More than 500 drugs may face ban

New Delhi: 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 (OTC) without doctors’ prescription, which is leading to their misuse.

“Our objective is to ensure only safe products are available in the market. We have reviewed products for several times and there is evidence from research papers and studies to show these medicines are irrational combinations,” the official said. 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. Also, because of the weak vigilance mechanism, adverse impacts of such drugs are often not reported.

While industry estimates have pegged a revenue loss of at least Rs 3,800 crore for 344 FDCs that are already banned, drug makers may have to bear much more heavy financial loss if more drugs are banned. Some industry executives say the financial impact can be to the tune of Rs 10,000 crore.The total local pharmaceutical retail market is pegged at over Rs 1 lakh crore annually.