State FDA asks cos making rimonabant to stop output, withdraw products
The Maharashtra Food and Drug Administration (FDA) have started action against the controversial anti-obesity drug, rimonabant, licenses of which were cancelled by the national drug regulator due to its severe psychiatric side effects including suicidal tendencies. There are five companies who either manufacture or market this obesity drug in the state.
"We have received directive from the DCGI office to initiate action against the slimming drug rimonabant in the state. Accordingly, we have initiated action against the drug. We have asked all the five companies in the state who either manufacture or market this drug to immediately stop production and also to withdraw the product from the market," Maharashtra State drug controller SA Momin said.
Drug Controller General of India (DCGI) Dr Surinder Singh had recently cancelled the licenses of 17 companies to manufacture rimonabant after the Europe's drug regulator European Medicines Agency (EMEA) suspended the manufacture of this drug in UK and the European Union countries on reports that the slimmming drug caused serious psychiatric side effects including suicidal tendencies.
Rimonabant was in the news for some time due to its severe side effects like depression and other psychiatric disorders. Last year, the UK's premier medical journal, The Lancet, had reported that four slimming drugs sold in the market put patients at risk of severe psychiatric side effects. But, the drug was not launched in US as it did not get the US FDA approval.
Rimonabant was launched by Sanofi Aventis in June 2006 in the European Union (EU) under the brand name Accomplia. Apart from 18 countries in the EU, Sanofi Aventis was selling the drug in 14 countries including some in Latin America. In India, the copycat versions of the drug are manufactured by Torrent Pharmaceuticals in the name of Remoslim, Zydus Cadila under the brand name of Slimona and Sun Pharmaceuticals under the brand names of Riocity and Riobec.