Tag: Dcgi

This step will further strengthen our collective fight against the pandemic, said Union Health Minister Mansukh Mandaviya.

Corbevax has become the first Covid-19 vaccine in India to be approved by the DCGI as a heterologous Covid-19 booster dose.

The Drugs Controller General of India (DCGI) has also granted emergency use authorisation (EUA) to Cadila for its ZyCoV-D for an additional dose of 3mg with a two-jab inoculation schedule 28 days apart for those aged above 12 years.

The government has still not not taken a decision on vaccinating those aged below 15 years. The health ministry has consistently said that additional need for vaccination and inclusion of population for vaccination are examined constantly.

The Corbevax vaccine is administered through intramuscular route with two doses, scheduled 28 days apart, and is stored at 2 to 8 degrees Celsius temperature and presented as 0.5 ml (single dose) and 5 ml (10 doses) vial and 10 mL (20 doses) vial pack.

The Drugs Controller General Of India has already approved Covovax for restricted use in emergency situations in adults on December 28.

In an application sent to the DCGI on February 9, Srinivas Kosaraju, the head of Quality and Regulatory Affairs of Biological E Limited said the firm had received approval for conducting phase 2/3 clinical study of Corbevax among children and adolescents aged 5-18 years in September.

A Lancet study has also shown that a single jab of this vaccine is 78.6-83.7% efficient against COVID-19, which is significantly better than the other two-shot vaccines.

Bharat Biotech has received approval from the Drug Controller General of India to conduct phase-3 trials for its COVID-19 intra-nasal vaccine (BBV154), sources in the company said on Friday.

The DCGI approval came after the SEC on COVID-19 of the CDSCO on January 19 recommended granting regular market approval to the SII's Covishield and Bharat Biotech's Covaxin for use in adult population subject to certain conditions.

Along with Molnupiravir, the CDSCO has also granted emergency use authorisation to the Serum Institute of India's Covid vaccine COVOVAX, Hyderabad based Biological E RBD Protein CORBEVAX.

SCA is a common genetic disorder among Indians affecting red blood cells. It is transmitted by parents who carry a defective beta-globin gene without suffering themselves.

The Drugs and Comptroller General of India (DCGI) has given a go-ahead to Bharat Biotech's Covaxin for vaccination of children in the 2-18 years age group.

Gennova submitted the proposed Phase 2 and 3 study titled 'A Prospective, Multicentre, Randomised, Active-controlled, Observer-blind, Phase II study seamlessly followed by a Phase III study to evaluate the Safety, Tolerability, and Immunogenicity of the candidate HGCO19 (COVID-19 vaccine) in healthy subjects' which was approved by the office of the DCGI, CDSCO.

Zydus Cadila on Thursday said it has applied for emergency use authorisation (EUA) with the Drug Controller General of India (DCGI) for its COVID-19 vaccine ZyCoV-D.