Introduction to key environmental aspects of pharmaceutical industry in India

Faculty :- Mr Shridhar Rajpurohit – LA (IMS )/ TUTOR /SAFETY

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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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Do’s

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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Do’s

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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Don’ts

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 ASSOCIATIONCONSUMERS/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