The Dark Side Of Indian Drug-Making

It’s rare for a stream near a public road to smell as if it’s a cocktail of industrial chemicals. But this is what water smells like in a stream next to a pharmaceutical plant in Patancheru, a rural area near Hyderabad, India’s main production base for pharmaceutical chemicals.

“Tankers dump effluents randomly near the villages around here,” asserts Lakshmir Narayanah, the owner of a small grocery shop who heads a water-users association in Patancheru. “The pipes in our wells corrode, the water smells bad, and we can’t even use it for washing ourselves.”

In 2007, Patancheru gained international notoriety after a study by Swedish researchers showed that water in the area was heavily contaminated by antibiotics. The state and national governments quickly promised to look into the problem and fix it, but there is little evidence so far that officials have made substantial changes, other than to ban new plants from setting up in the district.

China and India have become major global suppliers of active pharmaceutical ingredients (APIs), particularly for generic drug formulations. By 2012, a study from the Indian consulting firm Cygnus finds, India will be the world’s second-largest producer of antibiotics and other bulk drugs after China. Hyderabad, India’s API capital, is home to the corporate headquarters of major producers including Aurobindo, Dr. Reddy’s Laboratories, and Matrix Laboratories. About 300 plants produce APIs in the Patancheru district, 20 miles from Hyderabad in the state of Andhra Pradesh.

In the 2007 paper, Joakim Larsson, an associate professor of physiology at the University of Gothenburg, and colleagues described surprisingly high concentrations of antibiotics found in supposedly clean Patancheru water. Samples taken from water discharged from a local effluent treatment plant indicated that the facility was releasing about 45 kg of the antibiotic ciprofloxacin into the Patancheru environment on a daily basis, “which is equivalent to the total amount consumed in Sweden (population 9 million) over an average five-day period,” the authors wrote.

The major problem with releasing antibiotics into the environment, Larsson tells C&EN, is the risk that human pathogens could become increasingly resistant to antibiotic treatment. “I am most concerned about the global implications in terms of health risks of these releases,” he says. In a paper published in early 2009 in Regulatory Toxicology & Pharmacology with coauthor Jerker Fick, Larsson noted that human and industrial waste commingle in Patancheru’s water treatment plants (DOI: 10.1016/j.yrtph.2009.01.008). During treatment, domestic sewage is added to industrial waste, and clarified effluents are released into local rivers. What concerns Larsson is the quantity of antibiotics and antibiotic-resistant bacteria left in the effluents, which humans can come into contact with.

Producers in Patancheru have done little to reduce their emissions of antibiotics because they are under no pressure to do so, Larsson contends. “Producers are not regulated on the toxicity of their effluents or on the pharmaceuticals in their effluents, in India or elsewhere,” he says. “Even if they comply with regulatory standards, it’s irrelevant to the issue of pharmaceutical release.”

For local residents, the problem is larger than the efficacy of the industrial water treatment process. Residents of Patancheru, where farming still goes on, say they’ve seen almost no improvement in the environmental performance of local producers, or in enforcement by government officials, since 2007.

Vankatesh, who goes by one name, is the general secretary of the Youth Against Pollution Committee, an environmental organization based in the Patancheru village of Khajipally. He says his group organizes sting operations to stop tanker trucks from illegally dumping waste in the area. Last summer, Vankatesh says, the group handed over to local authorities a truck driver whom they had caught about to dump waste illegally. “There was no follow-up by the police or the Andhra Pradesh Pollution Control Board; the truck driver was released,” he recalls.

Within India, Patancheru has long been notorious for serious environmental pollution. Anil C. Dayakar, founder of the Hyderabad-based activist group Gamana, says his group has so far launched 15 public interest lawsuits against local drug companies, many of which are based in Hyderabad. The Andhra Pradesh Pollution Control Board, he claims, has been so ineffective in combating pollution in Patancheru that the only solution is to control companies by court orders.

But at the Hyderabad-based Bulk Drug Manufacturers Association (India), an official who asked not to be identified because he’s not authorized to talk to the media asserts that Patancheru API producers have together invested $55 million in pollution-control equipment in recent years. As a result, “pollution is not there at all,” he says.

According to this official, all remaining pollution in Patancheru is from household sources. “Fermented sewage smells a lot like industrial chemicals,” he argues. He further claims that Larsson’s research is financed by foreign-based pharmaceutical producers competing unsuccessfully with India, a claim that Larsson flatly denies.

Besides, this official asserts, it’s next to impossible to produce pharmaceuticals without polluting. “Do you think there is no pollution in Italy?” he asks, referring to another major API-producing country. “You cannot generate a product without generating effluents, and the question is how those effluents are treated. In Patancheru, the effluents are treated, reused, and disposed of safely.”

From outside India, there is so far little pressure on Hyderabad-area firms to improve their environmental performance. U.S. pressure on Indian pharmaceutical ingredients producers is unlikely, according to Peter Saxon, a New Jersey-based consultant who advises drug companies on regulatory compliance. The problem, he says, falls in a crack between the U.S. Food & Drug Administration and the Environmental Protection Agency. “FDA has no jurisdiction,” he says. “Environmental impact is handled by EPA,” which doesn’t inspect foreign manufacturers.

The international code of Good Manufacturing Practices, which pharmaceutical producers must follow to sell in developed countries, focuses on product quality and does not extend to the environmental realm. It would take at least five years for the code to be modified, says Chris Oldenhof, manager of external regulatory affairs at DSM and president of the API committee of the European Chemical Industry Council, a trade association. At present, he says, only a few leading companies, including DSM, have opted to voluntarily provide environmental audits to their customers.

Two major counties in Sweden have started to require environmental emission information when procuring pharmaceuticals, says Larsson, the researcher. He’s encouraged, because Sweden has traditionally played an influential role in global environmental trends. “Of course, at the moment, this represents a minute part of the global drug market,” he concedes.

Last January, India’s central government declared a ban on new industrial investment in Patancheru after an environmental survey showed the area to be critically polluted. As a result, API producers have been building their new facilities in Vizag, Andhra Pradesh’s second largest city, says Dayakar, the environmental activist. To get rid of their effluents, he says, companies have set up a pipeline into the sea. “Vizag is now just as bad as here,” he says. “In Patancheru, they hurt the farmers. In Vizag, industry harms fishermen.”