SOURCES OF HAZARDS IN PHARMA
 Manufacturing and formulation installations.
 Handling and storage of hazardous chemicals including warehouses,
 godowns, tank forms in ports/fuel depots/docks.
 Transportation (road, rail, air, water, pipelines).
 Emission of pollutants – the air pollutants include carbon monoxide (CO),
 nitrogen dioxide (NO2), particulate matter of 10 microns or less (PM10),
 total suspended particulate matter (SPM), sulphur dioxide (SO2), and
 volatile organic compounds (VOCs). The most common VOCs include
 methanol, dichloromethane, toluene, ethylene glycol,
N,Ndimethylformamide ,and acetonitrile.
 Effluents, especially those that are not easily biodegradable and toxic in
 nature. The effluent releases could go directly to streams, rivers, lakes,
 oceans, or other bodies of water. The releases due to runoff, including
 storm water runoff, could also be a potential hazard.
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HAZARDOUS WASTE – TYPES
 these are in the form of liquids, solids, contained
 gases or sludge.
 This waste, containing spent solvents and other toxic organics in
significant concentrations, requires treatment before it can be
disposed of safely.
 The toxic releases from the pharmaceuticals industry includes
on-site discharge of a toxic chemical to the environment. This
includes emissions to the air, discharges to bodies of water,
releases at the facility to land, as well as contained disposal into
underground injection wells.
 Natural calamities like such as flood, cyclone, earthquake,
tsunami.
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VARIOUS TYPES OF PHARMACEUTICAL WASTE –CHEMICAL WASTE
 Organic chemical residues from manufacturing processes
 Heavy metals
 Dust during formulation
 Gaseous Vapours / emissions during API /Bulk drugs
 Chemical Spills
 Leakages – water , oils, solvents , chemicals ,
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EXAMPLES OF CHEMICAL WASTE
 Carcinogenic & other Chemicals used will explore every chances
of gaseous/ fumes for Aromatic Amines , Benzene derivatives
,Solvents like Acetonitrile , Acetic Acid , Toluene, Methanol .
 All are very hazardous for Environment & Occupation .
 Needs Control measures especially in terms of EMS i.e.
Environment Management System ( ISO 14001) and OHSAS –
18001 .
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MOST COMMON ENVIRONMENT HAZARDS BY
PHARMA FIRM
 The hazards from the pharmaceuticals could be categorized as:
 Ecotoxic - damage is caused to the environment.
 Carcinogenic - contribute to the causation of cancer.
 Persistent - remain dangerous for a long time.
 Bio-accumulative – accumulates as it makes its way up the
food chain.
 Disastrous due to a catastrophe, mishap, calamity or grave
occurrence in any area.
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CONTD.
 Water Pollution – because of spillage , drains and generation of
effluent water , sewage water for uncontrolled pH , and treating
it ineffectively . MOST dangerous for aquatic living organisms or
their livelihood.
 Air Pollution – releases of gaseous , fumes , dust , particulates
to atmosphere , poor air quality ,
 Land /Soil Pollution – Spillage , chemicals , oils , lubricants
leakages to land /soil – seepage causation of non fertility to soil
/lands , dumping or disposal of incinerated sludge unauthorized
 Noise Pollution – persistent vibration in operating machines
, equipments , use of non acoustic power generators , air
compressors .
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CONTD.
 Odor :- spillage of blood , bio medical waste and culture burning
in autoclave etc -poor effect on ambient air quality , -leading to
mass air pollution and hazards to neighborhood – plants , trees,
human , animals etc .
 GLOBAL WARMING – CO2 Emission , CO , suspended
particulates in atmosphere , NOx , - very sensitive issue globally
now posing great threat of GLACIAL melting
 Heat Stress :- Uncontrolled work environment , high temp ,
exothermic reactions , use of solvents , - very dangerous
occupational hazard and also affecting ENVIRONMENT
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REGULATIONS AT NATIONAL LEVEL
 At National Level :FACTORY ACT 1948 Compliance
MoEF Environmental Clearance
Environment Protection Act 1986
Environmental Statements Submission to Pollution Boards – Form
V
Public Liability Act & Insurance 1991
MSDS for Hazardous materials and compliance
CCOE ( PESO ) License for classified solvent storage
Indian Electricity Act 1936 & rules
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CONTD.
 Disaster Management Act -2005
 Drugs & Cosmetic Act – 1940
 Indian Boiler Act 1923
 Hazardous Waste Management Act & Rules –
 The Petroleum Act – 1934 & Rules -2002
 The Explosives Act – 1884 & rules -1983
 Central Motor Vehicles Act for HW or Goods carrying -1989
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REGULATIONS AT STATE LEVEL
 Enforcement at STATE LEVEL : State Level Factory Rules -1963 and further amendments
 Pollution Control Board Consent To operate – a) WATER ACT
1974 , b) AIR ACT -1984
 Stack Monitoring Reports for emissions to Air
 Work Environment monitoring – Ventilation , Illumination ,Dust
& fumes
 Noise Monitoring
 Formation of SAFETY COMMITTEE as per 73 L
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CONTD.
 Hazardous Waste Disposal Records (manifest)
 Petroleum products storage on site – type ,storage , and License
– class A solvents , Class B chemicals , HSD , LPG stock etc
 Fire Hydrant system & FIRE NOC
 Trained FIRST AIDERS
 EPR & ERT – Emergency Preparedness & Response , Emergency
Response Team
 OHC – Occupational Health Centre , with Visiting Doctor & Male
Nurse
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CONTD.
 Approved Licensed Contractors
 ESI of Employees /Contractors / Sub Contractors
 Mock Drills – announced / un announced for Emergency
Evacuation
 Safety Committee Meetings & MOM
 Safety & Environment Promotional Activities
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EXISTING GAPS & CONCERN
 Non compliance too many –
 Loose Controls on ETP , Casual Approach for ETP maintenance
and Treatment
 Air Pollution – No proper designing of scrubbers , venturies
 Storm water and drain water common outlets , effluent load
problems
 Unskilled contract workers
 Lack of SOP and training needs
 Staff / workforce in adequate
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CONTD.
 Lack of Preventive maintenance activities - Break downs ,
emissions , leakages –air , water pollution
 Over capacity utilization of production schedules – system
failure , leading to Air /Water /Land pollution
 Old equipments – Poor Efficiency , trouble shooting ,
 Poor electrical safety – negligence to earthing , fire hazard
 Spillages , leakages of chemicals , oils , lubricants – water
pollution , air pollution , ambience pollution
 Gaseous emissions to atmosphere in night time high – Air
Pollution , poor ambience , plants
 Use of Non Acoustic D G sets - noise pollution , air pollution
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GAPS /CONCERNS FOR LEGAL
 Non adherence to PCB consent norms – diluted standards
 Erratic Behavior on SAFETY measures
 Spillages , leakages –ignorance and poor maintenance cause for
depletion of natural resources like water , power , forest ,
ozone layer depletion etc.
 Non compliance of Annual Environment Returns – forged /
manipulations in statement
 Lack of Safety Standards .
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MANAGING WASTE COMING OUT FORM PHARMA
FIRMS
 Impact of Waste – from Pharma Firms
 Air Pollution – 50 % of firms hazardous waste is wrongly
handled , not as per MSDS requirements leading to spillage ,
open to evaporation , unclean dust collectors , inefficient
scrubbers , use of scrubber absorption media for a long period .
 Water Pollution :- Adverse functioning of ETP , lack of
monitoring ETP by qualified personnel – leading to profuse
water pollution , discharged to CETP with extra allowance , non
standard use ETP material – in filtration , aeration ,
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CONTD. Spillage , Leakage , emissions , fumes , vapors direct impact on
work place monitoring and AIR Quality .
 Excessive wastages from R M , storage packing material
consumptions ,resulting in to natural and other source
depletions
 Land fertility problems due to waste dumping
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COMMONLY APPLIED SYSTEMS (DO’S & DON’TS )
 Most of the organization switching to water based / enzyme based
products – API / formulations – improved Environment Controls for
emissions, air quality and water pollution , optimize the process
conditions
 Organizations adapting to ISO -14001 – EMS for continual improvement
 Work place environment and ambience improvements with designed
Aspect /Impact controls , Waste minimization by improving material
consumptions.
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CONTD : Even establishing OHSAS culture for Behavioral
safety
 Internal audits / self inspection to ensure
conformance
 Training to employees / contractors
 Lock out /Tag Out Electrical system applied
 Work Permit systems
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 GMP system – Process Approach , validation,
compliance
 Environment Controls during manufacturing ,
maintenance , storage , transportation , handling .
 MSDS for base line requirements
 Documentation and records of H W collection and
disposal monitoring
 Improve on Technology
 Training of employees , contractors
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 Start Up / Shut Down procedures is must for better
environment Controls
 Improve on Engineering Controls to mitigate aspect
/impacts also unsafe conditions and unsafe acts
 Controls on interfaces of process
 Establish EHS policy and communicate to all
employees , contractors , visitors
 Provide primary , secondary containments at
spillages /leakages to arrest impact on environment
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 Haste ,
 Overloading of equipments
 Small spills , leaks - ignorance
 Use of excessive materials – R M , Packing etc .
 short cuts , process bypasses
 Critical process – untrained persons
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GOOD PRACTICES
 Training to employees / contractors
 Documentation
 Recording
 Self Inspections /Audits
 Display of various Environment educative posters
 Tool Box Talks at shop floors
 Adoption of GMP
 Consider ISO -14001 –EMS for continual
improvement
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ROLE OF KEY ACTORS IN MANAGING THE
WASTE COMING OUT PHARMA INDUSTRIES
 Government (national and state levels)
Making Policies & Establish
Refreshing the changes / amendments in policies , directives
through Web , Media and Updating the MoEF Consents
Survey of Industrial areas though PCB , DISH
Creation of CETP or Enviro Collection centers in Industrial
outlets
Air Monitoring at Industries
Work Place Environment monitoring
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CONTD. Central & State Pollution Control Boards
 Independent , Full Time MEMBER SECRETARY at PCB
Apex level of IAS grade .
 Creation of Regional PCB at all District level to ease
out local issues
 Public Liability Insurance Act 1991 made mandatory
for off site emergency
 Central Hazardous waste collection areas ear marked
by PCB to avoid unauthorized and suspicious
dumping
 Provision of CETP
 Industrial frequent visits and follow up on critical
env.issues
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CONTD, Violation memos to trouble shooter industries
 Show cause Notices on major violation of EPA 1986
act
 Shut down of major problematic Industries
 Mandatory to file /submit quarterly hazardous waste
statement to PCB
 In line WEB access to all industries by PCB for ease of
submission and monitoring by them .
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DRUG CONTROLLER
NATIONAL & STATE LEVEL
 Responsible for Drug & Cosmetic act enactment in
pharma industries.
 Empowered by Ministry of Chemicals for effective
implementation of Drug & Cosmetic act in totality
 Sampling of vehicles and industries for controls
taken on hazardous waste generation and it’s
disposal
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PHARMACEUTICAL ASSOCIATIONS
CHEMIST ASSOCIATIONS
 Interactions , dialogues with local industrial for their
problem
 Arranging work shops / seminars through
associations to diffuse the gravity situations and joint
forums to mitigate issues of hazardous waste
 Making presentation to Drug Authorities for facts and
getting their help in disposal of hazardous waste like
creation of authorized dumping outlets,
 Creation of CETP or Enviro care centers through
follow up with Regulatory authorities and standardize
practices
 Helping to small scale industries through Training
and awareness for acquainting to Pollution
/Environment Controls
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MEDICAL REPRESENTATIVE ASSOCIATION
CONSUMERS/CITIZENS GROUPS
 Main role by these group is expected through
campaigning for hazardous waste generation by
consumers through blisters , primary secondary
packing material coming out of drug usage
 This group to educate hospitals , nursing staff ,
dispensary staff for impact of packing material in
Environment
 Hazards of handling such waste while as an end user
 It is expected also by this group to share feedback
from customers- direct/ indirect agencies to pharma
company so that there will be further improvement to
mitigate on issues of hazardous waste by technology
developments and less impact on environment
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END OF SESSION
THANKS
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