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Zydus Cadila gets EUA from DCGI for hepatitis drug Virafin to treat COVID-19 expresspharma
April 25, 2021
Zydus Cadila has received restricted emergency use approval from the DCGI for the use of Pegylated Interferon alpha-2b (PegIFN) in treating moderate COVID-19 infection in adults.
Jubilant Pharma subsidiary announces development of novel oral formulation of Remdesivir expresspharma
April 20, 2021
Jubilant Pharma, a subsidiary of Jubilant Pharmova, announces successful completion of safety and pharmacokinetic/absorption studies in animals and healthy human volunteers in India using a novel oral formulation of remdesivir against the commercially ...
SEC of CDSCO recommends approval to Sputnik V for EUA in India expresspharma
April 13, 2021
The DCGI will take a final call on the recommendation. If approved, it will be the third COVID-19 vaccine to be available in India.
DCGI expert committee allows clinical trials for third dose of Bharat Biotech’s Covaxin expresspharma
April 06, 2021
The expert panel of DCGI has permitted Bharat Biotech to give a third dose of Covaxin to a few volunteers in its clinical trials of the COVID-19 vaccine, sources said.
DCGI extends shelf life of COVISHIELD: Document, sources expresspharma
April 01, 2021
India’s drug regulator has allowed the AstraZeneca COVID-19 vaccine to be used for up to nine months from its manufacture date, as opposed to the prescribed six months, according to a document reviewed by Reuters.
DCGI approval for Sputnik V vaccine expected in next few weeks: Dr Reddy’s official expresspharma
March 30, 2021
Dr Reddy’s Laboratories expects the Russian coronavirus vaccine Sputnik V to get approval from the Indian regulator in the next few weeks, a company official has said.
AstraZeneca Pharma India gets DCGI approval for Osimertinib tablets expresspharma
March 11, 2021
AstraZeneca Pharma India has received Import and Market Permission in Form CT-20 (Subsequent New Drug Approval) from the Drugs Controller General of India for Osimertinib 40mg/80mg film-coated tablets (Tagrisso).
Dr Reddy’s initiates process for EUA of Sputnik V expresspharma
February 22, 2021
As part of the review process, Dr Reddy's will present the safety profile of the phase 2 study, and interim data of the phase 3 study, which is expected to complete by February 2, 2021.
Serum Institute of India seeks permission for local trials of Novavax vaccine expresspharma
February 01, 2021
Serum Institute of India (SII) has applied to the DCGI to conduct a small domestic trial of Novavax’s COVID-19 vaccine, which was found to be 89.3 per cent effective in a UK trial.
DCGI calls for suggestions from industry to reduce compliance burden expresspharma
January 29, 2021
The Drug Controller General of India (DCGI) has asked industry associations to submit their representations highlighting aspects or issues in the Drug and Cosmetics Rule 1945 that can be made redundant to reduce the compliance burden on the industry.

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