The drug is used to treat neurological and psychiatric disorders
The Centre on Thursday told the Karnataka High Court that it has suspended the manufacture, sale and distribution of the fixed-dose combination (FDC) of Flupenthixol plus Melitracen with effect from June 13. This combination is used to treat neurological and psychiatric disorders.
The statement was made during the hearing of a plea filed by Lundbeck India Pvt. Ltd., Bangalore, which manufactures Deanxit tablets, a FDC of Flupenthixol plus Melitracen.
In its petition, the company had questioned the recommendation for suspension of this drug made on May 11, 2013 by the New Drug Advisory Committee (NDAC) to the Ministry of Health and Family Affairs. The company had claimed that the NDAC had not given the basis of apprehensions raised by it on the drug. The NDAC had said, “Rationality and essentiality of continued marketing of this FDC is questionable” while pointing out that “Melitracen is reported to be not efficacious as a single agent in depression, and Flupenthixol’s use is associated with potentially serious neurological side effects.” These aspects are “more relevant today in view of the fact that various other more efficacious, safety and relatively inexpensive alternative anti-depressants and anti-anxiety drugs are already available,” the NDAC said.
FDC of Flupenthixol, Melitracen is used to treat neurological and psychiatric disorders