08 October 2010
New Delhi, India
The Drug Controller General of India (DCGI) Thursday suspended manufacturing and import of the anti–diabetic drug Rosiglitazone.
The US FDA too had recently restricted its use after data suggested continued use of rosiglitazone (Avandia) could increase the risk of cardiovascular problems. European medicine agencies too had withdrawn the drug from the market.
In a meeting on Thursday, a committee of eminent doctors decided to suspend further manufacturing of the drug.
The expert committee observed that the Indian population was at relatively higher risk of cardiovascular diseases because of multiple factors such as "genetic predisposition, higher incidence of dyslipidemia, higher incidence of metabolic syndrome". The drug is widely used in India for correcting blood sugar levels.
All these factors, the experts said, may lead to more cardiovascular problems with continued use of rosiglitazone.
"Though data on the incidence and causality of cardiovascular events and adverse effect on lipid profile associated with the use of this drug is not available, the experts considered the information available in the published literature," said one of the officials.
In view of this, the committee suspended import of Rosiglitazone with immediate effect. It also prohibited manufacture and sale of Rosiglitazone under section 26 A of the Drugs and Cosmetics Act. A similar drug, Pioglitazone, is also under scrutiny and will be reviewed after six months.
Rosiglitazone was allowed in India in 2000 and is being marketed by many companies as a single drug as well as with other anti–diabetic drugs such as metformin and glibenclamide. In 2007, after reports appeared in the press about the risk factors, a warning was put in the package and other promotional literature.
On Thursday, the DCGI issued letters to all state drug controllers, asking them to suspend all licences granted to manufacture, sell and distribute Rosilitazone and its combinations with other drugs with immediate effect.
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