GSK's diabetic drug still on sale in India as regulators dither

Diabetic drug Rosiglitazone or GlaxoSmithKline's (GSK) blockbuster drug Avandia continues to be sold in India even after the US and European regulators have practically killed the drug as it increases the risk of heart attacks in diabetic patients.

Although several countries have started to act upon all rosiglitazone-containing drugs including Avandia after the US and the EU regulators stamped down or severely curtailed selling the drug in their markets, India's slow government machinery is yet to ban the drug in a country that currently is called the diabetes capital of the world having over 50 million diabetic patients.

In India, GSK sells the drug under the brand name of Windamet and Windia, while the generic versions under the brand name Rezult and others are sold by nearly 20 small firms and nearly 8 large companies including Sun Pharmaceuticals, Dr Reddy's Laboratories and Torrent Pharmaceuticals.

It is estimated that nearly 7-10 million diabetic patients in India use Windamet and Windia, while several millions more use generic versions of the drug.

While doctors in urban areas in India have been careful in prescribing rosiglitazone-containing drugs to type 2 diabetic patients, it is not the case in rural India, where doctors have not updated themselves on the harmful side effects of the drug.

After a prolonged investigation that started in 2007, the EU regulator the European Medicines Agency (EMA) last week suspended marketing authorisation for all drugs containing rosiglitazone, including Avandia, and said that drug will be pulled from Europe within the next few months. (See: Regulators in EU, US "kill" Glaxo's diabetes drug Avandia)