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Will diabetes drug pioglitazone come back into the market with an advisory for patients, or will it continue to be kept out of public consumption?
The Health Ministry had suspended the drug late last month, due to its possible link to urinary bladder cancer. A move that had a section of doctors come out in support of the drug, that they said, was well-suited for Indian patients.
The fate of pioglitazone is set for a review by the Drugs Technical Advisory Board (DTAB), later this week. But, which ever way the Government finally decides, it will continue to be on a sticky wicket.
Patients will be wary of taking a medicine that was suspended by the Government just last month, as it was unsafe, say a section of doctors.
Cautionary note
What if pioglitazone comes back into the Indian market, and the US and Europe end up banning the drug in six months or a year, asks C.M. Gulati, Editor of the drug-journal MIMS. “My fear is that the Government may have to eat crow,” he says, if such a development takes place.
Pioglitazone sells in the US and Europe, but with black-box warnings and advisories to patients, cautioning them that long-term use could cause urinary bladder cancer. Overseas regulators issue such advisories also to protect themselves from litigation in the future, if a patient develops a problem – as it means the patient took the medication with an understanding of its long-term impact, he points out.
Regulators in the US and Europe are taking it step by step, unlike in India, where they seem to be rushing into taking a decision, one way or the other, agrees another pharma industry-watcher.
It is not just about pioglitazone, says an industry representative. The Government has not followed the right process before it took the decision to suspend the drug, he points out, adding that the industry has not yet been called to make any presentation on the issue to the DTAB.
A group of experts, though, have already met, said a source familiar with the development, and it is likely the drug could come back into the market with a warning or advisory to guide patients.
Low-dose in India
Pioglitazone is used in the treatment of type II diabetes, and it has been available locally for about 10 years now. About 35 lakh patients are estimated to be on the medicine, according to industry. Doctors supporting the use of pioglitazone, say that it is used in low doses in India, and is best suited to address insulin-resistance seen in local patients. The concern overseas stems from high doses, of about 40 mg, used consistently in older patients, they point out.
With strong opinions being expressed, for and against pioglitazone, the outcome from the DTAB meet this week will be watched closely by doctors, patients and industry representatives.
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