Pharmachronicles

Top Menu

  • Home
  • Our Blog
  • Contact Us

Main Menu

  • Home Page
  • STUDENTS ZONE
  • Syllabus
  • Seminars & conferences
  • Online classes
    • Register
Sign in / Join

Login

Welcome! Login in to your account
Lost your password?

Lost Password

Back to login
  • Home
  • Our Blog
  • Contact Us

Pharmachronicles

Header Banner

Pharmachronicles

  • Home Page
  • STUDENTS ZONE
  • Syllabus
  • Seminars & conferences
  • Online classes
    • Register
  • UGC-Cancelled-List of journals

  • NAAC stops accepting applications for accreditation from pharmacy colleges

  • Pursuing MPhil/PhD while working as a teacher will effect experience: UGC

  • Public notice by government of india ministry of health and family welfare

Educational news
Home›Educational news›A new rule for global trails by Indian drug regulator

A new rule for global trails by Indian drug regulator

By admin
October 16, 2017
598
0
Share:

To ensure the efficacy of medicines marketed in India. Drug regulator has made an new rule to include in the clinical trails if they want to market in India which has been developed in other countries.

The decision was taken in a recent technical committee meeting, headed by director general of health services Jagdish Prasad. The committee, which was formed following directions from the Supreme Court, has a mandate to supervise clinical trials on new chemical entities.
The committee also decided that if proposal of such global clinical trials are already approved in ICH countries such as the US, Europe and Japan, then it will be reviewed on priority by the Indian drug regulator.
The ICH or International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use is a project that brings together the regulatory authorities of Europe, Japan and the United States and experts from the pharmaceutical industry in the three regions to discuss scientific and technical aspects of pharmaceutical product registration. Clinical trial proposals approved by an ICH country will also be considered for approval by the Drugs Controller General of India (DCGI) without referring to subject expert committee, unless there is some specific reasons which should be recorded in writing. “The decision has been taken in public interest keeping in mind the safety of Indian patients. It is important that drugs which are sold in the country are being tested on Indian subjects prior to their launch,” DCGI G N Singh said.Great move. I would call it an innovative idea to ban the products that do unethical practice. US pharma will be badly hit.V Kumar. The move is expected to benefit clinical research organisations and hospitals operating in India. These organisations along with various hospitals conduct clinical trials or testing of drugs on human beings on behalf of pharmaceutical companies, mainly multinational drug makers.

The clinical trial industry had suffered losses in India after certain unethical practices by a few organisations and hospitals came to light in 2011. This was followed by stringent regulatory norms and directions by the apex court itself for strict monitoring of trials.
SOURCE: https://timesofindia.indiatimes.com/india/to-market-new-drugs-in-india-global-trials-must-include-indians/articleshow/61029119.cms?from=mdr
Tagsclinical trailsDCGIICH
Previous Article

National ethical guidelines for biomedical research involving ...

Next Article

Membrane vacuum cleaner as a new target ...

0
Shares
  • 0
  • +
  • 0
  • 0
  • 0
  • 0

admin

Related articles More from author

  • Educational news

    Positive vibes for Doctor of pharmacy graduates

    October 16, 2018
    By Ramoju kishore kumar
  • Educational news

    Facing criticism, govt to go slow on replacing UGC with a new body

    October 31, 2018
    By admin
  • Educational newsMedical & HealthMedical research

    First ever 3D printing heart by scientist using human tissue

    April 18, 2019
    By Sriram Nagarajan
  • Educational newsPublications

    UGC-CARE List Group A ( UGC approved journals)

    October 2, 2019
    By admin
  • Educational news

    National ethical guidelines for biomedical research involving children

    October 14, 2017
    By admin
  • BLOGSEducational news

    Promotion to next higher class under Pharm.D Regulations 2008.

    September 16, 2017
    By admin

Leave a reply Cancel reply

You may interested

  • Educational news

    Will CRISPR a best way to fight against antibiotic resistant bacteria

  • PublicationsUncategorized

    List of UGC Approved journals 2020

  • Uncategorized

    Tips to improve communication skills

  • LATEST REVIEWS

  • TOP REVIEWS

  • Pharmacists are not eligible for certificate program of community health

    0
  • A New Class of Antimicrobials Has Just Been Found in Human Breast Milk Fresh super ...

    0

Timeline

  • May 24, 2021

    LIST OF SCOPUS INDEXED JOURNALS APRIL 2021

  • October 20, 2020

    List of UGC Approved journals 2020

  • June 8, 2020

    Brain Tumor Day -8th June – Endoscopic surgery: An innovative approach to treat brain tumour

  • June 4, 2020

    UGC-Cancelled-List of journals

  • June 1, 2020

    Saroj Group Of Hospitals restarts its complete operations – see major footfall in OPD consultation

Latest Comments

  • Sowmya V
    on
    December 13, 2019
    Nice keep it up

    Blood Test Might Predict Pregnancy Due Date and Preterm Birth

Find us on Facebook

Follow Us on Instagram

logo

Dui viverra Faucibus aliquet quis phasellus accumsan. Donec et facilisis sociosqu sed tortor elit eu aliquid turpis ridiculus.

Fly, shall, have greater fifth spirit midst under from stars thing is, had creepeth multiply kind. Man may they’re meat years have third bring replenish air two light deep fill.

About us

  • Dr.N.Sriram, Founder CEO, Pharmachronicles, HITS college of Pharmacy, Ghatkesar, Hyderabad, India
  • 9704361947
  • pharmachronicles@gmail.com
  • Recent

  • Popular

  • Comments

  • LIST OF SCOPUS INDEXED JOURNALS APRIL 2021

    By admin
    May 24, 2021
  • List of UGC Approved journals 2020

    By admin
    October 20, 2020
  • Brain Tumor Day -8th June – Endoscopic surgery: An innovative approach to treat brain tumour

    By Sriram Nagarajan
    June 8, 2020
  • UGC-Cancelled-List of journals

    By admin
    June 4, 2020
  • Blood Test Might Predict Pregnancy Due Date and Preterm Birth

    By Sundari srinidhi
    December 12, 2019
  • FDA is carefully evaluating prescription opioid medications approved to treat cough in children

    By admin
    July 16, 2015
  • Record Numbers of FDA‑Approved Drugs: Recent Trends

    By admin
    July 16, 2015
  • There make for Sixth that multiply blessed two divide creeping

    By admin
    July 16, 2015
  • Sowmya V
    on
    December 13, 2019

    Blood Test Might Predict Pregnancy Due Date and Preterm Birth

    Nice keep it up

Photostream

    Follow us

    • Contact
    • STUDENTS ZONE
    • About Us
    © Copyright Pharmachronicles. All rights reserved.