The Indian drug regulator (Drug Controller General of India DCGI) will now investigate safety concerns on Avandia and Actos, two key diabetes medicines that could potentially be affecting 10 million diabetics in India.
The move follows the US Food and Drug Administration (FDA) directive putting both the drugs, Rosiglitazone and Pioglitazone, under the strictest drug safety warnings (Black Box) following the publication of recent studies linking them to an increased risk of heart failures.
Versions of Avandia are being sold by Indian companies such as Sun Pharmaceuticals Ltd, Cipla Ltd, Glenmark Pharmaceuticals Ltd and Torrent Pharmaceuticals Ltd, besides Glaxo’s GSK Pharmaceuticals Ltd unit.
Source: http://www.livemint.com/2007/06/08002046/DrugregulatorasksGSK-for-Av.html
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