Govt flip-flop on pioglitazone hits sales

Industry experts, medical practitioners say post govt's suspension of drug, patients have become skeptical and now cautious while using it

Companies making pioglitazone, the anti-diabetes drug that was first banned and later allowed to be sold with a warning on the pack in the country, have seen revenues dip for the drug in the past few months.

According to latest market estimates, pioglitazone sales have dipped 42 per cent between May and August. Though sales picked up slightly in September, they are still much below the pre-ban level. Industry experts and medical practitioners say after the government had once banned the drug, patients became sceptical of it.

Companies such as Sun Pharma, Lupin and Abbott sell pioglitazone in India, the market for which is estimated to be Rs 700 crore annually.

According to latest data by pharma market researcher IMS Health India, medicines containing pioglitazone clocked sales of Rs 29 crore and Rs 38 crore in August and September, respectively. This is much below the Rs 50 crore in May and Rs 46 crore in June.

The Union government had suspended the sale of pioglitazone in July this year after seven cases of its causing potential risk of bladder cancer were reported in Chennai. However, following strong opposition from the industry and recommendations from the medical fraternity in favour of the drug, the government revoked the ban in August and instead asked companies to carry a boxed warning highlighting risks from its use.

Medical experts said pioglitazone should be prescribed only when other drugs ineffective or the patient is not able to tolerate them. That too, they say, after liver function tests since pioglitazone might damage the organ. However, before the suspension the drug was being prescribed widely. The temporary suspension and the boxed warning might have created awareness around the restricted use of the medicine. According to trade sources, pioglitazone is mostly sold in combination with metformin and glimepiride. Says C M Gulati of Monthly Index of Medical Specialities: “Such combinations are not permitted in any developed country. Besides, the sales data proves pioglitazone is being used as first-line therapy in India. When three drugs are combined and administered in one pill, there is no way of knowing which drug is really doing its job.”

Said Anoop Misra of Fortis C-Doc Centre of Internal Medicine, the temporary suspension has made people more cautious and patients, if aware, do not accept the drug easily.