GAMANA, Hyderabad & COMMUNITY ENVIRONMENTAL MONITORING, Chennai
European Commission urged to tackle environmental pollution by Pharma companies in India.
2 July 2018, Hyderabad /Chennai: Indian public health professionals, consumer rights groups and villagersaffected by pharmaceutical industry pollution have called upon the European Commission (EC) to include environmental criteria in overseas factory inspections that would oblige pharmaceutical companies to urgently tackle the grave environmental and human health crisis unfolding due to their manufacturing practices in India.
In a letter to the President and Vice-President of the European Commission and the EU Commissioners for the Environment, Industry, Health and Trade, the petitioners have called upon the EC to revise Good Manufacturing Practices (GMP) by including compulsory environmental standards in factory inspections. According to EU environmental and public health experts, the long-awaited strategic approach to Pharmaceuticals in Environment (PiE), which will contain a series of measures to alleviate pollution and other damage caused by pharmaceutical residues released into the environment, presents a key opportunity to do this.
The letter states, “The devastating environmental and human health impacts from the manufacturing of pharmaceuticals are well-documented. India’s Environment Ministry classifies pharmaceutical manufacturing as a “red category” activity owing to the hazardous waste it produces. However, Active Pharmaceutical Ingredient (API) discharges from factories are currently not regulated, and enforcement of existing pollution norms is extremely inadequate, as demonstrated by several studies and media stories. As a result of this, the lives of many people living in India’s pharmaceutical manufacturing hubs, such as Hyderabad, the capital of the southern Indian state of Telangana, Baddi Barotiwala Nalagarh Industrial town in the foothills of Himachal Pradesh, SIPCOT Cuddalore in Tamil Nadu, have been blighted by rampant pollution.”
“Successive studies have shown that air, water and soil at around the pharma manufacturing facilities in Telangana and Andhra Pradesh are significantly contaminated by toxic chemicals and Active Pharmaceutical Ingredients (APIs), notably from the production of antimicrobial drugs such as antibiotics. However, API discharges from factories are currently not regulated, and enforcement of existing pollution norms is extremely lacking and inadequate,” said Anil Dayakar of Gamana, a Hyderabad-based NGO and a signatory to the letter.
The letter highlights India’s huge antimicrobial resistance (AMR) problem and states that every year, 58,000 babies die in India as a result of contracting a multi-drug resistant infection. A study in March 2017 by scientists from the University of Leipzig investigating companies supplying the German market showed that insufficient wastewater management by drug manufacturing facilities in India is leading to “unprecedented” contamination of water resources with antimicrobial pharmaceuticals. The researchers found concentrations of antibiotics and antifungal substances that were several hundred times, or even several thousand times, higher than the levels predicted to select for resistance. In addition, 95 per cent of all samples tested positively for multi drug-resistant bacteria. (SEE NOTES)
“In light of the looming and severe public health crisis posed by AMR fuelled by, inter alia, pollution caused by pharmaceuticals throughout their life-cycle, we underline that only a multi-sectoral, multi-stakeholder approach can generate the required results for the continued health of people, animals and ecosystems, in Europe and globally,” said Dr. Sree Karuna Murthy Kolli, President, Indian Public Health Association (IPHA) Andhra Pradesh State, another signatory of the letter.
“India is one of the world’s largest manufacturers of pharmaceuticals and the EU one of its key export markets. Indian and multinational drug companies operate here because of cheap labour and lax implementation of environmental laws. The communities affected by pollution have already tried national legal avenues and won several landmark court cases, but this has not led to an improvement in the situation on the ground. This is why the EU cannot turn a blind eye to this problem,” said Shweta Narayan of Community Environmental Monitoring, a program that provides support to pollution impacted communities in India.
More than 50 public health professionals and about 30 CSOs from India and Europe have also called upon the EC to introduce an EU monitoring system for mandatory, routine collection of data on antimicrobials and AMR microorganisms in the environment, to introduce legally binding concentration limits and standards for residues of pharmaceutical substances in water, to ensure extended producer responsibility for the full life-cycle of products placed on the market, to support research into the various transmission dynamics of AMR via the environment and to develop comprehensive data collection for all antibiotics used in human medicine as well as in animal breeding and husbandry, and make those accessible to the public.
The signatories to the letter include Village Council (Panchayat) Presidents of some of the worst pharma pollution impacted villages of Edulabad, Makthala Anantharam Panchayat, China Raavarla and Palligudem; Ex panchayat president from Baddi Barotiwala Nalagarh region in Himachal; survivors of the Bhopal Gas Disaster, and the Vice President of Indian Public Health Association, doctors and public health professionals from Jawaharlal Institute of Postgraduate Medical Education & Research (JIPMER) Pondicherry, School of Public Health, PGI Chandigarh, Former National Advisors to India’s Ministry of Health, former deans of medical colleges in India and independent public health researchers and activists.
- Down to Earth, Newer, not better, 18.07.17, http://www.downtoearth.org.in/news/newer-not-better-58292; First Post, NGT’s reluctance to hold big pharma accountable for polluting Telangana watersunfortunate, 17.11.2017, https://www.firstpost.com/india/ngts-reluctance-to-hold-big-pharma-accountable-for-polluting-telangana-waters-unfortunate-body-is-simply-passing-the-buck-4214063.html
- Larsson, D.G.J., de Pedro, C., Paxeus, N., 2007. Effluent from drug manufactures contains extremely high levels of pharmaceuticals. J. Hazard. Mater. 148, 751–755. http://dx.doi.org/10.1016/j.jhazmat.2007.07.008
- New York Times, ‘Superbugs’ Kill India’s Babies and Pose an Overseas Threat, 03.12.2014, https://www.nytimes.com/2014/12/04/world/asia/superbugs-kill-indias-babies-and-pose-an-overseas-threat.html
- Bloomberg, 19.01.2017, Indian Travel Boom Is Sending Tourists Home With Superbugs https://www.bloomberg.com/news/articles/2017-01-19/superbug-stowaways-india-travel-boom-spreads-dangerous-microbes
- Changing Markets Foundation, Impacts of pharmaceutical pollution on communities and environment in India, February 2016, p16-17, http://changingmarkets.org/wp-content/uploads/2016/12/Impacts-of-pharmaceutical-pollution-on-communities-and-environment-in-India-WEB-light.pdf;
- The New Indian Express, NGT Notice to Drug Producer, 12.11.2013, https://www.pressreader.com/india/the-new-indian-express/20131112/281694022545697; IndiaEnvironmental Portal, Judgement of the National Green Tribunal regarding pollution caused by the industrial units in Patancheru and Bollaram, Medak District, Telangana, 24.10.2017, http://www.indiaenvironmentportal.org.in/content/448690/judgement-of-the-national-green-tribunal-regarding-pollution-caused-by-the-industrial-units-in-patancheru-and-bollaram-medak-district-telangana-24102017/
- Swedish Medical Products Agency, Swedish initiative for green medicine production, 04.07.2011, https://lakemedelsverket.se/english/All-news/NYHETER-2011/Swedish-initiative-for-green-medicine-production/; European Public Health Alliance, Joint Statement: Europe must align policies to tacklePharmaceuticals in the Environment and Antimicrobial Resistance, 17.05.2018, https://epha.org/joint-statement-europe-must-align-policies-to-tackle-pharmaceuticals-in-the-environment-and-antimicrobial-resistance/
Full letter to the EU President can be downloaded here
For more details, interviews, and photographs contact:
1.Anil Dayakar, Contact: +91 9848053103 . email@example.com.
Gamana,Plot No:31, Flat No: 201, Apoorva Building, Kalyana Nagar Phase-1,Hyderabad, India-500 038.
2. Shweta Narayan : +91 8056024315 firstname.lastname@example.org
Community Environmental Monitoring, A Program of The Other Media,No 92, 3rdStreet, Thiruvalluvar Nagar, Besant Nagar, Chennai – 600090