India releases list of drugs approved without local trials
This article was originally published in Scrip
Executive Summary
Faced with a barrage of questions and allegations of regulatory lapses in approving drugs for launch in the country, India's drugs regulator appears to have launched a transparency drive, putting out a host of approval details in public domain that includes a list of drugs recommended for approval without trials in the country.
You may also be interested in...
Expert Panel Affirms ‘Continued Marketing’ Of Ambrisentan, Everolimus In India
Years after a scathing Indian parliamentary report flagged concerns around regulatory lapses for drug approvals, an expert panel has endorsed the continued marketing of ambrisentan and everolimus in the country. But dronedarone, also featured in the report, is no longer sold by Sanofi in India.
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