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.
On analyzing samples of effluents from a wastewater treatment plant serving about 90 bulk drug manufacturers in Patancheru near Hyderabad, capital of the southern Indian state of Andhra Pradesh, the study found concentration of antibiotics and other drugs at 100 to 30,000 times the levels considered safe.
Incidentally Patancheru is dubbed one of the 24 environmental hotspots in the country.
The high levels of several broad spectrum antibiotics found in the effluents raise concerns about resistance development, the Swedish report said and called for increased focus on the potential release of active pharmaceutical ingredients from production facilities in different regions in India.
Activists say that 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," they warn.
In a 2005 Stan Cox of Kansas had described the devastation of water, land and human health he had seen around Patancheru which has emerged as a major production site of generic drugs for the world market.
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 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 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 Food and Drug Administration (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.
Meteorologist Dr. S. Jeevananda Reddy -- a former chief technical advisor to the United Nations and now a campaigner for tougher policies on pollution in the Patancheru area - says that the sheer quantity of drugs that plants are producing means that they pump out far more waste water than the treatment plant can handle.
The state permits each company to dispose of only a certain amount of water per day, and if its chemical concentration is too high, the company is fined. But, said Dr. Reddy, "The fines are peanuts to them." And, of course, the effluent is not even tested for presence of pharmaceuticals. The bulk-drug plants are often producing at two, three, sometimes ten times the permitted capacity.
Reddy has watched as tanker trucks full of effluent from drug factories are turned away by the water treatment plant because their company's daily quota has been exceeded. He says that rather than returning to the factory, the trucks will often head out into the countryside to dump their load. Those wastes would contain, if anything, higher concentrations of pharmaceuticals than seen in the Swedish study.
In 2004 a study by Greenpeace in nine villages in the Patancheru industrial area revealed "abnormally high incidence" of pollution-related diseases like cancer, respiratory and heart diseases caused by "cocktail of poisons in air, water and land".
Releasing the report, "State of Community Health at Medak district", Bidhan Chandra Singh and Sanjiv Gopal, Principal Research Investigator and Campaigner respectively of Greenpeace India, said the comparative study was significantly different from previous studies in that it had a large sample size of 10,874 people. Of them 8925 were from the nine study-group villages exposed to industrial pollution for over two decades and 1949 in the four control group villages having no industry.
Clinically confirmed cancer was found to be 11 times higher in the study group. Respiratory diseases affected one in every 20 persons. Heart diseases were 16 times higher. Congenital malformations and chromosomal abnormalities were 3.93 times higher.
When it comes to systemic diseases it was no better. Diseases of the nervous system were three times higher and circulatory system two times higher.
Those of endocrine, nutritional and metabolic systems were 1.84 times higher. Disorders of blood and blood forming organs were 2.9 times higher and those of skin.
In the light of the findings, the Greenpeace activists demanded immediate health assistance to community and long-term medical rehabilitation of affected persons. A state of chemical crisis should be declared in the area and ensure that the industry practices zero discharge of toxic effluents into water bodies. The industries should also be made to disclose to the community all the details of health effects of chemicals used in industrial products and processes and the wastes generated.
But nothing seems to have happened, if anything the situation has only deteriorated.
"So when we're raising the alarm over hazardous toys, food and drugs imported from China, India or other countries, it's important to remember that it's our own insatiable demand for those cheap products that pushes manufacturers into using slapdash practices -- and that it's people living and working downstream or downwind from the foreign factories who could well be paying the highest price of all," notes bitterly Stan Cox.