Toxic Waste Exposure Is the High Price Developing Countries Pay to Produce Our Medicine

Hazardous imports have been the top story on the evening news for weeks now. But the poor quality of some foreign-made products is only half the story. Before we ever see those products, manufacturing plants in the countries of origin can pose an even greater danger to human and ecological health.

Take India, which is now our biggest foreign source of pharmaceuticals. A just-published study by Sweden's Goteborg University shows that, whatever the quality of the drugs being shipped out of India, they are leaving behind a toxic mess. Even after days in a water-treatment plant, effluents discharged into streams and rivers in one Indian region show concentrations of antibiotics and other drugs at 100 to 30,000 times the levels considered safe.

In a 2005 story, I described the devastation of water, land and human health that I saw in the area around Patancheru, India -- damage that local villagers, doctors and environmentalists attribute to pollution from the 90 or more bulk-drug factories in the vicinity. State law says that the factories must haul their toxic wastes to an effluent treatment plant run by Patancheru Enviro Tech, Ltd. (PETL) on a tributary of the Nakkavagu rivulet. The treatment plant's outflow into the Nakkavagu (which waters a valley dotted with 14 villages) has often been found to carry industrial pollutants at many times the statutory limits.

Now the Swedish study, recently published online by the Journal of Hazardous Materials (abstract here free) has found record-breaking concentrations of 11 drugs -- antibiotics and treatments for high blood pressure, ulcers and allergies -- in wastes flowing from the PETL plant.

Noting that "to the best of our knowledge, the concentrations of these 11 drugs were all above the previously highest values [ever] reported in any sewage effluent," the authors singled out the antibiotic Ciprofloxacin (Cipro), which flows out of the plant at the rate of 100 pounds of active ingredient per day. That, say the authors, "is equivalent to the total amount consumed in Sweden (population 9 million) over an average five-day period"!

Concentrations of five other antibiotics were found at levels that are toxic to plants, blue-green algae and a range of bacteria. And before it leaves the facility, the stew of drugs is mixed with human sewage, creating perfect conditions for breeding dangerous, antibiotic-resistant bacteria.

In June, a front-page story by Washington Post reporter Marc Kaufman revealed that there are virtually no controls on the quality of drugs being imported from India. He wrote that India and China together supply as much as 20 percent of the U.S. market for generic and over-the-counter drugs and 40 percent of all bulk drugs used here, and that the two nations' share may rise to 80 percent by 2022. India's share of the U.S. market in 2006 was $800 million, exceeding China's.

According to Kaufmann, the FDA conducted 1,222 quality-assurance inspections of domestic drug-manufacturing plants in 2006. That same year, the agency carried out only 32 inspections of Indian drug plants, mostly to check on new import applications, not for quality control by existing suppliers. And "on-the-ground inspections of Indian and Chinese plants remain rare and relatively brief and are always scheduled in advance, unlike the surprise visits that FDA inspectors pay to domestic manufacturers." There is no indication that FDA inspectors pay any attention to environmental impacts of the plants.

The Swedish researchers calculated that if the quantities of pharmaceuticals they detected being released from the Patancheru treatment facility in a single 24-hour period could be collected and sold in Sweden, they would fetch an amount approaching $200,000, even in generic form. But, they wrote, because the production costs are so much lower than the eventual retail price, it is cheaper for companies to waste the drugs than to invest in pollution control.