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.