• Home
  • About Us
  • Contact US !
Incitasecurity
  • Home
  • Finance
  • Gadgets
  • Education
  • Latest Internet News
  • Technology
  • Social Media
  • Blogging
  • CrossFit
  • UpComing Car
No Result
View All Result
  • Home
  • Finance
  • Gadgets
  • Education
  • Latest Internet News
  • Technology
  • Social Media
  • Blogging
  • CrossFit
  • UpComing Car
No Result
View All Result
Incitasecurity
No Result
View All Result
Home Uncategorized

Govt eases norms to test & launch drugs

onkar by onkar
November 20, 2015
in Uncategorized
0
VIEWS
Share on FacebookShare on Twitter
Govt eases norms to test & launch drugs
No More Repeat Tests, Ethics Panel Gets More Freedom
In an attempt to ease norms for testing and introduction of new medicines in the country, the government has taken steps to fast-track approvals for clinical trials as well as launch of drugs already approved in other countries. Pharmaceutical companies planning to launch new drugs already approved outside India after conducting pre-clinical or toxicological studies on animals will not be required to repeat such studies in India for importing or manufacturing them here unless some specific concerns are raised, the Drugs Controller General o India, under the health ministry, said in a latest circular issued this week.

The drug regulator has also given more freedom and responsibility to the ethics committee -that monitors clinical trials for new medicines. As per the new norms the Ethics Committee is expected to cut timelines for launch of new medicines including biologics.

Ethics committee has also been allowed to add trial sites and investigators without the need to obtain a no objection certificate from the DCGI. However, companies will have to inform any changes to the DCGI. The move comes in the wake of concerns raised by the industry which complained of repeat tests and data submissions to different authorities. Of late, the regulator has also been cautious on approving new drug trials after the Supreme Court’s directive asking the government to ensure patient safety while approving clinical trials. The recommendations to ease the norms for additional tests were made by the Investigational New Drug Committee and Drug Technical Advisory Board.

Though, the latest order by the DCGI gives more power and independence to the ethics committee, but still the final authority of approval of the application will however be with DCGI.

Apart from commercial testing and research, norms have also been eased for academic research. Making it easier to conduct clinical trials for academic and re search purposes that are non-regulatory in nature the DCGI has said its permission will not be needed provided that the trials are approved by the ethics committee. However, the regulator can raise objections if there are any concerns highlighted.

[“source-timesofindia.indiatimes”]
Tags: Govt eases normsto test & launch drugs
Previous Post

Diabetes patients are two to four times more prone to cardiovascular diseases than non-diabeticsĀ 

Next Post

Pvt labs under lens for cheating on dengue tests

Next Post
Pvt labs under lens for cheating on dengue tests

Pvt labs under lens for cheating on dengue tests

Recent Post

  • Positive Quotes about the Future
  • The Power of DB Snatch in CrossFit: Unleash Your Strength and Agility
  • CrossFit Gym Christmas Party Ideas
  • Diane: Unleashing Strength and Stamina with CrossFit’s Intense WOD
  • 1776 CrossFit Workout: A Challenging and Patriotic Fitness Regimen
  • Curtis P CrossFit: Revolutionizing Fitness Training
  • CrossFit Granada Hills: Achieve Your Fitness Goals with High-Intensity Workouts
  • 3 Bridges CrossFit: The Ultimate Fitness Experience
  • Why Do People Hate CrossFit?
  • NEPA CrossFit Client: Transforming Lives through Fitness and Community
Incitasecurity

© 2023 JNews - Premium WordPress news & magazine theme by Jegtheme.

Navigate Site

  • Home
  • About Us
  • Contact US !

Follow Us

No Result
View All Result
  • Home
  • Finance
  • Gadgets
  • Education
  • Latest Internet News
  • Technology
  • Social Media
  • Blogging
  • CrossFit
  • UpComing Car

© 2023 JNews - Premium WordPress news & magazine theme by Jegtheme.