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Drug regulator suspends pharma firm from manufacturing eye drops claiming to replace reading glasses
3 months, 1 week ago

Drug regulator suspends pharma firm from manufacturing eye drops claiming to replace reading glasses

New Indian Express  

NEW DELHI: India’s drug regulator has suspended manufacturing and marketing permission of Mumbai-based ETOD Pharmaceuticals, which had claimed that their new eye drop could help people reduce dependency on reading glasses for those suffering from presbyopia, an age-related vision condition. The Central Drugs Standard Control Organisation had earlier granted the pharma company approval to manufacture and market their eye drop, …

India Drug Dcgi
‘Insulin’ homoeopathic tablets under CDSCO lens
5 months, 2 weeks ago

‘Insulin’ homoeopathic tablets under CDSCO lens

The Hindu  

The Central Drugs Standard Control Organisation has sought a review of the licence given to ‘Insulin tablets’, a homoeopathic medicine. Subsequently, the DCGI found the labelling violating Section 106A of the Drugs and Cosmetics Rules, 1945, which says no homoeopathic medicine containing a single ingredient shall bear a proprietary name on its label. Later, the Ministry found that the manufacturer …

Rajasthan Drugs Babu Insulin Tablets Dcgi Label
CDSCO set to ban these common cold, flu syrups for children under four years; pharma companies to issue warning on meds
1 year ago

CDSCO set to ban these common cold, flu syrups for children under four years; pharma companies to issue warning on meds

Hindustan Times  

The Central Drugs Standard Control Organisation is set to implement a ban on a widely used anti-cold cocktail medicine combination for infants and children under four years of age. Following the committee's recommendation on June 6, 2023, the Drug Controller General of India chief Dr. Rajeev Singh Raghuvanshi issued a letter on December 18, instructing all manufacturers of the common …

Children Drug Cold Four Years Dcgi Fdc Combination
Regulation for all medical devices from October 1, says DCGI
1 year, 5 months ago

Regulation for all medical devices from October 1, says DCGI

The Hindu  

India is on course to introduce regulations governing all the medical devices in the country on October 1. From October 1, regulations will be in place for the remaining medical devices, categorised under two more groups, the Drugs Controller General of India Rajeev Singh Raghuvanshi said here on Wednesday. An emerging sector, medical devices manufacturing is on the rise spurred …

India Medical Devices
Drugs Controller Told to Filter Out ‘Cocktail Drugs’ from Indian Market, Ban Likely Soon
1 year, 8 months ago

Drugs Controller Told to Filter Out ‘Cocktail Drugs’ from Indian Market, Ban Likely Soon

News 18  

The central government has told the country’s apex drugs controller to regulate the market of fixed-dose combination drugs in India – an issue pending for several months now. The Central Drugs Standard Control Organisation, the office of the Drugs Controller General of India, has already started working on this and the ban on these “cocktail drugs” may be announced within …

India Drugs Ministry Ban Cocktail Medicines Dcgi
Amazon, Flipkart issued notices for selling drugs without licence: Report
1 year, 10 months ago

Amazon, Flipkart issued notices for selling drugs without licence: Report

Hindustan Times  

Amazon and Flipkart Health plus are among the 20 online sellers that have been issued show-cause notices by the Drugs Controller General of India over the online sale of drugs in violation of norms. The show-cause notice dated February 8 by DCGI V G Somani cited a Delhi High Court order dated December 12, 2018, which prohibits online sales of …

Medicine Drugs Online Sale Licence Flipkart Dcgi Issued Notices
Amazon, Flipkart issued notices for selling drugs without licence: Report
1 year, 10 months ago

Amazon, Flipkart issued notices for selling drugs without licence: Report

Hindustan Times  

Amazon and Flipkart Health plus are among the 20 online sellers that have been issued show-cause notices by the Drugs Controller General of India over the online sale of drugs in violation of norms. The show-cause notice dated February 8 by DCGI V G Somani cited a Delhi High Court order dated December 12, 2018, which prohibits online sales of …

Drugs Sale Notice Licence Flipkart Dcgi Flipkart Health
DGCI issues notice to Amazon, Flipkart among other e-pharmacies over sale of drugs without license
1 year, 10 months ago

DGCI issues notice to Amazon, Flipkart among other e-pharmacies over sale of drugs without license

India TV News  

E-commerce giants Amazon and Flipkart were served show-cause notice along with 20 other online sellers by the Drugs Controller General of India regarding the sale of drugs without a licence. The show-cause notice dated February 8 by DCGI V G Somani cited a Delhi High Court order dated December 12, 2018, which prohibits online sales of medicines without a licence. …

Drugs Sale Amazon Notice Licence Flipkart Dcgi
DCGI Approves Market Authorisation for SII's Covid Vaccine Covovax as Heterologous Booster Dose
1 year, 11 months ago

DCGI Approves Market Authorisation for SII's Covid Vaccine Covovax as Heterologous Booster Dose

News 18  

The Drug Controller General of India has approved market authorisation to COVID-19 vaccine Covovax as a heterologous booster dose for adults who have been administered two doses of Covishield or Covaxin, official sources said on Monday. Prakash Kumar Singh, Director of Government and Regulatory Affairs at the Serum Institute of India, had recently written to the DCGI for the approval …

India Covid Dcgi Sii Covovax Booster Dose Heterologous Booster Dose
WHO drew premature link between children deaths in Gambia, India-made cough syrups: DCGI
2 years ago

WHO drew premature link between children deaths in Gambia, India-made cough syrups: DCGI

Firstpost  

New Delhi: The WHO drew a premature link between the deaths of children in Gambia and the four India-made cough syrups which adversely impacted the image of the country’s pharmaceutical products across the globe, India’s drug regulator has told the global health body. In a latest letter to Dr Rogerio Gaspar, Director at WHO, Drugs Controller General of India Dr …

India Deaths Pharmaceutical Cdsco Gambia Dcgi Somani
WHO drew premature link between Gambia children deaths, India-made cough syrups: DCGI
2 years ago

WHO drew premature link between Gambia children deaths, India-made cough syrups: DCGI

Deccan Chronicle  

New Delhi: The WHO drew a premature link between the deaths of children in Gambia and the four India-made cough syrups which adversely impacted the image of the country's pharmaceutical products across the globe, India's drug regulator has told the global health body. In a latest letter to Dr Rogerio Gaspar, Director at WHO, Drugs Controller General of India Dr …

India Deaths Pharmaceutical Cdsco Gambia Dcgi Somani
The Gambia children deaths | WHO drew premature link with India-made cough syrups, says drugs regulator
2 years ago

The Gambia children deaths | WHO drew premature link with India-made cough syrups, says drugs regulator

The Hindu  

The WHO drew a premature link between the deaths of children in Gambia and the four India-made cough syrups which adversely impacted the image of the country's pharmaceutical products across the globe, India's drug regulator has told the global health body. In the latest letter to Dr. Rogerio Gaspar, Director at WHO, Drugs Controller General of India Dr. V. G. …

India Deaths Pharmaceutical Cdsco Gambia Dcgi Cough
Panel Under Drug Regulator to Meet Soon to Decide Ban on Cocktail Meds, Codeine-based Cough Syrups
2 years, 3 months ago

Panel Under Drug Regulator to Meet Soon to Decide Ban on Cocktail Meds, Codeine-based Cough Syrups

News 18  

The apex panel under the drug regulatory body of India is set to decide the fate of cocktail medicines, including codeine-based cough syrups soon, News18.com has learnt. “The DTAB committee is slated to meet coming Monday to start deliberations over the FDC medicines, including codeine-based formulations,” the government official privy to the development told News18.com. The DCGI has been asked …

India Medicines Dcgi Drug Regulator Fdc Cough Syrups Cocktail Drugs
India Could Start Vaccinating Younger Kids Soon as Govt Panel Suggests Covaxin for 6-12 Age Group​ - News18
2 years, 8 months ago

India Could Start Vaccinating Younger Kids Soon as Govt Panel Suggests Covaxin for 6-12 Age Group​ - News18

News 18  

Amid a resurgence of Covid-19 cases, especially among children, the focus is back on vaccinating kids and now, there are indications from the government that India could soon start coronavirus jabs for younger children. Covaxin in the 6-12 age group The Subject Expert Committee has recommended Bharat Biotech’s Covaxin to the Drug Controller General of India for children aged between …

India Children Sec Vaccine Aged 12 Years Dcgi
DCGI Grants Emergency Use Authorisation to SII's Covid Vaccine Covovax for 12-17 Age Group
2 years, 9 months ago

DCGI Grants Emergency Use Authorisation to SII's Covid Vaccine Covovax for 12-17 Age Group

News 18  

India’s central drug regulator on Wednesday granted emergency use authorisation to Serum Institute of India’s Covid-19 vaccine Covovax for the 12-17 age group subject to certain conditions. Confirming the DCGI approval, Serum Institute of India CEO Adar Poonawalla on Tuesday tweeted:"@SerumInstIndia's brand Covovax has completed bridging studies in India and has been granted Emergency Use Authorisation by DCGI for adults …

India Emergency Age Group Vaccine Dcgi Emergency Use
COVID 19: Govt panel recommends permission for phase-3 trial of Covovax as booster dose in adults
2 years, 9 months ago

COVID 19: Govt panel recommends permission for phase-3 trial of Covovax as booster dose in adults

India TV News  

Highlights Govt has recommended permission for conducting a phase-3 clinical trial of Covid vaccine Covovax. An expert panel of India's central drug authority has recommended permission for conducting a phase-3 clinical trial of Covid vaccine Covovax as a booster dose in adults, official sources said on Sunday. The Subject Expert Committee on COVID-19 of the Central Drugs Standard Control Organisation …

India Trial Covid Singh Vaccine Permission Booster
Govt panel recommends permission for phase 3 trial of Sputnik Light vaccine as booster dose
2 years, 9 months ago

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

India Today  

An expert panel of India’s central drug authority has recommended permission to conduct a phase-3 clinical trial of the single-dose Covid-19 vaccine ‘Sputnik Light’ as a booster dose, official sources said on Saturday. "The Subject Expert Committee on Covid-19 of the Central Drugs Standard Control Organisation, which reviewed the application on Friday after detailed deliberation, recommended granting permission for the …

India Light Covid Vaccine Dcgi Dose Sputnik
Govt panel recommends granting emergency use authorisation to Covid vaccine Covovax for 12-17 age group
2 years, 9 months ago

Govt panel recommends granting emergency use authorisation to Covid vaccine Covovax for 12-17 age group

India Today  

An expert panel of the country's central drug authority has recommended granting emergency use authorisation to Serum Institute of India's Covid-19 vaccine Covovax for the 12-17 age group, official sources said on Friday. Prakash Kumar Singh, Director-Government and Regulatory Affairs at Serum Institute of India, had submitted an application to the DCGI on February 21, seeking EUA for Covovax for …

India Covid Singh Dcgi Serum Institute Emergency Use Covovax
Govt panel recommends EUA for Covid vaccine Covovax for 12-17 age group
2 years, 9 months ago

Govt panel recommends EUA for Covid vaccine Covovax for 12-17 age group

Hindustan Times  

An expert panel of the country's central drug authority has recommended granting emergency use authorisation to Serum Institute of India's Covid-19 vaccine Covovax for the 12-17 age group, official sources said on Friday. Prakash Kumar Singh, Director-Government and Regulatory Affairs at Serum Institute of India, had submitted an application to the DCGI on February 21, seeking EUA for Covovax for …

India Age Covid Singh Dcgi Covovax Eua
Govt Panel Recommends Emergency Approval For Covid Vaccine Corbevax For 12-18 Age Group
2 years, 10 months ago

Govt Panel Recommends Emergency Approval For Covid Vaccine Corbevax For 12-18 Age Group

ABP News  

New Delhi: An expert panel of India's central drug authority recommended on Monday that Biological E's Covid-19 vaccine, Corbevax, be granted restricted emergency use authorisation for the age group 12 to 18 years, PTI reported. On December 28 last year, the Drugs Controller General of India granted emergency use authorisation to Corbevax, India's first indigenously manufactured RBD protein sub-unit vaccine …

India Age Covid Pti Vaccine Dcgi Corbevax
Covishield, Covaxin get govt expert panel's recommendation for regular market approval
2 years, 11 months ago

Covishield, Covaxin get govt expert panel's recommendation for regular market approval

India TV News  

Highlights A DCGI Committee recommended regular market approval to Covishield and Covaxin Covishield and Covaxin are currently only authorised for emergency use in the country SII and Bharat Biotech submitted applications to DCGI seeking regular market approval An expert panel of India's central drug authority on Wednesday recommended granting regular market approval to Covid vaccines Covishield and Covaxin, which are …

Singh Expert Sec Approval Bharat Biotech Covaxin Covishield
CDSCO panel recommends emergency use authorisation for SII’s Covovax
2 years, 11 months ago

CDSCO panel recommends emergency use authorisation for SII’s Covovax

India TV News  

Highlights An expert panel of CDSCO has recommended emergency use authorization for Covovax. India's central drug authority has recommended granting emergency use authorization to Serum Institute of India's COVID-19 vaccine ‘Covovax’ with certain conditions, official sources said on Monday. Prakash Kumar Singh, Director, Government, and Regulatory Affairs at Serum Institute of India had submitted an application to the Drugs Controller …

India Emergency Application Cdsco Vaccine Dcgi Serum Institute
Expert panel recommends emergency nod for Serum Institute's Covid vaccine Covovax
2 years, 11 months ago

Expert panel recommends emergency nod for Serum Institute's Covid vaccine Covovax

India Today  

An expert panel of the country’s central drug authority has recommended granting emergency use authorisation to Serum Institute of India's Covid-19 vaccine ‘Covovax’ with certain conditions, official sources said on Monday. Prakash Kumar Singh, director, Government and Regulatory Affairs at Serum Institute of India had submitted an application to the Drugs Controller General of India in October for grant of …

India Emergency Covid Sec Vaccine Dcgi Serum Institute
Biological E seeks DCGI’s nod for phase-3 trial of Corbevax as booster dose in those vaccinated with Covishield or Covax
3 years, 2 months ago

Biological E seeks DCGI’s nod for phase-3 trial of Corbevax as booster dose in those vaccinated with Covishield or Covax

Live Mint  

Hyderabad-based pharmaceutical company Biological E has sought permission from India's drug regulator to conduct the phase-3 clinical trial for its COVID-19 vaccine Corbevax as a single booster dose for those who have been fully vaccinated with Covishield or Covaxin. The company, meanwhile, has put in an application seeking the nod of the Drugs Controller General of India to conduct the …

India Vaccine Dcgi Clinical Biological E Covishield Corbevax