National Green Tribunal
News Item Titled "Impact Of ... vs . Ankita Sinha & Ors." Reported In 2021 on 6 May, 2024
Item No. 02 Court No. 1
BEFORE THE NATIONAL GREEN TRIBUNAL
PRINCIPAL BENCH, NEW DELHI
Original Application No. 497/2024
News item titled "Impact of Pharmaceutical toxicity on the environment
and its regulatory aspects" appearing in Current Science dated
25.02.2024
Date of hearing: 06.05.2024
CORAM: HON'BLE MR. JUSTICE PRAKASH SHRIVASTAVA, CHAIRPERSON
HON'BLE DR. A. SENTHIL VEL, EXPERT MEMBER
Respondent: Mr. Mohit Singhal, Adv. for CPCB (Through VC)
ORDER
1. This original application is registered on the basis of an article titled "Impact of Pharmaceutical toxicity on the environment and its regulatory aspects" published in the 'Current Science' dated 25.02.2024.
2. The news item discloses that pharmaceutical-induced environmental contamination needs urgent attention because around 43% of global rivers are facing risks from Active Pharmaceutical Ingredients (APIs). The continuous emissions are posing potential hazards to the environment and human health. It also states that discussions on chemical waste reduction face limitations due to incomplete knowledge about their toxicity to humans. It discloses that pharmacies sometimes cannot filter all the chemicals used in pharmaceutical production (e.g. solvents, active pharmaceutical ingredients (APIs), excipients, additives, by-products, intermediates, etc.). These chemicals cause ecosystem imbalances that give rise to chemical pollution in the environment. The article discloses the causes of pharmaceutical pollution as under:
1"(1) Drug ingestion and excretion: When organisms consume pharmaceuticals, their bodies metabolize and excrete inactive metabolites as waste products, eventually finding their way into the environment through urine and faecal matter.
(2) Healthcare institutions disposal: Hospitals and healthcare facilities contribute significantly to pharmaceutical pollution due to inadequate disposal practices or contraventions in rules and regulations of standards.
(3) Drug manufacturing units: Some drug manufacturers dispose of excess drugs and other used chemicals/by-products in landfills or flush them, leading to pollution through wastewater run-off.
(4) Domestication of animals: Drugs fed to domestic animals are not always entirely metabolized, resulting in the excretion of excess pharmaceuticals. This leads to the settling of metabolites in the top layers of the soil (Figure 1).
(5) Agricultural usage: Insecticides and pesticides sprayed on agricultural products can contaminate the surrounding ecosystem.
(6) Domestic drug use and disposal: Improper disposal of pharmaceutical and personal care products by consumers results in the pollution of streams, groundwater, lakes and rivers. Pharmaceutical waste, chemical waste, personal care products and their waste results in pollution in household as well as in environment."
3. It also discloses the types of pharmaceutical pollutants as under:
"(1) Hazardous chemicals: These are chemical compounds or chemicals that cause serious harm. For example, gases such as hydrogen chloride, benzene and toluene, or compounds and metals such as asbestos, cadmium, mercury and chromium.
(2) Non-hazardous pollutants: These are substances found in the workplace that do not cause any harmful effects to the employees on exposure. These pollutants may not be immediately toxic in low concentrations, their cumulative effects can still have significant impacts on human health, ecosystems and the environment as a whole.
(3) Chemotherapy waste: Chemotherapy waste include chemicals from pharmaceutical medications and personal care products. It includes empty medicine bottles and other medications.
(4) Inert waste: This refers to waste that is not chemical or biological and does not react either with any other compounds leading to accumulation in environment. These compounds are not biodegradable. Examples are sand and gravel, which are particularly relevant to landfills because inert waste generally requires lower disposal cost than biodegradable or 2 compostable waste. It includes glass insulation, metal, wood, etc. (5) Radioactive hazardous pollutants: Radioactive (or nuclear) wastes are the products of nuclear power plants, power plants, hospitals and research facilities. Nuclear waste is also generated when nuclear reactors and other nuclear facilities are dismantled and destroyed. There are grouped into two broad categories: high-level radioactive waste and low-level radioactive waste. Examples include I-125, F-18 and I-131.
(6) Biohazardous pollutants: Biohazardous wastes (such as blood, body fluids and human cells), also known as biological waste, are potentially infectious and considered to threaten public health and the environment.
4. It also gives the heads and sub-heads showing how pharmaceuticals enter into the environment by revealing as under:
"Patient usage: The utilization of medications by patients, whether prescribed or over-the-counter, represents a significant contributor to chemical pollution. Essentially, a portion of the medications consumed by patients is naturally excreted, potentially entering the water systems after undergoing treatment in wastewater treatment plants. Additionally, pharmaceuticals can find their way into the environment through various means, such as inappropriate disposal of medications and discharge from manufacturing wastewater units. The release of drug compounds into the environment stems from multiple sources, including direct disposal from pharmaceutical manufacturing facilities, patient usage, animal excretion, aquafarming practices and the improper disposal of unused or expired medications (Figure 3).
Medical institutions: Medical institutions must return unused medications to the manufacturers or pharmaceutical waste recycling facilities. However, they are simply recycled or flushed. Thus, the lack of proper management leads to pharmaceutical waste in healthcare facilities.
Water treatment facilities: Inefficient removal of pharmaceutical residues occurs in water treatment plants, primarily attributed to inadequate design. Similar to the measures taken in water treatment plants, major efforts are taken to prevent the migration of these wastes into groundwater sources. Emphasis is laid on waste removal, employing various methods to impede waste entry into groundwater and other water bodies. Consequently, this waste is directed to landfills.
Pharmaceutical waste processing facilities: These specialized facilities manage substantial quantities of pharmaceutical chemical waste, producing residual waste even after undergoing processing. Waste from hospitals and various outlets is transported to these plants, undergoing efficient processing.3
Human and animal usage: Both humans and animals utilize medications for immediate disease prevention post-consumption. However, excretion of these drugs from the body occurs through processes such as urination, defecation and sweating. Over time, these pharmaceutical remnants are expelled from the body, subsequently entering into the environment.
Unused drugs: Unused medications are usually discarded or flushed down the toilet. These medications eventually permeate the environment and water bodies, integrating into the ecosystem.
Essential products: Medications serve purposes beyond disease treatment. Some formulations are used in cosmetics, beauty products and aromatherapy sprays. When applied to the skin, not all the components are fully absorbed into the body; some are eliminated during bathing. Consequently, remnants are left in the environment, contributing to the accumulation of pharmaceutical waste.
Residences and agricultural lands: Crops cultivated in residential areas or on farms often undergo applications of pesticides, insecticides and fungicides. These substances safeguard crops from bacterial infections, insect infestations, viral threats and fungal diseases. Additionally, the spray is formulated to enhance crop growth and overall productivity. However, the usage of sprays lead to mixture of chemicals into groundwater, contributing to the generation of pharmaceutical waste."
5. The pharmaceutical pollution and its effect are disclosed in the article as follows:
"(1) Impact on fish and aquatic life: Numerous studies have demonstrated that oestrogen and similar chemicals feminise male fish, altering the male-female ratio. These substances, commonly found in birth-control pills and postmenopausal hormonal treatments, have led to the presence of hermaphrodite fish species with both male and female characteristics in the Potomac River, USA. Elevated estrogenic levels in river water contribute to the prevalence of female fish near pollution sources, and popular antidepressants have been detected in the brain tissue of fish downstream of wastewater treatment plants (Table 1).
(2) Influence on wastewater treatment systems: Antibiotics, frequently employed in disease treatment, possess properties that can impact sewage systems and the microbiological alterations of water. The presence of antibiotics in sewage treatment inhibits the activity of sewage bacteria and disrupts the decomposition of organic matter. Additionally, antibiotics can hinder nitrifying bacteria in the process of treating wastewater.
(3) Effects on drinking water: Chemicals in pharmaceuticals may mix with water or be flushed in the toilets after exiting the body. Mostly, municipal wastewater treatment plants do not fully eliminate these chemicals and impurities from drinking 4 water, necessitating a combination of treatment methods.
Although the levels of these chemicals in rivers and streams are relatively low compared to standard doses, there is a growing concern that prolonged exposure could result in health problems. The potential synergistic effects of these compounds, particularly endocrine disruptors, pose risks to biological processes such as growth, development, reproduction and hormonal control. Studies have raised alarms about the presence of these chemicals in surface water and groundwater since the 1990s.
(4) Prolonged environmental impact: Certain chemical compounds persist in the environment and water bodies for an extended duration. When concentrations reach a specific threshold, typically 1 part per million, these chemicals begin to impact the environment. Some drugs, like antiepileptic medications, have prolonged effects, while others are pseudo- persistent, breaking down only after an extended period. This persistence continuously impacts the environment, with some substances having about 30% fat solubility, enabling bioaccumulation and potential entry into the food chain. Studies in Europe and the US have identified hundreds of these compounds in groundwater, sewage, treated wastewater and tap water, underscoring the widespread presence of these contaminants in various water sources.
(5) Antibiotics: Long associated with irresponsible use in human medicine and agriculture, antibiotics have also been linked to contamination from drug production. Studies conducted in India and China on antibiotic pollution during 2016 and 2017 support this conclusion (Table 1).
(6) Consequences on wildlife: The clean-up of sewage, whether by humans or chemicals, may affect wildlife as animals consume water containing these substances or swim in it. Research on the effects of chemicals on wildlife, while limited and uncertain, suggests potential significant impacts. Preliminary findings indicate that antidepressants may adversely affect their health, while reproductive suppressants may reduce fish populations in ponds."
6. It discloses the status of chemical pollution in India in following terms:
"India is recognized as the third largest pharmaceutical producer on a global scale, with a substantial presence comprising about 3000 pharmaceutical plants and an extensive range of around 10,500 products. The pharmaceutical manufacturing sector in India is acknowledged for its significant environmental impact, standing out as one of the most influential industries in the country. Hyderabad, commonly known as the 'API capital of India', is the hub of the country's major pharmaceutical industry. Studies have shown that local residents consider the groundwater in industrial areas to be highly polluted with multidrug resistant bacteria. It is estimated that about 60,000 infants die every year in India due to high doses of 5 antibiotics. Antimicrobial resistance is caused by contamination of water containing antibiotics."
7. The article suggests possible ways for reduction of pharmaceutical waste as follows:
"• Exploring antibiotic use is a crucial research focus for prominent entities dedicated to safeguarding public and environmental health, such as the World Health Organization (WHO) and the European Commission.
• The environmental contamination from pharmaceuticals presents an intricate and contentious challenge marked by unclear research, conflicting conclusions, diverse stakeholder interests and a high degree of complexity.
• Allocate resources to public education initiatives concerning the appropriate disposal of medications, integrating them into drug recovery programmes.
• Implement more stringent regulations to curb drug usage in numerous healthcare settings, including hospitals, nursing homes and other medical facilities.
• Urgently conduct further research to assess the potential impacts of these chemicals on human health.
• Implement measures to restrict bulk purchases of medicines, ensuring that only the necessary quantity is available and potentially mitigating excessive purchases.
• Emphasize proper disposal methods for water, advocating against indiscriminate disposal and instead promoting safe options such as burning or burying."
8. The news item raises substantial issue relating to compliance of the environmental norms, especially by the pharmaceutical companies.
9. Power of the Tribunal to take up the matter suo-motu has been recognized by the Hon'ble Supreme Court in the matter of "Municipal Corporation of Greater Mumbai vs. Ankita Sinha & Ors." reported in 2021 SCC Online SC 897.
10. Since, it is a PAN India issue, therefore, we deem it proper to implead the following as respondents in the matter:
6(1). Chief Secretary, State of Haryana.
(2). Chief Secretary, State of Rajasthan.
(3). Chief Secretary, State of Punjab.
(4). Chief Secretary, State of Himachal Pradesh.
(5). Chief Secretary, State of Uttar Pradesh.
(6). Chief Secretary, State of Chhattisgarh.
(7). Chief Secretary, State of Bihar.
(8). Chief Secretary, State of Uttarakhand.
(9). Chief Secretary, State of Jharkhand.
(10). Chief Secretary, State of Meghalaya.
(11). Chief Secretary, State of West Bengal.
(12). Chief Secretary, State of Maharashtra.
(13). Chief Secretary, State of Andhra Pradesh.
(14). Chief Secretary, State of Kerala.
(15). Chief Secretary, State of Tamil Nadu.
(16). Chief Secretary, State of Telangana.
(17). Chief Secretary, State of Karnataka.
(18). Chief Secretary, State of Madhya Pradesh.
(19). Chief Secretary, State of Odisha.
(20). Chief Secretary, State of Gujarat.
(21). Chief Secretary, State of Goa.
(22). Chief Secretary, State of Arunachal Pradesh.
(23). Chief Secretary, State of Sikkim.
(24). Chief Secretary, State of Nagaland.
(25). Chief Secretary, State of Manipur.
(26). Chief Secretary, State of Mizoram.
(27). Chief Secretary, State of Assam.
(28). Chief Secretary, State of Tripura.
(29). Chief Secretary, Union Territory of Delhi.7
(30). Chief Secretary, Union Territory of Chandigarh.
(31). Chief Secretary, Union Territory of Andaman & Nicobar.
(32). Chief Secretary, Union Territory of Dadra and Nagar Haveli & Daman and Diu.
(33). Chief Secretary, Union Territory of Lakshadweep.
(34). Chief Secretary, Union Territory of Puducherry.
(35). Chief Secretary, Union Territory of Ladakh.
(36). Chief Secretary, Union Territory of Jammu & Kashmir.
(37). Member Secretary, Haryana State Pollution Control Board.
(38). Member Secretary, Rajasthan State Pollution Control Board.
(39). Member Secretary, Punjab State Pollution Control Board.
(40). Member Secretary, Himachal Pradesh State Pollution Control Board.
(41). Member Secretary, Uttar Pradesh State Pollution Control Board.
(42). Member Secretary, Chhattisgarh Environment Conservation Board.
(43). Member Secretary, Bihar State Pollution Control Board.
(44). Member Secretary, Uttarakhand State Pollution Control Board.
(45). Member Secretary, Jharkhand State Pollution Control Board.
(46). Member Secretary, Meghalaya State Pollution Control Board.
(47). Member Secretary, West Bengal State Pollution Control Board.
(48). Member Secretary, Maharashtra State Pollution Control Board.
(49). Member Secretary, Andhra Pradesh State Pollution Control Board.
(50). Member Secretary, Kerala State Pollution Control Board.8
(51). Member Secretary, Tamil Nadu State Pollution Control Board.
(52). Member Secretary, Telangana State Pollution Control Board.
(53). Chief Secretary, Karnataka State Pollution Control Board.
(54). Member Secretary, Madhya Pradesh State Pollution Control Board.
(55). Member Secretary, Odisha State Pollution Control Board.
(56). Member Secretary, Gujarat State Pollution Control Board.
(57). Member Secretary, Goa State Pollution Control Board.
(58). Member Secretary, Arunachal Pradesh State Pollution Control Board.
(59). Member Secretary, Sikkim State Pollution Control Board.
(60). Member Secretary, Nagaland State Pollution Control Board.
(61). Member Secretary, Manipur State Pollution Control Board.
(62). Member Secretary, Mizoram State Pollution Control Board.
(63). Member Secretary, Assam State Pollution Control Board.
(64). Member Secretary, Tripura State Pollution Control Board.
(65). Member Secretary, Delhi Pollution Control Committee.
(66). Member Secretary, Chandigarh Pollution Control Committee.
(67). Member Secretary, Andaman & Nicobar Pollution Control Committee.
(68). Member Secretary, Pollution Control Committee, Dadra and Nagar Haveli & Daman and Diu.
(69). Member Secretary, Lakshadweep Pollution Control Committee.
(70). Member Secretary, Puducherry Pollution Control Committee.
(71). Member Secretary, Ladakh Pollution Control Committee.
(72). Member Secretary, Jammu & Kashmir Pollution Control Committee.9
(73). Central Pollution Control Board through its Member Secretary.
(74). Ministry of Environment Forest and Climate Change through its Secretary.
(75). Ministry of Agriculture through the Secretary.
(76). Ministry of Dairying and Veterinary Science through the Secretary.
11. Let notice be issued to the above respondents, except the CPCB who is already represented through the Counsel, for filing their response at least one week before the next date of hearing disclosing the compliance of the norms by pharmaceutical company, the regulatory guidelines in force, number of pharmaceutical companies in each of the State and number of such companies complying with norms and number of companies against whom action is taken for violation of the norms as also the proposed action for prevention of environment from pharmaceutical toxicity.
12. Learned Counsel for CPCB seeks four weeks' time to file the reply.
13. List on 20.08.2024.
Prakash Shrivastava, CP Dr. A. Senthil Vel, EM May 06, 2024 Original Application No. 497/2024 DV 10