Drugs Controller General Of India

Drugs Controller General Of India News

Bharat Biotech gets nod for India's first nasal COVID vaccine: Why this is a potential game-changer
Explainers

Bharat Biotech gets nod for India's first nasal COVID vaccine: Why this is a potential game-changer

Bharat Biotech says the vaccine is easy to administer as it is non-invasive and does not require trained healthcare workers. It also eliminates needle-associated risks such as injuries and infections and is scalable when it comes to manufacturing

Government panel recommends permission for phase 3 trial of Sputnik Light vaccine as booster dose
India

Government panel recommends permission for phase 3 trial of Sputnik Light vaccine as booster dose

The DCGI had on 4 February granted emergency use permission to Sputnik Light vaccine in India, subject to certain regulatory provisions

SEC recommends DCGI to approve Bharat Biotech's Covaxin for children between 2-18 years of age
India

SEC recommends DCGI to approve Bharat Biotech's Covaxin for children between 2-18 years of age

If approved, the two-dose vaccine will be given to children within 20 days apart.

States must form special teams to 'mercilessly' clamp down on black market of COVID-19 drugs: Centre to SC
India

States must form special teams to 'mercilessly' clamp down on black market of COVID-19 drugs: Centre to SC

In an affidavit, the Centre said the DCGI has communicated to all state drugs controllers to take strict action against hoarding and black marketing of drugs like remdesivir

DCGI approves DRDO's drug that helps reduce oxygen dependency in COVID-19 patients
India

DCGI approves DRDO's drug that helps reduce oxygen dependency in COVID-19 patients

The drug 2-deoxy-D-glucose (2-DG) comes in powder form in a sachet and is taken orally by dissolving it in water, the defence ministry said

WHO rejects SII’s proposal seeking extension of Covishield’s shelf life from 6 to 9 months
India

WHO rejects SII’s proposal seeking extension of Covishield’s shelf life from 6 to 9 months

The UN body has also sought a meeting with the Drugs Controller General of India to discuss the matter 10:12

Pfizer withdraws application for emergency use authorisation of its COVID-19 vaccine in India
World

Pfizer withdraws application for emergency use authorisation of its COVID-19 vaccine in India

In a statement, Pfizer said it had decided to withdraw the application after a meeting with the Drug Regulatory Authority of India on 3 Feb, in which the regulator stated that there may be need for "additional information"

COVID-19 panel recommends SII's Covishield for emergency use; new cases remain under 30,000 for 19th day
India

COVID-19 panel recommends SII's Covishield for emergency use; new cases remain under 30,000 for 19th day

The daily new coronavirus infections in India remained below 30,000 for the 19th consecutive day on Friday, taking the total caseload to 1,02,86,709

Indian regulator seeks more time as UK authorises Oxford COVID-19 jab; six things about cheap, easy to store vaccine
India

Indian regulator seeks more time as UK authorises Oxford COVID-19 jab; six things about cheap, easy to store vaccine

In India, a decision on emergency usage of the vaccine, which is being manufactured by Pune-based Serum Institute of India, is likely to come next year with the Subject Expert Committee (SEC) on COVID-19 seeking more time today

CDSCO asks Bharat Biotech to submit complete immunogenicity data of Phase 2 trial of COVID-19 vaccine
India

CDSCO asks Bharat Biotech to submit complete immunogenicity data of Phase 2 trial of COVID-19 vaccine

The vaccine candidate, 'Covaxin', is being indigenously developed by Bharat Biotech in collaboration with the Indian Council of Medical Research

DCGI approves commercial launch of Tata Group's low-cost COVID-19 test 'Feluda'
India

DCGI approves commercial launch of Tata Group's low-cost COVID-19 test 'Feluda'

This test uses an indigenously-developed, cutting-edge CRISPR technology for detecting the virus' genome sequence

Serum Institute of India gets DCGI's nod to resume clinical trial of Oxford COVID-19 vaccine
India

Serum Institute of India gets DCGI's nod to resume clinical trial of Oxford COVID-19 vaccine

SII has also been asked to submit to the DCGI's office details of medication used in accordance with the protocol for management of adverse events

India readies five sites for final phase of human trials of Oxford's COVID-19 vaccine
science

India readies five sites for final phase of human trials of Oxford's COVID-19 vaccine

Serum Institute of India has been chosen by Oxford University and its partner AstraZeneca to manufacture the COVID-19 vaccine

DCGI approves psoriasis injection for 'restricted emergency use' to treat COVID-19 patients
India

DCGI approves psoriasis injection for 'restricted emergency use' to treat COVID-19 patients

Drugs Controller General of India approved monoclonal antibody injection Itolizumab for limited use to treat moderate to severe cases of COVID-19.

COVID-19 treatment: Fabiflu by Glenmark, HCQ, Remdesivir and other drugs that are being used to treat coronavirus patients
India

COVID-19 treatment: Fabiflu by Glenmark, HCQ, Remdesivir and other drugs that are being used to treat coronavirus patients

Favipiravir is an antiviral drug which was developed by a Japanese pharma company, Fujifilm Toyama Chemical, to treat influenza.

Biocon gets DCGI nod for emergency use of CytoSorb to treat critical COVID-19 patients
Business

Biocon gets DCGI nod for emergency use of CytoSorb to treat critical COVID-19 patients

Biotechnology major Biocon on Wednesday said its subsidiary has received approval from the Drugs Controller General of India (DCGI) for a medical device to treat critical COVID-19 patients

Probe ordered after eradicated type 2 polio virus found in oral vaccine; Ghaziabad pharma company MD held
India

Probe ordered after eradicated type 2 polio virus found in oral vaccine; Ghaziabad pharma company MD held

The Health Ministry has ordered a probe after traces of polio type 2 virus were found in some batches of oral polio vaccine (OPV) manufactured by a Ghaziabad-based pharmaceutical company, even as the firm's managing director was arrested Saturday