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Drug regulator suspends product PresVu over unauthorised promotion
DCGI suspended the PresVu produced by Entod Pharmaceuticals after the company failed to respond to the queries on the product.
Published on Sep 12, 2024 09:00 AM IST
ANI | | Posted by Tapatrisha Das, New Delhi
DCGI suspends Entod’s marketing approval for PresVu eye drops amid misuse concerns
The drug had claimed that it will reduce the need for reading glasses for persons suffering from presbyopia
Published on Sep 11, 2024 07:48 PM IST
Amazon, Flipkart issued notices for selling drugs without licence: Report
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.
Updated on Feb 12, 2023 07:37 PM IST
PTI |
'Compliant with norms': India to WHO on cough syrups and Gambia kids' deaths
All four cough syrup samples of Maiden Pharmacueticals tested by the government have been found compliant with norms, the national drugs controller has said in a recent letter to the WHO.
Updated on Dec 16, 2022 12:16 PM IST
Gambia deaths: India says WHO's info ‘inadequate’ to determine aetiology
On October 13, Rutendo Kuwana from the WHO had written to the DCGI and sought to know the progress with the investigation of the manufacturer of the four cough syrups - the Sonipat-based Maiden Pharmaceuticals.
Updated on Oct 15, 2022 11:54 PM IST
‘Diligently following protocol’: Maiden Pharma breaks silence on Gambia deaths
Maiden Pharma's director Vivek Goyal said on Saturday, said the company has been in the business for over three decades and their products are not sold in domestic market. The company said it has the requisite export approvals for the products that have come under the scanner of drug authorities.
Updated on Oct 09, 2022 05:04 AM IST
Soumya Pillai, New Delhi
Covovax granted EUA for children aged 7-12
The Drugs Controller General of India (DCGI), the country’s drugs regulator, on Tuesday granted emergency use authorisation (EUA) to India’s first indigenously developed mRNA vaccine against Covid-19 manufactured by Pune-based Gennova Biopharmaceuticals
Updated on Jun 29, 2022 01:34 AM IST
India clears Corbevax as a booster dose for adults
Corbevax can be administered as a Covid-19 booster dose for individuals aged 18 years and above, six months after they have been administered the second doses of Covishield or Covaxin, the DCGi said.
Published on Jun 04, 2022 11:56 PM IST
Govt’s expert panel likely to review Covovax data
The move is significant as the government considers recommendations by NTAGI to make policy decisions regarding any expansions in the national Covid vaccination programme.
Updated on Mar 31, 2022 04:05 AM IST
DCGI approves trials for internasal booster dose
The trials for the adenovirus vectored vaccine, to be used as a spray to the nose, will be conducted at nine sites across the country with almost 900 participants in all.
Published on Jan 28, 2022 11:49 PM IST
Rhythma Kaul, New Delhi
SEC recommends Covaxin, Covishield for full market authorisation: Report
On January 14, the subject expert committee (SEC) of the Central Drugs Standard Control Organisation (CDSCO) sought more data from the two respective manufacturers for regular market approval.
Updated on Jan 19, 2022 10:44 PM IST
hindustantimes.com, New Delhi
DCGI needs more safety data for Covaxin nod for under 12
The approval on December 25 from the Drugs Controller General of India (DCGI) came nearly 10 weeks after the subject expert committee of the Central Drugs Standard Control Organisation (CDSCO) recommended Covaxin’s use in children on October 12 last year.
Updated on Jan 18, 2022 04:45 AM IST
Rhythma Kaul, New Delhi
2 new vaccines, Covid pill approved for use
The DCGI on Tuesday approved Covovax and Corbevax vaccines, as well as US pharma company Merck’s anti-viral drug, molnupiravir.
Published on Dec 28, 2021 11:23 PM IST
Rhythma Kaul, New Delhi
DCGI approves Covaxin for emergency use in age group between 12 and 18 years
The approval from DCGI came nearly 10 weeks after the subject expert committee of central drugs standard control organisation (CDSCO) recommended Covaxin’s use in children on October 12, this year, based on the clinical trials data submitted by the Hyderabad-based company.
Updated on Dec 26, 2021 01:12 AM IST
Rhythma Kaul, Hindustan Times, New Delhi
Serum Institute seeks DCGI nod for Covishield booster shot amid Omicron scare
In an application to DCGI, Prakash Kumar Singh, director of government and regulatory affairs at Serum Institute of India wrote that there is no shortage of Covishield in India now and the demand for booster dose is rising by each passing day in wake of the emerging new strains of the coronavirus.
Published on Dec 01, 2021 11:15 PM IST
Written by Sharangee Dutta | Edited by Amit Chaturvedi, Hindustan Times, New Delhi
Govt allows SII to export 5 crore doses of Covid-19 vaccine Covovax to Indonesia
Recently, Prakash Kumar Singh, Director, Government and Regulatory Affairs at SII, wrote to the DCGI seeking no objection certification to export 50 lakh vials of Covovax.
Published on Nov 15, 2021 11:17 PM IST
PTI | | Posted by Sharangee Dutta, Hindustan Times, New Delhi
Bharat Biotech submits data from Covaxin's trials on children to DCGI: Report
The Hyderabad-based firm, last month, completed the jab's phase 2/3 trials for kids.
Published on Oct 03, 2021 10:24 AM IST
hindustantimes.com | Written by Karan Manral, New Delhi
DCGI accepts proposal to study mixing of Covid-19 vaccine doses
The research will analyse mixing a dose each of Covaxin and Covishield. It will be conducted at Christian Medical College in Tamil Nadu's Vellore.
Published on Aug 11, 2021 08:00 AM IST
hindustantimes.com | Written by Karan Manral, New Delhi
Zydus Cadila submits additional data on its Covid-19 vaccine to DCGI: Report
The Ahmedabad-based firm's vaccine candidate, ZyCoV-D, is expected to be approved in August.
Published on Jul 27, 2021 08:33 PM IST
hindustantimes.com | Written by Karan Manral
Bharat Biotech submits Covaxin phase 3 trials data to DCGI: Reports
Also, according to reports, the Subject Expert Committee (SEC) is likely to meet on Tuesday to review the phase 3 data.
Published on Jun 22, 2021 09:50 AM IST
hindustantimes.com | Written by Karan Manral | Edited by Amit Chaturvedi, New Delhi
Ready to face whatever the court decides: Gautam Gambhir on drug hoarding case
The Bharatiya Janata Party MP from East Delhi had been found guilty of unauthorisedly stocking and distributing Fabiflu pills to Covid-19 patients by the Delhi government's drug control department.
Published on Jun 04, 2021 08:55 PM IST
hindustantimes.com, Hindustan Times, New Delhi
Serum seeks DCGI nod to manufacture Sputnik
SII, applied to Indian regulator, the drugs controller general of India (DCGI), Dr VG Somani, on Wednesday to seek approval for grant of licence.
Updated on Jun 04, 2021 04:36 AM IST
Rhythma Kaul, Hindustan Times. New Delhi
'A new weapon': Dr Naresh Trehan on Covid-19 antibody cocktail
The cocktail of casirivimab and imdevimab came into limelight after it was administered to former US President Donald Trump when he tested positive for Covid-19 last year.
Published on May 26, 2021 05:12 PM IST
hindustantimes.com | Edited by Amit Chaturvedi, Hindustan Times, New Delhi
DCGI gives emergency approval of DRDO-developed anti-Covid oral drug
The oral drug has been developed by Institute of Nuclear Medicine and Allied Sciences, a lab of DRDO, in collaboration with Dr Reddy’s Laboratories, Hyderabad. Phase III clinical trial results have shown that this molecule helps in faster recovery of hospitalised patients and reduces supplemental oxygen dependence.
Published on May 08, 2021 01:42 PM IST
Shishir Gupta, New Delhi