(24th July, 2014); Health Ministry prohibits the manufacture, sale and distribution of fixed dose combination (FDC) of Flupenthixol and Melitracen for human use on recommendations of the Drugs Technical Advisory Board (DTAB).
FDC of Flupenthixol with melitracen was approved on 28.10.1998 for the treatment of psychogenic depression, depressive neuroses, marked depression and psychosomatic affection accompanied by anxiety and apathy. The FDC was prohibited in view of the fact that the drug was not permitted to be marketed in the country origin i.e Denmark as well as countries like USA, Britain, Canada, European Union and Japan.
The FDC of Flupenthixol & Melitracen was also examined by New Drug Advisory Committee (Neurology & Psychiatry) and the Committee after deliberation felt that rationality and essentiality of continued marketing of this FDC is questionable as Melitracen is reported to be not efficacious as a single agent in depression. Flupenthixol use is associated with potentially serious neurologic side effects. Subsequent to the ban of the FDC.
And Central Government suspended the manufacture for sale, sale and distribution of fixed dose combination of Flupenthixol and Melitracen for human use on dated 18th June, 2013. In the meanwhile the manufacturers of the product i.e. M/s Lundbeck as well as M/s Mankind Pharma approached the honourable High Court of Karnataka for stay of the notification.
And the honourable High Court of Karnataka vide order dated 14th Aug 2013 quashed the notification and remanded the matter back to reconsider afresh and take a decision one way or other in accordance with the Law.
Afterwards, DTAB has examined the issue of said drugs in its 65th meeting on 25th November, 2013 and recommended that the use of the drug should be discontinued from the country.
Central Government was satisfied that the use of the drug ‘fixed dose combination of Flupenthixol and Melitracen’ for human use was likely to involve risk to human beings and whereas safer alternatives to the said drug are available. And therefore on the basis of the recommendations of the Drugs Technical Advisory Board and in exercise of the powers conferred by Section 26A of the Drugs and Cosmetic Act, 1940 (23 of 1940), the Central Government prohibits the manufacture for sale, sale and distribution of the “Fixed dose combination of Flupenthixol and Melitracen for human use” with immediate effect.
