Even as the industry has raised serious concerns over banning of three key medicines including anti-diabetic drug pioglitazone, the government is evaluating suspension of more such drugs with serious side-effects, mainly those which are not allowed for sale in their originating countries.
According to sources in know of developments, the drug controller’s office is also considering Buclizine, an anti-allergic medicine often prescribed for stimulation of appetite in babies, among other such medicines for suspension of manufacturing and sale in India.
Recently, the health ministry has banned sale of anti-diabetic drug Pioglitazone, pain killer Analgin and anti-depressant Deanxit because of the health risk associated with these medicines. While the decision is seen to impact various major drug makers including Abbott, Sun Pharma, USV, Lupin, Ranbaxy and Wockhardt, the industry is mostly concerned about the ban on Pioglitazone and it combinations as it alone commands a market of over Rs 700 crore.
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“The suspension of pioglitazone is very surprising. The ministry has flouted the process of banning a drug. It has not consulted the industry and there is a complete secrecy about what lead to this decision,” says Indian Pharmaceutical Alliance (IPA) Secretary General DG Shah.
According to Shah, banning of such medicine would mean patients using them would have to shift to expensive alternative medicines manufactured by multinationals.
“Most of the patients are expected to shift to gliptins, which are around four times more expensive than pioglitazone based drugs,” another industry official said.
Pioglitazone is currently available in India under various brands such as Diavista by Dr Reddy’s Labs, Sun Pharma’s Pioglit and Pioglar by Ranbaxy. While the drug is marketed in India since 2001, it was pulled out of France in 2011 due to suspected risk of bladder cancer. However, the medicine is currently sold in at least 32 countries including the US, Japan, Canada and Switzerland.
The move to ban these medicines comes in the wake of various Parliamentary Standing Committee recommendations. The standing committee in its 59th report on the working of the Central Drugs Standard Control Organisation has also suggested the need to suspend sale of Buclizine, which is not allowed for sale in Belgium –the country of its origin.