Disaster Management in Pharmaceuticals Industry:

Some First Ideas

March 27, 2009

German Technical CooperationIndo-German Environment Programme

Presentation at the National Seminar on “Hazard Management

in Pharmaceuticals Industry” organised by

the Department of Pharmaceuticals,

Ministry of Chemicals & Fertilisers, GoIndia

Pharmaceuticals Industry in India (1)

10,563 pharmaunits in India;

77.4% formulation, 22.6% mfg.

Figures as of 2007

» Manufacturing medical and biological products» Processing botanical drugs and herbs » Isolating active medical principles;» Manufacturing pharmaceutical products intended for internal and external consumption in

such forms as tablets, capsules, ointments, powders and solutions

» Industry site: A site owned and operated by a single

company. All the activities on the site are conducted directly by

this company or are carried out by third parties exclusively for

the company.

» Chemical park: A site accommodating several chemical

companies which are legally separate entities. The

infrastructure and a variable range of services are provided by

the largest chemical company on the site (the major user) or by

one (or more) independent infrastructure companies.

» Industrial park: Similar to the chemical park, but is (also or

more heavily) used by companies from other sectors.

Pharmaceuticals Industry in India (2)

Hazard Categories in Pharmaceuticals Industry

» 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.

Sources of Hazards in Pharmaceuticals Industry (1)

» 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,N-

Dimethylformamide, and acetonitrile.

» Effluents - 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.

Sources of Hazards in Pharmaceuticals Industry (2)

» Hazardous wastes – these are in the form of liquids, solids,

contained gases or sludges. As a general measure, about 200kg

of waste is generated per metric ton of active ingredient

manufactured by the pharmaceutical industry. This waste,

containing spent solvents and other toxic organics in significant

concentrations, requires treatment before it can be disposed off

safely.

» Toxic releases - these include on-site discharge of a toxic

chemical to the environment including emissions to the air,

discharges to bodies of water, releases at the facility to land, as

well as contained disposal into underground injection wells.

» Use of a hazardous technology.

» Natural hazard events such as flood, cyclone, earthquake,

tsunami.

“Disaster" means a catastrophe, mishap, calamity or grave occurrence in any

area, arising from natural or man made causes, or by accident or negligence

which results in substantial loss of life or human suffering or damage to, and

destruction of, property, or damage to, or degradation of, environment, and is

of such a nature or magnitude as to be beyond the coping capacity of the

community of the affected area.

“Disaster Management" means a continuous and integrated process of

planning, organising, coordinating and implementing measures which are

necessary or expedient for:

- Prevention of danger or threat of any disaster

- Mitigation or reduction of risk of any disaster or its severity or consequences

- Capacity-building;

- Preparedness to deal with any disaster

- Prompt response to any threatening disaster situation or disaster

- Assessing the severity or magnitude of effects of any disaster

- Evacuation, rescue and relief

-Rehabilitation and reconstruction

Picture Source: National Disaster Management Authority

What is Disaster ?

Picture Source: National Disaster Management Authority

» Hazards pose risks to the people in the neighbourhood, to the living

organisms and to the environment and to the environmental resources.

» Risks of hazards depend on the severity and likelihood of the event.

Impact of a Chemical Disaster

Source: National Disaster Management Authority

Institutional Framework for Disaster Management

Ministry of Chemicals & Fertilizers is part of the institutional framework for disaster management

Some Relevant Acts, Rules (1)

» Manufacture, Storage and Import of Hazardous Chemicals Rules,

1989 (The Environment Protection Act, 1986)

Identify whether the chemicals handled, used and stored or

imported are covered in the Schedule 1 and/or 3 of the Rules,

Schedule 2 for isolated storages.

Occupier (industry) to submit a safety audit update report once a

year and forwarding a copy within 30 days.

Occupier to prepare up-to-date on-site emergency plan before

commencing a new industrial activity involving specified chemicals.

Occupier shall conduct a mock drill of emergency plan every six

months and submit a report.

» The Public Liability Insurance Act, 1991

Owner to provide relief in case of death or injury or damage to

property from an accident on the principle of no fault.

Owner to draw insurance policies more than the paid-up capital but

less than Rs. 50 Crores.

The Chemical Accidents (Emergency Planning, Preparedness, And

Response) Rules, 1996 [The Environment Protection Act, 1986]

» Central Crisis Group shall be tile apex body to deal with major chemical

accidents and to provide expert guidance for handling major chemical

accidents. Meet once in six months.

» State Crisis Group shall be the apex body in the State to deal with major

chemical accidents and to provide expert guidance for handling major

chemical accidents. Meet once in 3 months.

» District Crisis Group shall be the apex body in the district to deal with

major chemical accidents and to provide expert guidance for handling

chemical accidents. Meet once in 45 days.

» Local Crisis Group shall be the body in the industrial pocket to deal with

chemical accidents and coordinate efforts in planning, preparedness and

mitigation of a chemical accident. Meet every month.

Some Relevant Acts, Rules (2)

Functions of Local Crisis Group

» Prepare local emergency plan for the

industrial pocket,

» Ensure dovetailing of the local

emergency plan with the district off-site

emergency plan.

» Train personnel involved in chemical

accident management.

» Educate the population likely to be

affected in a chemical accident about the

remedies and existing preparedness in

the area.

» Conduct at least one full scale mock-drill

of a chemical accident at a site every six

months forward a report to the District

Crisis Group.

» Respond to all public inquiries on the

subject.

»Sub-divisional magistrate» Inspector of Factories» Industries in the industrial

area»Transporters of hazardous

chemicals»Fire officer»SHO (police)»BDO»Rep of Civil Defence»Primary Health Officer»Editor of local News Paper»Community

leader/Sarpanch/Village Pradhan

»Rep. of NGO»Two eminent doctors»Two social workers

Some Relevant Acts, Rules (3)

Disaster Management Act, 2005

» National Disaster Management Authority - lays down the policies, plans

and guidelines for disaster management for ensuring timely and effective

response to disaster.

» State Disaster Management Authority - lays down policies and plans for

disaster management in the State.

» District Disaster Management Authority - acts as the district planning,

coordinating and implementing body for disaster management in the

district in accordance with the guidelines laid down by the National

Authority and the State Authority.

» “Local Authority" includes panchayati raj institutions, municipalities, a

district board, cantonment board, town planning authority or Zila Parishad

etc. for rendering essential services or, with the control and management

of civic services, within a specified local area.

Some Relevant Acts, Rules (4)

Ministries or Departments of GoIto prepare Disaster Management Plans

(as per Disaster Management Act)

» Specify measures to be taken for prevention and mitigation of

disasters in accordance with the National Plan.

» Specifications regarding integration of mitigation measures in its

development plans in accordance with the guidelines of the National

Authority and the National Executive Committee.

» Specify its roles and responsibilities in relation to preparedness

and capacity-building to deal with any threatening disaster situation or

disaster.

» Specify roles and responsibilities in regard to promptly and

effectively responding to any threatening disaster situation or

disaster.

Ministries or Departments of GoIto prepare Disaster Management Plans

(as per Disaster Management Act)

» Specify present status of its preparedness to perform the roles and

responsibilities on above.

» Specify the measures required to be taken in order to enable it to

perform its responsibilities specified above.

» Update annually the plan referred above and forward a copy of the

plan to the Central Government, which Government shall forward a

copy thereof to the National Disaster Management Authority for its

approval.

First Ideas for Pharmaceuticals Sector

» On-site plans for hazard/disaster preparedness/management

systems needed at the industry level, at the industry park level

» Off-site plans required around the industry/industrial park covering

the neighbourhood.

» SMEs may beneficially integrate their own disaster/hazard

management systems with the Industry Park level hazard/disaster

management systems for sharing of equipment, facilities, personnel

etc.

» Very less hazardous Industrial/Chemical Parks may possibly rely

partially/ completely on the emergency services of a nearby

chemical park.

NDMA

CCG

SDMA, DDMA

SCG, DCG

LCG

Disaster Management Team/Cell

(at Industry Park

level – shared emergency services)

National Response

Team

Disaster Management Team/Cell

(at industry level)

Industry level – onsite disaster management plans, Neighborhood – Offsite disaster

management plans; District level – District disaster management plans, State level - State Disaster Management Plans, National level – National Disaster Management Plans

Advantages of Industrial/Chemical Park Level Disaster Management

» Improved emergency response due to far shorter response times

and emergency services which know the disaster premises

perfectly.

» A resulting fall in the cost of fire protection equipment and

insurance premiums.

» The fact that the public emergency services only has to be called

out for major incidents – thereby drawing less public attention to

smaller incidents,

Next Steps (1)

» Managing hazards due to effluents, emission and hazardous

wastes: Could be handled by DoPharma through the environmental

management initiatives proposed to be taken up.

» Understanding DoPharma roles in hazard/disaster risk

management – Consultations with NDMA and the Central Crisis

Group(MoEF) to develop an overall strategy including the objectives,

results, processes, cooperation networks, steering structures and

learning & knowledge management.

» Preparation of Disaster Management Plans - Undertake preparation

of national/state/regional level Disaster Management Plan for

Pharmaceuticals Sector in India (through GTZ TC with national and

international experts).

Next Steps (2)

» Demonstrate pilot efforts - in a State/region and selected

Industrial Parks/Areas including setting up of disaster

management teams.

» Development of guidelines for Chemical Disaster Management

(CDM) in Pharmaceuticals Sector (Chemical Park level, industry

level).

» Capacity building (training/capacity development needs

assessment, plan preparation with strategy for implementation)

Thank You