- 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- Analgin was withdrawn from Sweden in 1997 for the risk of causing a sharp fall in white blood cells, a potentially fatal condition.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.
Why is the drug industry protesting ?
- Pioglitazone, however, continues to be sold in most other major markets, including the US, the UK, Japan, Canada.
- 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.
What do doctors say ?
- 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.
- 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.