DCGI has already given emergency use authorization (EUA) to BBIL for the intranasal vaccine. BBIL had in September this year applied for DCGI's approval for market authorization of its "Five Arms" intranasal heterologous booster dose, and it has now announced that iNCOVACC (BBV154) has received approval under Restricted Use in Emergency Situation for ages 18 and above.
New Delhi [India], October 21 (ANI): The production of India's first indigenously developed quadrivalent Human Papillomavirus (HPV) "CERVAVAC" vaccine, for the prevention of cervical cancer, by the Serum Institute of India will start in the first quarter of 2023 which got delayed due to COVID-19 pandemic, said SII CEO Adar Poonawala on Friday.
New Delhi [India], October 15 (ANI): Drugs Controller General of India (DCGI) on Saturday replied to World Health Organisation (WHO) and said as per the recently formed technical committee, the clinical features and the treatment received by the children as shared by WHO so far are inadequate to determine the aetiology.
New Delhi [India], September 11 (ANI): Bharat Biotech has applied for market authorisation from the Drugs Controller General of India (DCGI) for intranasal heterologous booster, sources told ANI.
Hyderabad (Telangana) [India] September 1 (ANI): Hyderabad-based vaccines manufacturer Biological E Limited announced on Thursday that the Subject Expert Committee (SEC) of the Central Drugs Standard Control Organization (CDSCO) reviewed and approved the Phase III infants clinical trial data and recommended for the manufacture of its 14-valent paediatric vaccine (investigational pneumococcal polysaccharide conjugate vaccine PCV14) against S pneumoniae infection in a single dose and multi-dose presentations.
New Delhi [India], August 17 (ANI): The tenure of Dr V G Somani as the Drugs Controller General of India (DCGI) has been extended by three months, according to an order issued by the Union Health Ministry.
New Delhi [India], June 15 (ANI): The subject expert committee meeting that was scheduled today to discuss Serum Institute of India's (SII) indigenously developed Quadrivalent human papillomavirus (qHPV) vaccine against cervical cancer, has recommended regular market authorisation for above 9 to 26-year-old male and female, according to sources.
New Delhi [India] June 15 (ANI): The first indigenously developed quadrivalent human papillomavirus (qHPV) vaccine against cervical cancer by the Serum Institute of India (SII) will be discussed by the Subject expert committee on Wednesday.
Hyderabad (Telangana) [India], June 4 (ANI): Biological E. Limited, a Hyderabad-based pharmaceutical and vaccines company, on Saturday, announced that its Corbevax COVID-19 vaccine has been approved by the Drug Controller General of India (DCGI) as a heterologous COVID-19 booster dose for individuals aged 18 years and above after six months of administration of primary vaccination (two doses) of Covaxin or Covishield vaccines for restricted use in an emergency situation.
New Delhi [India], May 4 (ANI): Hyderabad-based pharma company Bharat Biotech has sought permission from the Drugs Controller General of India (DCGI) to conduct trials of Covaxin as COVID-19 vaccine booster dose in the 2-18 age group, sources said.
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