Delhi High Court verdict on Fixed Dose Combination Drugs

Delhi High Court has given a major relief to the pharmaceutical sector by lifting a ban on more than 300 fixed dose combination drugs. 344 drugs had been banned due to potential health risks and an apparent lack of therapeutic justification.

Fixed Dose Combination Drugs is a mixture of more than two drugs in a fixed ratio. The verdict is based on the fact that the government did not consult statutory authorities like Drug Testing Advisory Board and the Drugs Consultative Committee before imposing the ban. There was no decision as to risk of the drugs to the consumers but was purely on the fact that proper procedure was not followed by the government. Furthermore, Central Drugs Standard Control Organisation was not a statutory body.

The ban was basically on the popular brands like Corex, Phensedyl, Vicks Action 500 Extra. Ban had an effect on over Rs. 3000 Crores on the Fixed Drug Market of India. The verdict is likely to be challenged in the Supreme Court.