The centre may soon impose a formal ban on the manufacture and sale of anti-obesity drug, rimonabant, by as many as 17 companies in India, in line with a similar ban in many parts of the world for suspected side effects it can cause.
The Union health ministry has already approved the minutes of the last Drug Technical Advisory Board (DTAB) meeting which had recommended a ban on the drug. The notification in this regard is expected any time now, informed sources said.
The highest drug advisory body, in its last meeting a couple of months back, had advised the Drug Controller General of India to take necessary steps to ban rimonabant and send instructions to the state licensing authorities to stop its production. However, the move got stuck following the long delay in the approval of the minutes of the DTAB meeting. The minutes, sent to the health ministry top brasses were sent back to be distributed among the members of the body again for further clarifications if any. Thus the minutes were again sent to the ministry after vetting by the members and were approved finally, sources said.
The drug, originally from global pharma giant Sanofi Aventis, faced 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 predicatement in the developed countries. In India, companies including Sun Pharmaceutical, 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 in December took up the issue before passing it for further action by the DTAB.
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. But a formal ban by Indian authorities would make sure that all versions of the drug would go off the shelves in the country very soon.