Scrip is part of Pharma Intelligence UK Limited

This site is operated by Pharma Intelligence UK Limited, a company registered in England and Wales with company number 13787459 whose registered office is 5 Howick Place, London SW1P 1WG. The Pharma Intelligence group is owned by Caerus Topco S.à r.l. and all copyright resides with the group.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By

UsernamePublicRestriction

India limits trials per investigator but finite expert pool a concern

This article was originally published in Scrip

Executive Summary

India has issued a string of new orders regarding clinical trials, including restricting the number of studies that an investigator can be involved in and an apparent tightening of the clause that permits a waiver of trials in the Indian population for new drugs already approved elsewhere.

You may also be interested in...



India Tweaks More Trial Rules But Can It Change The Narrative?

India has tweaked another set of trial rules including one that capped the number of trials per investigator as it seeks to clear the logjam of regulatory requirements that has been stifling the clinical research segment in the country. Much though could depend on actual implementation and it remains to be seen if such measures can alter the course of sector.

How Sanofi Is ‘Playing To Win’ In India, Watch Diabetes Space

Sanofi India managing director Rodolfo Hrosz talks to Scrip about the company’s refreshed India strategy including in the competitive diabetes segment, which is expected to see a flurry of new product activity. While Soliqua has hit the market, all eyes are also on Novo Nordisk’s Awiqli and Cipla’s partnered inhaled insulin in the wings.

Asia Deal Watch: Nippon Shinyaku Takes On Intractable Rare Disease With MiNA

Plus deals involving Incyte/CMS, Biocytogen/ABL, Bharat/Biofabri/Bilthoven, Dr. Reddy’s/Pharmazz, Veeda/Heads, Sosei Heptares/GSK, BioGeometry/Sanyou, Ono/Sibylla and Teijin/BioProjet

Topics

Latest Headlines
See All
UsernamePublicRestriction

Register

SC025753

Ask The Analyst

Ask the Analyst is free for subscribers.  Submit your question and one of our analysts will be in touch.

Thank you for submitting your question. We will respond to you within 2 business days. my@email.address.

All fields are required.

Please make sure all fields are completed.

Please make sure you have filled out all fields

Please make sure you have filled out all fields

Please enter a valid e-mail address

Please enter a valid Phone Number

Ask your question to our analysts

Cancel