India Removes Takeda’s Actos from Market due to Safety Concerns

India’s recent decision to ban three drugs from their market without giving any explanation has local drug makers confused.

Two weeks ago, India’s regulators banned Takeda’s diabetes treatment, Actos, as well as two other older treatments: an anti-depressant, Deanxit, and the painkiller Analgin. Reports say that the ban was “triggered by the health ministry’s commitment to a parliamentary committee that it would immediately suspend medicines not allowed for sale in major international markets.”

Prior to the ban, the drug was available in India as a generic from various manufacturers: Dr. Reddy’s, Sun Pharma, and Ranbaxy.

This move follows the April 1st decision by the Indian Supreme Court to deny a patent for Novartis’ cancer blockbuster Glivec (marketed as Gleevac in the U.S.)

Sun Pharma and Lupin claim that the regulator, the Drugs Controller General of India (DCGI) issued the bans without proper consultation with the Drug Technical Advisory Board.  D.G. Shah, secretary of general of the Indian Pharmaceutical Alliance said, “We are demanding a review. A ban has to be based on science or scientific data.”

If the ban stays in place, Indian companies could potentially lose 700 million rupees ($11.5 million) in sales. Dr. Reddy’s, Sun Pharma, Lupin and Ranbaxy all stand to be affected. Lupin group president Shakti Chakraborty, told The Business Standard, “this drug is in use in most advanced markets of the world, be it in the U.S., Japan or the U.K.  I believed the DCGI has invited comments and responses from the industry and it should come up for review.”

Lupin currently sells various combinations of pioglitazone, the main ingredient in Actos, which has been linked to bladder cancer.

The government is now looking closely at banning drugs prohibited in the U.S., U.K., Canada, Japan, the EU or Australia.

Analgin, sold in India by Sanofi and a few other generic manufacturers, was barred from sale in Sweden 36 years ago. France, Japan and Australia have pulled the drug, as well.

Deanxit, the anti-depressant made by Danish drugmaker Lundbeck, was previously banned in the company’s home country. The health ministry postponed suspending those medications for years, despite pressure from Parliament, IndiaToday reported.

Although studies have linked the diabetes drug, Actos, which is in the same class as the controversial drug Avandia from GlaxoSmithKline, to an increased risk of bladder cancer, it is still used worldwide. France and Germany have banned the sale of Actos, but it is still available in the U.S.  The Food and Drug Administration (FDA) has reviewed evidence and added a bladder cancer warning to the drug’s label. A previous black-box warning – the highest warning given by the FDA – highlights the risk of congestive heart failure.

Before Actos went off patent in the U.S. last August, safety concerns began to erode the sales of Actos. In any case, Actos sales brought in 122.9 billion yen for Takeda last year, which is about $1.5 billion, down from $4.3 billion in 2010.  Sales have sharply declined on generic erosion, causing Takeda to restructure their company by laying-off workers and cutting costs to survive.  There are more than 10,000 lawsuits pending over the safety of Actos in the U.S.

The market for Actos in India, as well as its generic market, amount to approximately one billion rupees, or $116 million.  This ban not only will affect Takeda but other India-based companies including Ranbaxy Laboratories, Wockhardt and Sun Pharmaceutical Industries, as well.

Feel free to contact one of our Gacovino Lake attorneys at 1-800-246-HURT (4878) for more information.

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