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In a first of its kind move, the government is set to revoke the suspension order on anti-diabetes drug pioglitazone, imposed late last month. However, pharmaceutical companies selling the drug will be required to carry a box warning indicating the possible risk of bladder cancer. The decision was taken in a meeting of the government's highest advisory body on drugs, the Drugs Technical Advisory Board (DTAB), on July 19, after strong opposition from the industry as well as the medical fraternity emphasising the need of the drug for patients in the country.
“DTAB has endorsed the suggestions made by a panel of experts. The proposal has been sent to the health ministry for vetting and the notification revoking the suspension of manufacturing of the drug is expected very soon,” a senior official told Business Standard. Earlier this month, Business Standard had reported that an expert panel consisting of diabetologists and pharmacologists from reputed institutes from across the country met the Director General Health Services and the Drugs Controller General of India on July 11 and advised revoking the suspension on sale of the drug in India, as there are few adverse events reported because of the use of the drug.
This would be the first time the government would revoke a ban on a drug in India.
Last month, the government had suspended manufacturing and sale of pioglitazone in India after V Mohan, a prominent diabetologist from Chennai, wrote to the Prime Minister’s Office highlighting the risks attached to the drug.
Pioglitazone, currently banned in France, is sold in various other countries, including the US and the UK, with a warning on the label cautioning against potential risks. In India, three million to four million people are believed to be prescribed the drug for diabetes. Medical practitioners argued there was not much scientific evidence or reported adverse events to ban the drug in India.
