Indian pharmaceutical companies that have launched their own versions of the diet drug rimonabant say the drug is safe and they do not plan to withdraw it from the market despite an overwhelming vote by a panel of U.S. experts last week questioning the safety of Sanofi's diet pill Acomplia.
However, Indian regulatory authorities -- like those in Europe where Acomplia has been on the market for more than a year -- are now expected to re-examine the situation following last week's unanimous recommendation by an FDA advisory panel against allowing Acomplia to be sold in the United States.
European regulators are expected to discuss the surprising U.S. developments at a meeting this week, and regulators in India -- where rimonabant has been on sale since May -- said they will be taking another look at the data as well.
"Under our pharmaco-vigilance programme, we would look into all overseas developments and their implications on Indian consumers," Drugs Controller General of India Dr. Venkateswarlu told the Economic Times of India.
Companies selling rimonabant in India found hope in the fact that there have been instances in the past where Indian regulators have allowed companies to market drugs that were approved in Europe but not in the United States.
Torrent Pharmaceutical Vice President Ruchir Modi said: “The drug is safe. We have also conducted our own clinical trials in over 100 patients and the results have been encouraging. However, we will follow the drugs controller general of India’s direction.”
“The drug has been approved in many European countries and no country has withdrawn it so far," added a spokesperson for Sun Pharma, another company selling a version of rimonabant.