Impacts of Pharmaceutical

1 IMPACTS OF PHARMACEUTICAL POLLUTION ON COMMUNITIES AND ENVIRONMENT IN INDIA Impacts of pharmaceutical pollution on communities and environment in India Impacts of pharmaceutical pollution on communities and environment in India CONTENTS EXECUTIVE SUMMARY Part 1 – AMR & pharmaceutical pollution I. Pharmaceutical pollution – Impacts on the environment and human health II. The environmental impact of antimicrobials III. Key levers of AMR IV. Occurrence of AMR in India Part 2 – The Indian pharmaceutical industry I. The expansion of the Indian bulk drug industry II. The emergence of Hyderabad and Visakhapatnam as poles of bulk drug manufacturing III. An export-oriented industry with global ambitions Part 3 - Pollution in Hyderabad and Visakhapatnam 2 3 I. A long history of pollution II. The investigation A. Manufacturing plants and the companies that operate them a. Hyderabad area b. Visakhapatnam area B. Industrial waste treatment in Hyderabad and Visakhapatnam: a tale of shocking dysfunction and industry capture C. Local pollution impacts in Hyderabad and Visakhapatnam areas a. Hyderabad and surrounding areas b. Visakhapatnam and surrounding areas D. Conclusion PART 4 – Solutions and call to action I. Recommendations for industry II. Recommendations for investors This report was researched and prepared for Nordea by Changing Markets and Ecostorm. III. Recommendations for policymakers Published in February 2016 Designed by Pietro Bruni Impacts of pharmaceutical pollution on communities and environment in India Impacts of pharmaceutical pollution on communities and environment in India Close-up of effluent by the Hetero plant in Gaddapotharam Executive Summary India is in the grip of a severe water pollution geographically dispersed industry reliant on a as hospitals from understanding the risks of doing subcontinent. crisis. A 2015 report from the Indian Government highly complex supply chain network comprising business with specific companies. With increasing estimates that the number of contaminated thousands of suppliers worldwide.2 Outsourcing of understanding of the financial risks to business as Based on evidence from an on-the-ground waterways has more than doubled in the past five production to the emerging markets, where labour a result of environmental degradation - key among investigation in the southern Indian states of years and that half of the country’s rivers are now is cheap, workforces skilled, and environmental them the pollution of water sources - and potential Telangana and Andhra Pradesh in early 2016, as polluted1. A variety of factors have contributed standards lax, has now become second nature for health problems that pharmaceutical pollution well as thorough analysis of industry data and the 4 5 to this critical situation, notably the staggering the pharmaceutical majors, many of which are can trigger notably with regard to antimicrobial latest academic research, this report documents quantities of untreated sewage generated in this based in the United States and Europe. resistance (AMR), this is a problem that must be local impacts of drug pollution – including extreme country of nearly 1.3 billion people. Another major addressed head-on. contamination of waterways and agricultural lands cause is industrial pollution, the dark side of India’s Indeed, the vast majority of the world’s drugs - and identifies some of the key players at the root economic development. are now manufactured in India and China. While There are several elements to consider of the problem. It draws links between polluting China has become the dominant supplier of the when assessing the pharmaceutical sector’s manufacturers and some of the large multinational In recent decades India’s pharmaceutical industry Active Pharmaceutical Ingredients (APIs)A used to environmental footprint. One is the energy used pharmaceutical companies they have dealings with, has scaled new heights in step with a steady rise in make medicines, India has a sizeable share of API during production and processing. Another is the highlighting the need to establish and implement population and thanks to its reputation as a low- production itself, and has also carved out a niche in generation of waste – solid, liquid or airborne - from strong environmental standards at every stage of cost manufacturing destination for multinational processing drugs, which it ships to markets around the manufacturing process. While pharmaceutical the supply chain. drug companies. In particular, its bulk drug the world as finished products. contamination of water has only recently production sector, which has a major hub in the permeated the public consciousness, it has been The overall picture that emerges is one of an southern Indian city of Hyderabad and a more recent Pharmaceutical supply chains are as opaque as on the scientific community’s radar for decades. industry with a disconcerting lack of commitment presence along the coastline of Andhra Pradesh, they are complex and while it is relatively easy to There is now a compelling body of research on the to environmental stewardship, be it on the part of has experienced a rapid ascent since the 1970s. describe broad trends, granular detail is hard to negative effects resulting from the accumulation of the manufacturing units in India or the large global While this has yielded obvious economic benefits come by. Information about the origin of APIs and pharmaceuticals in the environment, which range brands they are contracted by. What is more, the for both Indian and overseas-based firms, as well the finished products that end up on our pharmacy from the near elimination of entire species3 to the political context in India makes enforcement of as dividends for shareholders, scant attention has shelves is jealously guarded by drug firms, which feminisation of fish4 and the spread of AMR. any domestic measures to improve the situation been paid to the impact of increased pharmaceutical are unwilling to open up their supplier relationships in the short term challenging. In light of this, and production on the environment and inhabitants to public scrutiny. The situation is not helped by This report looks at the latter aspect, focussing on of the massive global threat antibiotic pollution living in proximity to factories and industrial parks. the hands-off approach of regulators who could the major public health threat posed by pollution represents, it is argued that the pharmaceutical easily demand more supply chain transparency. This from antibiotic production in India, which is industry must act swiftly and effectively to manage The emergence of a globalised pharmaceutical poses a number of problems: first, if there is no believed to be contributing to soaring drug its environmental impacts wherever they occur sector, which accelerated in the wake of the World information, it is impossible to hold bad companies resistance rates in the country and further afield. in the supply chain or run the risk of suffering Trade Organisation’s agreement on trade-related accountable and reward more progressive ones for This has serious implications for global health considerable reputational damage as a result. aspects of intellectual property rights (TRIPs) their efforts. Secondly, the lack of a level playing as antibiotic resistance genes spread around the in 1994, has given rise to a sophisticated and field prevents investors and public institutions such world through travel and trade with the Indian A. The U.S. International Trade Commission defines APIs as “the primary, active ingredient(s) of a final pharmaceutical product, produced in the first stage of pharmaceutical production and usually in bulk quantities.” (U.S. ITC, 2007). In this report they are largely synonymous with the term “bulk drug.” Impacts of pharmaceutical pollution on communities and environment in India Pollution on Musi river Impacts of pharmaceutical pollution on communities and environment in India PART 1 - AMR & pharmaceutical pollution I. Pharmaceutical pollution – impacts human or animal excretion, or in run-off from on the environment and human farms, scientists are increasingly exploring the role health that drug manufacturing discharges play in boosting concentrations of pharmaceutical substances in Compared to other forms of industrial pollution, the environment. The outsourcing of production the impact of effluent from the production of from countries such as the United States and EU pharmaceuticals on water and the biosphere Member States, where water treatment is relatively remains an underexplored issue and consequently well regulated and enforced, to emerging markets, off the public radar. However, a growing body of where sewage and industrial emissions are often scientific research indicates that the environmental dumped untreated or only partially treated in the consequences of discharging large quantities environment, adds to the urgency of addressing this of drugs and toxic chemicals into our natural aspect. surroundings are too great to be ignored and require rapid corrective action on the part of industry, as API residues are already widespread in the aquatic well as targeted policy interventions. environment, albeit mainly at trace levels.7 Nevertheless, there is clear evidence that even in For example, in 2013, a study published by the tiny doses some drugs have a measurable effect. EU’s Executive Agency for Health and Consumers One of the most shocking and widely reported 6 7 (EAHC) provided a wide-ranging assessment of examples of

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