Following its ban in Europe and the restricted use in the US, the union health ministry has suspended the import or manufacture of the controversial diabetes drug rosiglitazone in the country with immediate effect.
A decision to this effect was taken by an Expert Committee constituted by the ministry to examine safety issue and to recommend regulatory action to be taken in country in respect of continued marketing of rosiglitazone in the country in view of its ban in Europe and restricted use in US.
A meeting of the Expert Committee was held on October 7, 2010 and it recommended the suspension of import/manufacture of rosiglitazone and its fixed dose combinations in the country with immediate effect as its continued use would lead to more cardiovascular events and adverse effects on lipid profile, Drugs Controller General of India (DCGI) Dr Surinder Singh said.
The DCGI has directed all the state drugs controllers in the country to suspend all the licences granted to manufacture for sale and distribution of rosiglitazone and its fixed dose combinations with other drugs with immediate effect.
Rosiglitazone and its formulations as single drug or as combinations are being marketed in the country as anti-diabetic drugs. European Medicines Agency in its press release dated 23 September, 2010, has recommended the suspension of the marketing authorisations for the rosiglitazone-containing anti-diabetes medicines, and the US Food and Drug Administration (US FDA) had also announced on the same day that it will significantly restrict the use of the diabetes drug rosiglitazone to patients with type 2 diabetes who cannot control their diabetes on other medications.
Rosiglitazone is sold by GSK and its generic versions are manufactured in the country by Sun Pharmaceuticals Ltd, Dr Reddy’s Laboratories Ltd and Torrent Pharmaceuticals Ltd, among 30 other manufacturers. GSK sells the drug as Avandia overseas and Windia in India.
A decision to this effect was taken by an Expert Committee constituted by the ministry to examine safety issue and to recommend regulatory action to be taken in country in respect of continued marketing of rosiglitazone in the country in view of its ban in Europe and restricted use in US.
A meeting of the Expert Committee was held on October 7, 2010 and it recommended the suspension of import/manufacture of rosiglitazone and its fixed dose combinations in the country with immediate effect as its continued use would lead to more cardiovascular events and adverse effects on lipid profile, Drugs Controller General of India (DCGI) Dr Surinder Singh said.
The DCGI has directed all the state drugs controllers in the country to suspend all the licences granted to manufacture for sale and distribution of rosiglitazone and its fixed dose combinations with other drugs with immediate effect.
Rosiglitazone and its formulations as single drug or as combinations are being marketed in the country as anti-diabetic drugs. European Medicines Agency in its press release dated 23 September, 2010, has recommended the suspension of the marketing authorisations for the rosiglitazone-containing anti-diabetes medicines, and the US Food and Drug Administration (US FDA) had also announced on the same day that it will significantly restrict the use of the diabetes drug rosiglitazone to patients with type 2 diabetes who cannot control their diabetes on other medications.
Rosiglitazone is sold by GSK and its generic versions are manufactured in the country by Sun Pharmaceuticals Ltd, Dr Reddy’s Laboratories Ltd and Torrent Pharmaceuticals Ltd, among 30 other manufacturers. GSK sells the drug as Avandia overseas and Windia in India.
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