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Results For "Central-Drugs-Standard-Control-Organisation"

57 News Found

India’s first mRNA vaccine from Gennova gets DCGI approval
Drug Approval | June 30, 2022

India’s first mRNA vaccine from Gennova gets DCGI approval

It is a two dose vaccine to be administered intramuscularly at 28 days apart


CDSCO approves Jardiance for heart failure with preserved ejection fraction
Drug Approval | May 19, 2022

CDSCO approves Jardiance for heart failure with preserved ejection fraction

With the approval from the Central Drugs Standard Control Organisation (CDSCO), Jardiance is now the first approved therapy to improve outcomes for the full spectrum of heart failure regardless of ejection fraction


Drugs Controller clears Covaxin, Corbevax and ZyCov-D for kids
News | April 26, 2022

Drugs Controller clears Covaxin, Corbevax and ZyCov-D for kids

The approval by the DCGI comes following recommendations by the Subject Expert Committee (SEC) on Covid-19 of the Central Drugs Standard Control Organisation(CDSCO)


DCGI grants Covaxin Emergency Use Approval for children 6-12 years
Drug Approval | April 26, 2022

DCGI grants Covaxin Emergency Use Approval for children 6-12 years

Covaxin was earlier approved for children 12-18 years of age


Navidea Biopharmaceuticals gets regulatory approval of Lymphoaim in India
News | April 19, 2022

Navidea Biopharmaceuticals gets regulatory approval of Lymphoaim in India

Tc99m tilmanocept is designed for the precise identification of lymph nodes that drain from a primary tumor, which have the highest probability of harboring cancer


Hetero gets CDSCO approval to manufacture and sell Sputnik Light in India
News | March 21, 2022

Hetero gets CDSCO approval to manufacture and sell Sputnik Light in India

Sputnik Light is the first component of Sputnik V


Indian pharma companies must become the global benchmark of quality: Amit Jaju, Sr. MD, India, Ankura Consulting
interviews | March 13, 2022

Indian pharma companies must become the global benchmark of quality: Amit Jaju, Sr. MD, India, Ankura Consulting

Amit Jaju, Senior Managing Director, India in an interview with Thomas C Thottathil outlined the steps Indian pharma companies should follow to be compliant with global regulatory requirements


DCGI approves Bharat Biotech’s Phase 3 trials for intranasal vaccine
News | January 29, 2022

DCGI approves Bharat Biotech’s Phase 3 trials for intranasal vaccine

Intranasal vaccines are easier to administer in mass immunisation campaigns and help reduce or stop transmission


Covaxin and Covishield granted conditional market approval
News | January 27, 2022

Covaxin and Covishield granted conditional market approval

The vaccines are currently only authorised for emergency use in the country


SEC recommends regular market approval for Covishield and Covaxin
News | January 20, 2022

SEC recommends regular market approval for Covishield and Covaxin

However, these won’t be available at the nearest chemist store soon