344 Fixed-Dose Combinations: DCGI constitutes a sub-committee to relook the matter

New Delhi: Through a recent notification, Directorate General of Health Services has constituted a subcommittee for having a relook in the case of banned 344 Fixed-Dose Combinations (FDCs).

This comes in the follow-up of the Supreme Court order that referred the matter of FDCs to DTAB for re-examination.

Read also: SC refers 344 fixed-dose combination medicines to Drug Advisory Board for Re-examination

The sub-committee was constituted under the Chairmanship of Dr Nilima Kshirsagar, The Chair in Clinical Pharmacology, ICMR, Mumbai, to examine the banned 344 FDCs + 5 FDCs.

The notice states that in the 78th meeting of the Drugs Technical Advisory Board (DTAB) held on 12th February 2018 under the Chairmanship of the Director General of Health Services deliberated the directions of the Hon’ble Supreme Court of India dated 15.12.2017 in regard to the notifications issued by the Govt, of India prohibiting 344 FDCs +05 FDCs vide S.O. No. 705(E) to 1048 (E) dated 10.03.2016 and S.O. No. 1851(E) to 1855(E) dated 08.06.2017 respectively.

The Hon’ble Supreme Court in its order dated 15.12.2017 had directed that these cases should go to the DTAB and/or its sub-committee formed by the DTAB for the purpose of having a relook into these cases.

The 344 FDCs were banned on the recommendation of the Kokate committee, which was set up to study their safety and efficacy. An FDC drug contains two or more active ingredients in a fixed dosage ratio. In its report submitted on 20 January 2015, the expert committee under Chandrakant Kokate, vice-chancellor of KLE University, Karnataka, had deemed these FDCs irrational, and said they posed health risks.

The committee will not only hear the petitioners/appellants before but they also hear submissions from all India Drugs Action Network. The DTAB/sub-committee set up for the purpose will deliberate on the parameters set out in section 26A of the Drugs and Cosmetics Act.

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

Some of the well-known medicines on which the ban on sale was lifted by Delhi High Court include Pfizer’s Corex cough syrup, Glaxo’s Piriton expectorant and Crocin Cold, P&G’s Vicks Action 500 extra, Reckitt’s DCold, Piramal’s Saridon, Glenmark’s Ascoril and Alex cough syrups, Abbott’s Phensedyl cough syrup and Alembic’s Glycodin cough syrup.

Below is the attachment of notification.

http://www.cdsco.nic.in/writereaddata/Constitution DTAB held on 12_02_2018.pdf