After concerns have been raised on the safety and efficacy of a widely known anti-depressant — deanxit (Flupenthixol+Melitracen), the Drug Controller General of India (DCGI) has asked the manufacturers of this fixed dose combination (FDC) to establish the efficacy of the drug within the period of six months failing which the drug would be prohibited for manufacturing and marketing in the country.
While the drug was approved in the country in 1998, the FDC of Flupenthixol+Melitracen is not marketed in major developed countries like United States, Britain, Ireland, Canada, Japan and Australia. The drug came under scanner recently after it was found that even Denmark did not approve of this domestically developed drug. In fact, experts say that the anti depressant drug would perhaps be in greater demand as compared to India.
“Curiously, FDC of these tablets is allowed to be produced and exported but not allowed to be used in Denmark,” said the DCGI letter to the state drug controllers.
Even as the safety and efficacy of the FDC is under examination in consultation with the experts committee. In view of the concerns raised on the drug, the DCGI has instructed the manufacturers of the drug to establish the safety and efficacy of the FDC within six months, failing which the drug will be considered to be prohibited for manufacturing and marketing in the country.
The Drug Controller General of India has asked the state drug controllers to ask the manufacturers to provide the efficacy report related to the drug to the DCGI by June this year.
Earlier, last year the report by the parliamentary standing committee on health and family welfare also raised the concerns regarding the same drug. The committee observed that the drug controlling agency violated the rule by approving the FDC for clinical trials without considering the drugs’ regulatory status in their respective country of origin. The committee had also recommended an inquiry into the unlawful approval of the drug in the country.