Fix it or exit: India gives Deanxit and generics 6-month deadline
This article was originally published in Scrip
Executive Summary
The Drugs Controller General of India (DCGI) has set a six month deadline for manufacturers of the controversial fixed dose combination (FDC) of flupenthixol and melitracen (Lundbeck’s Deanxit) to establish the safety and efficacy of their products in India, with the threat of prohibition if they fail.