Drug Technical Advisory Board has recommended a ban on the use of anti-obesity drug, 'Rimonabant', in the country for the possible side effects it can cause.
The highest drug advisory body, in its meeting recently, has advised the Drug Controller General of India to take steps to ban Rimonabant and send instructions to the state licensing authorities to ask the manufacture to stop its production and take steps for issuing notification by the health ministry to formally ban the drug in the country, it is learnt.
The drug from global pharma giant sanofi-aventis faces the ban as the studies showed that it had serious psychiatric side effects including the suicidal tendencies. The drug, a potential blockbuster, was launched in Europe in 2006, but faced similar predicament in the developed countries. However, many Indian companies including Sun Pharma, Torrent Pharmaceuticals, Zydus Cadila and Ranbaxy, have been into the manufacturing of its generic version.
Following the European drug regulator's recommendation, the National Health Regulator had issued notification banning the drug recently and the DCC in its meeting took up the issue before passing it for further action by the DTAB. The central drug authorities have also communicated to some States to make sure that Rimonabant was not produced. But it had not recommended a call back so far.
Sanofi-aventis had already stopped the sales of the anti-obesity drug called Acomplia throughout Europe, in view of concerns that the medicine entailed more risks than benefits for those taking it. The French company had also announced that it would not take the same drug to other countries also. In 2007, the United States Food and Drug Administration (FDA) had banned the anti-obesity drug based on manufacturer's studies that revealed Acomplia increased the risk of the patient developing depression, anxiety and stress disorders.
The European Medicines Agency, after its study, has also revealed that overweight or obese people who had been treated with Acomplia were at a double the risk of suffering from psychiatric problems than a group of patients who had been given a placebo instead for their condition.