Ban on Diabetes Drug
Use of Rosiglitazone has been found to be associated with risk of cardiovascular events i.e. Congestive Heart Failure and Myocardial Infarction.
European Medicines Agency on 23 September, 2010, recommended the suspension of the marketing authorisations for the rosiglitazone-containing anti-diabetes medicines. These medicines will stop being available in Europe within the next few months. USFDA have significantly restricted the use of diabetes drug rosiglitazone to patients with Type 2 diabetes who cannot control their diabetes on other medications. UAE agency is yet to take a final decision on the withdrawal of rosiglitazone.
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 for the purpose on 7.10.2010. The Committee recommended that import/manufacture of Rosiglitazone should be suspended with immediate effect and its 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. 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 has banned the drug under Section 26A of the Drugs and Cosmetics Act by a notification dated 12.11.2010.
This information was given by Minister for Health and Family Welfare Shri Ghulam Nabi Azad in written reply to a question raised in Rajya Sabha today.
DS/GK