The Drugs Controller General of India (DCGI) on Monday said it has suspended the sale of anti-obesity drugs 'Sibutramine' and 'R-Sibutramine' in the country as continued use of both drugs could lead to heart attacks.
DCGI, in a letter dated November 12, has directed all state drug controllers to "suspend all the licences granted to manufacture for sale and distribution of Sibutramine and R-Sibutramine and their formulations with immediate effect." According to the DCGI, the originator of the drugs, Abbott, has already stopped the marketing of and distribution of the drug in the country based on the results of sibutramine cardiovascular outcomes study (SCOUT).
Various countries, including those in Europe, US, Canada and Australia have either suspended or withdrawn the marketing authorisation of Sibutramine in October 2010, the letter said.
Taking into account the actions taken by various countries, an expert committee was constituted to examine the safety issue and to recommend regulatory action to be taken in the country in respect of continued sale of Sibutramine.
The committee, in its meeting held on November 12 has recommended as an immediate step to suspend import and manufacturing of Sibutramine and R-Sibutramine and their formulations in the country.
It noted that the continued use of Sibutramine and R-Sibutrameine is associated with increased risk of cardiovascular events such as heart attacks and stroke. Abbott manufactures Sibutramine under the brand names Reductil, Meridia, Sibutral, Ectiva and Raductil in the US. In India, apart from Abbott around 20 companies, including Sun, Torrent and Mankind, sell their own generic versions of Sibutramine.