Prof. (Dr.) Prashant MehtaM.Sc, Ph.D. (Chemistry), MBA, Ph.D. (Management)

National Law University, Jodhpur

DECODING THE INDIAN HEALTHCARE SYSTEM Bio-medical Waste Trail

• Residential

• Commercial

• Institutional

• Construction Waste

• Municipal services

• Treatment plant sites

• Industrial

• Agricultural

• Healthcare Waste

Municipal Solid Waste (MSW)

Industrial Solid Waste

Bio-Medical / Hospital Waste

Agricultural Waste

Classification Bio-Medical Waste

Hospital Wastes

Non Hazardous Wastes

Hazardous Wastes

Radioactive and Cytotoxic

Wastes

Infectious Wastes

Sharps Non Sharps

Solids

IncinerableNon Incinerable

(Autoclave, Microwave)

Liquids

Non Infectious Wastes

Bio-DegradableNon

Biodegradable

Regulatory Framework: India

Environmental Protection Rules, 1986 - This regulations were drawn up by the government under the powersconferred on it in terms of the Environment Protection Act, 1986.

1. The Municipal Solid Wastes (Management and Handling) Rules 1999

2. The Hazardous Waste (Management and Handling) Rules, 1989

3. The Plastics (Manufacture, Usage and Waste Management Rules), 2009

4. The E-Waste (Management and Handling Rules), 2010

5. National Rural Health Mission (NRHM) under Ministry of Health and Family Welfare, in 2007 developed andadopted an Infection Management Environment Plan (IMEP) which outlines a comprehensive framework forimplementation of infection control measures and effective healthcare waste management generated byhealthcare facilities.

6. The issue of Bio-Medical Waste Management (BMWM) in India has attracted the attention of the highest judicialbody at the level of Supreme Court of India.

7. It has issued instructions regarding management of Bio-Medical Waste and Government of India was one of thefirst countries to frame and implement Bio-Medical Waste Management and Handling Rules, 1998 (lateramended in 2000 and 2003) in the exercise of power conferred by Sections 6, 8, and 25 of the Environment(Protection) Act, 1986.

Bio-Medical Waste Management and Handling Rules

• Definition of biomedical waste - Any waste that is generated during the diagnosis, treatment, or immunization of human beings or animals, or in research activitiespertaining to or in the production or testing of biologicals.

• Application of the Biomedical Waste Rules - The rules apply to all persons who generate, collect, receive, store, transport, treat, dispose, or handle BMW’s in any form.

• Duty of occupier (operator) - of a healthcare facility (hospital, nursing home, clinic, dispensary, veterinary institution, animal house, pathological laboratory, blood banketc) to ensure that BMWs are handled without any adverse effect to human health and the environment, and according to the prescribed treatment and disposalrequirements as per the Biomedical Waste Rules.

• Prescribed authority - State Pollution Control Boards (SPCBs) in States and Pollution Control Committees in territories are responsible for permitting and enforcing therequirements of the Biomedical Waste Rules.

• Permit - Each occupier (operator) handling BMW’s and providing services to 1,000 or more patients per month is required to obtain a permit from the prescribedauthority.

• Recordkeeping - Each occupier (operator) is required to maintain records on the generation, collection, reception, storage, transportation, treatment, and disposal ofBMWs. All records are subject to inspection and verification by the prescribed authority at any time.

• Accident reporting - Each occupier (operator) is required to report any accident related to the management of BMW’s.

• Annual reporting - Each occupier is required to submit an annual report to the prescribed authority to provide information about categories and amounts of wastesgenerated and treated, and modes of treatment used.

• Common disposal/ Incineration sites - Local public entities are required to provide common disposal / incineration sites, and the occupiers (operators) of such sites arerequired to comply with the Biomedical Waste Rules.

• Segregation, Packaging, Transportation, and Storage - BMWs are not to be mixed with other waste. According to the Rules, BMWs are to be segregated into labelledbags/containers. Transportation of BMWs is to be conducted in authorized vehicles. No untreated waste is to be stored more than 48 hours, unless special permission isobtained from the regulatory authorities.

• Standards - Technology and discharge standards for incineration, autoclaving, microwaving, liquid waste discharges, and deep burial are prescribed in the BiomedicalWaste Rules.

Categories and Segregation of Bio-Medical Waste

S. No. Bio-Medical Waste Categories Container Colour Treatment and Disposal

1. Human anatomical waste Yellow Incineration / Deep Burial

2. Animal Waste Yellow Incineration / Deep Burial

3. Microbiology and biotechnology waste (infectious

wastes from laboratory)

Yellow / Red Incineration / Autoclaving / Microwaving

4. Waste sharps (for example, needles, syringe,

scalpels)

Blue / White /

Translucent

Disinfection / Mutilation / Autoclaving / Microwaving

5. Discarded medicines and cytotoxic drugs Black Incineration/Destruction and Secure Landfilling

6. Soiled waste (items contaminated with blood or

body fluids such as cotton dressings, beddings)

Yellow / Red Incineration / Autoclaving / Microwaving

7. Solid waste (for example, tubing, catheters,

intravenous sets)

Blue / White /

Translucent / Red

Disinfection by chemical treatment / Autoclaving / Microwaving

8. Liquid waste (from laboratory, washing, cleaning,

housekeeping, disinfecting)

- Disinfection by chemical treatment and discharge into drains

9. Incineration ash Black Municipal Landfilling

10. Chemical wastes Black Chemical treatment and discharge into drains for liquids, and

secured landfills for solids.

BMW Categories Draft - 2011 Amendments

BMWM RULES - 2011 BMWM RULES - 1998Every occupier generating BMW, irrespective of the quantum of wastes

comes under the BMW Rules and requires to obtain authorization.

Occupiers with more than 1000 beds required to obtain authorization.

Duties of the Operator are clearly listed Duties of Operator were absent

Categories of Biomedical Waste reduced to Eight. Category No. 8

(containing liquid waste generated from laboratory, cleaning, washing,

and disinfection activities) and Category No. 9 (containing incineration

ash) have been discarded.

Biomedical waste was divided in ten categories

Treatment and disposal of BMW made mandatory for all the Healthcare

Establishments.

Treatment and disposal of BMW made mandatory for all the Healthcare

Establishments with more than 1000 beds.

A format for annual report is appended with the Rules. Accident reporting

has been made mandatory.

There was no format for Annual Report

Form VI i.e. the report of the operator on HCEs not handing over the BMW

added to the Rules. It empowers the operator of CBMWTF to report

against the HCEs who are not carrying out proper segregation of their

wastes.

Form VI absent

Healthcare Waste and Examples

Types of Healthcare Wastes Examples

Communal or General healthcare waste (solidwastes that are not infectious, chemical, orradioactive)

Infectious waste (wastes suspected of

containing pathogens)

Anatomical waste

Sharps

Pharmaceutical waste

Genotoxic waste

Chemical waste

Heavy metal waste

Pressurized containers

Radioactive waste

Cardboard boxes, paper, food waste, plastic and glass bottles

Cultures, tissues, dressings, swabs, and other blood-soaked items; waste from isolation wards

Recognizable body parts, amputated organs, placenta, aborted foetuses

Needles, scalpels, knives, blades, broken glass

Expired or no longer needed medicines or pharmaceuticals

Wastes containing genotoxic drugs and chemicals (used in cancer therapy)

Laboratory reagents, film developer, solvents, expired or no longer needed disinfectants, and

organic chemical wastes (for example, formaldehyde, phenol-based cleaning solutions)

Batteries, broken thermometers, blood pressure gauges

Aerosol cans, gas cylinders (that is, anaesthetic gases such as nitrous oxide, halothane, enflurane,

and ethylene oxide; oxygen, compressed air)

Unused liquids from radiotherapy; waste materials from patients treated or tested with unsealed

radionuclides

Problems With Healthcare Wastes

• According to the Ministry of Environment and Forests (MoEF) gross generation of bio-medical wastes in India is4,05,702 kg/day of which only 2,91983 kg/day is disposed, which means that almost 28 percent of the bio-medical and hospital waste is left untreated and not disposed off.

• Extrapolating from past figures of number of beds and average quantity of waste generation at the rate of 1 to1.5 kg per bed per day, it is estimated that about 0.33 million tonnes of hospital waste is being generated peryear which is far less than waste generated by other developed countries.

• Almost 53.25 percent of healthcare establishments are in operations without the adequate authorization fromState Pollution Control Board (SPCB), and the waste generated from such facilities goes unaccounted / untreatedand is dumped without any treatment illegally.

• The waste generated by healthcare establishments by the process of rendering healthcare services, can behazardous, toxic, and even lethal due to the presence of pathogens in sufficient concentration or quantity thatcould result in rapid proliferation, transmission, and spreading of infectious, dangerous and fatal communicablediseases such as Hepatitis, HIV/AIDS, Cancer, and other blood borne diseases.

• During incineration, in most cases there is no proper filtering of emitted flue gases which pollutes the air causingillnesses to the nearby populations. Therefore institutionalizing effective healthcare waste management systemsin all healthcare facilities is a key prerequisite to improving efficiency and effectiveness of healthcare of people.

Waste Exposure Risk

• Until recent times, healthcare waste in India was not segregated before disposal to the dump site or incinerator.

• Infectious wastes containing potentially harmful micro-organisms can also infect hospital patients, healthcareemployees, and visitors to patients and rag pickers mostly women and children from the lowest socio-economicstrata, awareness of health risks in general is poor. .

• As a result many of them contract diseases from used needles, syringes, and other sharps present risks of injuryand infection (for example, hepatitis B and C, and HIV), other infected bio-medical waste.

• Chemical and pharmaceutical wastes may cause intoxication or injuries such as burns.

• Genotoxic wastes are hazardous and may have mutagenic, teratogenic or have carcinogenic properties.

• Radioactive sources may cause severe injuries to humans such as destruction of tissue. They then becomecarriers of great health risk to the general populace.

• WHO predicts that India is on the verge of having an HIV epidemic. Tuberculosis (TB) and HIV combined togetheris taking great toll on the human health and life. Hepatitis B and C infections are on the rise. Mortality due toHepatitis C has gone up significantly.

• Management of healthcare waste is very important for controlling diseases.

Major Challenges

• Indian healthcare establishments have pitiable operational strategies, absence of documentedwaste management and disposal policy, very poor budgetary support in the government runhospitals, private hospitals ignore the rules for monetary consideration, untrained ward attendants,and other supporting staff.

• There are no waste management committees at present in Indian hospitals which should essentiallybe consist of the head of the establishment, all the departmental heads, hospital superintendents,nursing superintendents, hospital engineers with a waste management officer along with anenvironmental control advisor and an infection control advisor.

• Insufficient support and guidance from regulatory agencies further complicates the problem ofwaste management. Regulations in the form of waste reduction and recycling targets, carbon creditearnings, development of minimum energy efficiency standards for equipments are necessary forprevention of pollution and reduction of environmental load on sustained basis.

• Adequate and requisite number of sanitary landfills is lacking in India.

• Resistance to change is often a barrier to implementation of new programmes.

Major Challenges

• It is the ethical, social responsibility, and duty of state, legislators, hospitals, healthcare professionals,and the general public to make sure that environmentally acceptable waste disposal techniques isintroduced and implemented effectively.

• At present we have good enactments of laws, but political will is lacking to enforce these laws.

• There is no forum for ordinary citizen to approach for compensation.

• The present system provides only one remedy, that is, to go to ordinary civil courts, which areoverburdened with heavy pendency, and it may take decades to get relief to compensate the losscaused by the medical wastes under the head of public nuisance.

• There is no effective tribunal like consumer forum to provide a speedy remedy for the personsinfected with disease by medical waste. The Environmental Tribunals have to be constituted.

• Training Development of safe and effective system of bio-medical waste management along withhandling protocols, detailed institutional plans, strict policies, appropriate training and feedbackprograms for all the healthcare workers is very important.

Conclusions: Waste Related

• Waste hierarchy as well as rules are not framed for all kinds categories of waste and Waste management effortsin India are not directed by a clear-cut policy.

• Medical wastes should be classified according to their source, typology, and risk factors associated with itshandling, storage, and ultimate disposal.

• The segregation of waste at source is the key step. Reduction, reuse, and recycling should be considered inproper perspectives.

• MoEF / Pollution Control Boards / States do not have a complete data about all the various kinds of waste beinggenerated in India, risks associated to health /environment, and instances of the polluter being held responsiblefor unsafe disposal were very few.

• Absence of adequate funds and trained manpower for waste management and handling activities, weakcompliance to laws, ineffective monitoring, and absence of a single body taking ownership of waste issues inIndia is burgeoning challenge.

• The challenge before us is to scientifically manage growing quantities of bio-medical waste that is untreated, ifwe really want to protect our environment and provide better health for community.

Recommendations: Caring For Billion+Health is not everything but everything else is nothing without health

• Development of Efficient Delivery Mechanism and Efficient Consumer Response

• Need for Balanced and Equitable Healthcare System at all levels

• Needed Government Initiatives: Taxation, Industry Status, Comprehensive Legislation, Eliminatingmultiple clearances, Licenses, Increase Public Finance Expenditure etc.

• Making Healthcare Affordable by Developing Alternative Methods of Financing

• Developing Sustainable Public Private Partnership

• Strong Focus on Research and Development Activities

• Mechanism to Tackle Regulatory Deficiency must be developed

• Extensive Use of Technology: Electronic Health Records, Database, Social Networking Sites etc.

• Develop Value Based Healthcare System

• Develop Healthcare and Bio-waste Awareness

• Waste Management and Disposal should be made mandatory at both urban and rural level

Comments

Snapshots – Scattered Wastes

Snapshots – Rag Picking

Snapshots – Mixed Wastes

Snapshots – Miscellaneous

Snapshots – Miscellaneous

Snapshots – Miscellaneous

ReferencesCORPORATE RESEARCH REPORTS:

• HEALTHCARE IN INDIA: A REPORT BY BOSTON ANALYTICS, JANUARY 2009• GLOBAL INFRASTRUCTURE: TREND MONITOR INDIAN HEALTHCARE EDITION: OUTLOOK 2009 –2013 BY

KPMG• STRATEGIES FOR PROVIDING EQUITABLE HEALTHCARE, BY ECS LIMITED, MARCH 2008• PHARMACEUTICAL OFFSHORING LANDSCAPE, ZINNOV MANAGEMENT CONSULTING, SEPTEMBER 2008• INDIAN PHARMACEUTICAL INDUSTRY ON COURSE OF GLOBALIZATION, DEUTSCHE BANK RESEARCH,

APRIL 2008• HEALTHCARE IN INDIA: EMERGINGMARKET REPORT 2007 BY: PRICEWATERHOUSE AND COOPERS (PWC)• HEALTHCARE OUTLOOK, TEN INDUSTRY TRENDS 2007, A QUARTERLY REPORT BY TECHNOPAK, FEBRUARY

07 / VOLUME 1• HEALTHCARE OUTLOOK, NEW PARADIGMS IN HEALTHCARE DELIVERY 2007, A QUARTERLY REPORT BY

TECHNOPAK, FEBRUARY 07 / VOLUME 2• HEALTHCARE OUTLOOK, TRENDS IN HEALTHCARE DESIGN 2007, A QUARTERLY REPORT BY TECHNOPAK,

FEBRUARY 07 / VOLUME 3• HEALTHCARE, MARKET OVERVIEW, INDIA BRAND EQUITY FOUNDATION (IBEF) OCTOBER 2007• OVERVIEW OF THE HEALTHCARE INDUSTRY IN INDIA, THE INDO ITALIAN CHAMBER OF COMMERCE AND

INDUSTRY, APRIL 2007• HEALTHCARE REPORT: BY ERNST & YOUNG, INDIAN BRAND EQUITY FOUNDATION (IBEF), 2006• BOOMING CLINICAL TRIAL MARKET IN INDIA: RNCOS REPORT, NOVEMBER 2007• DRAFT NATIONAL PHARMACEUTICALS POLICY, 2006, PART - A (CONTAINS ISSUES OTHER THAN

STATUTORY PRICE CONTROL), DEPARTMENT OF CHEMICALS AND PETROCHEMICALS, GOVERNMENT OFINDIA, DECEMBER 28, 2005

• HEALTH ATTAINMENTS AND DEMOGRAPHIC CONCERNS: NATIONAL HUMAN DEVELOPMENT REPORT,2001: CHAPTER 5

• THE STATE OF HUMAN DEVELOPMENT: NATIONAL HUMAN DEVELOPMENT REPORT, 2001: CHAPTER 1• HEALTHCARE IN INDIA, CARING FOR MORE THAN A BILLION: BY SRIVATHSAN APARAJITHAN Y, MATHUR

SHANTHI, MOUNIB EDGAR L., NAKHOODA FARHANA, PAI ADITYA AND BASKARAN LIBI, IBM INSTITUTEOF BUSINESS VALUE, IBM GLOBAL BUSINESS SERVICES

• CASE STUDY ON MANIPLE CURE & CARE: INDEGENEOUS CONCEPT THAT COMBINES HEALTHCARE ANDRETAIL IN A SINGLE FORMAT: BY PRICE WATER HOUSE AND COOPERS(PWC) AND DYNAMIC VERTICALSOLUTIONS

• INDIAN PHARMACEUTICAL INDUSTRY: ISSUES AND OPPORTUNITIES: RESEARCH AND MARKETS REPORT (http://www.researchandmarkets.com/reports/35229)

SUMMARIES:

• INADEQUATE REGULATIONS UNDERMINE INDIA'S HEALTHCARE: BY: MUDUR GANPATI: BMJ 2004;328;124- DOI:10.1136/BMJ.328.7432.124-A

• HEALTH CARE IN INDIA: LEARNING FROM EXPERIENCE: BY THEWORLD BANK GROUP• HEALTHCARE INDICATORS: BY MS. MUKHERJI SRIMOTI, COMMERCIAL SPECIALIST, THE U.S.

COMMERCIAL SERVICE IN INDIA, THE AMERICAN CENTER, NEW DELHI• INDIA’S NATIONAL HEALTH SYSTEM PROFILE:WHO• OPPORTUNITIES IN HEALTHCARE: “DESTINATION INDIA”: FICCI AND ERNST & YOUNG.• RURAL HEALTH CARE SYSTEM: THE STRUCTURE AND CURRENT SCENARIO• INTRODUCTION TO NURSING AND HEALTH CARE DELIVERY SYSTEM IN INDIA• A POLICY FRAMEWORK FOR REFORMS IN HEALTH CARE, PERSPECTIVES ON HEALTH CARE IN INDIA: BY

PRIMEMINISTER’S COUNCIL ON TRADE AND INDUSTRY• FAILURE OF PUBLIC HEALTHCARE SYSTEM: CJ: BY SINGH CHANDRA SHEKAR, FEBURARY, 2008• FINANCING THE HEALTH CARE SECTOR IN INDIA: BLOG BY DR SINGH HARMEET, MBA (BIRMINGHAM)• IN CHINA, INDIA, HEALTH CARE BURDEN SHIFTS TO POOR, GROUND-LEVEL IMPLEMENTATION 'IS SIMPLY

NOT THERE': BY POWELL ALVIN, HARVARD NEWS OFFICE• STRENGTHEN THE INDIAN HEALTHCARE INDUSTRY (RECOMMENDATIONS): MODE 1 GATS REPORT INDIA

PAGE 83, 84• ROLE OF PRIVATE SECTOR IN HEALTH CARE IN INDIA CHALLENGES, OPPORTUNITIES & STARTEGIES: BY

LATH G K, CEO, APOLLO HOSPITAL BILASPUR, MP• UNHEALTHY PRESCRIPTIONS: THE NEED FOR HEALTH SECTOR REFORM IN INDIA: BY SUNIL NANDRAJ,

INFORMING REFORMING, THE NEWSLETTER OF THE INTERNATIONAL CLEARING HOUSE OF HEALTHSYSTEM REFORM INITIATIVES ICHSRI, APRIL-JUNE 1997, PP. 7-11.

• MEDICAL TOURISM IN INDIA: ISSUES AND CHALLENGES: BY CHACKO PHEBA, THE ICFAI UNIVERSITYPRESS.

• HEALTH INSURANCE IN INDIA: OPPORTUNITIES, CHALLENGES AND CONCERNS: BY MAVALANKAR DILEEPAND BHAT RAMESH, IIM AHMEDABAD

• INDIA BRAND EQUITY FOUNDATION (IBEF), MARCH 2013, AUGUST 2013 REPORT (WWW.IBEF.ORG)• HEALTHCARE INDIA SECTOR NOTES, MAY 2014, (WWW.IIMJOBS.COM)• INDIAN HEALTHCARE SYSTEM – OVERVIEW AND QUALITY IMPROVEMENTS, DIRECT RESPONSE, 2013:04,

SWEDISH AGENCY FOR GROWTH POLICY ANALYSIS , WWW.GROWTHANALYSIS.SE• INDIAN PHARMA, INC.: CAPITALIZING ON INDIA’S GROWTH POTENTIAL, www.pwc.com/India• INDIAN PHARMA INC. CARING FUP OR NEXT LELVEL OF GROWTH, www.pwc.com/India

ReferencesWebsites:

• www.technopak.com• www.kpmg.com/infrastructure• www.ibef.org• www.dbresearch.com• www.dynamicverticals.com• www.bostonanalytics.com• www.ibm.com/healthcare/hc2015• www.pwc.com/globalhealthcare• www.wikepedia.com/healthcare• www.ficci.com• www.timeswellness.com• www.fortishealthworld.com• www.whoindia.org• www.who.int• www.mohfw.nic.in• www.crisil.com• www.pharmabiz.com• www.pharma.org

Journals

• JOURNAL OF THE ACADEMY OF HOSPITAL ADMINISTRATION• INDIAN JOURNAL FOR THE PRACTICING DOCTOR• JOURNAL OF HEALTHCARE AND MEDICAL TECHNOLOGY AND MANAGEMENT• INDIAN JOURNAL OF MEDICAL ETHICS• THE PHARMA REVIEW AND PHARMA TIMES• JOURNAL OF HOSPITAL PHARMACY

Other Publications:

• MINISTRY OF HEALTH, GOVERNMENT OF INDIA• INDIAN MEDICAL COUNCIL & INDIAN DENTAL COUNCIL• EXPRESS HEALTHCARE MANAGEMENT• INDIAN HEALTHCARE FEDERATION• MEDICA: PHARMACEUTICAL INDUSTRY PUBLICATIONS• MEDICA: HEALTHCARE SERVICES PUBLICATIONS

Chapters:

• COMPETITION CONCERNS: THE PHARMACEUTICAL INDUSTRY BY CUTS INTERNATIONAL• CHAPTER 10: DRUG PRICE DIFFERENTIALS ACROSS DIFFERENT RETAIL MARKET SETTINGS: AN ANALYSIS

OF RETAIL PRICES OF 12 COMMONLY USED DRUGS: BY GODWIN S K AND VARATHARAJAN D., HEALTHADMINISTRATOR VOL: XIX NUMBER 1: 41-47

• HEALTHCARE POLICY AND ADMINISTRATION IN INDIA: BY SAPRU R K, STERLING PUBLICATION, IIEDITION, CHAPTER 15, PAGES 228-249.

My Books:

• Indian Health Sector and Healthcare System: A critical Insight, LAP Lambert Academic Publishing,Germany, 2012, ISBN-10: 3659268895, ISBN-13: 978-3659268892, Prashant Mehta

• Indian Retail Analytics: An In-depth Study of Indian Retail Market, its Dimensions, Opportunities,Problems, and Prospects, LAP Lambert Academic Publishing, Germany, 2012, ISBN-10: 3659147303,ISBN-13: 978-3659147302 PrashantMehta

My Publications:

• Legal Provisions and Management Perspectives of Biomedical and Hospital Waste in India. JournalClub for Management Studies (JCMS),1(II), 11-36 (2014).Dr. Prashant Mehta. ISSN No : 2394 - 3033, V –1, I – 2, 2014

• Biomedical Waste Disposal: Indian Perspective: Scholasticus, Journal of National Law University,Jodhpur Vol. 5 No. 1, September 2007, Prashant Mehta, ISBN: 0975-1157, Indexed