Although the Drugs Controller General of India (DCGI) banned the sale of anti-obesity drug, rimonabant, produced and marketed by 17 drug companies more than a fortnight ago, the products are still being sold in most parts of the country, it is learnt.
DCGI issued the ban order last month and top companies drug companies such as Zydus Cadila, Ranbaxy, Sun Pharmaceuticals, Cipla and Torrent Pharmaceuticals were in dilemma as they had the bulk of the market share. The decision was taken on the backdrop of a recommendation by the European Medicines Agency (EMEA) to its member countries to ban the rimonabant formulations, which reportedly caused serious psychiatric side effects including suicidal tendencies.
Though most of the manufacturers have stopped manufacturing the drug following the order from the DCGI, the drug regulator is yet to officially inform the state drug control authorities. Therefore these products are still available in the market and may continue to be there till the stocks last.
Higher officials from at least four state drug regulatory offices have confirmed that they have not received any official intimation from the DCGI on the action to be taken against the anti-obesity products. "We are not aware, under which section the action is taken by the DCGI and we have not received any official letter from him regarding this," said a higher official from Maharashtra State Food and Drug Administration (FDA).
Even if the immediate action is taken directly by him, the usual procedure is that the order should be published in the gazette and brought under Section 26A. The DCGI will then send a letter to the state drug control offices which will support them to monitor the successful implementation of the order, added the official.
The authorities will then inspect the manufacturing site to ensure cessation of manufacturing of rimonabant. The companies should have to withdraw the product from the top level of distribution chain, including the C&F and the stockist level, even though they will be allowed another six months to one year time period to sell out the remaining stocks in the distribution chain to the market.
"We came to know about the action from the media and have received official intimation from major companies like Sun Pharma and Cipla about curbing of supplies of the product. But many of the products are still available in the market and the manufacturers other than these two companies have not informed us about the manufacturing status of their product," said a wholesaler who is dealing with rimonabant products from four companies.
"As far as we know, once the license of the product is cancelled, the batches of the product in the market should also be withdrawn in due course. Any delay in this action is a problem with the drug recall system of the regulatory authority in the country," said the trade source.
As per the industry sources, the anti-obesity market in India is estimated at nearly Rs 15 crore. Sun Pharma with its two brands - Riobant and Riosity - and Zydus Cadila with Slimona brand are the major players in the rimonabant market in India. Riomont from Cipla, Rimoslim of Torrent pharmaceuticals and Rimobest from Aristo Pharmaceuticals are the other rimonaband generic brands available in the country.