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drug controller general of india

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Biological E's ‘Corbevax’ gets DCGI approval for two clinical trials

  • Biological E received approval for Phase 3 comparator safety and immunogenicity trial in adults after a review of Phase 1 and 2 clinical trials data by a subject expert committee.
Union health minister Mansukh Mandaviya meets Mahima Datla, MD of Biological E. Limited, in New Delhi.(ANI / File Photo)
Union health minister Mansukh Mandaviya meets Mahima Datla, MD of Biological E. Limited, in New Delhi.(ANI / File Photo)
Published on Sep 03, 2021 03:08 PM IST
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By hindustantimes.com | Written by Kunal Gaurav, Hindustan Times, New Delhi

Covishield and Covaxin: What’s next after Drug Controller’s approval?

The approval does not mean the ongoing trials of both these vaccines will be stopped. Trials will go on along with emergency vaccination drive. More data from ongoing trials will help experts understand the efficacy of the vaccines better.
Health workers preparing for Covid-19 vaccination mock drill at Rajawadi Municipal Corporation Hospital in Mumbai.(PTI)
Health workers preparing for Covid-19 vaccination mock drill at Rajawadi Municipal Corporation Hospital in Mumbai.(PTI)
Updated on Jan 03, 2021 06:31 PM IST
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Hindustan Times, New Delhi | By hindustantimes.com | Edited by Poulomi Ghosh

Approval for Covaxin a giant leap for novel product development in India: Bharat Biotech

The phase-III human clinical trials of Covaxin began mid-November. Bharat Biotech aims to recruit 26,000 volunteers across the country for the phase-III trials.
A medic fills a syringe with Covaxin, a government-backed experimental Covid-19 vaccine, before administering it to a health worker during its trials.(Reuters File Photo)
A medic fills a syringe with Covaxin, a government-backed experimental Covid-19 vaccine, before administering it to a health worker during its trials.(Reuters File Photo)
Published on Jan 03, 2021 02:58 PM IST
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New Delhi | By Press Trust of India | Posted by Kanishka Sarkar

‘Finally paid off’: Adar Poonawalla thanks PM Modi, DCGI after Covishield gets final approval

Even before getting the approval from the apex drug controller of India, Serum Institute of India stockpiled about 40-50 million doses of the Covid-19 vaccine, taking a major risk.
Adar Poonawalla, Chief Executive Officer (CEO) of the Serum Institute of India, thanked all stakeholders after Covishield got final nod in India.(REUTERS)
Adar Poonawalla, Chief Executive Officer (CEO) of the Serum Institute of India, thanked all stakeholders after Covishield got final nod in India.(REUTERS)
Updated on Jan 03, 2021 08:29 PM IST
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Hindustan Times, New Delhi | By hindustantimes.com | Edited by Poulomi Ghosh

Covaxin approval: All you need to know about Bharat Biotech Covid-19 vaccine’s efficacy, price

Bharat Biotech followed a double-bind, randomised, multi-centre phase two clinical trial which included children as well. Its third phase trial is still going on.
A volunteer being vaccinated by a medic during the Bharat Biotech's 'Covaxin' human trial in Jaipur.(PTI)
A volunteer being vaccinated by a medic during the Bharat Biotech's 'Covaxin' human trial in Jaipur.(PTI)
Updated on Jan 02, 2021 10:00 PM IST
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Hindustan Times, New Delhi | By hindustantimes.com | Edited by Poulomi Ghosh

Bharat Biotech’s Covaxin safe, says Phase 1 trial data

The results of Phase 1 results of Covaxin had not been publicly released yet even though the data was first presented to Drugs Controller General of India (DCGI) on October 2 when the company applied for approval to start Phase 3 trials.
Bharat Biotech has developed the whole-virion inactivated SARS-CoV-2 vaccine candidate (BBV152) in collaboration with ICMR.(Reuters File Photo)
Bharat Biotech has developed the whole-virion inactivated SARS-CoV-2 vaccine candidate (BBV152) in collaboration with ICMR.(Reuters File Photo)
Updated on Dec 17, 2020 05:47 AM IST
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Hindustan Times, New Delhi | By Rhythma Kaul

Serum Institute seeks approval for Covid-19 vaccine; Adar Poonawalla thanks PM for support

The institute’s move comes on the heels of the US pharmaceutical giant, Pfizer, applying for a similar approval with the DCGI
Vials of COVISHIELD before they are packaged inside a lab at Serum Institute of India, Pune, earlier in November.(File photo)
Vials of COVISHIELD before they are packaged inside a lab at Serum Institute of India, Pune, earlier in November.(File photo)
Updated on Dec 07, 2020 06:49 PM IST
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Hindustan Times, New Delhi | By HT Correspondent | Edited by Smriti Sinha

AIIMS to submit proposal for phase 3 trials of Covaxin next week

Bharat Biotech last week got an approval from drugs controller general of India to conduct phase 3 clinical trials of its anti Covid-19 vaccine candidate, Covaxin, in India.
AIIMS plans to recruit anywhere between 2,000-5,000 participants for the upcoming phase 3 trial once they get the approval.(AP File Photo)
AIIMS plans to recruit anywhere between 2,000-5,000 participants for the upcoming phase 3 trial once they get the approval.(AP File Photo)
Updated on Oct 31, 2020 03:13 AM IST
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Hindustan Times, New Delhi | By Rhythma Kaul, New Delhi

Bharat Biotech to submit revised Phase 3 clinical trial protocol to DCGI by next week

Covaxin is India’s first vaccine candidate against Covid-19
Human clinical trials for Covaxin began across India in July 2020. As per the current plan, the Phase 3 trial, to determine vaccine efficacy, will begin early to mid-November this year.(Representational Photo/AP)
Human clinical trials for Covaxin began across India in July 2020. As per the current plan, the Phase 3 trial, to determine vaccine efficacy, will begin early to mid-November this year.(Representational Photo/AP)
Updated on Oct 24, 2020 08:31 AM IST
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Hindustan Times,New Delhi | By Rhythma Kaul

India’s first Covid-19 vaccine will be at least 60% effective: Bharat Biotech

Late Thursday, Bharat Biotech received approval from DCGI to conduct a Phase 3 clinical trial. Its interim results are likely to be released by April or May next year
As per the current plan, the Phase 3 trial to determine vaccine efficacy will begin early to mid-November with 26,000 study subjects at 25 to 30 sites across 13-14 states.(Representational photo/Reuters File)
As per the current plan, the Phase 3 trial to determine vaccine efficacy will begin early to mid-November with 26,000 study subjects at 25 to 30 sites across 13-14 states.(Representational photo/Reuters File)
Updated on Oct 23, 2020 03:07 PM IST
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Hindustan Times, New Delhi | By Rhythma Kaul

Data breach at Dr Reddy’s forces lab to temporarily shot operations across globe

The Hyderabad-based lab is authorised to test and distribute the Russian Covid-19 vaccine in India
Dr Reddy’s Laboratories had recently received approval from the drugs controller general of India to conduct an adaptive phase 2/3 clinical trial in India for Russia’s Sputnik V vaccine candidate against Coronavirus disease (Covid-19).(REUTERS File)
Dr Reddy’s Laboratories had recently received approval from the drugs controller general of India to conduct an adaptive phase 2/3 clinical trial in India for Russia’s Sputnik V vaccine candidate against Coronavirus disease (Covid-19).(REUTERS File)
Updated on Oct 22, 2020 03:48 PM IST
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Hindustan Times, New Delhi | By Rhythma Kaul

Covid-19 vaccine: Sputnik V to undergo trial in India, Dr Reddy’s gets DCGI approval

Russia is approving vaccines after small-scale trials, which is a cause for concern over Sputnik V’s safety. This is why Dr Reddy’s was not given permission to test it among a comparatively larger population in India.
Sputnik V, the first registered Covid-19 vaccine of the world, will now undergo trials in India.(REUTERS)
Sputnik V, the first registered Covid-19 vaccine of the world, will now undergo trials in India.(REUTERS)
Updated on Oct 17, 2020 04:06 PM IST
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Hindustan Times, New Delhi | By hindustantimes.com | Edited by Poulomi Ghosh

Zydus Cadila begins human dosing in trials of Covid-19 vaccine candidate

No safety concerns were observed for the Covid-19 vaccine candidate, ZyCoV-D, in repeat-dose toxicology studies, according to the details shared by the company.
A pharmaceutics worker shows a shot of a vaccine developed by Zydus Cadila to treat the Covid-19 coronavirus after it received approval from the Drug Controller General of India to start phase one and two of human clinical trials, in Ahmedabad.(AFP File Photo)
A pharmaceutics worker shows a shot of a vaccine developed by Zydus Cadila to treat the Covid-19 coronavirus after it received approval from the Drug Controller General of India to start phase one and two of human clinical trials, in Ahmedabad.(AFP File Photo)
Updated on Jul 17, 2020 05:59 AM IST
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Hindustan Times, New Delhi | By Rhythma Kaul

Bharat Biotech to start human trials for first indigenous Covid-19 vaccine from July

A release from the company said the vaccine was developed in collaboration with the Indian Council of Medical Research (ICMR) and National Institute of Virology (NIV).
Human clinical trials are scheduled to start across India in July 2020.(REUTERS)
Human clinical trials are scheduled to start across India in July 2020.(REUTERS)
Updated on Jun 30, 2020 02:23 PM IST
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Hindustan Times, Hyderabad | By Srinivasa Rao Apparasu| Edited by Meenakshi Ray

The scary truth behind generic drugs in India

Often, generic drugs manufacturers produce medicines of higher quality for European and American markets, where regulation is tighter, whilst blithely selling inferior and ineffective drugs in India
Our faith in Indian generic medicines is often misplaced. They frequently don’t work. Sometimes, no matter how many tablets you take, they will not treat the disease or infection(Shutterstock)
Our faith in Indian generic medicines is often misplaced. They frequently don’t work. Sometimes, no matter how many tablets you take, they will not treat the disease or infection(Shutterstock)
Updated on Jul 13, 2019 06:58 PM IST
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In injectable contraceptive, forest dept finds a solution to control monkey menace

The drug — Reversible Inhibition of Sperm Under Guidance (RISUG) — developed by Sujoy Guha has been successfully tried on animals such as rats, rabbits and the common monkey (rhesus macaque) besides humans.
To control the monkey menace in the city, the Delhi government’s forest department is pinning all its hopes on an injectable contraceptive, developed by an IIT Delhi professor in the 1980s, for human males.(Praful Gangurde)
To control the monkey menace in the city, the Delhi government’s forest department is pinning all its hopes on an injectable contraceptive, developed by an IIT Delhi professor in the 1980s, for human males.(Praful Gangurde)
Published on Apr 27, 2019 06:13 AM IST
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New Delhi | By Baishali Adak

ICMR questions Mumbai hospital’s stem-cell therapy

On Thursday, doctors at Surya Hospital announced in a press conference that they had successfully treated a premature baby using stem cells.
The Indian Council of Medical Research (ICMR) has called into question the ethics and protocols followed by a Santacruz-based super-speciality paediatrics hospital in its use of stem-cell therapy to treat a 26-week-old preterm baby’s lung condition.(REUTERS)
The Indian Council of Medical Research (ICMR) has called into question the ethics and protocols followed by a Santacruz-based super-speciality paediatrics hospital in its use of stem-cell therapy to treat a 26-week-old preterm baby’s lung condition.(REUTERS)
Updated on Apr 26, 2019 08:27 AM IST
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Mumbai | By Aayushi Pratap

Barcoding raw materials used in drugs to become mandatory

The Union health ministry will make it mandatory for all active pharmaceutical ingredient (API) packages to be barcoded to detect spurious drugs and monitor imported and indigenously produced raw materials used to manufacture medicines.
Image for representation(Mint file photo)
Image for representation(Mint file photo)
Updated on Apr 21, 2019 07:51 AM IST
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Hindustan Times, New Delhi | By Rhythma Kaul

‘Pharmacy’ to be used in place of ‘chemists & druggists’

Under the Drugs and Cosmetics Rules, the description “chemists and druggists” is displayed by licencees who employ registered pharmacists but do not have a pharmacy for compounding – preparing personalised medication for patients -- against prescriptions.
The Drug and Technical Advisory Board (DTAB) has approved changing the Drugs and Cosmetics Rules to bring uniformity to medical store signboards.(HT Photo/Representative Image)
The Drug and Technical Advisory Board (DTAB) has approved changing the Drugs and Cosmetics Rules to bring uniformity to medical store signboards.(HT Photo/Representative Image)
Published on Apr 19, 2019 07:27 AM IST
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Hindustan Times, New Delhi | By Rhythma Kaul

Government awards Delhi patient Rs 67 lakh for faulty J&J implant

The Central Drugs Standard Control Organisation (CDSCO), India’s regulatory body for pharmaceuticals and medical devices, has directed J&J to pay the compensation amount to the Delhi patient within 30 days from the date receipt of the order, which was sent out a week ago.
At least 200 applications are under consideration by state-level committees for compensation from patients who received the faulty Articular Surface Replacement (ASR) hip implant in India.(REUTERS/Representative Image)
At least 200 applications are under consideration by state-level committees for compensation from patients who received the faulty Articular Surface Replacement (ASR) hip implant in India.(REUTERS/Representative Image)
Updated on Apr 05, 2019 07:49 AM IST
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Hindustan Times, New Delhi | By Anonna Dutt

New clinical trial rules to fast-track access to drugs

Requirement of a local clinical trial may be waived for approval of new drug if it is approved and marketed in any of the countries to be specified by the drug controller general of India (DCGI) with approval of government from time to time and certain other conditions.
New clinical trial rules to fast-track access to drugs(Getty Images/iStockphoto)
New clinical trial rules to fast-track access to drugs(Getty Images/iStockphoto)
Updated on Mar 26, 2019 07:18 AM IST
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New Delhi | By HT Correspondent

Johnson & Johnson show-caused by DGCI over ad

The Drug Controller General of India (DCGI) has issued a show-cause notice to Johnson & Johnson for using government test results to advertise the safety of its baby talcum powder, which is in violation of the Indian law.
Johnsons Baby Powder from Johnsons and Johnsons Product at Spencers retail store Kaushambhi in Ghaziabad. Image for representation.(Pradeep Gaur/ Mint file photo)
Johnsons Baby Powder from Johnsons and Johnsons Product at Spencers retail store Kaushambhi in Ghaziabad. Image for representation.(Pradeep Gaur/ Mint file photo)
Updated on Mar 06, 2019 12:42 AM IST
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Hindustan Times, New Delhi | By HT Correspondent

Centre approves Rs 30L to Rs 1.23 cr relief in faulty hip implants case

The drug controller general of India said this is the highest ever compensation amount in the Indian history.
Faulty Articular Surface Replacement (ASR) hip implants, manufactured by DePuy International Limited — a subsidiary of Johnson & Johnson Pvt Ltd, were recalled in 2010 globally after complaints of more-than-usual revision surgeries due to complications such as metal leaching and infections, among others.(Bloomberg/Representative image)
Faulty Articular Surface Replacement (ASR) hip implants, manufactured by DePuy International Limited — a subsidiary of Johnson & Johnson Pvt Ltd, were recalled in 2010 globally after complaints of more-than-usual revision surgeries due to complications such as metal leaching and infections, among others.(Bloomberg/Representative image)
Updated on Nov 30, 2018 12:01 AM IST
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Hindustan Times, New Delhi | By HT Correspondent

Health ministry notifies new draft rules for online sale of drugs

According to estimates, the total e-pharma industry in India is less than 0.5% of the retail pharmacy landscape currently, but is growing at more than 100% rate.
The rules ban sale of narcotics, psychotropic drugs and tranquillizers.(AP FILE PHOTO)
The rules ban sale of narcotics, psychotropic drugs and tranquillizers.(AP FILE PHOTO)
Updated on Sep 01, 2018 09:03 PM IST
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Hindustan Times, New Delhi | By Rhythma Kaul

India bans import of rabies vaccine from Chinese manufacturer

The drug controller general of India on Tuesday banned the import of the rabies vaccine from Chinese vaccine manufacturer Changchun Changsheng Life Sciences, which was found to have faked records and ordered to stop production earlier this month by China’s drug controller.
Rabies kills an estimated 20,000 people in India each year, according to the National Rabies Control Programme.(Getty Images/Picture for representation)
Rabies kills an estimated 20,000 people in India each year, according to the National Rabies Control Programme.(Getty Images/Picture for representation)
Published on Aug 01, 2018 12:12 AM IST
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HT Correspondent, New Delhi | By Rhythma Kaul
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