Drug regulator may step up ban on FDCs

The move resonates views that hold there is no place for "irrationality" and therapeutic justification in the sale of drugs

The drug controller has decided to ban more fixed dose combinations (FDCs) as recommended by the Chandrakant Kokate Committee. As a preparatory work, the Central Drugs Standard Control Organisation (CDSCO) has started issuing show-cause notices to companies, giving them opportunity to defend their FDCs, a senior official told Business Standard.

The source added that this move is in line with the view that there is no place for “irrationality” and therapeutic justification in the drugs being sold. Around 70 show-cause notices have been sent to companies already, it is learnt.

Meanwhile, court verdicts are awaited on the various cases filed by pharmaceutical companies challenging the ban of 344 FDCs earlier this year. Earlier this month, the government decided to transfer all the FDC cases registered in various high courts to the Supreme Court.

The Professor Kokate Committee identified a number of FDCs as irrational in February 2016, after examining 1083 samples. Subsequently, 344 FDCs were banned.

Around 150 petitions were filed by pharmaceutical companies against the ban of 344 FDCs, while the government argued that this was done on grounds of safety, efficacy and rationality of these medicines. The government had justified this ban, saying that consumers have better alternatives.

The February ban included some common medicines like Vicks Action 500 Extra, Nimulsulide, Analgin, Pioglitazone etc.

In 2007, the government had decided to ban 300-odd FDCs, after which companies went to court and the order was stayed.