CDSCO challenges FDC order in Supreme Court, Final hearing on the 19th Sept

New Delhi: Through a recent notification, CDSCO, Ministry of Health and Family Welfare has announced that it (Union of India) had challenged the order of the Hon'ble Delhi High Court dated 01.12.2016 and 21.12.2016 passed in the various writ petitions filed by the pharmaceutical companies regarding 344 banned FDC drugs. The Union of India had also filed transfer petition in various cases before the Hon'ble Supreme Court.

The government has also announced that In order to make the final decision on the issue, the final hearing has been scheduled on 19.09.2017 and all the firms who had filled the petition are requested to remain present to forward their submissions before the Hon'ble Supreme Court on that date. It may be noted that the matter will be heard by the Hon'ble Supreme Court even in the event of the absence of the respective parties.

Following are the list of parties whose cases have been challenged/transferred in the SC

http://www.cdsco.nic.in/writereaddata/noticedated7_9_2017.pdf

Medical Dialogues had earlier reported that India's Pharmaceuticals industry had been reeling under the Health Ministry's Gazette notification issued on March 12, 2016, banning 344 fixed dose drug combinations. Many of them popular brands of over the counter antipyretic (used to prevent or reduce fever) and anti-inflammatory drugs sold for years now.

The ban covered about 6,000 brands and major pharma houses including Pfizer Ltd., Sun Pharmaceutical Industries Ltd., Cipla Ltd., Sanofi India Ltd., Alkem Laboratories Ltd. and Wockhardt Ltd.

Read also: List of Banned Fixed Dose Composition drugs

After the ban, the companies immediately knocked on the doors of the high court, challenging the government order. In June 2016, the Delhi High Court reserved its verdict in over 450 petitions filed by drug and healthcare majors challenging the Centre's decision to ban 344 fixed dose combination (FDC) medicines.

Read also: HC reserves verdict on pleas against ban on 344 FDC drugs

In December 2016, Justice Rajiv Sahai Endlaw of the Delhi high court had quashed the notification, holding that the government had failed to consult statutory authorities like the Drug Testing Advisory Board and the Drugs Consultative Committee for the ban. The court, however, did not rule on whether FDC drugs are harmful to consumers.

Read also: Big Relief to Pharma Companies: Delhi HC quashes ban on FDC drugs

In its hearing on June 2017, the High Court denied interim relief to three pharmaceutical companies- Mankind Pharmaceuticals, Akum Drugs and Pharmaceuticals Ltd and JB Chemicals and Pharma Ltd.

Read also: Delhi High Court to hear pharma firms plea on fixed dose drugs ban