- The health ministry has suspended the sale of two drugs —painkiller Analgin and anti-diabetes drug Pioglitazone and all its combinations.
- While the ban on Analgin in India has come after almost 36 years after the drug was banned in the US (which banned it in 1977).
- Pioglitazone was
pulled out of France in 2011 for an increased risk of bladder cancer.
- Analgin was withdrawn from Sweden
in 1997 for the risk of causing a sharp fall in white blood cells, a
potentially fatal condition. It is still being marketed in
India, the house panel noted. The drug is also banned in France, Canada,
Australia, New Zealand, Japan among a host of other countries.
- Experts say that the
glitazone class comprises only two molecules - pioglitazone and
rosiglitazone. The latter was banned three years ago due to
reports of cardio vascular side effects.
- Pioglitazone, however, continues
to be sold in most other major markets, including the US, the UK, Japan,
Canada.
Why is the drug industry protesting ?- The domestic
drug industry is protesting the move, saying this ban would force
lakhs of patients to move to more
expensive alternatives and insulin.
So what will diabetes patients wl hav to do noe ????- Most of the patients
would have to shift to gliptins
class of molecules, which
are at least 3 to 4 times more
expensive or insulin, which is the next line of
treatment.
- In the Indian
market, Pioglitazone is marketed as a single drug as well as in
combinations with other drugs such as Metformin, Glimepiride, Alogliptin.
Some of the well-known brands in the category include Glizone by Zydus
Cadila, Pioz by USV.
- The government has
told the Parliament that it plans to suspend sale of medicines that
are banned in one of the six major global drug markets for harmful
side-effects.
- If a drug is banned by the US, the
UK, Canada, Japan, European Union or Australia, its sales will be stopped
in India until clinical data proves that it will not
have an adverse effect on patients in the country, if government’s new
plans are enforced.
What do doctors say ?- Doctors
here in India had said in a study last year that more robust data on use
of pioglitazone on Indian patients was needed.
- Till
that time, the patient should be adequately informed
about this adverse effect and the drug should be used in as small a dose
as possible,
with careful monitoring and follow up.
- Earlier
this month, the ministry had suspended sale of dextropropoxyphene, sold
as Wockhardt's Proxyvon, a widely-used pain-killer.
- Pioglitazone was
pulled out of France in 2011 for an increased risk of bladder cancer.