Last year, the U.S. Food and Drug Administration ramped up its attention to China after focusing on India the last couple years. FDA inspectors at Zhejiang Hisun Pharmaceutical found deleted records that might show a drug was impure, disappearing audit trails, and a worker who ran instead of handing over what looked like a computer memory stick. The problems in India are exemplified by one of the country’s biggest generics makers, Ranbaxy, now owned by Sun Pharmaceutical. Ranbaxy paid a $500 million fine in 2013 to settle charges that it sold adulterated drugs and lied to the FDA. Later, the agency banned imports from a Ranbaxy factory where workers hid failures on quality tests by repeating them until they got acceptable results. In factories run by another drugmaker, Wockhardt, inspectors found urine spilling over open drains and mold growing in storage areas for raw materials. The FDA has said it will expand its offices in both countries, though the process has been particularly slow in China where the government held up visas for new workers. The FDA is also conducting the first widespread evaluation of the safety and quality of generics, whether made abroad or at home.
Generic drugs took off in the U.S. during the 1980s with the passage of the Hatch-Waxman Act, which made it easier and cheaper to bring a drug to market. In the 90s, generic production proliferated in India and China, where manufacturing can cost half as much as in Europe or the U.S. But regulation and oversight didn’t keep up. In the face of the rapid rise of generic-drug imports, regulators have adopted different approaches. The European Union mandates batch testing, where a sample from each shipment is tested before it can be released for sale; the FDA focuses on inspections and doesn’t do spot tests, although the FDA and the European Medicines Agency in 2013 agreed to share information on inspections and safety studies. Concerns with generics aren’t limited to India and China: in 2012, Teva Pharmaceuticals of Israel pulled one version of Wellbutrin after regulators said it wasn’t the same as the brand-name medicine.
While the FDA’s critics are pleased by its plans to add staff and step up overseas inspections, they think more needs to be done. Some experts would like doctors and patients to be given more information on where drugs come from. One argument is that the key to safer generics is for overseas drugmakers to take responsibility for implementing the necessary quality-control procedures and local regulators to develop the expertise needed to enforce them. That may improve India’s U.S. exports but not benefit all patients. G.N. Singh, India’s top drug regulator, told India’s Business Standard that if he had to impose U.S. standards on factories making drugs for the Indian market, “we will have to shut almost all of those.”
The Reference Shelf
- The FDA’s FAQ for consumers on generic drugs.
- A history of generic drugs from U.S. Pharmacist.
- Consumer Reports reviews safety concerns about generic drugs from India.
- An article in Fortune about Ranbaxy and the charges that led to its $500 million settlement.
- A paper on India’s drug industry and the political and economic issues behind its safety problems by Searching for Safety, a nonprofit group.
First published May 6, 2014
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Lisa Beyer at firstname.lastname@example.org