The government is considering banning anti-obesity drug ‘Rimonabant’ in India after studies indicated that it causes serious psychiatric side effects, including suicidal tendencies.
Rimanobant, a patented drug from global pharmaceutical giant Sanofi Aventis, launched in 2006 in Europe, was considered a potential blockbuster by many.
In India, its generic version is manufactured by 17 companies, including Zydus Cadilla, Sun Pharmaceutical, Torrent Pharmaceuticals and Ranbaxy Laboratories.
“The matter of banning the drug Rimonabant was discussed at the Drug Coordination Committee’s meeting held on December 10 and will be discussed at the Drug Technical Advisory Body (DTAB) meeting on Monday,” said Drug Controller General of India (DCGI) Surinder Singh.
Once DTAB gives a clear signal about banning the drug, the health ministry will issue a notification in this regard, according to Singh.
The National Health Regulator had issued a notification under which manufacturers were asked to stop producing Rimonabant immediately following the European drug regulator’s recommendation to member countries to not allow the drug to be sold in their countries.
“We have also communicated the same to all state licensing authorities and they have been asked to make sure that the drug is not produced in the country, he added.
“However, it would take some time before the issue gets cleared as we have not yet recommended a callback of the drug,” Singh said, while making it clear that no side effects of the drug were reported in the country.
