The Central Drugs Standard Control Organisation (CDSCO) is examining the safety and efficacy of the anti-depressant drug combination of flupentixol and melitracen, amid indications that India will also ban this drug which already got banned in Denmark, the country of its origin.

The issue of safety and efficacy of the FDC, sold under the trade names of Deanxit and Anxidreg by the inventor company, was being examined by the CDSCO in consultation with the experts, pointed out DCGI Dr G N Singh, asking the concerned manufacturers of this FDC to establish safety and efficacy within a period of six months.

If the manufacturers fail to establish the safety and efficacy within six months, the drug will be considered for being prohibited for manufacture and marketing in the country, the DCGI said in a notice sent to the State Drug Controllers.

“The FDC of flupenthixol+melitracen tablets was approved by this the authorities on October 28, 1998 for manufacturing and marketing in the country. However, concerns have been raised on the safety and efficacy of the drug. Concerns have been also raised that there must be some very good reasons for Danish Medicine Agency (Denmark) not to approve a domestically developed drug where an antidepressant drug would perhaps be in greater demand as compared to India,” the notice said.

“Curiously, these tablets are allowed to be produced and exported, but not allowed to be used in Denmark. The drug is not marketed in major developed countries such as United States, Britain, Ireland, Canada, Japan and Australia,” the DCGI pointed out.

The FDC was originally manufactured by Lundbeck of Denmark.