Pharmdog Millionaires, continued: Stan Cox on India's "Dirty" Drug Business

I'm glad to know that our good friend Girish Malhotra is also covering this critical issue of pharmaceutical pollution in the Patancheru economic zone in India. As usual, Malhotra does not dwell on problems but focuses on proactive solutions. In his typical fashion, he sees these solutions as being within reach with a little creativity and focus. Malhotra says, "If the manufacturing processes can be improved, depending on the total capacity of the quinolone plants in Patancheru area, significant quantities of ciprofloxacin instead of going to waste water and solid disposal can be recovered as a product."

Thanks to the much publicized study by researchers in Sweden, the problem of drug manufacturers’ polluting Patancheru (near Hyderabad) has become a hot-button issue, and a chance for the pharmaceutical industry in India to reflect upon its unbridled growth. A key snippet from that study:

The discharge load of ciprofloxacin corresponds to approximately 45 kg of active pharmaceutical ingredient per day, which is equivalent to the total amount consumed in Sweden (population nine million) over an average 5-day period.

Of further concern is that the industrial effluent is mixed with human sewage within the plant to improve biological treatment efficiency. Hence, there is a risk that pathogens will be exposed to antibiotics for prolonged periods. Ciprofloxacin is genotoxic and induces horizontal transfer of resistance between different species of bacteria, effects that may be observed at concentrations as low as 5–10 μg/L . . . Therefore, the recipient waters and the treatment plant itself may be spawning grounds for resistant bacteria. One may also anticipate a reduced overall performance of the plant due to the expected toxicity of the pharmaceuticals to the microorganisms within the plant. Moreover, the microbial flora downstream from the plant is likely to be severely affected by the mixture of residual fluoroquinolones. Thus, there are multiple reasons to consider alternatives to normal biological treatment for the removal of high levels of antibiotic residues from wastewater.

Someone very close to the issue is Stan Cox, senior research scientist for the non-profit Land Institute (Salina, Kansas) and a leading authority on issues of pharmaceutical contamination in the developing world. Cox has lived previously in Hyderabad, has written extensively on pollution in India, and is the author of Sick Planet: Corporate Food and Medicine (2008), from HarperCollins-India. I corresponded with Cox, fresh off a recent visit to India, via email regarding the issue.

PhM: What did you learn during this most recent trip to India?

S.C.: The AP story [on pollution at Patancheru] happened to come out while I was there, and I did speak with some of the people I'd  spoken with for Sick Planet. They said very little has changed. The main problem remains the huge volume of production, which overwhelms the local capacity to treat effluents, either at the plants or at the common treatment plant (which is really just equipped for normal sewage). The local edition of the Times of India was spurred by the AP story to do a good 3- or 4-part series in the last week of January, and they found that things are as bad as ever.

PhM: How large is the problem of pharmaceutical pollutants in the rivers (and elsewhere in the environment) in India?

S.C.: The Patancheru area accounts for almost 40 percent of the country's bulk-drug production. I am told that in the states of Gujarat and Maharastra, which are other big producers, wastes are handled better, but I don't have firsthand knowledge. Other localities are infamous for other types of pollution; for example, the area around Tirupur in southern India is badly polluted by the textile industry.

PhM: Until recently, drug makers were not necessarily targeted as a source of pollution in India (and other developing nations). Why was this?

S.C.: Patancheru has been hit with serious pollution since the ‘80s. Until the late ‘90s, it was mainly industries other than drugs, but those companies have been largely displaced by pharmaceutical manufacturers and smaller companies that supply them with intermediates, solvents, etc. There has been a lot of community outcry over Patancheru's pollution for 20 years. (One of the earlier big issues was noxious mercaptan compounds being discharged into the air, apparently from antacid production—a much more obvious nuisance that got people's attention.) Everybody recognizes pollution's a problem there, and the state Pollution Control Board (PCB) says it is enforcing the existing laws, but things don't seem to improve. Industry growth has been so rapid they can't keep up.

When I was writing about it and until the Swedish study in 2007, all that was known was that general pollution indicators in surface and groundwater were much higher around the valley's 14 villages than in areas outside the zone, and people complained of all kinds of symptoms affecting themselves and their animals. That was assumed to be from solvents and other chemicals. Now we know end-products are in the environment as well. So to address your question, there has been continuous low-level concern over pollution by the bulk-drug companies there for a couple of decades, but actual pharmaceutical compounds in the water are a bigger story, so the situation's getting more attention now.

PhM: What’s the root of the problem? Why are drug makers polluting rivers—carelessness, cost savings, lack of regulatory oversight, a combination of these factors?

S.C.: It's a combination, all right! I think it was the Swedish article that pointed out that if they were recovered, the volumes of drugs coming out of that outlet pipe would have a huge dollar value, but apparently the companies feel it would cost more than that to recover them. I spoke with a researcher at nearby Osmania University who says a study she's just completing shows that properly treating their effluents would cost the companies only a very small fraction of their profits. She thinks they just haven't done the calculations and are assuming it would cost them too much.

There are pollution laws, but they don't require testing for the long list of compounds that EPA requires, and certainly don't require testing for pharmaceuticals. So technically, I guess the companies aren't doing anything illegal when it comes to the drugs in the effluent. As I always stress, the number-one problem is the huge and growing production in response to  both domestic and foreign demand, and the 90 or so facilities produce much more effluent than the system can handle properly. The PCB puts limits on daily production by each factory, so as not to overload the Common Effluent Treatment Plant, but local environmentalists charge that they regularly overproduce. They do get fined for it, but I was told the fines are "peanuts" compared to the money they're making.

PhM: Who are these companies in Patancheru? Are they mostly Indian generic firms, or subsidiaries of global firms?

S.C.: I think they are all majority Indian ownership, but as you know, there are now extensive agreements between Indian and Western companies for production of a wide range of products. And some Indian companies are buying U.S. and [Western] ones.

PhM: Is the global pharmaceutical community cognizant of these problems? Is anyone stepping up to take some blame or responsibility for correcting the problem?

S.C.: I don't think there is much awareness at all outside India (but . . . I'd like to know what's happening in China).

PhM: Do multinational manufacturers have the proper mechanisms in place to ensure that their global facilities are being environmentally responsible? If not, what kinds of things do they need to be doing?

S.C.: According to Marc Kaufman of the Washington Post, FDA inspects Indian drugmakers' plants far less often than it does U.S. ones, and announces all visits in advance. They predominantly inspect applicants for new permits, not plants already exporting to the U.S. And of course, they are solely interested in the safety and quality of the end products going out the front gate, not the effluents going out the back. I don't know what the law says can be done, but I know what should be done. EPA or some U.S. entity should make regular inspection trips aimed specifically at environmental practices—and inspect not only the makers of finished products, but their suppliers; the big companies often outsource the “dirtiest” steps.

PhM: Is there a likelihood that any of the polluters in India will be prosecuted? Is there any way that the ramifications will work their way back to the parent companies?

S.C.: Good question. India's having its own economic crisis, which, I believe, will make it that much less likely that authorities will crack down on highly profitable companies. They will continue to fine companies, who will continue to pay. I hope the attention drawn to this by you folks in the U.S. press will shine a bit more light on it. It would be great if U.S. companies would say, "We'd pay a bit more for bulk drugs from India that are certified to have been produced cleanly" (and if that can be ensured).

PhM: What’s the real danger to humans from this contamination? What problems are encountered when drugs enter the water supply? (Please use Cipro or another drug as an example.)

S.C.: The greatest concern with Cipro and other antibiotics is over the potential for selecting drug-resistant bacteria. The effluent from the treatment plant would seem almost ideal for doing that, because it contains those very high concentrations of antibiotics mixed with human wastes. The water coming out of that pipe has been through treatment, but I can tell you it's not clean. It's dark brown and foamy and stinks of both sewage and chemicals.

PhM: What are the broader environmental problems—to fish and wildlife, for example?

S.C.: Having so many compounds with strong biological activity released into that watershed could have effects throughout the food web, starting with microbial populations. Farmers there will show you pictures of their water buffalo that simply dropped dead after grazing and drinking water there. (The companies pay to haul or pipe drinking water into the area for the people, but they use ground and surface water for all sorts of purposes; one farmer told me, "We milk the buffalo and sell the milk, but we won't drink it ourselves!") There is no proof that the pollution killed the animals, but it seems to happen much more frequently there than elsewhere. . . . I recall reading that statistical measures of biodiversity show it to be much lower in that valley than in surrounding areas.

--PWT

 

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  • <p>We have to recognize that active pharmaceutical ingredients are toxic and that is how they kill disease curing bacteria. Problems at Patancheru were detected as Dr. Joakim Larsson published his work. Problem is at every chemical producing site that produces active pharmaceutical ingredients. Laws do not require to meet toxin standards (as there are none) but chemical effluent standards. By the way FDA's plant inspections have nothing to do with looking at their effluent. FDA and other regulatory bodies are more concerned with cGMP rather than the process technology or their efficiency. Many of the reporters sensationalize rather than understand. Processes of API manufacture need significant help. When it is reported in many publications that the conversion yield of many API could be as low as 10% where does the 90% of the material go. Some of it might be recycled but rest is in water or ground. In 2008 Eli Lilly was given a green award when they improved their process. That was the highlight. They did good work but even at this improvement their improved process takes 146 kg of materials to produce ONE kg of product. This is not a efficient process. What and how are the 145 Kg handled should be the question. We have a manufacturing technology issue and it is time we address it. </p>

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  • <p> It is stated by Marc Kaufman of the Washington Post that FDA inspects Indian drugmakers' plants far less often than it does U.S. ones, and announces all visits in advance. This can be construed as FDA is not doing its job and Indian companies are getting away with whatever. Mr. Kaufman and other writers have to understand and clearly state that FDA and other regulatory agencies inspect the plants for "repeatability rather than efficiency". </p> <p> Pollution and toxicology problems are not due to repeatability but due to poor processes. No one wants to understand and recognize it. </p>

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