New Delhi: Anti-obesity drug sibutramine, sold under brand names such as Reductil, Meridia and Sibutrex, will now be sold in India with a warning for people over 55 years and those with heart conditions.
An expert panel, which met on 9 February, has suggested asking drug makers to place a boxed warning on the drug pack describing its so-called contra-indications—situations in which the medicine could be harmful.
The drug controller general of India (DCGI) had called the meeting after sibutramine was banned in Europe in the month of January and a warning was issued against it by the US Food and Drug Administration (FDA).
“We will ask all manufacturers to place a boxed warning,” said DCGI Surinder Singh.
Sibutramine, which was approved for marketing in India in December 1999, has annual sales worth Rs23.7 crore, according to market researcher ORG IMS Research Pvt. Ltd.
The drug is sold in India by at least 10 pharmaceutical companies, including Abbott India Ltd, Cipla Ltd, Glenmark Pharmaceuticals Ltd, Torrent Pharmaceuticals Ltd and Sun Pharmaceutical Industries Ltd.
On 21 January, the European Medicines Agency (EMEA) recommended the suspension of marketing authorizations for sibutramine.
The move came after a sibutramine cardiovascular outcome trial (SCOUT), conducted on 10,000 patients, showed the drug increases the risk of stroke or heart attack.
On 22 January, Mint reported DCGI would call a meeting of the expert committee to decide the fate of the drug in the country.
“In the (Tuesday) meeting, Abbot presented us with data on the drug and we decided to go by that,” Singh said, “since the EMEA is yet to come out with the final outcome of the SCOUT study.”
Last year, India stopped sale of another anti-obesity drug, rimonabant, after it was banned by EMEA.
Singh said he would ask companies to generate data on the drug and submit it to his office if they find evidence of any adverse effects.
FDA is closely following any adverse affects of the drug, though it has not banned it, Singh said.