Monday, 14 March 2016

15 March, 2016

500 more drugs may face ban
Around 500 more medicines, including popular antibiotics and anti-diabetic drugs, may soon face a ban for being "irrational", unsafe and inefficacious, official sources said. The health ministry, which banned 344 fixed-dose combinations (FDCs) including popular cough syrups like Phensedyl, Corex and Benadryl last week, is evaluating a list of over 6,000 products. According to a senior official, at least 1,000 such FDCs are currently under "severe scrutiny" and 500 of them are likely to face a ban within six months.

"There is primary evidence in around 1,000 cases, which shows these are irrational FDCs. However, in some cases the data is incomplete so we have asked for further studies. In around 500 cases, we are at the last leg and waiting for some documents," an official told TOI.

TOI was the first to report the ban on 344 FDCs including Phensedyl and Corex on Saturday .
The health ministry is of the view that irrational FDCs are causing anti-microbial resistance and in some cases the toxicity is so high that it can even lead to failure of organs. There are also concerns many of these FDCs being available over-the-counter without doctors' prescription, which is leading to their misuse.

Meanwhile, the Delhi High Court on Monday granted Pfizer a stay order, pending a further hearing, on the ban on its popular cough syrup Corex.
While some drug makers including Pfizer have argued that some of the banned drugs have been available in India for around 30 years to make a point for safety and efficacy , health ministry officials argue that a long market life is not enough to prove safety . "Just because adverse events have not come to notice or have not been reported so far does not mean we ignore scientific evidence showing discrepancies," the official said.

While many of these products are sold at the chemists level, officials and health experts say often adverse events are not reported because patients do not come back to doctors unless these drugs are used repetitively, leading to severe problems.
15.03.2016







Invest in the human soul. Who knows, it might be a diamond in the rough


Mary McLeod Bethune

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