Pioglitazone ban: Health Ministry's decision draws ire from all corners

The Union Health Ministry's decision to ban anti-diabetes drug pioglitazone has come in for sharp criticism from the pharma industry in the country. Indian Pharmaceutical Alliance (IPA) secretary general DG Shah said, 'There is complete secrecy and confusion about what led to banning the drug by the government which will adversely impact around 30 lakh patients who are using the drug at present.'

Some even believe that this move is a calculated one which will force patients to consume more expensive drugs like gliptins. The industry is justifiably peeved because the drug is available in many countries including extremely regulated ones like the US (with a warning), Japan, UK, Switzerland, Canada and Australia. The only major country where pioglitazone is banned is France.

It was banned along with analgin (a painkiller) and deanxit (an anti-depressant) and while these drugs have a controversial history, the ban of pioglitazone has taken the entire industry by surprise. In its response to a parliamentary committee the health ministry said, 'It has since been decided that whenever a drug is banned due to adverse drug reactions in countries with well-developed and efficient regulatory system viz. USA, UK, EU, Australia, Japan and Canada, the manufacture, import and marketing of such drugs would be immediately put under suspension till the safety of the drug is examined and established in the country'.

But as the industry insiders correctly point out, the drug pioglitazone isn't banned in any of the aforementioned countries. We spoke to our expert Dr Rajiv Kovil, renowned diabetologist and the founder of the Diabetes Care Center, to find out more about the ban, and how it can affect patients.

Could you tell us why pioglitazone has been banned and is it a justified move?

Dr Kovil: It doesn't make any sense at all, because neither did the USFDA find any evidence to banpioglitazone, nor did the EMEA (European Medicines Agency). I for one do not understand where the health authorities in India found enough evidence to ban the drug and its combinations. There is no evidence across the globe sufficient enough to ban it.

The newspapers have reported that the drug is banned in the US, UK and Australia. Is that true?

Dr Kovil: That is not true. It has been banned only in France and certain parts of Europe. It was banned when the controversy about bladder cancer came up. It has been two years since then, and there has been a lot of clarity following those findings. Another factor that comes to mind are the findings about heart failure and pioglitazone. It has been almost six to seven years since then and there have been subsequent trials showing that there is no increase in the risk of heart failure, it is just that doctors should use the drug with caution in people who are at a higher risk of developing heart disease. Read more