Asia Raises Bar for New Drugs, Manufacturers With Tougher CMC Reviews, GMP Inspections: A Look At India (Part 6)
This article was originally published in PharmAsia News
Executive Summary
Like most other Asian nations, India will not consider an application for marketing approval of a drug unless it comes with a certificate of pharmaceutical product showing that a major market has already approved the product, said Mark Rosolowsky, executive director, GRS-CMC, Bristol-Myers Squibb