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The Latest Breaking News from DCGI

India wants 1,000 new clinical trial sites. Patients are still being left in the dark

Thirty-five-year-old Ritu Bhalla was twice diagnosed with blood cancer, at the ages of four and 11. She developed chronic hepatitis B as a long-term side-effect after cancer treatment.

Newslaundry

TOI Health News Morning Briefing| AstraZeneca's anti-cancer drug withdrawn in India, preventing dehydration in 50s, signs of heatstroke, role of fish oil supplements in cardiovascular health and more

DCGI orders withdrawal of AstraZeneca's cancer drug due to potential adverse effects

The Times of India

India's drug regulator orders withdrawal of AstraZeneca's cancer drug due to potential adverse effects

The Drug Controller General of India (DCGI) has asked all state drug regulators to withdraw AstraZeneca's anti-cancer drug Olaparib tablets. This drug which is mostly used for the treatment of patients with gBRCA mutation and advanced ovarian cancer and breast cancer has potential adverse effects, DCGI has said.

The Times of India

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Can resveratrol-copper be used to prevent metastasis without trials?

TMC researchers find resveratrol-copper combo reduces chemotherapy toxicity, may prevent cancer metastasis, and offer multiple health benefits.

The Hindu

DCGI directs drug makers to put warning on FDC of Chlorpheniramine Maleate and Phenylephrine HCL not to use in children below 4 years.

The Hindu

India’s alarming ‘fixed dose combination’ problem

Pharmaceutical companies in India use these fixed dose combination drugs to escape liability under multiple laws without much concern for public health

The Hindu

Regulator issues alert over sale of falsified versions of 2 drugs

Drugs regulator Drugs Controller General of India has directed States and Union Territories to keep vigil on sale and distribution of falsified versions of two drugs, liver medication Defitelio and Takeda’s cancer drug Adcetris after alerts from World Health Organization

The Hindu

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Drugs regulator issues alert after pharma firm Abbott India recalls antacid syrup Digene Gel

The public notice issued by the apex drug controller on its website said: “The impugned product may be unsafe and its use may result in adverse reaction.”

The Hindu

Regulation for all medical devices from October 1, says DCGI

India is on course to introduce regulations governing all the medical devices in the country on October 1, Drugs Controller General of India Rajeev Singh Raghuvanshi said at iPhex 2023

The Hindu

Letter to DCGI seeks emergency use nod for investigational antibiotics to save lives

Intensivists and infectious diseases specialists, faced with a dire situation where effective antibiotics to treat drug-resistant infections are lacking, have called on the government to allow emergency use authorisation (EUA), as successfully done during the COVID-19 pandemic, for certain life-saving drugs.

The Hindu

DCGI calls for bridging bio-tech interface to get out of generic mindset

The Hindu

WHO alert on cough syrups 'alarming'; there are missing links that need to be probed: Expert

"The information from WHO that cough syrups manufactured by an Indian pharma company caused the death of 66 children due to the presence of ethylene glycol is alarming, Professor Y. K. Gupta, senior pharmacologist and vice-chairman of the Standing National Committee on Medicines said.

The Hindu

DGCI allows Serum Institute to export malaria vaccine to U.K.

The Drugs Controller General of India (DCGI) has granted permission to send two lakh doses of the vaccine

The Hindu

Bombay HC issues notice to Central govt, Bill Gates, Serum Institute over plea on alleged Covid vaccine death

Dilip Lunawat in his petition, "blamed the Government and others for misrepresenting the facts about the COVID-19 vaccine by making false claims about its safety and 'forcing' medical practitioners to take the vaccine. Read more on Dynamite News:

Dynamite News

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The Hindu

CorbeVax cleared as precaution dose vaccine, awaits WHO’s emergency use listing

This the first time that a booster dose that is different from the one used for primary vaccination has been allowed in the country

Dynamite News

CORBEVAX booster shot approved for 18 years and above jabbed with Covaxin, Covishield

Corbevax booster for heterologous first has been approved by the Centre.Last month the National Technical Advisory Group on Immunisation (NTAGI) recommended Biological E's CORBEVAX as a heterologous booster for adults above 18 yrs old. Read more on Dynamite News:

The Hindu

Serum Institute of India to launch vaccine to prevent cervical cancer

Drugs Controller General of India’s approval of SII’s anti-cervical cancer vaccine follows the recommendation of the institute’s COVID-19 vaccine in June last year

The Hindu

Corbevax gets DCGI nod as COVID-19 booster after two doses of Covishield or Covaxin

Clinical trial data is reported to have shown that the Corbevax booster dose provided significant enhancement in immune response and a good safety profile.

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The Times of India

DCGI grants emergency use authorisation to Corbevax for those aged 5-12, Covaxin for 6-12 age group, ZycovD for above 12 year olds: Report

The Drugs Controller General of India (DCGI) gives restricted emergency use authorisation to BharatBiotech's COVAXIN for children between the age of 6-12 years, news agency ANI tweeted on Tuesday citing sources.

Dynamite News

Drugs Controller allows restricted emergency use of Covaxin for 6-12 years

DCGI (Drugs Controller General of India) gives restricted emergency use authorisation to BharatBiotech's Covaxin for children between the age of 6-12 years. More details on Dynamite News:

The Hindu

Nod for Covovax vaccine for 12-17 age-group

Serum Institute’s Adar Poonawalla says ‘younger age groups will follow shortly’

The Hindu

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

The recommendations have been sent to the Drugs Controller General of India (DCGI) for final approval.

The Times of India

COVID vaccine for kids: Approval granted to COVID vaccine Corbevax for children between 12-18 years; here’s all we know

Drugs Controller General of India (DCGI) grants final approval to Biological E's COVID-19 vaccine Corbevax, for children between 12-18 years of age.

The Hindu

Coronavirus updates | February 8, 2022

India records 65,000 new cases, 1,169 deaths

The Hindu

Submitted proposal to DCGI to test Sputnik Light as Covid booster dose: Dr Reddy's

Last year, the company received permission from the DCGI to import the Sputnik vaccine into India for restricted use in emergency situations

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