The Maharashtra Food and Drug Administration (FDA) is yet to initiate any action in the state against the controversial anti-obesity drug rimonabant which has been cancelled by the national drug regulator due to its severe psychiatric side effects including suicidal tendencies.
"We are not taking any action against the slimming drug rimonabant in the state because we did not get any direction in this direction from the DCGI. We will initiate action against the drug only when we get official direction from the DCGI as we cannot act on media reports," a senior Maharashtra FDA official said. He also added that the Maharashtra FDA did not issue manufacturing licences for this drug in the state and only marketing has been going on in the state.
Meanwhile, acting on the DCGI directive the companies have stopped manufacturing and sale of the drug. "Immediately after receiving the DCGI communication, we have stopped manufacturing, promotion and distribution of rimonabant throughout the country," a Sun Pharma spokesperson said.
The DCGI's action in which he has cancelled the licences of 17 companies to manufacture rimonabant came after the Europe's drug regulator European Medicines Agency (EMEA) suspended the manufacture of this drug in UK and the European Union countries because it caused serious psychiatric side effects including suicidal tendencies.
Rimonabant was launched by Sanofi Aventis in June 2006 in the European Union (EU) under the brand name Accomplia. But, the drug was not launched in US as it did not get the US FDA approval. 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.
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.