More drug combos under scannerJune 11, 2019
India may ban more fixed dose combinations (FDCs), currently available in the market, which are suspected to be `irrational’.
The Drugs Technical Advisory Board (DTAB), which advises the drug regulator on safety issues of pharmaceutical products, has constituted a sub-committee to examine some 150-odd FDCs, reports said.
The government slapped a ban on 344 FDCs in 2016 following a report submitted by a panel led by Kokate, vice-chancellor of KLE University in Karnataka.
Deliberating on a petition filed by drug companies challenging the government’s ban, the Supreme Court referred the matter to DTAB for a fresh review in December 2017. The SC asked the board to check whether these drugs should continue to be sold.
As per order, an expert panel under the chairmanship of Dr Kshirsagar reviewed the safety and efficacy of these drugs and recommended to continue the ban as the FDCs in question had no rational basis.