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Generic Pharmaceuticals Brush Aside FDA Panel’s Rejection

Despite of the FDA’s advisory panel refusal to endorse acomplia for sale in the U.S, the  
Indian pharmacies, which recently launched their own generic equivalents of the drug, seem resolute to not extract their generic versions from the market. All Indian pharmacies still have a firm faith in the safety of the drugs and thus have not planned for any voluntary withdrawal.

The companies averred that they have planned to wait until the government takes any step. Health ministry officials declared that they would inspect the matter and would provide a hearing to both the innovator and the generic pharmacy before taking up a call. The Indian administration has provided approval for sale to six companies including innovator Sanofi Aventis, Zydus Cadila, Sun Pharma and Torrent Pharmaceuticals which introduced the “breakthrough weight-loss drug” in May.

“We will study the available text on this drug. Under our pharmaco-vigilance programme, we will analyze all overseas developments and their subsequent repercussions on Indian customers. In accordance with the principle of natural justice, we would offer a trial to both the innovator and the generic company,” said Drugs Controller General of India, Dr Venkateswarlu.

Meanwhile, the Paris-based drug maker Sanofi Aventis announced that the company would tender sufficient data to the U.S. Food and Drug Administration (FDA) for the drug’s approval. The U.S. FDA’s Endocrinologic and Metabolic drugs advisory committee had unanimously rebuffed acomplia’s approval last week citing adverse physiological effects.    The panel alleged that the drug’s benefits do not prevail over its psychiatric risks.

The French drug maker had earlier anticipated that the preparation would be able to engender sales of $3.5 billion by 2012. At present, acomplia is approved in the UK and few other countries along with proper advices with regard to its psychiatric side effects.

Indian Pharma experts opine that the US committee’s judgment is fine as an instant decision, but the U.S. FDA’s final verdict is more important to Indian pharmaceuticals.  There have been incidents in the past wherein the Indian regulator permitted companies to sell those drugs that were accepted in some European countries but not in the US.

Ahmedabad-based Torrent Pharmaceutical, which is marketing the drug as Rimoslim, is expecting the sale of Rs 10 crore in the very first year of its product launch and has no plans to draw out the medicine from the market. Torrent Pharmaceutical V-P marketing Ruchir Modi said: “The drug is absolutely safe. We have already carried out our own clinical tests in more than 100 patients and the outcomes have been hopeful. However, we will consider directions of the drug controller general of India’s (DCGI).

Mumbai-based Sun Pharma also asserted that the company will mull over the regulator’s regulation. “The remedy has been accepted in a number of European countries and no country has extracted it so far”, said a company spokesperson.