In the cutthroat business of generic drug manufacturing it’s the little things that can bolster a company’s bottom line—like fabricating data about quality instead of fully testing products. Some major drug plants in India that exported medications to the U.S., it seems, did just that.
Such shoddy practices can lead to medicine that does not perform as it should or, worse, causes harmful side effects. In recent years these kinds of incidents have prompted the U.S. Food and Drug Administration to place bans on several prominent drug suppliers in India. To follow up, FDA Commissioner Margaret Hamburg is going to India this week to meet with its health minister and industry officials. India’s drug and food programs will be at the top of the agenda, according to the FDA. India is currently the second-biggest drug provider, after Canada, and the eighth-largest exporter of food products to the U.S.
The meeting comes shortly after the U.S. curbed imports at yet another plant belonging to Ranbaxy Laboratories, Ltd., India’s largest drug manufacturer and one of the largest U.S. suppliers. Last month the FDA banned a Ranbaxy plant from producing or distributing drug ingredients for the U.S. market; the firm was caught retesting materials to produce acceptable findings after they had failed the first time around. The company had neither investigated nor reported why the products failed initially, the FDA says. Since 2008 the FDA has issued four bans against Ranbaxy plants. At present, no Ranbaxy human drug products are being imported into the U.S. The company has already pleaded guilty to federal drug safety violations as part of a $500-million settlement with the FDA, after a whistleblower from inside Ranbaxy came forward. Separately, Ranbaxy has experienced other quality and control lapses, one of which allowed pieces of glass to get into its generic Lipitor tablets in 2012. Ranbaxy is not the only Indian company that has been cited for sending flawed products to the U.S. Wockhardt and RPG Life Sciences have also received FDA admonishments.
Some critics have blamed lackluster FDA inspection practices for the mishaps, noting that although the FDA inspects domestic plants every two years, it only inspects foreign plants about once every seven to 13 years. In fiscal 2009, for example, the FDA inspected 1,015 domestic establishments but only 424 in all foreign countries combined. FDA data indicates that in 2013 the agency performed 111 inspections at Indian drug facilities.
Simply ramping up the number of FDA inspections overseas would not solve the problem, however, says Roger Bate, a scholar at the American Enterprise Institute who studies the drug market. More unannounced inspections in India, along with testing products these plants send to the U.S. would help, he says, but any watershed changes would need to be fueled by the Indian government. The power to inspect and shut down facilities rests with each state in India, and some states are more diligent than others, he says. He notes that empowering India’s Central Drugs Standard Control Organization—equivalent to the FDA—to take action would help address the issue.
Commissioner Hamburg’s eight-day trip will apply needed pressure to the Indian government to crack down on the problem, Bate says. Hamburg is slated to take up food and drug safety issues during meetings with the CEOs of major drug and food producers and with India’s ministers for Commerce and Industry, Health and Family Welfare, and the drug controller general as well as state-level regulators.
She will also be meeting with World Health Organization officials and speaking at the World Spice Congress. India supplies nearly one quarter of the spices, oil and food colorings used in the U.S., but an FDA evaluation last fall found that some of the Indian spices were contaminated. Just one of many findings: almost 9 percent of the 1,057 spice shipments from India were laced with salmonella.
(For more data on what’s in your spices check out Graphic Science in the March edition of Scientific American.)