Is Pioglitazone banned in India?

Pioglitazone is an oral diabetes drug whose Indian history is compressed into a few weeks of 2013, which is why searches still ask whether it is banned.

On 18 June 2013 the Health Ministry suspended its manufacture and sale under GSR 379(E), citing a signal for bladder cancer that had led France and Germany to withdraw the drug. The same notification round suspended analgin and the flupentixol + melitracen antidepressant. Diabetologists objected that pioglitazone was inexpensive, effective and used by millions, and that the cancer signal was small. The Drugs Technical Advisory Board reviewed the evidence, and in July 2013 the government revoked the suspension, attaching a boxed warning about bladder cancer and a condition that the drug not be used as first-line treatment. Deccan Herald reported both revocations.

Single-ingredient pioglitazone has been legal since then and is sold as Pioz, Pioglit and others.

Some combinations have a separate history. The 328-FDC notification of 7 September 2018 banned glimepiride + pioglitazone + metformin and pioglitazone 30 mg + metformin 500 mg under S.O. 4471(E), 4472(E) and 4479(E). The Delhi High Court quashed those entries, and the CDSCO's appeal is pending, so those products are on sale pending a decision. Patients on any pioglitazone product should discuss the bladder-cancer warning with their doctor rather than stop treatment.