Articles about Central Drugs Standard Control Organization (CDSCO)

India: Phase-2 trials of world's first one-shot pneumococcal vaccine soon

04 May 2022

India
India: Phase-2 trials of world's first one-shot pneumococcal vaccine soon

India is set to begin the phase-2 trials of the world's first one-shot pneumococcal vaccine for adults soon.

Expert panel recommends emergency use authorization for Zydus's three-dose vaccine

20 Aug 2021

India
Expert panel recommends emergency use authorization for Zydus's three-dose vaccine

The Subject Expert Committee (SEC) on COVID-19 of the Central Drugs Standard Control Organisation (CDSCO) has recommended granting an emergency use authorization (EUA) to ZyCoV-D, the three-dose COVID-19 vaccine developed by Zydus Cadila, on Friday.

J&J withdraws vaccine approval request in India, CDSCO says

02 Aug 2021

India
J&J withdraws vaccine approval request in India, CDSCO says

Johnson & Johnson has withdrawn its proposal seeking an accelerated approval of its COVID-19 vaccine, Janssen, in India, the country's drug regulator said.

Government expert panel recommends conducting trials on mixing Covishield, COVAXIN

30 Jul 2021

India
Government expert panel recommends conducting trials on mixing Covishield, COVAXIN

The Subject Expert Committee (SEC) on COVID-19 of the Central Drugs Standard Control Organization (CDSCO) has given its go-ahead for conducting clinical trials involving the mixing and matching of Covishield and COVAXIN vaccine doses.

Expert panel says no to Covovax's children trials in India

01 Jul 2021

India
Expert panel says no to Covovax's children trials in India

A Subject Expert Committee (SEC) on COVID-19 of the Central Drugs Standard Control Organization (CDSCO) has denied permission to Pune-based Serum Institute of India (SII) for conducting clinical trials of its second COVID-19 vaccine, Covovax, in children.

COVAXIN phase 2/3 trials for 2-18-year-olds recommended by expert panel

12 May 2021

India
COVAXIN phase 2/3 trials for 2-18-year-olds recommended by expert panel

In a bid to extend the country's vaccination drive to include people below 18 years, an expert panel on Tuesday recommended Hyderabad-based Bharat Biotech's COVID-19 vaccine COVAXIN for phase 2/3 clinical trials on children and adolescents aged two to 18 years.

Foreign COVID-19 vaccines: Decision on EUA applications within three days

15 Apr 2021

India
Foreign COVID-19 vaccines: Decision on EUA applications within three days

India's drug regulator will make a decision on applications seeking approval for restricted emergency use of foreign-produced vaccines within three working days from the date of submission, the government said on Thursday.

Panel recommends permission for Phase I Intranasal COVID-19 vaccine trial

20 Jan 2021

India
Panel recommends permission for Phase I Intranasal COVID-19 vaccine trial

An expert panel, Central Drugs Standard Control Organisation, (CDSCO) on Tuesday recommended granting permission for conducting the Phase I clinical trial of an intranasal vaccine against COVID-19 developed by Bharat Biotech, official sources said.

'Finally paid off,' says Adar Poonawalla after Covishield gets approval

03 Jan 2021

India
'Finally paid off,' says Adar Poonawalla after Covishield gets approval

Serum Institute of India's (SII) chief Adar Poonawalla today wished everyone a happy new year along with a great announcement.

Coronavirus vaccine: Bharat Biotech's COVAXIN gets expert panel nod

03 Jan 2021

India
Coronavirus vaccine: Bharat Biotech's COVAXIN gets expert panel nod

A government-appointed panel on Saturday recommended emergency-use authorization (EUA) to the COVID-19 vaccine developed by Hyderabad-based Bharat Biotech.

Coronavirus: India's daily death toll remained under 300 last week

01 Jan 2021

India
Coronavirus: India's daily death toll remained under 300 last week

India recorded less than 300 deaths linked to coronavirus every day between last Thursday and today, the government said.

India set to start COVID-19 vaccination; panel approves Oxford vaccine

01 Jan 2021

India
India set to start COVID-19 vaccination; panel approves Oxford vaccine

In a development that will soothe the coronavirus-battered nation, the Central Drugs Standard Control Organization (CDSCO) panel on Friday gave approval to the vaccine developed by the University of Oxford and British-pharma giant AstraZeneca.

India could approve coronavirus vaccine soon, key meeting today

01 Jan 2021

India
India could approve coronavirus vaccine soon, key meeting today

After the meeting on Wednesday to judge the emergency use authorization applications of coronavirus vaccine developers remained without a conclusion, the subject expert committee (SEC) will meet again today.

UK's approval to Oxford-AstraZeneca vaccine paves way for India

31 Dec 2020

India
UK's approval to Oxford-AstraZeneca vaccine paves way for India

The United Kingdom on Wednesday approved the vaccine developed by Oxford University and the British-Swedish pharmaceutical company AstraZeneca, giving the vaccine an endorsement that will likely be considered by Indian drug regulators.

Indian government could approve Oxford-AstraZeneca's coronavirus vaccine by next week

23 Dec 2020

India
Indian government could approve Oxford-AstraZeneca's coronavirus vaccine by next week

The coronavirus vaccine, developed by the University of Oxford and AstraZeneca, is likely to get approval from the Indian government for emergency use by next week, two people privy to the development told Reuters.

Trial will continue: Centre on SII vaccine's "adverse reaction" claims

02 Dec 2020

India
Trial will continue: Centre on SII vaccine's "adverse reaction" claims

With the coronavirus vaccine trials being conducted by Serum Institute of India (SII) being shrouded in controversy after a participant complained of an "adverse reaction," the Centre on Tuesday said there's no need to stop the process.

Coronavirus: Bharat Biotech aims to launch COVAXIN by June 2021

24 Oct 2020

India
Coronavirus: Bharat Biotech aims to launch COVAXIN by June 2021

Hyderabad-based pharmaceutical firm Bharat Biotech is expecting to launch its coronavirus vaccine candidate, COVAXIN, by June next year.

India rejects large scale trial of Russia's COVID-19 vaccine

08 Oct 2020

India
India rejects large scale trial of Russia's COVID-19 vaccine

India's drug regulator has refused to allow a large scale clinical trial of Russia's Sputnik V COVID-19 vaccine.

NewsBytes Briefing: Amazon unhappy with Future Group-Reliance deal, and more

08 Oct 2020

Technology
NewsBytes Briefing: Amazon unhappy with Future Group-Reliance deal, and more

Last night, Amazon expressed discontent over Future Group's deal to sell its businesses to Reliance Retail and issued the former a legal notice.

One in seven volunteers for Sputnik V report side effects

18 Sep 2020

Technology
One in seven volunteers for Sputnik V report side effects

Sputnik V, the COVID-19 vaccine developed and approved by Russia, has shown side effects in some trial volunteers.

Dr. Reddy's bringing coronavirus vaccine to India by 2020-end

16 Sep 2020

India
Dr. Reddy's bringing coronavirus vaccine to India by 2020-end

In a major development, Hyderabad-based pharma company Dr. Reddy's Laboratories has partnered with the Russian Direct Investment Fund (RDIF) to source their Sputnik V COVID-19 vaccine for India.

Coronavirus: How soon could Russian vaccine be available in India?

12 Aug 2020

World
Coronavirus: How soon could Russian vaccine be available in India?

On Tuesday, Russia announced what it claims is the first COVID-19 vaccine, developed by the Gamaleya Research Institute of Epidemiology and Microbiology in Moscow.

SII gets nod for Oxford COVID vaccine phase 2/3 trials

03 Aug 2020

India
SII gets nod for Oxford COVID vaccine phase 2/3 trials

The Serum Institute of India (SII) has gotten the approval to conduct phase 2 and 3 human clinical trials of the COVID-19 vaccine candidate developed by Oxford University.

Remdesivir reportedly approved for COVID-19 treatment in India

02 Jun 2020

India
Remdesivir reportedly approved for COVID-19 treatment in India

Remdesivir has been approved by India's top drug regulator for "restricted emergency use" on COVID-19-infected adults and children.

#GoodNews: Pune's Mylab approved to make COVID-19 test kits

24 Mar 2020

Technology
#GoodNews: Pune's Mylab approved to make COVID-19 test kits

In a major development, Pune-based molecular diagnostics company Mylab Discovery Solutions has been given the go-ahead to develop testing kits for the novel coronavirus disease (COVID-19).

SC seeks Center's response on faulty hip implants by J&J

06 Oct 2018

India
SC seeks Center's response on faulty hip implants by J&J

The Supreme Court yesterday sought the Center's response on a plea alleging that "faulty" and "deadly" hip implants, made by US-based pharma major Johnson & Johnson (J&J), have been fitted into the bodies of 14,525 Indian patients, termed as "medical negligence" by an expert committee.

Health Ministry to rename drug regulator CDSCO; invites suggestions

07 Sep 2018

India
Health Ministry to rename drug regulator CDSCO; invites suggestions

The Union Health Ministry has invited suggestions for renaming the country's drug regulator CDSCO in line with its expanded roles.

Government plans to make companies responsible for drug regulation violations

03 Jun 2018

India
Government plans to make companies responsible for drug regulation violations

To ensure the quality of drugs, Health Ministry is planning to make companies, which market and promote medicines, responsible for any violation of drug regulations like manufacturers.

Health Ministry bans sale of 14 steroid-creams sans doctor's prescription

08 Apr 2018

India
Health Ministry bans sale of 14 steroid-creams sans doctor's prescription

Health Ministry has banned over-the-counter (OTC) sale of 14 steroid-based creams and ointments by bringing them under the Schedule H of the Drugs and Cosmetics Rules, 1945.

Bengaluru Lake Frothing: Centre seeks CPCB's response over phosphorus pollution

19 Sep 2017

Bengaluru
Bengaluru Lake Frothing: Centre seeks CPCB's response over phosphorus pollution

Bengaluru's Bellandur Lake frothing has turned the Centre's attention to high phosphorus content in laundry detergents, bars, and industrial cleaners.

India reviewing US FDA ban on anti-bacterial soaps

13 Sep 2016

Business
India reviewing US FDA ban on anti-bacterial soaps

Sources have stated that India's Central Drug Standard Control Organization (CDSCO) is in the process of reviewing the US FDA's ban on certain compounds used in anti-bacterial soaps.

FDA gives the final verdict on antibacterial soaps

04 Sep 2016

Business
FDA gives the final verdict on antibacterial soaps

The US Food and Drug Administration declared a final command meant to protect the people from the chemicals in antibacterial soaps.