Remove Interim Stay asked for on FDC drugs: Government to HC

The central government on Monday asked the Delhi High Court to vacate the interim stay on ban on some fixed dose combinations (FDC) medicines sold by pharma majors saying they "endanger patient safety".

Defending its decision to ban 344 FDC medicines through its March 10 notification, the government in an affidavit filed before the high court said: "The interim order granted to the Petitioner (pharma companies) would be against the public interest and endanger patient safety."

"Their objective is only to gain profits and the petition has been filed only to gain time and obstruct the legitimate functions of the government of India," the affidavit read.

Meanwhile, the Delhi high court on Monday deferred, to March 28, the hearing on pleas of pharma companies challenging the ban which means some of popular durgs such as Pfizer's Corex cough syrup, Reckitt's D'Cold and P&G's Vicks Action 500 extra will be available to consumer till next Monday.

Justice R.S. Endlaw also directed the government to provide the experts committee report, which recommended the ban, to all the pharma companies that are in court against the ban.

The high court had last week stayed operation of the ban on some FDC drugs of around 30 pharma companies including Cipla, Procter and Gamble (P&G), Pfizer, Glenmark, Glaxo Smithkline, Abbott Healthcare, Reckitt Benckiser, Piramal, etc.

Justice Ednlaw had asked the government not to take coercive steps against these companies till March 21.

In its affidavit, the government said FDC medicines are "new drugs" and require fresh licence from Drugs Controller General of India (DCGI). It said licences for FDCs were obtained from state authorities without seeking DCGI approval between 1988 to 2012.

A report of Parliamentary Standing Committee on health had said unauthorised FDCs that posed a risk to people need to be withdrawn immediately, the government said.