Tag: WHO

Before a new drug, biologic or medical device is approved and authorized for market launch, it has to undergo a long and complex process involving extensive testing and clinical trials to ensure its safety and efficacy. However, for patients who have exhausted all other options, sometimes an unapproved or pre-approved or investigational drug could be the only hope. ......

The branding of a new drug by pharmaceutical companies is a crucial decision for the success of that drug in the market. However, the present regulatory regime in India does not provide any rules or guidelines for selecting a brand/ trade name for a pharmaceutical drug in India. Often, the absence of such guidelines leads to fly-by-night operators or smaller traders attempting to brand their products as closely as possible to the trademark of a reputed drug, even if they do not share characteristics or have the same active ingredient(s). This creates confusion amongst health professionals and pharmacists alike, which further has the potential to endanger the lives of patients and consumers....