Ban on anti Diabetes medicine Pioglitazone irrational


The recent decision taken by Indian Health Ministry to suspend the manufacture and sale of Pioglitazone, a medicine that is widely used to reduce blood sugar in Diabetes patients is a very short sighted move.
Pioglitzone belongs to a group of anti diabetic medicines called Glitazones and was approved in 1999 in adults with type 2 diabetes mellitus. It reduces blood sugar primarily by reducing insulin resistance. Beyond the effects on glucose metabolism, pioglitazone has positive effects on fat metabolism and blood pressure too. This makes pioglitazone treatment effective beyond sugar control in Diabetics.
Like any other effective medicine, Pioglitazone sometimes can cause side effects in some patients. This includes weight gain, edema, worsening of cardiac failure, increased risk of fractures and slight increase in chance for Urinary bladder cancer.
In 2011 the news of slight increase in risk of bladder cancer resulted in safety review of the drug by both European Medicine Agency and FDA of USA. After reviewing all the studies of the drug, both EMA and FDA opined that benefit versus risk balance of Pioglitazone remains positive and allowed continued use of the medicine in selected patients. As of now there is no prohibition for prescribing this medicine in any of the countries of the World except France. More over Pioglitazone is prominently cited to be used as a second or third line drug in Diabetes in recent guidelines of scientific societies like American Diabetes Association, European Association for Study of Diabetes and International Diabetes Federation.
India has nearly 70 million people suffering from Diabetes. A vast majority of them are from economically weaker sections of the society. As most of Indian Diabetic patients are not covered by health insurances or Government Health schemes, they have to shell out large sums of money from their pockets for health care.
Ever since its launch in 1999, Pioglitazone has proved to be a very effective and cheap medicine for reducing blood sugar.
Unfortunately in a surprising move the Government of India in a Gazette notification dated 18th June, 2013, has suspended with immediate effect, the sale and manufacture of all formulations containing Pioglitazone.
No Scientific society in India has recommended such a measure. A recent review article in Indian Journal of Endocrinology and Metabolism said:
“Clearly more studies are needed, probably focused on the Indian population. It is also important that physicians recognize the early signs and symptoms of cancer including bladder cancer. At the same time, it is important to recognize the benefits of pioglitazone and use it judiciously in appropriate patients who would benefit from the use of this drug”
Instead of making the drug available with caution and black box warnings like the European Union and USA, Indian Government has suddenly suspended the use of an important and very beneficial drug. Absence of Pioglitazone as a treatment option in Diabetes will severely affect sugar control in a large section of patients. More and more people may have to switch to logistically difficult and costly therapies like Insulin or Gliptins.
Let us hope that a sustained pressure on Government from medical scientific societies, patient groups and Civil society may ensure that this useful medicine will remain in armamentarium of clinicians.

Links
http://care.diabetesjournals.org/content/early/2012/04/17/dc12-0413
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3193778/
http://www.ema.europa.eu/ema/index.jsp?curl=pages/news_and_events/news/2011/10/news_detail_001368.jsp&mid=WC0b01ac058004d5c1
http://www.fda.gov/Drugs/DrugSafety/ucm266555.htm

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