Diabetes drug pioglitazone and all its combinations are back.

The Health Ministry has revoked its earlier suspension on the diabetes drug, and has allowed the manufacture and prescription of pioglitazone and its formulations, but with several riders - including a box warning in “bold red letters” to caution patients.

The move comes a little over a month after the Health Ministry had initially suspended the sale and distribution of the drug for its links to urinary bladder cancer.

The suspension had caught doctors, patients and drug companies by surprise, following which there were hi-decibel protests and submissions to the Ministry. Doctors said that the drug was best suited for Indian patients.

Lacing its notification with much caution, the Health Ministry said that it was aware that the drug was risky and safer alternatives were available. Nevertheless, it proceeds to say that the Drugs Technical Advisory Board recommended the revocation of the suspension of pioglitazone, with certain conditions including that the manufacturers carry warnings on the packing, product insert and promotional literature.

The drug should not be used as a first line of therapy to treat diabetes. It would carry the warning in bold red letters and also would carry advice for healthcare professionals, the notification said.

Further, it added, that the drug not be given to patients with a history of bladder cancer, be restricted to the elderly and prescribed after knowing the patients history. Those prescribed with the drug would also be put through 6 monthly reviews, the notification added.

Pioglitazone is a Rs 700-crore plus market in India, and several companies including USV, Sun Pharma and Ranbaxy make the medicine.

The drug is banned in France, restricted to existing prescriptions in Germany and sold with patient and doctors warnings in the US and the EU.

jyothi.datta@thehindu.co.in

(This article was published on August 1, 2013)
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