Friday, June 25, 2010

Bulk Dug Industry Spewing highest Drug Levels into Water Bodies


  Why Andhra Pradesh (India) a Bulk Drug Hub?

     The developed countries have set strict limits and enforce them ruthlessly, on more than 30 chemical compounds and their toxicity in the effluents discharged by the industries making Bulk Drugs, technically known as "active pharmaceutical ingredients": raw materials for pills, capsules, etc. When it comes to the cost of patented prescription drugs in the United States, the sky's the limit. But in the global bulk-drug market, low cost is the name of the game.


    The polluting industries like Bulk Drug/Drug Intermediates are moved from developed to developing countries, being environmentally dirtier process. Because of laxity in enforcement, instead of monitoring various chemical compounds and their toxicity in the effluents, only the total quantity of pollutants is tracked, with almost no information on specific toxic compounds. It is serious, because some of the drug industry's solvents, byproducts, and ingredients can harm people even at low concentrations. As market competition is fierce in bulk drug industry, corner cutting on waste treatment is rampant.

Magnitude of Pattancheru Pollution

     The seriousness of the pollution problem from bulk drug industries at Pattancheru near Hyderabad is highlighted in 2007, by Joakim Larsson, an environmental scientist at the University of Gothenburg in Sweden. When he analyzed vials of treated wastewater taken from CETP Pattancheru (PETL), where about 90 bulk-drug industries dump their residues, he found the discharge load of Ciprofloxacin, corresponding to approx 45 kg of active ingredient per day. This is equivalent to the total amount of Ciprofloxacin consumed in Sweden (population 9 Million) over an average 5 day period.

     And it wasn't just ciprofloxacin being detected. The supposedly treated wastewater of PETL has 21 different active pharmaceutical ingredients, used in generics for treatment of hypertension, heart disease, chronic liver ailments, depression, gonorrhea, ulcers and other ailments. Half of the drugs measured at the highest levels of pharmaceuticals ever detected in the environment, researchers say.

  In economical terms, if the equivalent amount of the 11 most abundant active substances released by PETL during 24 hrs were to be purchased as final products in a Swedish pharmacy, they would cost over 100,000 British Pounds.

   The Associated Press (AP) reported that the so called treated wastewater from PETL contained 150 times the highest levels detected in the U.S. Before Larsson's study detected such large concentrations of ciprofloxacin and other drugs in the treated wastewater, the levels of pharmaceuticals detected in the environment and drinking water worldwide were minute, well below a human dose.

Adverse Impacts of Pharmaceutical Contamination


     The pharmaceutical contamination is an emerging concern worldwide. The medicines are excreted without being fully metabolized by people who take them, while hospitals & health-care facilities annually flush millions of Kgs of unused/expired pills down the drain. Until Larsson's research, there had been widespread consensus among researchers that bulk-drug makers were not a source.

  As the AP reported, researchers are finding that human cells fail to grow normally in the laboratory when exposed to trace concentrations of certain pharmaceuticals. Some waterborne drugs also promote antibiotic-resistant germs, especially when- as in PETL- they are mixed with bacteria in human sewage. Even extremely diluted concentrations of drug residues harm the reproductive systems of fish, frogs and other aquatic species in the wild. Experts say one of the biggest concerns for humans is whether the discharges from PETL is spawning drug resistance.

  "Not only is there the danger of antibiotic-resistant bacteria evolving; the entire biological food web could be affected," said Stan Cox, senior scientist at the Land Institute, a nonprofit agriculture research center in Salina, Kan. Cox has studied and written about pharmaceutical pollution in Pattancheru. "If Cipro is so widespread, it is likely that other drugs are out in the environment and getting into people's bodies."

     The more bacteria is exposed to a drug, the more likely that bacteria will mutate in a way that renders the drug ineffective. Such resistant bacteria can then possibly infect others who spread the bugs as they travel. Ciprofloxacin was once considered a powerful antibiotic of last resort, used to treat especially tenacious infections. But in recent years many bacteria have developed resistance to the drug, leaving it significantly less effective.

Regulation & Control of Contamination

  Before Larsson's team tested the treated water at PETL, researchers largely attributed the source of drugs in water to their use, rather than their manufacture. In the U.S., the EPA says there are "well defined and controlled" limits to the amount of pharmaceutical waste emitted by drug makers.

  But in AP State, the Regulator (APPCB) & the Bulk-Drug Industry are invariably in a denial mode. They say standards have now been tightened & are being met and hence the screening for the residues & their toxicity at the end of the treatment process is not required, as per the Schedule-I (S.No.55) of the Environment (Protection) Rules, 1986


There is no incentive to Bulk-Drug industry in India, to minimize the release of certain drugs into waste waters, requiring substantial investments, because of high profit margin- high value of final product compared to much lower production cost of bulk-drugs, which is reported to be around 15% of the cost in developed countries, by externalizing environmental costs on to the society.

 Because of laxity in enforcement of rules and standards, the non-compliance has become a high-profit business. The contamination can only be prevented, when non-compliance is made high-risk business by heavy penalties and stringent & speedy penal action. The other aspect is restriction on the use of water, being liberally used for dilution and charging the water reasonably high, like any other solvent used by the bulk-drug industry.

 Shifting the Problem from PETL (18 Km Pipeline)


     The Minister of State for Environment & Forests, Govt. of India, is reported to have complimented APPCB &PETL for commissioning 18 KM pipeline for transferring PETL treated effluents to surface-water standards to Amberpet STP & discharging into Musi. He is also reported to have stated that this will minimize water pollution at Pattancheru.


   The following remain unanswered regarding the performance of PETL & Pollution Loads:


a) The Swedish Environmental Scientist pointed out that the process of water treatment  plant of PETL is outdated and the treated water, though
     free from suspended solids and clarified, is still contaminated. How is it ensured that the discharges from PETL into 18 km pipeline are free
     from traces of toxic pharmaceutical ingredients and conform to inland -surface water standards? 


b) If the outlet standards, applicable for discharge into inland surface waters, are being  met by PETL, why not the treated effluents from PETL,
    be utilized by the member  industrial units in Pattancheru Area? What is the need to use the 18 Km pipeline, to  convey treated effluents,
   suitable for discharge into inland surface waters, all the way  to STP at Amberpet, incurring considerable recurring expenditure for pumping

c) The very fact that commissioning of 18 KM pipeline will minimize water pollution at Pattancheru, as reported to have been stated by the
     Minister, does it amount to shifting the pollution problem from Nakka Vagu to Musi River, for diluting the pollution concentration levels
    (pollution load remains the same) and the accountability, that too cleverly camouflaged in a pipeline ?

d)  How does 18 KM pipeline & STP Amberpet help to prevent the load of 11 most  abundant active pharmaceutical substances discharged
     from PETL and   accumulating down stream of Musi, which is not a perennial river?

e) As the waterborne drugs promote antibiotic-resistant germs, especially when they  are mixed with bacteria in human sewage, how does STP
    Amberpet get over the problem?

 Bay of Bengal Provides new Dumping Place  

  As the villagers downstream of Musi are agitating against the discharge of effluents through pipelines, the pollution problem of Pattancheru & Industrial areas around Hyderabad is being shifted to north coastal districts of AP in the name of industrial development.

    The justification given is, that effluents generated by these units, containing predominantly dissolved inorganic salts, which are being discharged into water bodies in and around land locked Hyderabad, can safely be discharged into sea by laying a pipeline deep into sea. The Parwada Pharma City and many Bulk Drug and Chemical units set up along the coast are already discharging the supposedly treated effluents into Bay of Bengal.

    There is no guarantee that traces of toxic pharmaceutical ingredients, the persistent, bioaccumulative and toxic wastes from the bulk drug units, which found their way into surface and ground water sources in and around Hyderabad, are not being discharged into sea, particularly when the detection is going to take much longer and becomes much more difficult.  

   The discharge of toxic effluents into sea, even though they are diluted to some extent, is bound to have an adverse impact on the aquatic life in the years to come, as the total pollution load being discharged remains the same. This is going to hamper the fish stock availability, affecting the livelihood of the large fishermen community in the area apart from health hazards for people consuming contaminated fish.

    The ecosystems and resources of the land-sea interface and the communities dependent on coastal resources are going to be adversely affected, by permitting discharge of toxic effluents from bulk drug units into sea, as it cannot be pushed beyond its limit to absorb wastes.

What is the Responsibility of Developed World?

. Is it not the responsibility of European Countries and the U.S for the environmental damage and the human risks in the Third World Countries producing drugs for the well being of the developed countries?"  

 The developed countries may think that they are protecting their environment by importing the drugs at the cost of the environment & people in the developing countries. But it is going to raise antibiotic bacterial resistance in the world, making it a Global Concern. People might say, that's just a dirty River in India or Bay of Bengal, but we live on a small Planet, everything is interconnected. The water in a River in India/ Bay of Bengal could be the rain coming down in a Town in Europe or USA in a few weeks.

US Responsibility?

What is the responsibility of U.S. — which spent $1.4 billion on Indian-made drugs in 2007 – the largest customer?

The Current Good Manufacturing Practice (cGMP) Regulations enforced by the US Food and Drug Administration (FDA). provide for systems that assure proper design, monitoring, and control of manufacturing processes and facilities

 If a bulk-drug company is not complying with cGMP regulations, any drug it makes is considered "adulterated" under the law.  This kind of adulteration means that the drug was not manufactured under conditions that comply with cGMP.  It does not mean that there is necessarily something wrong with the drug..

 Even if the drugs are not defective, FDA can bring a seizure or injunction case in court to address cGMP violations.   When FDA brings an injunction case, FDA asks the court to order a company to stop violating cGMPs.  Both seizure and injunction cases often lead to court orders that require companies to take many steps to correct cGMP violations. FDA can also bring criminal cases because of cGMP violations, seeking fines and jail time.

Thursday, June 10, 2010

Points to be addressed byDAE/ NPCIL regarding Nuclear Power

Point No.1. Does Nuclear Power (NP) provide Energy Security?

The energy security is better defined as the Nation's ability to sustain adequate, reliable energy services in ways that maximize economic competitiveness and minimize environmental degradation

The Nuclear power is not a 'home grown' source of energy and does not provide security in energy supplies, as most of the Uranium supplies required for nuclear power, are being imported, from politically-unstable countries like Kazakhstan.

As per one estimate, without adding any new nuclear reactors at the current consumption rate of uranium, we have uranium to last for about 50 to 60 years. Therefore it is not sustainable source of energy.

As exploitable sources of Uranium ore containing reasonable concentrations of Uranium 235 become exhausted, the costs will go up. And as higher-grade ores are exhausted, more energy will be consumed and more CO2 will be released in mining and enriching the remaining poor-grade uranium ores.

The idea of obtaining large quantities of uranium, by reprocessing radioactive spent fuel & other waste from nuclear reactors/ nuclear weapons, is widely regarded as an expensive failure, apart from being medically dangerous to nuclear workers and releasing large amounts of radioactive material into the Air and Water contaminating the Food-Chain.

Most of the non-nuclear decarburization scenarios provide far greater security of energy supplies than nuclear power, without its associated worries about radiation contamination, the security of uranium supplies, and terrorist attacks on nuclear plants & nuclear materials in transit and proliferation of nuclear weapons.

Point No.2. Is Nuclear Power CO2- Free?

The fact is, "It takes energy to make energy"- even Nuclear Energy. Although a Nuclear power plant itself releases no carbon dioxide, the production of nuclear electricity, depends upon a vast complex and hidden industrial infrastructure (Nuclear Fuel Cycle- very Expensive, Sophisticated and Dangerous Way to Boil Water) is the intensive user of Fossil Fuel -the kind of energy the Nuclear power is touted as replacing -with the concurrent production of Carbon Dioxide.

Far from being an answer to the problem of CO2 Emissions and Climate Change, Nuclear Power would be a miss-allocation of resources, making things worse by diverting funds away from better and cheaper alternatives. We get six times the reductions in CO2, by investing in Energy-Efficiency, rather than Nuclear Power and much faster too.

Point No.3. Is Nuclear Power Safe, Clean & Green?

The head of the International Renewable Energy Agency –- an intergovernmental group known as IRENA that advises about 140 member countries on making the transition to Clean Energy –- dismissed the notion of including Nuclear Power among its favored technologies. The IRENA will not support nuclear energy programs because it is a complicated process; it produces radioactive waste and is relatively risky.

Contrary to the Nuclear industry claims, smoothly running nuclear power plants are also not radioactive emission free. They are permitted routinely to emit hundreds of thousands of Curies of radioactive gases and other radioactive elements into the environment every year, with significant exposure to radiation. A German study has shown that within a 10-mile radius of their reactors, childhood leukemia has increased to a frightening level.

In addition, thousands of tons of solid radioactive waste is getting accumulated. This waste contains extremely toxic elements, which will inevitably pollute the environment and human food-chains, a legacy that will lead to epidemics of Cancer, Leukemia, Genetic disease in populations living near Nuclear power plants and Radioactive waste facilities for many generations to come for thousands of years.

If the Nuclear Power is so safe and entails as little risk as the Nuclear Industry claims, the insurance premium will not need to be particularly high. Why should the proposed "Civil Liability for Nuclear Damage Bill 2009" of Govt. of India should impose any liability caps on nuclear accident insurance? Why are the American Nuclear Power Plant Vendors demanding Nuclear-Accident Immunity, a pre-condition for their entry in the Indian Civil Nuclear Sector?

Point No.4. Is Nuclear Power Cheap?

When nuclear reactors were first commercialized half a century ago, they were encouraged by governments that saw Nuclear Energy as a peaceful, redemptive byproduct of the deadly power unleashed at Hiroshima. The US federal official, Lewis L. Strauss said Nuclear Energy would produce electricity "Too Cheap to Meter." It has never given consumers anything like that.

Nuclear Power is not only a high-risk technology in terms of safety, but also with respect to financial investment. It does not stand a chance in a market economy without state subsidies. The costs for decommissioning of nuclear power plant are very high & the cost of isolating radioactive byproducts/wastes from the biosphere & safeguarding them for hundreds of thousands of years, which defy human imagination, cannot even be estimated.

When the environmental costs and all the overt and hidden subsidies/costs are factored in,Nuclear Power is one of the most expensive ways of generating electricity.

Point No.5 Do We Accept the Socialization of Nuclear Power?

Various studies found that there is no financial return on investment in Nuclear Power without substantial government subsidies. The open market system of capitalism won't support Nuclear Power without government subsidies, as it is found to be a very risky business to invest in Nuclear Power.

Standard economic theory states that subsidies can be justified when they lead to an overall increase in social welfare. But the environmental and health risks associated with radioactive waste, accidents, and risk of meltdown, nuclear proliferation, and the threat of terrorism, decrease the overall contribution to social welfare provided by Nuclear Power plants.

The United Nations Environment Protection (UNEP) Organization, specifically dictates that that the removal of subsidies that are economically costly and harmful to the Environment and to People, represents a Win-Win Policy. It is hard to imagine a more poignant case in point than Nuclear Power Industry.

Point No.6 What Right do we have to Commit Future Generations?

When we consider the entire life cycle of a Nuclear Power plant, from construction to decommissioning, combined with sourcing uranium and disposal of the radioactive wastes, the current generation would be making decisions that impact people far into the future. We are supposed to tell future generations, for at least 10,000 years, to keep their feet off nuclear waste dumps. Mankind has no experience of communicating so many years ahead in time, making Nuclear Waste a serious language problem.

Saturday, June 5, 2010

Development of What & for Whom ?

Human Development

Human development is about creating an environment in which people can develop their full potential and lead productive, creative lives in accordance with their needs. There are four basic pillars of human development: Equity, Sustainability, Productivity and Empowerment. This way of looking at development, often forgotten in the immediate concern with accumulating commodities and financial wealth and economists & political leaders have emphasized this as the purpose & the end of development.

Economic Development Vs Economic Growth

A country's economic development is related to its human development, which encompasses, among other things, general well-being, health and education. Economic development' or 'development' is a term that economists, politicians, and others use frequently and modernization, westernization, and especially Industrialization are other terms people have used when discussing economic development.

Economic Growth implies only an increase in quantitative output; it may or may not involve development. The Economic growth is often measured by rate of change of Gross Domestic Product (GDP). Since the calculations used to arrive at GDP, do not account for the destruction or depletion of natural resources, degradation of environment etc, this popular measure is extremely misleading. It tells us we are making progress, even as our ecological foundations are crumbling and vast majority of people are deprived of the basic needs of quality-life

With the American advertising saturating global TV networks, the US Lifestyle- Consumerism, Malls, Bright Wasteful Lighting, SUVs, Inefficient Buildings with excessive lighting and air-conditioning etc, has become the model of development for millions of people in Asian and African countries.

Against Development that harms Planet Earth

As a society, we have failed to discriminate between technologies that meet our needs in a sustainable way and that those harm the planet Earth. As a result of population size, consumption patterns, life-styles, and technology choices, we have surpassed the planet's carrying capacity. At humanity's hand the Earth is undergoing profound transformation – one with consequences we cannot fully grasp.

To lighten humanity's load on earth, the major driving forces- Environmental Decline, Grossly Inequitable Distribution of Income, Resource Consumptive Economic Growth and Rapid Population Growth, have to be addressed by redirecting Technology and Trade. The Wealth inequality being the most intractable problem, the future of rich and poor alike hinges on reducing poverty and thereby eliminating this driving force for global environmental decline.

The decision makers should consistently ask themselves, whether a choice they were about to make would help the poorest of the poor– 20% of the world's people who share less than 2% of the world's income – and acted only if the answer were Yes, more people might break out of the poverty trap & have the opportunity to live sustainably.

Energy and Development

No one questions the need of Energy for Development, but the economic and environmental concerns should not be subordinated, while choosing the sources of energy and its use. The Energy and Economic Policy should not be embodied with the myth that economic vitality requires steadily increasing energy consumption and it must share a least-cost, resource-efficient emphasis. The energy waste bleeds the economy. The Europeans use approximately 50% less energy per capita than Americans, while maintaining the same standard of living. Therefore per capita consumption is not an indicator of development

The per capita energy consumption of primary energy in India was just 3.5% of US, 6.8% of Japan, 37% of Asia, and 18.7%of the world average. India's energy intensity (energy consumption per unit of GDP), however, is high compared to Japan, the US, and Asia as a whole by 3.7, 1.55 and 1.47 times respectively. This indicates inefficient use of energy with a substantial scope for energy savings/conservation in India.

India will have to strive to bring down the energy intensity per unit of GDP i.e. energy consumption, to about one fourth of the present level, if we have to be competitive with Japan in global market. Enough cost-effective energy efficient measures and technologies/processes are currently available, to reduce electricity demand between 10% & 20% over the next 5 years ie 2015 and between 20% % 35% by 2025. Aggressive, concerted, long-term public policy initiatives will be required to implement efficiency- related decisions in the market. and to alter the way that the people buy and use electrical / electronic appliances.

Most energy-efficiency measures cost far less than the initial generation of electricity and its transmission and inefficient distribution over long distances. The Energy Efficiency both on Supply Side & Demand Side, coupled with Renewable Sources of energy –Wind, Solar, Cogen etc provide cost effective and eco-friendly alternative to capacity additions based on fossil fuels and nuclear(fission).


There exists a deep sense of entitlement, a feeling that people can do anything and have anything they want, as long as they earn enough money, by whatever means. But the world cannot be treated like that any longer. Global resources are finite and the misapplication of science & technology has seriously damaged the ecosystems of this unique planet, threatening the ongoing existence of many millions of species, including ourselves. Self sacrifice and Responsibility, the noble traits, will lead the world toward Sanity and Survival.