Wednesday, 10 July 2013

Pioglitazone ban is controversial

Doctors in India have shown their concern following unexpected decision by the Government to suspend the sales of Pioglitazone (pio). The Government suspended the manufacture, sale and distribution of pio at the end of June citing the concerns for adverse effects, particularly, bladder cancer according to a report published in BMJ. The doctors in the country feel that it should not have been banned.

In fact, unless a drug comes into the category of poison, no drug should be banned only because of some side effects. 

In US the drug is still available with some warning. In France, it was banned three years ago and in Germany it has been suspended sales only for the new patients. In no other country it is banned. Banning is always based in any country only on the basis of the data of that country. In India, there are no reports that use of pio has caused bladder cancer.

For most diabetologists, the news came as a shock as they were not taken into confidence.
I personally feel that when the Government decides to ban a particular drug, IMA, Specialty Organizations to which the drug belongs, MCI etc. should be taken into confidence.
The drug has been in Indian market for 12 years and has never shown any safety concerns. 3 million patients in India are on pio and in one stroke, the Government has asked them to stop the drug.

Alternative is to shift to gliptins which are available at ten times the cost. Is it the gliptin market which has pressurized the Government to ban the pio. 

Pio is more suited for Indians as it is the drug of choice for insulin resistance which is like an epidemic in Indian population.

Also in India, pio is used in lower doses i.e. 7.15 to 15 mg which is not he case in Western countries. The Indian market for pio as on today is 120 million $. 

The doctors are protesting and for now the Government has agreed to a meeting of technical experts to discuss the situation.

Hope the decision is reversed. 


  1. Why do we doctors always doubt and question our Govt's noble intentions? It decided to ban Pio because it is concerned that thousands (if not millions) of Indians will succumb to deadly bladder cancers if they continued taking it. It is another matter that far more Indians die in a single day of tobacco-related ailments than Pio kills in a whole year. But would our Govt even think of banning tobacco? Oh come's excise duties & taxes from tobacco sales that fuels our politicians' fancy SUVs and MUVs. It is tobacco that funds their mistresses' diamond jewellery. Now, think....

  2. I', myself is a pediatrician and is diabetic. I completely agree with Dr Aggrwal's view. Only a few points are there in favour of banning. 1. Bladder cancer. 2 . in older heart patient's in can cause fluid retention. But in 7.5-15 mg/d dose and in young and for first 2 years there is no unsafe reports.I think this can be used with caution or only with prescription of specialist but it should not be banned.

  3. I am a practicing Physician for more than 25 years and using Pioglitazone to control NIDDM.It is an excellent drug and I have hardly encountered any serious side effects in my patients.I want to raise an important point that all medicines have side effects but we keep them in mind.My sincere request to our to discuss the matter with competent authorities before taking such a knee jerk reaction.

  4. Dr. PK Pandit
    I am a practicing Physician using Pioglitazone to many of my Diabetic patients. My patients are from a vary poor socio-economic condition. Many of them will not be able to afford a costly gliptin molecule. So without a potent Insulin sensitizer like Pioglitazone their glycemic control will be at stake and will suffer much more morbidity & mortality due to uncontrolled diabetes than the so called urinary bladder cancer which i have not come across to any single patients of mine.Does our Govt. really thinks of the poor or the decision is being dictated by some other factors?

  5. Dr AS Deora
    I am a practicing physician using Pioglitazone to majority of my diabetic patients in combination with other OHAs.The drug is very effective n has its place in management of diabetes.Banning such an useful drug would further limit the options for the physician in selecting OHAs.Gliptins are very costly n beyond the reach of poor patients.Majority of patients require 3 drugs for tight glycaemic control.Govt must revise its decision after holding discussions with experts in the field