Notification banning 344 FDCs quashed by High Court

In a relief to pharma companies, the Delhi High Court on Thursday quashed the Centre’s notifications to ban 344 fixed dose combination (FDC) popular medicines such as Corex, Saridon, Benadryl, D’Cold Total and Vicks Action 500.

Justice R S Endlaw, allowing the 454 pleas filed by the pharma companies, quashed the government notifications issued on March 10, holding they was issued without following the procedure statutorily prescribed.

It also said that central government, though acting in public interest, seems to have banned the FDC drugs in a “haphazard manner”.

“All 344 notifications dated March, 10 2016 purportedly in exercise of power under section 26A of the Drugs Act are found to have been issued without following the procedure statutorily prescribed to be followed prior to issuance thereof and resultantly it is held that the notifications are not based on satisfaction of the Central Government prescribed to be on the advice of and in consultation with the DTAB (Drug Testing Advisory Board) and DCC (Drug Consultative Committee). 

“Resultantly the said notifications are quashed,” said the court.

Companies like Pfizer, Glenmark, Procter and Gamble, Reckitt Benckiser, Cipla and others had moved the court against the government decision, and the court had granted a stay on the notification.

The government had told the court that FDC medicines sold by pharma majors “endanger patient safety”.

FDCs are combination of two or more drugs in a single pill and are widely used to improve patient compliance as it is easier to get someone to take one drug than several.

The government had banned the drugs on the ground that they involve risk to humans and hence needed to be withdrawn immediately and contended that safer alternatives were available.

The pharma companies had argued that the ban order was passed without considering clinical data and had termed the government’s claim as absurd. The court in its judgement also said: “I have already held above that this Court in exercise of power of judicial review cannot adjudicate whether these FDCs are risky to the consumers or lack therapeutic value or therapeutic justification.”