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Times Of India
04 July 2013
Doctors and patients alike slam the Centre’s ban on pioglitazone

Wadala resident Asha Pillai, 60,hasbeenonanti–diabetic drug pioglitazone for four years. When she read media reports that the drug was banned, she booked an appointment with her doctor. "I have been on 7.5 milligrams of pioglitazonedailyandithascontrolled my sugar levels ," said Pillai. "My doctor Dr Vijay Panikar said my last dose will be good enough for two weeks. After a month, my sugar levels will shoot up. He will put me on another drug."

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With pioglitazone getting pulled off the market, diabetics in India will have to resort to insulin or costlier tablets

Her doctor said the new combination may not be as effective as pioglitazone. Pillai will then have to switch to insulin, administered through a daily injection.

Ulhasnagar resident Peter Raiyaper, 59, has been on pioglitazone since 2006. "My diabetes has been well controlled since then," he said. "I started with extremely high sugar but my sugar levels now fluctuate between 120 and 145. Most importantly, I haven’t experienced any side effect."

Toboot,whilepioglitazonecostsRs 3 per tablet, the new drug will cost Rs 40. Diabetics generally take one pill a day.Thatmakestheirnewmonthlyexpense Rs 1,200 as opposed to the Rs 100–odd they used to spend earlier.

Pillai and Raiyaper are two among 30 lakh Indians who now have to decide between the painful insulin shot and costly–yet–less–effective drugs. The Centre on June 18 banned pioglitazone and two other drugs – analgin, a painkiller,anddeanxit,ananti–depressant – citing health risks. Pioglitazone was first banned in France and doctors believe India simply followed it without considering medical data .

The ban has baffled doctors, who say the benefits of this ‘insulin sensitiser’ outweigh the risk s. According to Dr Panikar, who studied 95 patients with bladder cancer, only 35 were diabetic. Of those, a mere three were on pioglitazone. Various doctors’ associations have either written to the Centre already or are in the process of writing about the efficacy of the drug and how it should not have been banned. A group of physicians

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"Every effective drug will have side effects," said Dr Panikar. "The government should have considered the fact that pioglitazone’s benefits outweigh therisks.Whenpioglitazonecameinto the market in 2000, the sale of insulin and other combination drugs went down drastically. Now, patients will have to be put on insulin or on other drugs that are not as effective."

Experts say there were only two molecules found in the glitazone class – rosiglitazone and pioglitazone. While rosiglitazone was banned due to reports of cardiovascular side effects three years ago, pioglitazone, which was the only molecule left, faced a blanket ban too.

"The US is already thinking of reintroducing rosiglitazone due to its effectiveness in patients," said Dr Siddhart Shah, editor, Journal of Association of Physicians of India. "India has to think on similar lines."

The medical industry is also buzzing with theories that the sudden ban was meant to promote drugs that were losing business due to this cheaper option. Panikar said: "The hitch is that no other molecule does the work that pioglitazonedoes.Ourfightisnotwiththe othermoleculesbutagainstthelossofa moleculethatiseffectivewhenusedjudiciously."

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Asha Pillai and Peter Raiyaper

Glitazones are known for health risksincardiacpatientsandtheelderly. But experts say since India is known to have younger diabetics, this drug was essential and its prescription could have been managed through smaller doses. To be sure, the drug has been linked to bladder cancer and causes side effects like water retention, anemia and even heart failure. While most physicians agree that piogliazone is harmless if used judiciously in patients who do not have other health risks, some doctors still prefer to keep the drug at bay.

"It is better to put the patient on insulinthanputhimatriskofdeveloping side effects," said a senior physician.

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