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Indian govt to revoke suspension of Pioglitazone

24 July 2013 | News | By BioSpectrum Bureau

For the very first time, the Indian government would be revoking a ban on a popular drug in the country in merely a month after the drug was banned

For the very first time, the Indian government would be revoking a ban on a popular drug in the country in merely a month after the drug was banned

New Delhi: A month after the Indian government banned the popular anti-diabetes drug Pioglitazone, it is now planning to revoke the suspension order. This is for the first time that a government would revoke a ban on a drug in the country.

The decision came as a conclusion to a meeting of the government's highest advisory body on drugs, the Drugs Technical Advisory Board (DTAB) that faced strong opposition from the industry as well as the medical fraternity that pointed out the need of the drugs for the country's patients.

The board has however instructed pharmaceutical companies selling the drug to carry a box warning indicating the possible risk of bladder cancer.

"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 government official told mediapersons.

The Indian government had suspended manufacturing and sale of pioglitazone in the country last month after a medical professional from south-Indian state Chennai wrote to the country's prime minister about the risks attached to the drug.

 

While Pioglitazone is currently banned in France, it is sold in various other countries, including the US and the UK, with a warning on the label cautioning against potential risks. In India, about three to four million people are said to have been prescribing Pioglitazone for diabetes.

Immediately after its ban in India, many medical practitioners across the country had argued that there was not much scientific evidence or reported adverse events caused due to the drug.

An expert panel consisting of diabetologists and pharmacologists further had met the Director General Health Services and the Drugs Controller General of India (DCGI) earlier this month to advise him on revoking the suspension on sale of the drug in India.

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