• 9964432222
  • Mail Us
  • Appointment
  • Locate Us
  • Chat Now
  • Courses
  • Login
  • Register
Manifest IAS
JournalsOfIndia
Advertisement
  • Home
  • SNIPPETSfor Prelims
  • ARTICLESfor Mains
  • BROWSEBY SOURCE
  • DOWNLOADS
No Result
View All Result
  • Home
  • SNIPPETSfor Prelims
  • ARTICLESfor Mains
  • BROWSEBY SOURCE
  • DOWNLOADS
No Result
View All Result
JournalsOfIndia
No Result
View All Result
Home Science & Tech

Covishield shot

January 2, 2021
in Science & Tech, Law & Policy
Reading Time: 3 mins read
0
Covishield shot
277
VIEWS
Share on WhatsAppShare on TelegramShare on Facebook
image_pdfMake PDF

In news

A panel under  India’s  top drug regulator clears Covidshield shot

Key highlights

  • The Subject Expert Committee (SEC) recommended that the Indian version of the Covid-19 vaccine developed by the University of Oxford and AstraZeneca, should be approved with certain conditions. Outside India it is known as AZD1222
  • AZD1222, on which Covishield is based, received the approval of the UK MHRA for “emergency” use on people aged 18 years and above
  • The current  recommendation is significant, as it paves the way for India to get its first vaccine against the novel coronavirus
  • This recommendation has come two days after regulators in the United Kingdom approved the use of the Oxford-AstraZeneca vaccine among the British public 
  • Meanwhile,  an expert body in India was considering an application for clearance for Covishield, which is being tested and manufactured under licence by Serum Institute of India (SII). 
  • The Subject Expert Committee had on Wednesday sought additional information from the Pune-headquartered firm, including a fact sheet of information about the vaccine for the general public.
  • Now, Subject Expert Committee (SEC) recommended that the Central Drugs Standard Control Organisation (CDSCO) should grant approval to Covishield despite the candidate not having completed phase 2/3 clinical trials in India
  • The panel has recommended the approval of two full doses of the vaccine that should be administered around 4-6 weeks apart
  • If the Drug Controller General of India (DCGI) greenlights this, SII will be able to supply Covishield to the government for mass vaccination before it completes these trials.

What is Emergency Use Approval/Authorization (EUA)of a Vaccine?

  • It is a mechanism to facilitate the availability and use of medical countermeasures, including vaccines, during public health emergencies, such as the current COVID-19 pandemic
  • In India, such authorization is given by the Central Drugs Standard Control Organisation (CDSCO).

Regulatory provisions for the approval of vaccines in India: 

  • In India, Clinical trials of new drugs and vaccines, and their approvals, are governed by the New Drugs and Clinical Trials Rules(NDCT), 2019.
  • But, these Rules do not use the term “emergency use authorization”. 
  • This term is used mainly by the regulatory agencies in the US and some other countries and has become popular in the context of the current epidemic. 
  • However, that does not mean that the Indian regulatory system does not have provisions for “special situations” like the current one.
  • The NDCT rules 2019 provide for an “accelerated approval process” in several situations that would include the one like the current pandemic.
  • In such situations, there is a provision for granting approval to a drug that is still in clinical trials, “provided there is a prima facie case of the product being of meaningful therapeutic benefit”.
  • Provisions of these rules says that “Accelerated approval may also be granted to a new drug if it is intended for the treatment of a serious, or life-threatening condition, or disease of special relevance to the country, and addresses unmet medical needs,”. The definition of new drug in the 2019 Rules includes a vaccine.
  • Further,the new rules make it clear that a new drug, or a vaccine, can be considered for approval if “remarkable” effectiveness is reported even from phase-II trials.
  • Provided, the remarkable efficacy is observed with a defined dose in the phase-II clinical trials of the investigational new drug for the unmet medical needs of serious and life threatening disease in the country, it may be considered for grant of marketing approval by the central licensing authority based on phase-II clinical trial data. 
  • In such cases, additional post licensure studies may be required to be conducted after approval to generate the data on larger population
  • Therefore, the approval granted to drugs or vaccines that are still in clinical trials is temporary, and valid only for one year. 
image_pdfMake PDF
Source: The Indian Express
Tags: Prelims

Related Posts

Nipah virus

Nipah virus

May 21, 2022
Respiratory Syncytial Virus (RSV)

Respiratory Syncytial Virus (RSV)

May 21, 2022
Systems Reform Endeavors for Transformed Health Achievement in Gujarat (SRESTHA-G project)

Systems Reform Endeavors for Transformed Health Achievement in Gujarat (SRESTHA-G project)

May 20, 2022
Article 142 of the Constitution

Article 142 of the Constitution

May 20, 2022
‘Gifted seat’ norms by AICTE

‘Gifted seat’ norms by AICTE

May 20, 2022
National Policy on Biofuels, 2018

National Policy on Biofuels, 2018

May 19, 2022
Sudden Infant Death Syndrome

Sudden Infant Death Syndrome

May 19, 2022
The first Global Report on Assistive Technology (GReAT)

The first Global Report on Assistive Technology (GReAT)

May 18, 2022
What is the Places of Worship Act?

What is the Places of Worship Act?

May 18, 2022
First ‘smoke free’ state in India

First ‘smoke free’ state in India

May 17, 2022
Please login to join discussion

Our Offline Classroom Student

PRELIMS 2021 POLITY QUESTIONS ANALYSED

https://youtu.be/5q8hBcRGhAs

PRELIMS 2021 HISTORY QUESTIONS ANALYSED

https://youtu.be/v0SIZ7SUybg

CONGRATULATIONS TO 2020 TOPPERS !!!

Rank 25 Vaibhav Rawat 

Rank 218 Kankanala Rahul Reddy
Rank 385 Sagar A Wadi
Rank 504 Malashree MV
Rank 573 Shridevi B V
Rank 707 Mamatha G

COURSES OFFERED

PRELIMS SURESHOTS

May 2022
MTWTFSS
 1
2345678
9101112131415
16171819202122
23242526272829
3031 
« Apr    

Browse by Category

  • Agriculture
  • Disaster Management
  • Economy
  • Environment
  • Ethics
  • Foreign Affairs
  • Geography
  • Governance
  • History
  • Law & Policy
  • Opinion
  • People in News
  • Places in News
  • Science & Tech
  • Security
  • Society
  • Sports
  • Uncategorized

Browse by Tags

AIR BBC Business Standard CNN Deccan Herald DownToEarth Down to Earth DTE Economic Times ET GS-1 GS-2 GS-3 GS-4 Hindustan Times IE India & the world Indian express India today Indiatoday Kurukshetra LiveMint Mains News News Paper Newspaper PIB PIB & The Hindu pre Prelims PRS India RSTV Science Reporter Survey The Hindu The Hindustan Times The India Express The Indian Express The New Indian Express Times of India TOI TOPPERS UNDP website Wikipedia Yojana
JournalsOfIndia

Our vision is to orient the readers to grasp the facts objectively and analyse critically. In the rush of reaching first to the readers, the websites miss the balanced opinion, which is the need of the hour. We aim to reach the readers with more crispness, preciseness and relevance. We bring the articles in UPSC way for the civil services aspirants and the Wisest Way for general readers.

Categories

  • Agriculture
  • Disaster Management
  • Economy
  • Environment
  • Ethics
  • Foreign Affairs
  • Geography
  • Governance
  • History
  • Law & Policy
  • Opinion
  • People in News
  • Places in News
  • Science & Tech
  • Security
  • Society
  • Sports
  • Uncategorized

Browse by Tag

AIR BBC Business Standard CNN Deccan Herald DownToEarth Down to Earth DTE Economic Times ET GS-1 GS-2 GS-3 GS-4 Hindustan Times IE India & the world Indian express India today Indiatoday Kurukshetra LiveMint Mains News News Paper Newspaper PIB PIB & The Hindu pre Prelims PRS India RSTV Science Reporter Survey The Hindu The Hindustan Times The India Express The Indian Express The New Indian Express Times of India TOI TOPPERS UNDP website Wikipedia Yojana

Newsletter

The most important UPSC news and events of the day.

Get Journals daily newsletter on your inbox.

© 2020 JournalsOfIndia - A free initiative by Manifest Team.

  • Login
  • Sign Up
  • Home
  • SNIPPETS
  • ARTICLES
  • BROWSE
  • DOWNLOADS
No Result
View All Result

© 2020 JournalsOfIndia - A free initiative by Manifest Team.

Welcome Back!

Login to your account below

Forgotten Password? Sign Up

Create New Account!

Fill the forms bellow to register

All fields are required. Log In

Retrieve your password

Please enter your username or email address to reset your password.

Log In