vaccine is approved in 29 countries, including Russia and Argentina.
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 Board decided to award full marks for it to students, following an outrage over the board allegedly promoting 'gender stereotyping' and supporting 'regressive notions'
The Inlaks-Ravi Sankaran Internship for field biology, ecology and conservation is inviting applications from young applicants with bold and unconventional ideas for tackling conservation problems.
Covaxin is being indigenously developed by Bharat Biotech in collaboration with the Indian Council of Medical Research (ICMR).
The NTA had treated the two options as correct answers to the Physics question and had granted four marks to those examinees who had marked these options.
BE's Corbevax is the first such vaccine in India to be approved as a heterologous COVID-19 booster in the country.
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.
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 Supreme Court of India granted custody of a man suffering from cerebral palsy to his mother, a US national, after determining it was in his best interest due to his inability to make independent decisions. The court overruled a Madras High Court decision, finding the lower court's interaction with the son insufficient to assess his needs. The Supreme Court emphasized the son's limited cognitive capacity and the availability of specialized support in the US, where he had completed most of his schooling.
Under its new chairman Tuhin Kanta Pandey, the Securities and Exchange Board of India (Sebi) has gravitated towards greater transparency and ease of doing business, setting an objective of "effective and optimum" regulation. On Monday, during its first board meeting under Pandey, the regulator has decided to constitute a high-level committee (HLC) to review conflicts of interest and unveiled initiatives to simplify regulatory processes.
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.
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 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.
'It is imprudent on the part of Indian insurance companies to invest out of the shareholders' fund in a private limited company.'
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.
The more people get vaccinated, the better it will be for the country and the economy, the National Conference vice president said.
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.
'Understand your financial goals. Next, categorise them by size. Then evaluate your investment options.'
Security breach came days after the firm got approval to conduct trials for Covid-19 vaccine candidate Sputnik V.
FIFA's disciplinary committee will be asked to look into allegations of discrimination raised by the Palestinian Football Association (PFA) after it submitted a proposal to suspend Israel in May, world soccer's governing body said on Thursday.
As of now, Gennova Biopharmaceuticals has launched a vaccine, Gemcovac-OM, which is based on the Omicron variant.
Almost five years later, the three services have still not fully understood that joint/theatre commands are not a discussion point; they are the prime minister's diktat on a military reform measure that is in line with what armed forces around the world have implemented, points out Ajai Shukla.
Hours after Desai said that the draft is ready to be submitted to the state government, Chief Minister Pushkar Singh Dhami said the Uniform Civil Code will soon be implemented in Uttarakhand.
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.
Covaxin is being developed by Bharat Biotech jointly with the Indian Council of Medical Research (ICMR)- National Institute of Virology (NIV). The Phase III human clinical trials of Covaxin began mid-November, targeted to be done in 26,000 volunteers and it is the country's first and only Phase III efficacy study for a COVID-19 vaccine, a press release from the vaccine maker said on Saturday night.
Can a culture survive as a way of life, even as the language and writing at its core, alter with time? Can we be rational and Malayalee or do we have to necessarily be religious and proudly cultural to be Malayalee? asks Shyam G Menon.
Once the UK drug regulator gives its approval to the Oxford vaccine, the expert committee on COVID-19 at the Central Drugs Standard Control Organisation (CDSCO) will hold its meeting and thoroughly review the safety and immunogenicity data from the clinical evaluations conducted abroad and in India before granting any emergency authorisation for the vaccine here, official sources said.
