Panel to review efficacy of FDC drugs

NEW DELHI: India’s chief advisory body on drugs is set to decide on the fate of more than 300 banned drugs in a meeting later this month following complaints from the drug industry.

These drugs are used to treat cough, cold, anti allergies.

The Drugs Technical Advisory Board (DTAB) is expected to set up expert committees, which will review the safety, efficacy and therapeutic justification of these drugs—called fixed dose combinations (Fdcs)—before recommending any action in their January 22 meeting.

Drug makers claim the government did not consult statutory bodies before banning these drugs—an FDC drug contains two or more active ingredients in a fixed dosage ratio—in 2016-17.

“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,” DTAB chairman Jagdish Prasad said in an interview.

The Supreme Court in December referred the matter of FDCS to DTAB for a fresh review on whether these drugs should continue to be marketed. The court also set aside the ban on 15 drugs that were banned and which were manufactured before September 21, 1988 as these cases were never meant to be referred to the Kokate Committee.

For the remaining 344 FDCS, the court suggested that DTAB decide whether the manufacture and sale of these drugs should be regulated, restricted or banned outright, and submit its report and recommendations to the government within six months.

“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,” said Prasad.

In January 2017, the government filed an appeal against a December 2016 ruling of the Delhi high court, quashing its March 10, 2016 notification banning 344 FDC drugs, citing health risks and lack of therapeutic justification. On March 31, the apex court had stayed proceedings in all high courts against the ban on 344 FDC drugs.