HC quashes ban on 344 drugs

The drugs included known brands like Corex, Vicks

New Delhi: The Delhi High Court on Thursday set aside the Centre’s ban on 344 fixed dose combination (FDC) medicines that it had said lacked therapeutic efficacy. The decision came after six months of hearing more than 400 petitions filed by drugmakers against it. The 344 drugs also included wellknown brands like Corex cough syrup.

The Delhi High Court on Thursday set aside the Centre’s ban on 344 fixed dose combination (FDC) medicines that it had said lacked therapeutic efficacy. The decision came after six months of hearing more than 400 petitions filed by drugmakers against it.

The 344 drugs also included well-known brands like Corex cough syrup, Vicks Action 500 extra and several antidiabetes medications.

Justice Rajiv Sahai Endlaw allowed 454 petitions moved by various pharma and healthcare majors, like Pfizer, Glenmark, Procter and Gamble and Cipla, challenging the government’s March 10 notification banning the FDCs, saying the decision was taken by the Centre without following procedure in the Drugs and Cosmetics Act.

The court had from March 14 onwards stayed the operation of the Centre’s decision with regard to medicines of several pharma majors. The court on Thursday said that proceedings till issuance of the notification of March 10, 2016, “do not suggest there was any grave urgency.”

It also said that the power under Section 26A (power to prohibit manufacture of drugs and cosmetics in public interest) of Drugs and Cosmetics Act cannot be exercised in public interest except when a drug poses a risk to consumers.

The drug companies had contended that the Centre has not properly implemented the powers under Section 26A, under which the ban was ordered.

They had also argued that the ban order was passed without considering clinical data and had termed as “absurd” the government’s claim that it took the decision to ban FDCs on the ground that safer alternatives were available.