Safety last

The ban on a popular diabetes drug only shows poor side-effects monitoring

The Indian drugs regulator recently banned popular anti-diabetes drug pioglitazone for its link to bladder cancer in globally reported studies. This link had led France and Germany to ban the drug in 2011. The move is a wake-up call to India’s drug industry and its doctors — either significantly scale-up adverse event reporting and post-market studies of drugs or face repeats of this scenario in future.

The Indian Pharmaceutical Alliance says over 30 lakh Indian patients are on the drug. There is an uproar among doctors and drug companies. They are outraged by the ban’s suddenness. They argue the drug still retails in the US, albeit with a black box warning regarding cautionary use. Importantly, they argue the drug has shown no evidence of a heightened risk of bladder cancer among Indian patients.

Let’s take each of these arguments by turn. First, the suddenness. Prima facie, the move seems out of the blue. But pio’s link with bladder cancer had already become a matter of concern for some years. In early 2012, the Journal of the Association of Physicians of India (JAPI) devoted a special issue to the drug, taking up various facets of its risks and benefits. Irrespective of what they concluded, the fact is that pio was in the dock. Doctors knew it, and companies knew it.

Second, the “US does it” argument. Let’s rewind a bit. Not too long ago, another popular painkiller in India, nimesulide, turned controversial for its link to liver toxicity. That drug was never approved in the US. When the Indian government sought to restrict its use, some doctors and companies (not the same ones) objected that it wasn’t right for India to base its actions on those of the US and harked to approvals in some European countries! In this context, what is the sanctity of either argument?

… contd.

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