The Drugs Technical Advisory Board (DTAB) of the Indian government is to recommend ban on many fixed dose combination (FDC) drugs.

The move comes at a time when the Drug Controller General of India (DCGI) and the pharma industry are locked in a battle over a wide range of such drugs. The DCGI actually wants to knock off the market as many as 294 FDCs, holding them irrational.

In November last the Madras High court in southern India stayed an order of the DCGI asking state drug controllers to take action against the FDC drugs. But the Board’s latest decision will strengthen the case of the Controller, reports Pharma Bizz, an Indian portal on the drug industry

Drug Controller General of India Dr M Venkateshwarlu said, "The DTAB has approved a proposal by which a large number of FDC drugs comes under the category of rejected, absurd, etc will be banned. A sub-committee will identify the drugs which will be banned".

The official, a no-nonsense man, is of the view that while the safety of the combinations may not necessarily be at stake, the question is whether these formulations are prescribed for valid medical reasons or driven by commercial motives.

“Some drug combinations are needed in certain therapeutic segments like tuberculosis, malaria or diabetes, but there are many combinations which are obviously irrational,” Venkateshwarlu says.

But when the federal government finally acts on the Board’s recommendation, that too could also be challenged in the courts.

Source-Medindia
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