Indian court sets 3-parameter format for trial applicants
This article was originally published in Scrip
Executive Summary
India's Supreme Court has ordered the specific inclusion of three parameters when seeking information from applicants for trials in India. They are the assessment of risk versus benefit to the patients, innovation vis-à-vis existing therapeutic option, and unmet medical need in the country.
You may also be interested in...
Indian Clinical Research Sector: Hope And Despair Amid Shutdowns
India's clinical research segment has had a rough time of late. Uncertainties, evolving regulations and compliance deviations have hurt the sector that is now scarred with firms downing the shutter, mistrust and constant speculation. Scrip spoke to a number of CROs who appear to have weathered the storm, but it seems the industry may not be out of the woods just yet.
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