Indian drugmakers are fighting the country's new ban on the diabetes drug pioglitazone, otherwise known as Actos. Regulators suspended sales of the drug last week, citing safety worries, including concerns about an increase in the risk of bladder cancer.
The drug is a popular one in India, and several Indian drugmakers sell plenty of its generics. And those companies are up in arms, claiming that the government didn't follow its own procedures for suspending a drug. "We are demanding a review," said Indian Pharmaceutical Alliance chief D.G. Shah (as quoted by the Business Standard). "A ban has to be based on science ... [and] it has to follow a proper process."
Shah says the government was supposed to consult the industry before deciding to ban pioglitazone. If officials don't allow a consultation with drugmakers now, then the association may sue to challenge the ban. Among the domestic pharma companies affected by the ban are Lupin, Sun Pharmaceutical, Ranbaxy Laboratories and Dr. Reddy's Laboratories.
Actos has run into safety problems in other countries, though few have pulled it from the market. France and Germany suspended its sale in 2011, for instance. The U.S. FDA conducted a new review after studies highlighted potential links with bladder cancer, but ended up backing the drug. Actos already has a black-box warning of heart failure risks on its label.
Indian officials say they're willing to reconsider, if that proves appropriate. "We can review the order if the industry submits enough scientific evidence in favor of the drug," one official told the Standard.
- read the Standard article