The Union health ministry has banned the manufacture and sale of the controversial fixed dose combination (FDC) of Flupenthixol and Melitracen for human use with immediate effect in the country. The combination of Flupenthixol and Melitracen is an anti-depressant drug, sold as deanxit in India.
Now, 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 hereby prohibits the manufacture for sale, sale and distribution of the following drug with immediate effect “Fixed dose combination of Flupenthixol and Melitracen for human use”, the ministry in its notification, G.S.R. 498(E), said.
This is the second time the government is banning this drug. Earlier on June 18 last year, the health ministry had banned ‘deanxit' in the country along with two other drugs--anti-diabetic drug pioglitazone and pain-killer drug analgin.
But immediately after the ministry's notification, two writ petitions were filed in the Karnataka High Court by Bengaluru-based Lundbeck India and New Delhi-based Mankind Pharma. The petitioners contended that the studies made on the drug has proved its safety, efficacy and benefits.
However, the government contended before the court that melitracen is reported as not efficacious as a single agent in depression and use of flupenthixol is associated with potentially serious neurological side effects. Besides, the government contended that the combination drug is not permitted in USA, UK, Denmark, Canada, Japan and Australia.
After hearing both the parties, the court in its order dated August 14, 2013, quashed the ministry's notification, and remanded the matter back to reconsider afresh by the government and take a decision one way or other in accordance with the law.
The ministry then asked the Drugs Technical Advisory Board (DTAB, a statutory body under the Drugs and Cosmetics Act, 1940, to examine the issue of suspension of manufacture and sale of the drug. After detailed examination in its 65th meeting on 25th November, 2013, the DTAB, highest authority in the union health ministry on technical matters, recommended that the use of the drug should be discontinued in the country.
On the recommendation of the DTAB, the health ministry has once again banned the controversial drug as “the 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'.