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In a move that has taken patients, doctors & firms by surprise, the Indian Health Ministry has “suspended” diabetes drug pioglitazone and its combinations.
The drug has been under scanner over the linked risk of urinary bladder cancer & heart failure, a Health Ministry official said.
Representatives of firms making the medicine in India, point out, however, that the drug sells in the US & Europe, with an advice of caution to doctors. The drug is, however, banned in France.
With the exact number of patients on pioglitazone & its combinations being difficult to nail, industry estimates peg it between 3 and 30 lakh. The drug is used as a 3rd line of treatment in type II diabetes.
The Indian 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 & its combinations are an estimated about Rs. 600 crore segment, say industry representatives, and several large companies make it, including Ranbaxy, Sun Pharma, Lupin & USV.
A pioglitazone maker said that the concern is of sustained use of 40 mg in older patients. What the central 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 nearly ten years, another industry representative said adding that alternatives such as DPP - 4 inhibitors or “gliptins” are more expensive for consumers.
The central government has been secretive in taking this decision, he said.
The Ministry official, though, pointed out that they had discussed the issue with industry & doctors before taking a decision.
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