In a move that has taken patients, doctors and companies by surprise, the Health Ministry has “suspended” diabetes drug pioglitazone and its combinations.
The drug has been under scanner over the linked risk of urinary bladder cancer and heart-failure, a Health Ministry official said.
Representatives of companies making the medicine in India, point out, however, that the drug sells in the US and Europe, with an advice of caution to doctors. The drug is, however, banned in France.
With the exact number of patients on pioglitazone and its combinations being difficult to nail, industry estimates peg it between three and 30 lakh. The drug is used as a third line of treatment in type II diabetes.
The Health Ministry representative pointed out that the drug has been suspended, “not banned”, but companies will have to stop selling, manufacturing, promoting or distributing the drug, with immediate effect.
Pioglitazone and its combinations are an estimated Rs 600-crore segment, say industry representatives, and several large companies make it, including Ranbaxy, Sun Pharma, Lupin and USV.
A pioglitazone-maker said that the concern is of sustained use of 40 mg in older patients. What the Government should have done is to advise the use of a lower dosage, rather than suspend it totally, he pointed out, as it is a critical drug. The product has been selling in India for about 10 years, another industry representative said adding that alternatives such as DPP-4-inhibitors or “gliptins” are more expensive for consumers. The Government has been secretive in taking this decision, he said.
The Ministry official, though, pointed out that they had discussed the issue with industry and doctors before taking a decision.