Expert panel recommends banning 343 fixed drug combinations

An expert panel formed by an apex advisory board on drugs to review the "safety, efficacy and therapeutic justification" of 349 fixed dose combination (FDC) medicines, which were banned in 2016, have backed the Health Ministry's decision to ban the drugs, barring six of them.

The panel set up by the ministry has submitted its recommendations to the Drugs Technical Advisory Board (DTAB), which will forward the same to the health ministry soon, a government official said.

After reviewing the 349 FDCs, the panel had recommended that 343 of them should be banned, while the remaining six drugs be restricted or regulated.

The Supreme Court had last year directed the DTAB to review the safety, efficacy and therapeutic justification of the 349 FDCs, following which a sub-committee was formed to
FDC means a combination of two or more drugs in a fixed dosage ratio. The banned FDCs include painkillers,
"Rationality needs to be demonstrated by safety, efficacy and therapeutic justification. None of the FDCs meet the criteria of a rational and safe drug. The people of India have been made the consumers of unsafe medicines for too long and this is one step towards rectifying the grave situation of a pharma market brimming with innumerable irrational FDCs," AIDAN said in a statement,