Karnataka HC quashes health ministry's ban on anti-depressant drug

Written By Unknown on Rabu, 11 September 2013 | 22.44

AHMEDABAD: The Karnataka high court has quashed the Union Health Ministry's notification dated June 16, 2013 suspending the manufacture for sale and distribution of anti-depressant fixed dose combination of 'melitracen' and 'flupenthixol'.

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 of 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."

The petitioners also contended with the popularity of the drug as anti-depressant. More than 63 lakh prescriptions were issued early this year. Deanxit, Franxit, Placida, Restfull, Exzilor, Duhap among others are the brands for this combination in the Indian market.


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