India Bans Actos – and the Industry Wonders Why | Levin Papantonio Rafferty - Personal Injury Law Firm

India Bans Actos – and the Industry Wonders Why

In June, the government of India joined those of France and Germany in banning Takeda's flagship diabetic treatment, pioglitazone – better known as Actos, which as been strongly implicated in placing patients at an increased risk of developing bladder cancer. According to a media source in that country, the reason was “the [Indian] Health Ministry’s commitment to a parliamentary committee that it would immediately suspend medicines not allowed for sale in major international markets.”  

That is not good enough for Big Pharma in that country, which market their own generic version of the popular medication. Sun Pharmaceuticals and Lupin Ltd.,  both of which are based in India, have raised objections, alleging that the ban was not grounded in scientific evidence – and the Drugs Controller of India (DTAB) failed to follow its own established procedures in banning potentially harmful medications.  D.G. Shah, who is the secretary general of the Indian Pharmaceutical Alliance (IPA), is demanding that the government agency review the decision. If the DTAB does not reconsider the ban, the IPA is considering legal action.

Lupin president Shakti Chakraborty was quoted in the India, defending pioglitazone as he pointed out that  the medication  “ in use in most advanced markets of the world, be it the US, Japan or the UK.” The DTAB has agreed to reconsider its decision if India's pharmaceutical industry “submits enough scientific evidence in favour of the drug .”


Dey, Sushmu. “Drug Makers Oppose Ban on Diabetes Pill.” Business Standard, 3 July 2013.

McCoffrey, Kevin. “Why India's Actos Ban Has Even Local Firms Puzzled.” Medical Marketing and Media, 8 July 2013.

Staton, Tracy. “India Yanks Takeda's Actos on Safety Concerns.” Fierce Pharma, 27 June 201

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