DTAB to review efficacy of 300 banned drugs
India’s chief advisory body on drugs is set to decide on the fate of over 300 banned drugs in a meeting later this month.
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 had earlier claimed 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 — between 2016-2017.
DTAB chairman Jagdish Prasad told Mint, “Many of these drugs should not have been banned in first place. We will constitute expert committees comprising clinical experts to review their safety before we decide on the final action.”
The Supreme Court in December referred the matter of FDCs to the DTAB for a fresh review of 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 outright banned, and submit its report and recommendations to the government within six months.
“We will constitute committees which will consult all 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. We have to ensure that industry should not get severely impacted,” said Prasad.
In January 2017, the Centre 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.
The ban covered about 6,000 brands from major pharma houses, including Pfizer Ltd, Wockhardt Ltd, Alkem Laboratories Ltd, Cipla Ltd, Sanofi India Ltd, and Sun Pharmaceutical Industries Ltd.
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