Karnataka High Court Quashes Ministry of Health and Welfare's Notification Banning Anti-depressant Drug

AHMEDABAD, India, September 10, 2013 /PRNewswire/ --

The Karnataka High Court has quashed the union health ministry's notification dated June 16, 2013 suspending the manufacture for sale, sale and distribution of anti-depressant fixed dose combination of 'melitracen' and 'flupenthixol'.

On August 14, Justice AS Bopanna of Karnataka High Court has ordered, "The recommendation dated 11.05.2013 of the NDAC at Sl. No. 7(10) and the notification dated 18.06.2013 in No. G.S.R.377(E) issued by the Ministry of Health and Family Welfare stand quashed subject to the observations and liberty granted to the respondents in the body of the order."

While dealing with the writ petition challenging the said notification, the High Court in its order has held that, "The notification appears to be a result of the knee-jerk reaction of the Department related Parliament Standing Committee on Health and Family Welfare, though the Expert Committee was still at the stage of requiring phase-IV clinical trial. Whether such phase-IV clinical trial is to be conducted on 'Indian population' or 'special population,' the same can be done only if the drug is available and prescribed. Further the drug would be available only on the prescription of a Medical Practitioner. That apart, the Expert Committee itself has required the firm to generate data on safety, tolerability and efficacy."

Previous studies have proved the fixed dose combination's safety, efficacy and benefits. It has also been stated to be marketed in 23 countries across the world. The petitioners also contended with the popularity of the drug as anti-depressant and well as the fact that more than 63 lakhs prescriptions were issued early this year.

Deanxit, Franxit, Placida, Restfull, Exzilor, Duhap etc. are some of the brands for this combination in Indian market.

Primary Media Contact: Gaurang Darji, [email protected], 91-9925038960

Secondary Media Contact: Pritesh Trivedi, [email protected], 91-9727260309