FDC Ban: Drugs Technical Advisory Board to review efficacy, safety, justification of drugs

New Delhi: The Drugs Technical Advisory Board (DTAB) is expected to set up expert committees to review the safety, efficacy and therapeutic justification of 344 FDCs banned drugs before suggesting any action in its meeting on 22 January 2018.

This comes in the follow-up of the Supreme Court order that referred the matter of FDCs to DTAB for re-examination. The medical Dialogues team had earlier reported that court had also set aside the ban on the drugs that were banned and manufactured before 21 September 1988 as these cases were never meant to be referred to the Kokate Committee. The court said that DTAB will decide whether the manufacture and sale of these drugs should be regulated, restricted or prohibited, and submit its report and recommendations to the government within six months.

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

During an interview DTAB chairman, Jagdish Prasad told Mint, “Many of these drugs should not have been banned in the first place. We will constitute expert committees comprising clinical experts to review their safety before we decide on the final action.”

“We will constitute committees, which will consult all the stakeholders concerned, before taking a final call and submit the report to the government for action within six months. Patients’ safety is paramount to us and we will do our best to make sure that the safety is not compromised. Simultaneously, we have to ensure industry should not get severely impacted,” Prasad told the Mint.

A petition was filed against the December 2016 verdict of the Delhi high court quashing its 10 March 2016 notification banning 344 FDC drugs, citing health risks and lack of therapeutic justification on January 2017 by the government.

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

On 31 March, the apex court had stayed proceedings in all high courts against the ban on 344 FDC drugs.

The ban covered 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.

It was imposed following a report by a six-member government-appointed committee headed by Chandrakant Kokate, vice-chancellor of KLE University, Karnataka which had submitted its report on 20 January 2015, had termed 344 FDCs irrational, saying that they pose health risks.

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.

Speaking with Mint, S. Srinivasan, co-convenor of All India Drugs Action Network said, “The 344 FDCs account for only about 5% of the value of total FDCs in India, approximately half of which are considered to be irrational. The government should proactively take advantage of the space afforded by this order to weed out other irrational FDCs in the interest of patient safety. They should implement the order and get it done within six months.”

An FDC drug contains two or more active ingredients in a fixed dosage ratio.