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Indian Express
27 October 2010
By Teena Thacker
New Delhi, India

FDA also restricted use of rosiglitazone in response to data suggesting its use could increase risk of cardiovascular problems IN A meeting with the state drug controllers on Thursday, the Drug Controller General of India (DCGI) is likely to take up the issue of a complete ban on the widely used anti–diabetic drug, rosiglitazone.

"Once a consensus is received by the state drug controllers, the DCGI will propose the Health Ministry to ban the drug," sources in the DCGI office revealed.

Earlier this month, DCGI Dr Surinder Singh had suspended the manufacturing and import of rosiglitazone. In a letter to the state drug controllers, he had asked them to suspend licenses of manufacturers for sale and distribution of rosiglitazone and its fixed dose combinations.

However, flooded with complaints about rosiglitazone being still available in the market, the DCGI is likely to move further and approach the Health Ministry to ban it completely.

Earlier this month, the US Food and Drug Administration (FDA) also restricted the use of the anti–diabetic drug in response to a data suggesting that the use of rosiglitazone (Avandia) could in crease the risk of cardiovascular problems. The European Medicines Agency, too, recommended the suspension of the marketing authorisations for the drug.

Rosiglitazone is widely used in India for correcting blood sugar levels. In view of the FDA recommendations, an expert committee which met the DCGI had also observed that the Indian population was at a relatively higher risk of cardiovascular diseases because of factors such as "genetic predisposition, higher incidence of dyslipidemia and metabolic syndrome". All these factors, according to the experts, may lead to more cardiovascular problems with the continued use of rosiglitazone.

Welcoming the DCGI move, Dr Anoop Misra, Di rector and Head, Department of Diabetes and Metabolic Diseases, Fortis Hospitals and among the members of the expert committee said, "10–25 per cent patients in India who still use rosiglitazone face high risk of heart attacks. Rosiglitazone could easily be replaced by several new and safe anti–diabetic drugs." Another anti–diabetic drug, Pioglitazone is also under watch and will be reviewed after six months.

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