Showing posts with label Pioglitazone ban. Show all posts
Showing posts with label Pioglitazone ban. Show all posts

Wednesday, 24 July 2013

India poised to revoke Pioglitazone ban

The Drug Technical Advisory Board (DTAB) has advised the Government to revoke the suspension of the diabetes drug pioglitazone. 

The DTAB met on July 19 and recommended that pioglitazone be put back in the market in India with a box warning about bladder cancer.


The DTAB is an advisory body and the government may or may not accept its advice but it is likely that the recommendations may be accepted. 

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.