Drugs Controller General of India
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Drugs Controller General of India (DCGI) is the head of department of the Central Drugs Standard Control Organization of the Government of India responsible for approval of licences of specified categories of drugs such as blood and blood products, IV fluids, vaccines, and sera in India. Drugs Controller General of India, comes under the Ministry of Health & Family Welfare. DCGI also sets standards for manufacturing, sales, import, and distribution of drugs in India.
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DCGI suspends ENTOD's PresVu eye drops licence after misleading marketing claims, company to challenge order in courtThe drug regulator said the company made claims for the drug product for which it had not obtained approval from the Central Licensing Authority, thereby violating provisions under the New Drugs and..DNA - Published | |
DCGI bans all charges, except supply, processing costs on blood unitsThe Drugs Controller General of India (DCI) on Thursday banned all charges except supply and processing costs on blood units.DNA - Published | |
Blood not for sale, charge processing cost only, DCGI tells blood banksDCGI has also asked the drug controller cum licensing authorities to direct all blood centres to adhere to the revised guidelines for recovery of processing charges. When a person donates blood, it is..IndiaTimes - Published | |
Rule regulating Ayush ads set to go, but amendments to fill void in limbo for a yearThe Drug Controller General of India (DCGI) has suggested that a rule regulating the advertisement of ayush drugs should only be withdrawn after amendments to the Drugs and Magic Remedies Act are..IndiaTimes - Published | |
DCGI: In case of adverse reaction, don't use Digene gelThe Drug Controller General of India (DCGI) has advised doctors and healthcare professionals to educate their patients to discontinue the use of Digene gel - a commonly prescribed anti-acidity..IndiaTimes - Published | |
Antacid Digene Gel recalled by Abbott, DCGI issues alert against household medication; know whyDigene Gel, which is used as an antacid in many Indian homes, is now under the radar of the DGCI as an alert has been issued after the product's recall.DNA - Published | |
Mandatory testing of cough syrup before exports, DCGI asks labs to give top priority to such samplesCough syrup exporters will have to produce a certificate of analysis issued by a government laboratory before the product is exported, effective June 1, the Directorate General of Foreign Trade (DGFT)..IndiaTimes - Published | |
Covid jab Covovax as heterologous booster to be available on CoWIN soon; to cost Rs 225 per doseCovovax can be administered to those who have already vaccinated with Covishield or Covaxin. The Drugs Controller General of India (DCGI) on January 16 had approved the market authorisation for Covovax..IndiaTimes - Published | |
Covid vaccine news: SII's Covovax approved as heterologous booster dose for adultsDCGI has approved market authorisation to COVID-19 vaccine Covovax as a heterologous booster dose for adults.DNA - Published | |
Bharat Biotech's Intranasal Covid-19 Booster gets DCGI nod for emergency useFor individuals 18 years of age and older, the DCGI has authorised the use of Bharat Biotech's five arms heterologous booster, ANI reported.DNA - Published | |
DCGI approves '5-arms intranasal heterologous booster dose' for restricted useIndiaTimes - Published | |
India's first intranasal Covid vaccine by Bharat Biotech gets DCGI approvalBharat Biotech's intranasal vaccine has been approved for primary immunization against Covid in adults for restricted use in emergency situation.DNA - Published | |
Corbevax Covid booster expected to get final approval from government soon: ReportEarlier on June 4, DCGI approved Corbevax as a precaution dose for those aged 18 and above.DNA - Published | Bharat Biotech's intranasal Covid-19 vaccine to get DCGI nod soon? Here's what we knowThe Drug Controller General of India gave its nod to conduct clinical trials for BBIL's intranasal vaccine as a booster dose.DNA - Published |
DCGI grants emergency use authorisation to India's first mRNA Covid-19 vaccine: SourcesThe Subject Expert Committee under India's drug regulator has found data submitted by Gennova Biopharmaceuticals "satisfactory".DNA - Published | Covid-19 vaccine: SII's Covovax gets nod for emergency use in children aged 7 to 11 yearsThe DCGI had approved Covovax for restricted emergency use in adults on December 28, 2021, and in 12-17 years age group on March 9, 2022.DNA - Published Also reported by •IndiaTimes |
India's first mRNA Covid-19 vaccine to get Emergency Use Authorisation soonThe Subject Expert Committee (SEC) in a meeting held on Friday recommended Emergency Use Authorisation (EUA) for India's first mRNA COVID-19 vaccine, sources have said. The Drugs controller general of..IndiaTimes - Published | Allowing Corbevax as booster for those vaccinated with Coivishield, Covaxin likely to be considered by NTAGIThe Drugs Controller General of India (DCGI) on June 4 approved Corbevax as a precaution dose for those aged 18 and above. India's first indigenously-developed RBD protein subunit vaccine, Corbevax, is..IndiaTimes - Published |
Govt panel recommends emergency approval for SII's Covovax for 7-11 year oldsAn expert panel of India's central drug authority on Friday recommended granting emergency use authorisation to Serum Institute's Covovax for children aged 7 to 11 years, official sources said. The..IndiaTimes - Published | Bharat Biotech's Covid nasal vaccine phase 3 trials completedThe company will submit its data to the Drugs Controller General of India (DCGI) next month, said Dr Krishna Ella, Bharat Biotech chief.DNA - Published |
DCGI clears Corbevax as Covid booster shot for those aged 18 and aboveIn April, DCGI had given emergency use authorisation (EUA) to Corbevax for children between 5 and 12 years.DNA - Published | Mixed-vax trial has yielded positive data: CMC VelloreA study by Christian Medical College, Vellore, on the effectiveness of mixed booster doses has yielded positive results and is currently being evaluated by central agencies, officials from the..IndiaTimes - Published |
Bharat Biotech seeks DCGI nod for phase 2/3 Covaxin booster trial among two to 18-year-oldBharat Biotech has sought permission from India's drug regulator to conduct a phase 2/3 study of its Covid vaccine Covaxin as a booster dose among those aged two to 18 years, sources told PTI...IndiaTimes - Published | DCGI gives approval for Bharat Biotech's Covaxin for children aged 6-12The Drug Controller General of India (DCGI) has given a restricted emergency use approval for Bharat Biotech's Covid-19 vaccine, Covaxin, for children between the age of six and 12. A Subject Expert..IndiaTimes - Published Also reported by •DNA |
DCGI grants approval to Corbevax for kids aged 5-12, Covaxin for 6-12 age groupThe Drug Controller General of India (DCGI) on Tuesday granted emergency use approval to Covid-19 vaccines, Covaxin and Corbevax, for children below 12. Bharat Biotech's Covaxin has got nod for use in..IndiaTimes - Published | Bharat Biotech asked to provide more data on Covid-19 vaccine Covaxin for children aged below 12The Subject Expert Committee (SEC) of the Drug Controller General of India (DCGI) has asked Bharat Biotech for additional data on its Covid-19 vaccine, Covaxin, for administering it to children aged..IndiaTimes - Published |
Novavax says its Covid vaccine gets India authorisation for adolescentsNovavax Inc on Tuesday said that the Drugs Controller General of India (DCGI) has granted emergency use authorisation for its Covid-19 vaccine for adolescents aged 12 to 17 in the country. The..IndiaTimes - Published | Phase 2,3 trial data of India's first mRNA Covid vaccine submitted to DCGIPune-based Gennova Biopharmaceuticals has submitted the phase-II and phase-III trials data of India's first mRNA Covid vaccine to the regulator Drugs Controller General of India (DCGI) on Friday, said..IndiaTimes - Published |
Covid-19: Covovax gets DCGI’s EUA nod for 12-17-year-oldsIn a move that will further expand the basket of Covid vaccines approved for adolescents, the drug regulator has given emergency approval to Serum Institute of India’s Covovax for use in 12-17 year..IndiaTimes - Published | DCGI's EUA nod to Covovax for 12-17 years age groupIndia's drug regulator has granted restricted emergency use authorisation to Serum Institute of India's COVID-19 vaccine Covovax for the 12-17 years age group subject to certain conditions, official..IndiaTimes - Published |
Biological E seeks EUA for Covid vaccine Corbevax for children in 5-12 age group: Official sourcesRecently, the subject expert committee recommended emergency use authorization (EUA) for Biological E's Covid-19 vaccine Corbevax for the age group of 12 to 18 years under certain conditions. The drugs..IndiaTimes - Published | Covid-19: SII's Covovax vaccine recommended for Phase 3 trial as booster dose in adultsThe Pune-based SII had sought the permission from the DCGI to conduct Phase 3 study to evaluate the safety and immunogenicity of Covovax.DNA - Published |
Government panel recommends EUA for Covid vaccine Covovax for 12-17 age groupPrakash Kumar Singh, director-government and regulatory affairs at Serum Institute of India (SII), had submitted an application to the DCGI on February 21, seeking EUA for Covovax for the 12 to 17..IndiaTimes - Published | SII seeks permission for Covovax vaccine phase-3 study of booster dose in adultsThe Drugs Controller General Of India (DCGI) had approved Covovax for restricted use in emergency situations in adults on December 28.DNA - Published |
Corbevax gets emergency use nod for 12-18 age groupHyderabad-based pharmaceutical company Biological E Ltd has received an emergency use approval from Drugs Controller General of India for use in children aged 12 to 18 yearsIndiaTimes - Published | Covid: DCGI grants EUA to BE's Corbevax for use in kids aged 12-18 yearsVaccine maker Biological E Limited’s (BE), receptor binding domain (RBD) protein sub-unit Covid-19 vaccine Corbevax has bagged emergency use authorisation (EUA) from the Drugs Controller General of..IndiaTimes - Published |
Corbevax Covid-19 vaccine recommended for emergency use in 12-18 years age groupThe Drugs Controller General Of India (DCGI) has already approved Corbevax for restricted use in emergency situation in adults on December 28.DNA - Published | DCGI gives emergency use nod to SputnikIndiaTimes - Published |
DCGI grants emergency use permission to single-dose Sputnik Light Covid vaccineThe Drugs Controller General of India (DCGI) on Sunday granted emergency use permission to single-dose Sputnik Light Covid vaccine in the country. This comes following recommendations of an expert..IndiaTimes - Published | Single-dose Sputnik Light Covid Vaccine receives emergency use permission from DCGIUnion Health Minister Mansukh Mandaviya on Sunday said that the Drugs Controller General of India (DGCI) grants emergency use approval to single-dose Sputnik Light COVID-19 vaccine.DNA - Published |
Submitted proposal to DCGI to test Sputnik Light as Covid booster dose: Dr Reddy'sIndiaTimes - Published | Covaxin granted Emergency Use Listing in 13 nations as on Jan 31 according to WHO: GovtCovaxin has been granted Emergency Use Listing (EUL) in 13 countries as on January 31 according to the WHO, Minister of State for Health Bharati Pravin Pawar informed the Lok Sabha on Friday...IndiaTimes - Published |
SII gets DCGI nod to manufacture drug substance, test it for developing jab against OmicronIndiaTimes - Published | Biological E gets DCGI nod for Phase 3 clinical trials of Corbevax as booster doseBiological E, Hyderabad-based pharmaceutical company on Tuesday received the emergency-use authorisation for manufacturing and marketing of Corbevax.DNA - Published |
Pharma firms to roll out anti-Covid pill shortly as DCGI approves emergency useWith the Drugs Controller General of India (DCGI) approving the anti-Covid-19 pill Molnupiravir for emergency use in the country, Strides Pharma on Tuesday said it will launch the capsule immediately..IndiaTimes - Published | Covaxin gets DCGI nod for emergency use for kids aged 12-18 yearsIndigenously developed Covid-19 vaccine Covaxin has received approval from the Drugs Controller General of India (DCGI) for emergency use in children aged between 12-18 years. The drug regulator’s..IndiaTimes - Published |
DCGI nod to Covaxin for use in children above 12 years with certain conditionsIndiaTimes - Published | DCGI seeks more data from SII over its application seeking emergency authorisation for CovovaxIndiaTimes - Published |
Bharat Biotech seeks DCGI's nod for its intranasal COVID-19 booster dose clinical trialsThe company is hoping for early approval for the trails of the intranasal COVID-19 booster given the fast spread of the Omicron variant.DNA - Published Also reported by •IndiaTimes | As Omicron fear intensifies, Serum Institute of India seeks DCGI's approval for Covishield booster shotRecently, Kerala, Rajasthan, Karnataka, and Chhattisgarh have also urged the Centre to decide on allowing booster doses of the COVID-19 vaccine.DNA - Published Also reported by •IndiaTimes |
