Fix it or exit: India gives Deanxit and generics 6-month deadline

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.

Deanxit has been under the spotlight in India for considerable time now, more so after a Parliamentary Committee report last year had highlighted that the Danish Medicine Agency had not...