The review of these FDCs began in 2019 and the committee submitted its report in late 2021, recommending a ban on 156 FDCs. These include mefenamic acid and paracetamol injections for painkillers, fever and inflammation, and omeprazole magnesium and dicyclomine HCl for treating abdominal pain.
This is the second biggest action after the ban on 344 FDCs in 2016. The government has taken this decision after the recommendations of the Drug Technical Advisory Board (DTAB) and the expert committee constituted by the government. It is being told that about 16 more FDCs are under observation and they are also likely to be banned soon.
Earlier, some companies had challenged the government's ban in court. In December 2017, the Supreme Court had referred the matter to the DTAB to review whether the sale of these drugs should continue. The Supreme Court had suggested that the DTAB should decide whether the manufacture and sale of these drugs should be regulated, restricted or completely banned, and had asked the committee to submit its report and recommendations to the government. The government has now banned these drugs based on the committee's report.
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