The Union health ministry has finally banned the manufacture and distribution of the controversial diabetes drug rosiglitazone in the country and has asked the state drug authorities to recall the medicine from the market with immediate effect. Following its ban in Europe and the restricted use in the US, the government had suspended the import/manufacture of this medicine in the country on October 7 this year.

“As the manufacture and sale of rosiglitazone stands prohibited with immediate effect, it is requested that you may kindly ensure that the manufacturers licenced to manufacture the drug formulations containing rosiglitazone in your State stop manufacturing these formulations with immediate effect and make arrangement to recall the formulations from the market. The chemists and druggists in your State should also be directed to stop the sale of these formulations with immediate effect and return the unused stocks to the manufacturers”, the drugs controller general (India) has directed the state drug controllers.

The Drugs Consultative Committee in its meeting held on 28.10.2010 considered the matter and recommended ban of the drug under the Drugs and Cosmetics Act. Accordingly, the government banned the drug under Section 26A of the Drugs and Cosmetics Act by a notification dated 12.11.2010, ministry sources said.

Earlier, the question of examining the safety issues of rosiglitazone in the country was considered by an expert committee set up by the Central Drugs Standard Control Organisation (CDSCO) for the purpose on 7.10.2010. The committee recommended that import/manufacture of rosiglitazone should be suspended with immediate effect and it manufacture, sale or distribution should be prohibited under Section 26A of the Drugs and Cosmetics Act. The State Drugs Control Authorities were requested on the same day to suspend the manufacture of the drug in the country.

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.