The Union Health Ministry has suspended the sale of two drugs – painkiller Analgin and anti-diabetes drug Pioglitazone and all its combinations . Earlier the Ministry had suspended the manufacture for sale, sale and distribution of another pain killer, dextyropropoxyphene (banned in the US in 2010, following a study which suggested that the use of this drug can lead to serious toxicity to the heart even when used at approved therapeutic doses. In 2009, the European Medicines Agency had pursued dextyropropoxyphenes withdrawal from the market across the European Union nations, saying the drugs risks, particularly the risk of a potential fatal overdose, are higher than its benefits).
Several pharma companies in India manufacture dextyropropoxyphene which is sold under different brand names and is primarily used in the treatment of mild or moderate pain. Some companies also sell the drug in combination with other compounds such as paracetamol or dicyclomine. While Wockhardt markets the drug as Proxyvon, Ranbaxy sells the drug under the brand name Sudhinol.
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Analgin was withdrawn from Sweden in 1997 for the risk of causing a sharp fall in white blood cells, a potentially fatal condition.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. Pioglitazone, howevercontinues 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. “There are over 30 lakh patients using this drug. There is no evidence to show that the drug has caused any adverse drug reactions in India, despite being marketed in the country since 2001,” said DG Shah, secretary general, Indian Pharma Alliance.
“We fail to understand, why all of a sudden the government has decided to pull out this drug from the market , when it is readily available the world over. 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,” he added.
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 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, UK, Canada, Japan, European Union or Australia, its sales will be stopped in India until clinical data proves that it will not have adverse effect on patients in the country, if government’s new plans are enforced.
“This drug belongs to the same family as Rosiglitazone, which has faced a ban in major countries for increased risk of heart-attacks . Even the innovator of Pioglitazone, Takeda Pharma , has had to issue additional warnings that the drug can cause fluid retention that precipitate or worsen congestive heart failure ,” said CM Gulhati, a drug regulatory expert.
During 2010-2011 , the Drug Controller General banned several drugs such as anti-diabetes medicine Rosiglitazone, anti-obesity drug Sibutramine, pain-killer Nimesulide for pediatric use, antibiotic Gaifloxacin, as well as Cisapride and Tegaserod, which are used for treating gastro-intestinal motility and irritable bowel syndrome , respectively.
Some of these government imposed bans, however , have been subsequently challenged in courts.