By Tarun Arora*

1. Introduction

Quandary owes its existence to the entry and presence of pharmaceuticals in the environment (PiE). Pharmaceuticals, while indispensable for preserving life and health against diseases, also pose a major threat to the right to life, health, and a clean, hygienic environment. Pharmaceuticals enter into the environment through excreta, improper disposal of expired or discarded medicines, veterinary uses, and other human uses such as swimming pools, etc. Path-breaking studies have found that improper disposal of expired or discarded medicines has resulted in contamination of groundwater, pharmaceutical compounds in the food chain, and extinction of two species of vultures in South Asia. These problems are attributed to various factors such as unawareness and neglectful approach of the public, public authorities, institutions, effective municipal laws, proper implementation, cost-effective technology, etc. Stakeholders have not been made aware of the adverse effect of improper disposal of expired or discarded medicines.

This Paper critically examines available legal frameworks, regulatory Standard Operating Procedure, and remedies against improper disposal of expired or discarded medicines by end-users and other stakeholders. This Paper also analyses the status of implementation of rules with special reference to the urban areas of the State of Punjab in order to identify gaps in implementation and realize the goal of safe disposal of expired or discarded medicines,

The study is based on analysis of primary and secondary data. The primary data, gathered from the stakeholders through field visits and structured interviews, cover information regarding issues such as the proper method of disposal of pharmaceuticals, methods in practice, and gaps in implementation. The study presents the areas to improve the proper disposal of unused and expired pharmaceuticals as well as the scope of participation by the supply chain to improve mechanisms for waste disposal that include human resources and infrastructure. It also presents suggestive measures to build the capacity of stakeholders for addressing gaps in the implementation of regulatory mechanisms.

2. Entry of Pharmaceuticals in Environment

Hitherto pharmaceuticals have been considered a life savior, increasing the longevity of human life as well as other living creatures. Various studies reveal continued growth amongst the aging population as a result of a global increase in per capita consumption of medicines.[1] Numerous pharmaceutical compounds such as antibiotics, anti-fungal, anti-cancer properties, analgesics, blood lipid-lowering agents, antiepileptic, and β-blockers have been detected in sewage and surface waters across the nations.[2] The wastewater is released for recycling, though the water processed through advanced wastewater treatment systems also contained pharmaceutical compounds. Pharmaceutical residues have also been detected in bio-solids planned for use in land remediation.[3] As a healthy environment embraces adequate management of waste from industries and household activities, concern over the management and extermination of pharmaceutical residues grows considerably.[4] Pharmaceuticals enter the environment during different phases of their life cycle. They are detected in the environment in trace quantities. Some studies suggest that 90% of the pharmaceutical compounds detected in waterways are a result of patient use, improper disposal, and excretion with improper disposal and discharges from manufacturing sites accounting for 5-10%.[5] This problem affects the environment around the globe—in developed as well as developing countries. As per the report of EFPIA, about three to eight percent of medicines sold in Europe remain unused.[6] In Germany, it is estimated that nearly 5700 tonnes of medicines per year go unused.[7] An Associated Press study estimated that hospitals and long-term-care facilities flush 250 million pounds of unused drugs annually.[8] Pharmaceutical compounds discharged through various channels usually end up in waterways and thereby cause aquatic imbalance. Various studies have shown that pharmaceuticals are highly active compounds that target specific biologic systems and might have adverse impacts on the physiology and behavior of a variety of organisms even at low concentrations.^[9] Freshwater systems also contain about 200 pharmaceuticals from around the world.^[10]

Pharmaceutical residues have also been detected in marine waters and sediments.^[11] Some studies have demonstrated the presence of pharmaceutical compounds at trace levels in surface and groundwater. In regard to the question of safe and proper disposal of pharmaceuticals in India, no specific studies have been carried out so far. However, learning the lessons from foreign studies during legal research on pollution by pharmaceutical industries, the attention of the author was driven towards the adequacy of legal mechanisms and remedies against illegal or unlawful disposal of expired or discarded medicines in urban areas. The course of different interactions at different levels and in different states with people of different backgrounds revealed that individuals of all ages and socio-economic backgrounds are hardly aware of the appropriate method of disposal of expired or discarded medicine. Only those from the technical background of pharmaceutical industries, students, and research scholars of pharmaceutical departments possessed the required information concerning the method of disposal of such waste. Against this backdrop, the evaluation of respective rules has been undertaken with a holistic approach to study law in its relation to environmental science, pharmaceutical studies, and technology.

3. Legal Remedies Against PiE

As stated earlier, pharmaceuticals enter the urban environment of Punjab mainly through two methods: (1) expired or discarded medicines and (2) excreta and release of pollutants through swimming pools, etc. The Constitution of India imposes a fundamental duty on its citizens to protect and improve the natural environment including forests, lakes, rivers, and wildlife, and to have compassion for living creatures.[12] This language implies an individual obligation to prohibit or forbear oneself from discharging pollutants. Legal remedies against the unlawful discharge of pharmaceuticals in the environment can be discussed under two frameworks: Direct Regulatory Framework and Indirect Regulatory Framework.

3.1. Direct Regulatory Framework

The Direct Regulatory Framework consists of delegated legislations in India such as the Bio-Medical Waste (Management & Handling) Rules, 2016 [BMW(M&H)R]; the Solid Waste Management Rules, 2016 [SWMR], etc. framed under the framework law namely the Environment (Protection) Act, 1986 [EPA].

3.1.1. The BMW (Management and Handling) Rules, 2016

These BMW Rules were framed by the Government of India in the exercise of powers conferred by SS. 6, 8, and 25 of the EPA and in suppression of the BMW(M&H)R, 1998. The preamble of these rules clearly defines the objectives of the rules: to create an effective and improved method of collection, processing, treatment, and disposal of the BMW in environmentally sound management, thereby reducing the BMW generation and its impact on the environment.

Expired or discarded medicines are covered under S. 2 (e) which defines the term ‘biological waste’. Cl. (d) specifies pharmaceutical waste such as antibiotics, cytotoxic drugs including all items contaminated with cytotoxic drugs along with glass or plastic ampoules, vials, etc. This waste has to be segregated in Yellow-colored non-chlorinated plastic bags or containers.[13] It also prescribes the following three methods of disposal of pharmaceutical waste:

- by returning these to the manufacturer or supplier for incineration at temperature >1200 ⁰C, or
- to the CBMWTF or hazardous waste treatment, storage, and CBMWTF for incineration at >1200 ⁰C, or
- encapsulation or Plasma Pyrolysis at > 1200⁰

All other discarded medicines shall be either sent back to the manufacturer or disposed of by incineration. The Rules adequately define the duties of the HCF, the occupier, and the operator of a CBMWTF regarding handling and management of BMW covering expired or discarded medicines.

The BMW(M&H)R 2016 enumerates the duties of the Occupier as follows:

- to take required steps to segregate and handle BMW without adverse effect to human health and the environment and in accordance with these rules;
- to transport waste as per norms mentioned in Sch. I to the CBMWTF;
- to isolate treated BMW from MSW;
- to ensure training to all its health care workers and others involved in the handling of BMW at the time of induction and thereafter at least once every year and;
- to maintain the details of training programmes conducted, the number of personnel trained and the number of personnel not undergone any training in Annual Report;
- to maintain a BMWR;
- to designate a qualified person to review and monitor the activities relating to BMW management within that establishment;
- to maintain all records for the operation of incinerators, hydro or autoclaving, etc. for a period of five years;
- to achieve the standards for treatment and disposal of BMW as specified in Sch. II.[14]

Additional duties of every operator of a CBMWTF include taking necessary steps to ensure the collection, transportation, handling, storage, treatment and disposal of BMW from the occupier without any adverse effect to the human health and the environment; establishing a bar coding and global positioning system for handling BMW; updating the prescribed authority regarding occupiers not handing over the segregated BMW in accordance with Rules; training all its workers involved in disposal of waste at the time of induction and at least once a year thereafter; assisting the occupier in training for BMW management, medical examination as per norms, occupational safety of all its workers, reporting of incidents to the prescribed authority, maintain a log book for each of its treatment equipment according to weight of batch, categories of waste treated, time, date and duration of treatment cycle and total hours of operation; handing over the plastic after autoclaving or microwaving by mutilation or shredding, to the recyclers with valid consent, ensure operation of CBMWTF on holidays also, maintain all record for operation of incineration, hydro or autoclaving for a period of five years; and upgrade existing incinerators to achieve the standards for retention time in secondary chamber and Dioxin and Furans.[15]

Apart from those listed above, the duties of the State Pollution Control Board have also been specified in detail. However, these Rules suffer from a serious lacuna as they do not cover a common man or individual who is the end-user of medicine and consumes medicine at places beyond HCF covering diagnosis, treatment, immunization, research center or hospital, nursing home, clinic, dispensary, veterinary institution, animal house, blood bank, etc. It is a serious drawback in the language of the Act to keep end-users out of the operation of the Act.

Regarding penalty provisions, the BMW(M&H)R, 2016 provides that an occupier or operator of a CBMWTF shall be liable for all the damages caused to the environment or the public due to improper handling of BMWs.[16] Furthermore, cl. (2) of Rule 18 provides he shall be liable for action under S. 5 and S. 15 of the Act, in case of violation. Through S. 5, the EPA authorizes the Central Government to direct the closure, prohibition, or regulation of any industry, operation, or process, or stop or regulate the supply of electricity or water or any other service. In terms of penalty for contravention of the provisions of the Act and the Rules, orders, and directions, S. 15 of the Act prescribes the punishment of imprisonment for a term up to five years or a fine up to one lakh rupees, or with both. Where failure or contravention continues, an additional fine may be added. This fine may extend to five thousand rupees for every day during which such failure or contravention continues after the first conviction of such failure or contravention. Whereas S. 15 (2) provides that if the failure or contravention referred to in sub-section (1) continues beyond a period of one year after the date of conviction, the offender shall be punishable with imprisonment for a term, which may extend to seven years.

3.1.2. The Solid Waste Management Rules, 2016

These Rules cover expired medicine under the expression ‘domestic hazardous waste’. The expression “domestic hazardous waste” is defined under S. 3 (i) (17) as discarded paint drums, pesticide cans, CFL bulbs, tube lights, expired medicines, broken mercury thermometers, used batteries, used needles and syringes, and contaminated gauge, etc., generated at the household level. These Rules laid down the duties of various stakeholders for the safe management of SW by emphasizing segregation of waste through waste generators at the source itself. The Rules contain comprehensive criteria for setting up SW processing and treatment facilities by notifying buffer zone. [17]

Rule 4 prescribes responsibilities of the occupier for management of hazardous and other wastes. It states that for the management of hazardous and other wastes, an occupier shall follow the steps mentioned below:

1) prevention;

2) minimization;

3) reuse;

4) recycling;

5) recovery, utilization including co-processing;

6) safe disposal.[18]

It further states that the occupier shall be responsible for safe and environmentally sound management of hazardous and other wastes.[19] The hazardous and other wastes generated in the establishment of an occupier shall either be sent or sold to an authorized actual user or shall be disposed of in an authorized CBMWTF.[20] The hazardous and other wastes shall be transported from an occupier’s establishment to an authorized actual user or an authorized CBMWTF in accordance with the provisions of these rules.[21] If an occupier intends to get their hazardous and other wastes treated and disposed of by the operator of treatment storage, CBMWTF is under obligation to give the operator of that CBMWTF specific information as may be needed for safe storage and disposal.[22] It is the duty of the occupier to take all the steps while managing hazardous and other waste to:

contain contaminants and prevent accidents and limit their consequences on human beings and the environment; and
provide persons working on the site with appropriate training, equipment, and the information necessary to ensure their safety.[23]

Rule 5 inflicts an obligation on the State Government for environmentally sound management of hazardous and other wastes. It states that the Department of Industry in the State or any other government agency authorized on behalf of the State Government is responsible for ensuring earmarking or allocation of industrial space or shed for recycling, pre-processing, and other utilization of hazardous or other waste in the existing and upcoming industrial park, estate and industrial clusters.[24]

3.2. Analysis

The provisions of both the BMW(M&H)R and the SWMR reveal that the shortcoming of the BMW(M&H)R has been plugged in the SWMR, 2016 by covering an ordinary person being a generator of waste. Similarly, the definition of ‘waste generator’ as defined under Rule 2(56) is required in the BMW(M&H)R, 2016 as the end-user is an individual who has not been covered within the scope of a polluter. These Rules merely define occupier, operator of a CBMWTF, HCF, etc., and exclude end-users using the medicines. The definition of ‘waste generator’ as given under Rule 2(56) is wide enough to cover every person or group of persons, every residential premise, and non-residential establishment including Indian Railways, Defense Establishment which generate SW. Critical examination of the above rules depicts that the disposal of pharmaceuticals at landfill sites is not an eco-friendly exercise as it may affect the food chain and other living creatures as well. Another drawback of these Rules is that it does not incorporate any provision for violation by anyone or breach of contravention of any duties laid down under these Rules. It is only in Form II for application for authorization under Rule 16(1)(e) that gives a cursory reference of penal aspects against violation of the SWMR. However, the enforceable part does not contain a single word on penalty or liability aspects, turning rules into toothless mechanisms.

Another area of concern is that none of these provisions—the BMW(M&H)R, the SWMR & the EPA—incorporate any provision concerning whistleblowers or complaints against violations. Only the Pollution Control Board of the State shall act as a prosecuting agency. There is hardly any provision in the Act or the Rules encouraging the public-spirited person to initiate or opt for legal redressal. Rather, S.19 prohibits the court from taking cognizance on a complaint made by any person unless the person has given a notice of not less than sixty days, in the manner prescribed, of the alleged offense and of his intention to make a complaint, to the Central Government or the authority or officer authorized as aforesaid.

This provision carries serious repercussions in its fold. Firstly, the period of sixty days seems clearly inappropriate and undermines the strength of initiative taken by any public-spirited person or NGO. Secondly, the service of notice to the prescribed authorities gives the opportunity (i) for the violators to take restorative action and (ii) may be a breeding ground for corruption and collusion.

3.3. Indirect Regulatory Framework

In the Indirect Regulatory Framework, there are few provisions of general laws such as Indian Penal Code, 1860 (IPC); Criminal Procedure Code, 1973 (Cr.P.C) and Code of Civil Procedure, 1908 (CPC), Punjab Municipal Corporation Act, 1976 (PEMA), etc. which authorize the courts to expand the scope of provisions concerning public welfare, peace, tranquility, and remedies against nuisance to deal with the issue by way of legal fiction. The discussion on Indirect Regulatory Framework can be carried out as follows:

3.3.1. Indian Penal Code, 1860

Though IPC is pre-independence and colonial legislation, its relevance in modern times cannot be overlooked. Numerous instances can be seen wherein the scope of the enforceable provisions has been stretched by the use of legal fiction making the provisions relevant in contemporary times. Looking at the gist of chapter XIV titled ‘Of Offences Affecting the Public Safety, Convenience, Decency, and Morals’, the scope of the following provisions can be interpreted in a wider context to cover the entry of pharmaceuticals into the environment by improper disposal such as throwing it openly, or in open water, or any stream or river, etc. Any such kind of gesture or omission to dispose of the expired, discarded, or unused drugs may invoke application of these rules as such act or omission may result in the contamination of soil, groundwater, surface water, flora, and fauna, air, etc. The relevant provisions are as follows:

i. A person shall be guilty of public nuisance who does any act or is guilty of an illegal omission which causes common injury, danger, or annoyance to the public or to the people in general who dwell or occupy property in the vicinity, or which must necessarily cause injury, obstruction, danger, or annoyance to persons who may have occasion to use any public right.[25]
ii. Any negligent act likely to spread infection of any disease dangerous to life shall be punished with imprisonment of either description for a term which may extend to six months, or with fine, or with both.[26]
iii. Whoever voluntarily corrupts or fouls the water of any public spring or reservoir, so as to render it less fit for the purpose, for which it is ordinarily used, shall be punished with imprisonment of either description for a term which may extend to three months, or with fine which may extend to five hundred rupees, or with both.[27]
iv. Whoever voluntarily vitiates the atmosphere in any place so as to make it noxious to the health of persons in general dwelling or carrying on business in the neighborhood or passing along a public way, shall be punished with fine, which may extend to five hundred rupees.[28]

S.284 deals with negligent conduct concerning poisonous substances that may likely cause injury to any person and provides for either imprisonment for a term which may extend to six months or a maximum fine of one thousand rupees or both. Above all, S. 290 is like a residuary provision covering the kinds of nuisance not otherwise covered under preceding sections. It is followed by another penal provision in case of continuation of nuisance after injunction to discontinue.

3.3.2. Criminal Procedure Code, 1973

S.133 of Cr.P.C. empowers a District Magistrate or a Sub-Divisional Magistrate or any other Executive Magistrate, on receiving the report of a police officer or other information and on taking such evidence (if any) as he thinks fit considers, that any unlawful obstruction or nuisance should be removed from any public place or from any way, river, or channel which is or may be lawfully used by the public; he may order to remove such obstruction or nuisance in a time-bound manner. Basically, it deals with public nuisance, and it can be applied against manufacturers, retailers, or CBMWTF, HCF, clinical or nursing home or Municipal Corporation in case they deviate from the legitimate course of conduct regarding proper disposal of pharmaceutical waste.

3.3.3. Code of Civil Procedure, 1908

S. 91 of CPC provides a remedial instrument to issue an injunction to the wrongdoer in case his or her act affects the public or falls within the meaning of public nuisance. Such action may be initiated either by the Advocate General or by two or more persons with the leave of the Court.

3.3.4. The Punjab Municipal Corporation Act, 1976

There are few provisions of PMCA, 1976 which can be invoked to remedy improper disposal of expired or discarded medicine as it can be covered within the meaning of term ‘nuisance’ as defined under S. 2(31) of the Act. It provides as, ‘any act, omission, place, animal or thing which causes or is likely to cause injury, danger, annoyance or offense to the sense of sight, smell or hearing or disturbance to rest or sleep, or which is or may be dangerous to life or injurious to health or property.

The Act further imposes an obligation on the MC for reclamation of unhealthy localities and abate all nuisance under S. 44. Discharge of any chemical, refuse or waste, or any liquid of a temperature higher than forty-five-degree centigrade is also prohibited under S. 203.

The Municipal Commissioner has been placed under a duty under S. 278 to provide or appoint in proper and convenient situations, public receptacles, depots or places for the temporary deposit of rubbish, filth, and other polluted and obnoxious matter, to provide dustbins for the temporary deposit of rubbish, to provide covered vehicles or vessels or other suitable means for removal of rubbish and offensive matter. A corresponding duty has also been laid down under S. 279 on owners and occupiers to collect and deposit rubbish or polluted matter in the manner prescribed by the Commissioner. The owners have been prohibited to allow the accumulation of such obnoxious or polluting matter. The failure or contravention to comply with the above provisions may invoke penalties for individuals as well as companies.

As shown, PMCA provides some provisions prohibiting the discharge or disposal of pharmaceuticals in a way that would cause any adverse effects on the environment within the jurisdiction of corporations. For municipal councils and other small towns, there is a separate law namely Punjab Municipal Council Act, 1911 providing identical provisions to address this issue.

Status of Implementation

The level of implementation of the above laws can be explained as follows:

Considering expired or discarded medicines within the purview of BMW(M&H)R, the information provided by Punjab Pollution Control Board revealed that there are a total of five CBMWTFs in the State of Punjab. These CBMWTFs cover a radius of around 75 km for the collection of BMW in which expired or discarded medicines are also collected for proper disposal. The CBMWTFs are situated in five districts namely Pathankot, Amritsar, Ludhiana, Sri Mukatsar Sahib, and Mohali (also known as Sahibjada Ajit Singh Nagar).

There was a total of twenty-two districts at the time of data collection; the 23^rd district, Malerkotla, was declared in May 2021. The Punjab Pollution Control Board has earmarked the primary area of operation of these five CBMWTFs, which can be presented as follows:

District-wise Allotment to CBMWTF

SN	Name of CBMWTF	Primary Area	Secondary Area in case of inadequate services by primary area facility
1	M/s Rainbow Environments Pvt. Ltd. Mohali*	Mohali, Ropar, Fatehgarh Sahib, Nawansahar, Patiala and partial Jalandhar District	Ludhiana, Barnala and Bathinda
2	M/s Medicare Environmental Management Pvt. Ltd., Ludhiana*	Ludhiana,Sangrur, Barnala, Patiala.	Mohali, Ropar, Fatehgarh Sahib, Nawansahar, Hoshiarpur, Patiala and Sangrur
3	M/s Amritsar Enviro-care Pvt. Ltd. Amritsar	Amritsar, Tarntaran, Ferozpur, Kapurthala and partial Jalandhar District	Sri Mukatsar Sahib, Fazilka, Faridkot, Moga, Pathankot, Gurdaspur, Mansa
4	M/s BMW Treatment Plant Pvt. Ltd., Pathankot	Pathankot, Gurdaspur, Hoshiarpur and GT Road- Jalandhar- Pathankot	Amritsar and Tarntaran
5	M/s Med Waste Solutions Pvt. Ltd. Sri Mukatsar Sahib	Sri Mukatsar Sahib, Mansa, Fazilka, Faridkot, Moga, Bathinda and Mansa	Jalandhar, Ferozpur and Kapurthala

Source: Punjab Pollution Control Board, Patiala. Information Chart was prepared on 22.03.2019.

* Little changes as to the re-distribution of the area of Jalandhar and Patiala have been done in subsequent notification by the PPCB.

To obtain first-hand experience, on-spot visits were made at three CBMWTF sites, namely M/s BMW Solutions Pvt. Ltd, Sri Mukatsar Sahib, M/s Medicare Environmental Management Pvt. Ltd., Ludhiana and M/s Rainbow Environments Pvt. Ltd. SAS Nagar. Subsequently, due to restrictions on movement on account of the second wave of Covid, the other two authorized officials, M/s Amritsar Enviro- care System Pvt. Ltd. and M/s BMW Treatment Plant Pvt. Ltd., Pathankot, were interviewed online. The information gathered from these CBMWTFs can be presented as follows:

SN & Question	Mohali	Ludhiana	Amritsar	Pathankot	Sri Mukatsar Sahib
1. Whether your Site dispose of only BMW or expired or discarded medicines also?	Both	Both	Both	Both	Both
2. Since when (From which year), your Site has been made operational.	2004	2002	2004	2004	2019
3. Respective areas covered by your site.	As above	As above	As above	As above	As above
4. Method of Disposal of Bio-Medical Waste and Pharmaceuticals- expired and discarded drugs	Incinerator & autoclaving	Incinerator & autoclaving	Incinerator, autoclaving, Shredding, Chemical decomposition	Incinerator, autoclaving, Shredding, Chemical decomposition	Incinerator & autoclaving
5. Any Additional Efforts being made to dispose of Covid Waste	No, common procedure is adopted	No, common procedure is adopted	Separate Vehicle designated for Covid Waste and two hours in the evening for disposal of Covid Waste	No, common procedure is adopted	Separate Vehicle designated for Covid Waste and two hours in the evening for disposal of Covid Waste
6. Collection of Disposal	Daily	Daily	Daily	Daily	Daily
7. Number of Clientage	2044	3022	2007	1516	2027
8. Waste load in Tons (daily)	5- 5.5 Ton	3.25- 3.5 Ton	3 – 3.5Ton	1.25- 1.75 Ton	1.9 to 2.08 Ton
9. Level of Awareness in general public regarding disposal of expired or discarded medicines	Poor	Below average	Poor	Poor	Satisfactory, as people segregate expired and discarded drugs and Covid Waste also.
10. Do you collect expired or discarded medicines from Manufacturers, Wholesalers or Retailers or General Public.	No, only HFCs. But few vendors and manufacturers are accommodated once or twice a year on their needs.	No, only HFCs.	No, only HFCs.	No, only HFCs.	No, only HFCs.

The table depicts that these CBMWTFs are satisfactorily performing their jobs. To cross-check the information provided by these CBMWTFs, field visits were also conducted at a few of the HCFs registered as clients with these CBMWTFs. The nodal officers of the client HCFs endorsed these facts through their documentary records. Further, the SIs of various municipal bodies and waste disposal sites were also visited during the lockdown period with the purpose to collect information regarding the segregation of SW collected from domestic areas from medical waste, expired or discarded waste, and Covid Waste. The SIs shared frankly that after collection of SW from municipal areas, the Covid waste is separated and transported to all the respective five CBMWTFs. The ground staff took all precautions at the time of segregation of wastes.

So far as door-to-door collection of BMW, expired or discarded drugs, Covid waste is concerned, there are two models of transportation. Except for Bathinda, the CBMWTFs at other places designated a special vehicle for the collection of Covid waste from the Covid hospitals and quarantine centers. In Bathinda, the transport vehicles were the same, but each transport vehicle carried a black drum hanging backside of the tank for collecting biomedical and Covid waste from urban areas, HFC as well as quarantine centers.

In the context of any difficulties being faced by Facilities in running their operations properly, the representative of M/s Amritsar Enviro-care Pvt. Ltd. shared that, at the beginning of lockdown in 2020, health workers did not segregate BMW from plastic and other kinds of waste. Even the yellow bags carrying BMW from quarantine centers also carried empty plastic water bottles, packed boxes, or half-eaten fruits and were dispatched in the vehicles designated for collection of BMW. However, so far as the sensitization and awareness among the general masses are concerned, the government and municipal authority should take appropriate capacity-building measures for the general public to segregate unused, expired, or discarded medicines from domestic waste.

5.1. Conclusion

The utilization of legal mechanisms that provide remedies to the issue of pharmaceuticals entering the water, air, and soil is a progressive aspect of law. Laws and regulatory framework, though having some inherent defects as to afford active citizenry, is hardly brought into use by the stakeholders. Few studies have been conducted on the scientific aspects of the presence of pharmaceutical compounds in soil, surface water, groundwaters, etc. in the region while there are a total of 36 Universities (20 Public Funded + 16 Private), One All Indian Institute of Medical Sciences, Bathinda; One Punjab Institute of Medical Sciences, Jalandhar and One Health University namely Baba Farid University of Health Sciences, Faridkot. Various districts have state-of-the-art health infrastructure, but the level of people’s awareness about the ill effects of improper disposal of expired or discarded medicines is alarmingly low. To date, not a single case has been entertained at any level highlighting the problem of pharmaceuticals in the environment. The people despite being literate and well off are not sensitive enough to the gravity of the problem. They usually acknowledge that vultures have been extinguished from the area and there had been a long gap since they witnessed any vulture in the region. Nonetheless, they are unaware of the root cause. While the food chain is contaminated and empty bottles of syrups, vials, and packaging materials flow on rivers, few instances of their unrealistic and unscientific trends of using expired or discarded medicines for agriculture to kill insects were observed during the field visits. On the other hand, there are several instances in other states wherein the writ jurisdiction of higher judiciary under Articles 32 and 226 have been resorted to providing remedies in case of pollution by BMW and directions to the implementing mechanism for proper compliance of BMW.[29]

To sum up, there will be no question of availing the tools of legal remedies unless the people are made aware of their right to a clean and healthy environment and the threat posed to it by improper, illegal, and unlawful disposal of such waste. A substantial portion of the urban population throw away expired, unused, or discarded medicines in dustbins, which are ultimately collected by the transporting vehicles of agencies hired by Municipal Authorities. Here, it would not be out of place to record special efforts made by M/s Amritsar Enviro-Care Pvt. Ltd. which has designated a special vehicle for the collection of Covid waste from its jurisdiction and even earmarked separate timings for putting Covid waste into incinerators or autoclaving, etc.

5.2. Suggestive Measures for Effective Implementation of Regulatory Framework

The residues of BMWs accumulate in the MSW due to ground-level staff and end-users’ lack of awareness of their harm. This results in improper disposal of unused expired or discarded medicines which pose a threat to the right to a clean and healthy environment. Its long-term impacts are beyond imagination. It is high time to address the issue of pharmaceuticals in the environment with a multi-pronged strategy. The strategy should be based on the integration of law, science, and technology, as lawmaking alone will not be a solution to this problem. The technical aspects of the disposal of discarded medicines have to be tested based on the WHO guidelines. The issue must also be addressed with a holistic approach and proactive participation by state and non-state actors. With minor but significant amendments to BMW(M&H)R’s definition of ‘waste generator,’ the law can bring private individuals within the range of the rules; encourage civic participation through Grievance Redressal Mechanism; provision citizen suits for public-spirited individuals and NGOs; incentivize whistleblowers; require senior officials to organize mandatory training of municipal officials, outsource agencies’ staff to segregate and dispatch unused, expired or discarded medicines to the CBMWTF and mandatory display of information in public domain and website; proper budgeting arrangement for sensitization and awareness of the general public; and consistent awareness advertisements by Ministry of Health, Family Planning and Welfare through Television Channels, Radio and other instruments of Mass Media may play a significant role in addressing this evil.

Good urban governance warrants integration and vigorous participation of stakeholders covering the strong political will of elected representatives. It also warrants the commitment of public administration, urban local bodies, manufacturers, wholesalers, retailers involved in the supply chain, non-government organizations, social organizations, and the participation of citizens.

List of Abbreviations

BMW Bio-Medical Waste

BMW(M&H)R BMW (Management and Handling) Rules, 2016

CBMWTF Common BMW Facility/ies

⁰C Centigrade

Cl. Clause

CPC Code of Civil Procedure, 1908

Cr.P.C. Criminal Procedure Code, 1973

EPA Environment (Protection) Act, 1986

HCF Health Care Facility

IPC Indian Penal Code, 1860

NGO Non-Government Organization

PiE Pharmaceuticals in Environment

PMCA Punjab Municipal Corporation Act, 1976

S. Section

SI Sanitary Inspector

SoP Standard Operating Procedure

SS. Sections

SW Solid Waste

SWM Solid Waste Management

SWMR Solid Waste Management Rules, 2016

Tarun Arora serves as a Professor and Dean of School of Legal Studies at Central University of Punjab, India and is also associated with the United Nations Development Programme as an Expert on International Biodiversity Law and different statutory committiees/ Board of Studies of Law in Higher Educational Institutions (HEIs). His areas of expertise are Environmental Law, Constitutional Law, Jurisprudence, and Human Rights. http://cup.edu.in/Faculty_Profile_Webpages/Law/Prof_Tarun_Arora.pdf

References
[1] See Mark Crane et al., Chronic Aquatic Environmental Risks from Exposure to Human Pharmaceuticals, 367 Sci. Total Env’t 23–41 (2006); Klaus Kummerer, Pharmaceuticals in the Environment, 35(1) Ann. Rev. Env’t & Res. (2010); D. G. Joakim Larsson, Pollution from Drug Manufacturing: Review and Perspective, 369 Phil. Trans. Royal Soc’y London B Biological Sci. 1 (2014); Nordea Report, Impact of Pharmaceuticals Pollution on Communities and Environment in India 1 (2016).

[2] See generally Kumari Shalini et al., A Review on Pharma Pollution, 2 Int’l J. Pharm Tech Rsch. 2265-70 (2010).

[3] Available at https://ntn.org.au/wp-content/uploads/2015/05/NTN-Pharmaceutical-Pollution-in-the-Environment-2015-05-1.pdf (last visited Nov. 26, 2016).

[4] See id.

[5] Royal Soc’y of Chemistry, Pharmaceuticals in the Environment (R. E. Hester & R. M. Harrison eds., 2016); See also Thomas Heberer, Occurrence, Fate, and Removal of Pharmaceutical Residues in the Aquatic Environment: A Review of Recent Research Data, Toxicology Letters (2002); Klaus Kummerer, Pharmaceuticals in the Environment: Sources, Fate, Effects, and Risks (Springer-Verlag, Berlin, Heidelberg ed., 3rd ed. 2008); Lial Tischler, Potential Contribution of Unused Medicines to Environmental Concentrations of Pharmaceuticals, Pharm. Rsch. & Mfrs. Am. (2007); Lial Tischler et. al., Landfill Disposal of Unused Medicines Reduces Surface Water Releases 9(1) Integr. Env’t ASST. Mgmt. (2012); Daniel J. Caldwell et. al., A Risk Based Tool to Manage Active Pharmaceutical Ingredients in Manufacturing Effluent, Env’t Toxicol. & Chemistry (2015) (under revision).

[6] Executive Agency for Health and Consumers, Final Report on Study on Environmental Risks of Medicinal Products (2013).

[7] See START, Project on Pharmaceuticals for Human Use: Options of Action for Reducing the Contamination of Water Bodies (2006).

[8] Jeff Donn et al., Health Facilities Flush Estimated 250m Pounds of Drugs a Year, USA Today (Sept. 14, 2008), https://usatoday30.usatoday.com/news/health/2008-09-14-drugs-flush-water_N.htm [https://perma.cc/H5PJ-4VSS].

[9]Supra note 3.

[10] See Stephen R. Hughes et al., Global Synthesis and Critical Evaluation of Pharmaceutical Data Sets Collected from River Systems, 47 Env’t Sci. Tech. (2012).

[11] Michael Stewart, Pharmaceutical Residues in the Auckland Estuarine Environment (Auckland Council ed., 2013). See also A. J. Watkinson et al., The Occurrence of Antibiotics in an Urban Watershed: From Wastewater to Drinking Water, 407 Sci. Total Env’t. (2009).

[12] Article 51-A (g), the Constitution of India.

[13] BMW(M&H)R, Sch. I (d).

[14] Ibid, Rule 4.

[15] Ibid. Rule 5.

[16] Ibid. Rule 18.

[17] SWMR, Rule 3(1) (17).

[18] Ibid, Rule 4(1).

[19] Ibid, Rule 4(2).

[20] Ibid, Rule 4(3).

[21] Ibid, Rule 4(4).

[22] Ibid, Rule 4(5).

[23] Ibid, Rule 4(6).

[24] Ibid, Rule 5(1).

[25] IPC, 1860- S. 268.

[26] Ibid, S. 269.

[27] Ibid, S. 277.

[28] Ibid, S. 278.

[29] Almitra Patel v. Union of India 1997 (6) SCALE 12 (SP); Almitra Patel v. Union of India1997 (6) SCALE 10 (SP) ; Almitra Patel v. Union of India 1997 (6) SCALE 11 (SP); Almitra Patel v. Union of India 1997 (6) SCALE 12 (SP); Almitra Patel v. Union of India AIR 1998 SC 993; Almitra Patel v. Union of India 1998 (4) SCALE 9 (SP); Almitra Patel v. Union of India 1999 (2) SCALE 685; Almitra Patel v. Union of India 1999 (5) SCALE 154; Almitra Patel v. Union of India 1999 (7) SCALE 1 & 2000 (2) SCC 166; Almitra Patel v. Union of India 2001 (1) SCALE 568; B.L. Wadehra v. Union of India AIR 1996 SC 2969.